Pamidronate Disodium
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Questions & Answers
Side Effects & Adverse Reactions
Bisphosphonates, including pamidronate disodium, have been associated with renal toxicity manifested as deterioration of renal function and potential renal failure.
DUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG (see DOSAGE AND ADMINISTRATION for appropriate infusion durations). Renal deterioration, progression to renal failure, and dialysis have been reported in patients after the initial or a single dose of pamidronate disodium.
Focal segmental glomerulosclerosis (including the collapsing variant) with or without nephrotic syndrome, which may lead to renal failure, has been reported in pamidronate disodium–treated patients, particularly in the setting of multiple myeloma and breast cancer. Some of these patients had gradual improvement in renal status after pamidronate disodium was discontinued.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Patients treated with pamidronate disodium for bone metastases should have the dose withheld if renal function has deteriorated. (See DOSAGE AND ADMINISTRATION.)
PREGNANCY: PAMIDRONATE DISODIUM SHOULD NOT BE USED DURING PREGNANCY
Pamidronate disodium may cause fetal harm when administered to a pregnant woman. (See PRECAUTIONS, Pregnancy Category D.)
There are no studies in pregnant women using pamidronate disodium. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
Studies conducted in young rats have reported the disruption of dental dentine formation following single- and multi-dose administration of bisphosphonates. The clinical significance of these findings is unknown.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. Patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). Patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. Diuretic therapy should not be employed prior to correction of hypovolemia. The safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established.
Pamidronate disodium is indicated for the treatment of patients with moderate to severe Paget’s disease of bone. The effectiveness of pamidronate disodium was demonstrated primarily in patients with serum alkaline phosphatase ≥3 times the upper limit of normal. Pamidronate disodium therapy in patients with Paget’s disease has been effective in reducing serum alkaline phosphatase and urinary hydroxyproline levels by ≥50% in at least 50% of patients, and by ≥30% in at least 80% of patients. Pamidronate disodium therapy has also been effective in reducing these biochemical markers in patients with Paget’s disease who failed to respond, or no longer responded to other treatments.
Pamidronate disodium is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma. The pamidronate disodium treatment effect appeared to be smaller in the study of breast cancer patients receiving hormonal therapy than in the study of those receiving chemotherapy, however, overall evidence of clinical benefit has been demonstrated (see CLINICAL PHARMACOLOGY,Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma, Clinical Trials section).
History
There is currently no drug history available for this drug.
Other Information
Pamidronate Disodium is a sterile bone-resorption inhibitor available in 30 mg and 90 mg vials for intravenous administration. The pamidronate disodium obtained by combining pamidronic acid and sodium hydroxide is provided in a sterile, ready to use solution for injection. Each mL of the 30 mg vial contains, 3 mg Pamidronate Disodium, 47 mg Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric acid to adjust pH. Each mL of the 90 mg vial contains, 9 mg Pamidronate Disodium, 37.5 mg Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric acid to adjust pH. The pH of a 1% solution of pamidronate disodium in distilled water is approximately 8.3. Pamidronate, a member of the group of chemical compounds known as bisphosphonates, is an analog of pyrophosphate. Pamidronate disodium is designated chemically as phosphonic acid (3-amino-1-hydroxypropylidene) bis-, disodium salt, and its structural formula is:
Pamidronate disodium is soluble in water and in 2N sodium hydroxide, sparingly soluble in 0.1N hydrochloric acid and in 0.1N acetic acid, and practically insoluble in organic solvents. Its molecular formula is C3H9NO7P2Na2 and its molecular weight is 279.1 (calculated as the anhydrous form).
Inactive Ingredients: Mannitol, Phosphoric acid (for adjustment to pH range of 6.0 to 7.0) and Water for Injection.
Sources
Pamidronate Disodium Manufacturers
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Mylan Institutional Llc
![Pamidronate Disodium Injection [Mylan Institutional Llc ]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Pamidronate Disodium | Mylan Institutional Llc
Hypercalcemia of MalignancyConsideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia. Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hemotologic malignancies, the use of glucocorticoid therapy may be helpful.
Moderate HypercalcemiaThe recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium* of approximately 12 to 13.5 mg/dL) is 60 to 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency.
Severe HypercalcemiaThe recommended dose of pamidronate disodium in severe hypercalcemia (corrected serum calcium* >13.5 mg/dL) is 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency.
*Albumin-corrected serum calcium (CCa, mg/dL) = serum calcium, mg/dL + 0.8 (4.0-serum albumin, g/dL).
RetreatmentA limited number of patients have received more than one treatment with pamidronate disodium for hypercalcemia. Retreatment with pamidronate disodium, in patients who show complete or partial response initially, may be carried out if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.
Paget’s DiseaseThe recommended dose of pamidronate disodium in patients with moderate to severe Paget’s disease of bone is 30 mg daily, administered as a 4 hour infusion on 3 consecutive days for a total dose of 90 mg.
RetreatmentA limited number of patients with Paget’s disease have received more than one treatment of pamidronate disodium in clinical trials. When clinically indicated, patients should be retreated at the dose of initial therapy.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of pamidronate disodium in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4 hour infusion given on a monthly basis.
Patients with marked Bence-Jones proteinuria and dehydration should receive adequate hydration prior to pamidronate disodium infusion.
Limited information is available on the use of pamidronate disodium in multiple myeloma patients with a serum creatinine ≥3.0 mg/dL.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not yet known, however, in a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits (see Clinical Trials section).
Osteolytic Bone Metastases of Breast CancerThe recommended dose of pamidronate disodium in patients with osteolytic bone metastases is 90 mg administered over a 2 hour infusion given every 3 to 4 weeks.
Pamidronate disodium has been frequently used with doxorubicin, fluorouracil, cyclophosphamide, methotrexate, mitoxantrone, vinblastine, dexamethasone, prednisone, melphalan, vincristine, megesterol, and tamoxifen. It has been given less frequently with etoposide, cisplatin, cytarabine, paclitaxel, and aminoglutethimide.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not known, however, in two breast cancer studies, final analyses performed after 24 months of therapy demonstrated overall benefit (see Clinical Trials section).
Calcium and Vitamin D SupplementationIn the absence of hypercalcemia, patients with predominantly lytic bone metastases or multiple myeloma, who are at risk of calcium or vitamin D deficiency, and patients with Paget’s disease of the bone, should be given oral calcium and vitamin D supplementation in order to minimize the risk of hypocalcemia.
Method of AdministrationDUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG. (SEE WARNINGS.)
There must be strict adherence to the intravenous administration recommendations for pamidronate disodium in order to decrease the risk of deterioration in renal function.
Hypercalcemia of MalignancyThe daily dose must be administered as an intravenous infusion over at least 2 to 24 hours for the 60 mg and 90 mg doses. The recommended dose should be diluted in 1000 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP. This infusion solution is stable for up to 24 hours at room temperature.
Paget’s DiseaseThe recommended daily dose of 30 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4 hour period for 3 consecutive days.
Osteolytic Bone Metastases of Breast CancerThe recommended dose of 90 mg should be diluted in 250 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 2 hour period every 3 to 4 weeks.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4 hour period on a monthly basis.
Pamidronate disodium must not be mixed with calcium-containing infusion solutions, such as Ringer’s solution, and should be given in a single intravenous solution and line separate from all other drugs.
Note : Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Akorn-strides, Llc
Pamidronate Disodium | Akorn-strides, Llc
Hypercalcemia of MalignancyConsideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia. Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hemotologic malignancies, the use of glucocorticoid therapy may be helpful.
Moderate HypercalcemiaThe recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium* of approximately 12 to 13.5 mg/dL) is 60 to 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency.
Severe HypercalcemiaThe recommended dose of pamidronate disodium in severe hypercalcemia (corrected serum calcium* >13.5 mg/dL) is 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency.
*Albumin-corrected serum calcium (CCa, mg/dL) = serum calcium, mg/dL + 0.8 (4.0-serum albumin, g/dL).
RetreatmentA limited number of patients have received more than one treatment with pamidronate disodium for hypercalcemia. Retreatment with pamidronate disodium, in patients who show complete or partial response initially, may be carried out if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.
Paget’s DiseaseThe recommended dose of pamidronate disodium in patients with moderate to severe Paget’s disease of bone is 30 mg daily, administered as a 4 hour infusion on 3 consecutive days for a total dose of 90 mg.
RetreatmentA limited number of patients with Paget’s disease have received more than one treatment of pamidronate disodium in clinical trials. When clinically indicated, patients should be retreated at the dose of initial therapy.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of pamidronate disodium in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4 hour infusion given on a monthly basis.
Patients with marked Bence-Jones proteinuria and dehydration should receive adequate hydration prior to pamidronate disodium infusion.
Limited information is available on the use of pamidronate disodium in multiple myeloma patients with a serum creatinine ≥3.0 mg/dL.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not yet known, however, in a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits (see Clinical Trials section).
Osteolytic Bone Metastases of Breast CancerThe recommended dose of pamidronate disodium in patients with osteolytic bone metastases is 90 mg administered over a 2 hour infusion given every 3 to 4 weeks.
Pamidronate disodium has been frequently used with doxorubicin, fluorouracil, cyclophosphamide, methotrexate, mitoxantrone, vinblastine, dexamethasone, prednisone, melphalan, vincristine, megesterol, and tamoxifen. It has been given less frequently with etoposide, cisplatin, cytarabine, paclitaxel, and aminoglutethimide.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not known, however, in two breast cancer studies, final analyses performed after 24 months of therapy demonstrated overall benefit (see Clinical Trials section).
Calcium and Vitamin D SupplementationIn the absence of hypercalcemia, patients with predominantly lytic bone metastases or multiple myeloma, who are at risk of calcium or vitamin D deficiency, and patients with Paget’s disease of the bone, should be given oral calcium and vitamin D supplementation in order to minimize the risk of hypocalcemia.
Method of AdministrationDUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG. (SEE WARNINGS. )
There must be strict adherence to the intravenous administration recommendations for pamidronate disodium in order to decrease the risk of deterioration in renal function.
Hypercalcemia of MalignancyThe daily dose must be administered as an intravenous infusion over at least 2 to 24 hours for the 60 mg and 90 mg doses. The recommended dose should be diluted in 1000 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP. This infusion solution is stable for up to 24 hours at room temperature.
Paget’s DiseaseThe recommended daily dose of 30 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4 hour period for 3 consecutive days.
Osteolytic Bone Metastases of Breast CancerThe recommended dose of 90 mg should be diluted in 250 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 2 hour period every 3 to 4 weeks.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4 hour period on a monthly basis.
Pamidronate disodium must not be mixed with calcium-containing infusion solutions, such as Ringer’s solution, and should be given in a single intravenous solution and line separate from all other drugs.
Note : Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Generamedix, Inc.
Pamidronate Disodium | Generamedix, Inc.
Hypercalcemia of MalignancyConsideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia. Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hematologic malignancies, the use of glucocorticoid therapy may be helpful.
Moderate HypercalcemiaThe recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium* of approximately 12 to 13.5 mg/dL) is 60 to 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency.
Severe HypercalcemiaThe recommended dose of pamidronate disodium in severe hypercalcemia (corrected serum calcium * >13.5 mg/dL) is 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency.
__________________
*Albumin-corrected serum calcium (CCa,mg/dL) = serum calcium, mg/dL + 0.8 (4-serum albumin, g/dL).
RetreatmentA limited number of patients have received more than one treatment with pamidronate disodium for hypercalcemia. Retreatment with pamidronate disodium, in patients who show complete or partial response initially, may be carried out if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.
Paget’s DiseaseThe recommended dose of pamidronate disodium in patients with moderate to severe Paget’s disease of bone is 30 mg daily, administered as a 4 hour infusion on 3 consecutive days for a total dose of 90 mg.
RetreatmentA limited number of patients with Paget’s disease have received more than one treatment of pamidronate disodium in clinical trials. When clinically indicated, patients should be retreated at the dose of initial therapy.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of pamidronate disodium in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4 hour infusion given on a monthly basis.
Patients with marked Bence-Jones proteinuria and dehydration should receive adequate hydration prior to pamidronate disodium infusion.
Limited information is available on the use of pamidronate disodium in multiple myeloma patients with a serum creatinine ≥3 mg/dL.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1 mg/dL. In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.The optimal duration of therapy is not yet known, however, in a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits (see Clinical Trials).
Osteolytic Bone Metastases of Breast CancerThe recommended dose of pamidronate disodium in patients with osteolytic bone metastases is 90 mg administered over a 2 hour infusion given every 3 to 4 weeks.
Pamidronate disodium has been frequently used with doxorubicin, fluorouracil, cyclophosphamide, methotrexate, mitoxantrone, vinblastine, dexamethasone, prednisone, melphalan, vincristine, megestrol, and tamoxifen. It has been given less frequently with etoposide, cisplatin, cytarabine, paclitaxel, and aminoglutethimide. Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration.
In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not known, however, in two breast cancer studies, final analyses performed after 24 months of therapy demonstrated overall benefits (see Clinical Trials).
Calcium and Vitamin D SupplementationIn the absence of hypercalcemia, patients with predominantly lytic bone metastases or multiple myeloma, who are at risk of calcium or vitamin D deficiency, and patients with Paget’s disease of the bone, should be given oral calcium and vitamin D supplementation in order to minimize the risk of hypocalcemia.
Method of AdministrationDUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG (SEE WARNINGS).
There must be strict adherence to the intravenous administration recommendations for pamidronate disodium in order to decrease the risk of deterioration in renal function.
Hypercalcemia of MalignancyThe daily dose must be administered as an intravenous infusion over at least 2 to 24 hours for the 60 mg and 90 mg doses. The recommended dose should be diluted in 1000 mL of sterile 0.45% or 0.9% sodium chloride injection, or 5% dextrose injection. This infusion solution is stable for up to 24 hours of room temperature.
Paget’s DiseaseThe recommended daily dose of 30 mg should be diluted in 500 mL of sterile 0.45% or 0.9% sodium chloride injection, or 5% dextrose injection, and administered over a 4 hour period for 3 consecutive days.
Osteolytic Bone Metastases of Breast CancerThe recommended dose of 90 mg should be diluted in 250 mL of sterile 0.45% or 0.9% sodium chloride injection, or 5% dextrose injection, and administered over a 2 hour period every 3 to 4 weeks.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% sodium chloride injection, or 5% dextrose injection, and administered over a 4 hour period on a monthly basis.
Pamidronate disodium must not be mixed with calcium-containing infusion solutions, such as Ringer’s solution, and should be given in a single intravenous solution and line separate from all other drugs.
Note: Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Pfizer Laboratories Div Pfizer Inc
Pamidronate Disodium | Pfizer Laboratories Div Pfizer Inc
Hypercalcemia of MalignancyConsideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia. Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hemotologic malignancies, the use of glucocorticoid therapy may be helpful.
Moderate HypercalcemiaThe recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium1 of approximately 12 to 13.5 mg/dL) is 60 to 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency.
Severe HypercalcemiaThe recommended dose of pamidronate disodium in severe hypercalcemia (corrected serum calcium1 >13.5 mg/dL) is 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency.
1 Albumin-corrected serum calcium (CCa, mg/dL) = serum calcium, mg/dL + 0.8 (4.0-serum albumin, g/dL). RetreatmentA limited number of patients have received more than one treatment with pamidronate disodium for hypercalcemia. Retreatment with pamidronate disodium, in patients who show complete or partial response initially, may be carried out if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.
Paget's DiseaseThe recommended dose of pamidronate disodium in patients with moderate to severe Paget's disease of bone is 30 mg daily, administered as a 4 hour infusion on 3 consecutive days for a total dose of 90 mg.
RetreatmentA limited number of patients with Paget's disease have received more than one treatment of pamidronate disodium in clinical trials. When clinically indicated, patients should be retreated at the dose of initial therapy.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of pamidronate disodium in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4 hour infusion given on a monthly basis.
Patients with marked Bence-Jones proteinuria and dehydration should receive adequate hydration prior to pamidronate disodium infusion.
Limited information is available on the use of pamidronate disodium in multiple myeloma patients with a serum creatinine ≥3.0 mg/dL.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not yet known, however, in a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits (see Clinical Trials section).
Osteolytic Bone Metastases of Breast CancerThe recommended dose of pamidronate disodium in patients with osteolytic bone metastases is 90 mg administered over a 2 hour infusion given every 3 to 4 weeks.
Pamidronate disodium has been frequently used with doxorubicin, fluorouracil, cyclophosphamide, methotrexate, mitoxantrone, vinblastine, dexamethasone, prednisone, melphalan, vincristine, megesterol, and tamoxifen. It has been given less frequently with etoposide, cisplatin, cytarabine, paclitaxel, and aminoglutethimide.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not known, however, in two breast cancer studies, final analyses performed after 24 months of therapy demonstrated overall benefit (see Clinical Trials section).
Calcium and Vitamin D SupplementationIn the absence of hypercalcemia, patients with predominantly lytic bone metastases or multiple myeloma, who are at risk of calcium or vitamin D deficiency, and patients with Paget's disease of the bone, should be given oral calcium and vitamin D supplementation in order to minimize the risk of hypocalcemia.
Method of AdministrationDUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG. (SEE WARNINGS.)
There must be strict adherence to the intravenous administration recommendations for pamidronate disodium in order to decrease the risk of deterioration in renal function.
Hypercalcemia of MalignancyThe daily dose must be administered as an intravenous infusion over at least 2 to 24 hours for the 60 mg and 90 mg doses. The recommended dose should be diluted in 1000 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP. This infusion solution is stable for up to 24 hours at room temperature.
Paget's DiseaseThe recommended daily dose of 30 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4 hour period for 3 consecutive days.
Osteolytic Bone Metastases of Breast CancerThe recommended dose of 90 mg should be diluted in 250 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 2 hour period every 3 to 4 weeks.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4 hour period on a monthly basis.
Pamidronate disodium must not be mixed with calcium-containing infusion solutions, such as Ringer's solution, and should be given in a single intravenous solution and line separate from all other drugs.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
App Pharmaceuticals, Llc
Pamidronate Disodium | App Pharmaceuticals, Llc
Hypercalcemia of Malignancy
Consideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia. Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hematologic malignancies, the use of glucocorticoid therapy may be helpful.
Moderate Hypercalcemia
The recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium* of approximately 12 to 13.5 mg/dL) is 60 to 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency.
Severe Hypercalcemia
The recommended dose of pamidronate disodium in severe hypercalcemia (corrected serum calcium* >13.5 mg/dL) is 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency.
_______________________
*Albumin-corrected serum calcium (CCa, mg/dL) = serum calcium, mg/dL + 0.8 (4-serum albumin, g/dL).
Retreatment
A limited number of patients have received more than one treatment with pamidronate disodium for hypercalcemia. Retreatment with pamidronate disodium, in patients who show complete or partial response initially, may be carried out if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.
Paget's Disease
The recommended dose of pamidronate disodium in patients with moderate to severe Paget’s disease of bone is 30 mg daily, administered as a 4-hour infusion on 3 consecutive days for a total dose of 90 mg.
Retreatment
A limited number of patients with Paget’s disease have received more than one treatment of pamidronate disodium in clinical trials. When clinically indicated, patients should be retreated at the dose of initial therapy.
Osteolytic Bone Lesions of Multiple Myeloma
The recommended dose of pamidronate disodium in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4-hour infusion given on a monthly basis.
Patients with marked Bence-Jones proteinuria and dehydration should receive adequate hydration prior to pamidronate disodium infusion.
Limited information is available on the use of pamidronate disodium in multiple myeloma patients with a serum creatinine ≥ 3 mg/dL.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
• For patients with normal baseline creatinine, increase of 0.5 mg/dL.
• For patients with abnormal baseline creatinine, increase of 1 mg/dL.
In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not yet known, however, in a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits (see Clinical Trials).
Osteolytic Bone Metastases of Breast Cancer
The recommended dose of pamidronate disodium in patients with osteolytic bone metastases is 90 mg administered over a 2-hour infusion given every 3 to 4 weeks.
Pamidronate disodium has been frequently used with doxorubicin, fluorouracil, cyclophosphamide, methotrexate, mitoxantrone, vinblastine, dexamethasone, prednisone, melphalan, vincristine, megesterol, and tamoxifen. It has been given less frequently with etoposide, cisplatin, cytarabine, paclitaxel, and aminoglutethimide.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
• For patients with normal baseline creatinine, increase of 0.5 mg/dL.
• For patients with abnormal baseline creatinine, increase of 1 mg/dL.
In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not known, however, in two breast cancer studies, final analyses performed after 24 months of therapy demonstrated overall benefits (see Clinical Trials).
Calcium and Vitamin D Supplementation
In the absence of hypercalcemia, patients with predominantly lytic bone metastases or multiple myeloma, who are at risk of calcium or vitamin D deficiency, and patients with Paget’s disease of the bone, should be given oral calcium and vitamin D supplementation in order to minimize the risk of hypocalcemia.
Preparation of Infusion
Method of Administration
DUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG (see WARNINGS).
There must be strict adherence to the intravenous administration recommendations for pamidronate disodium in order to decrease the risk of deterioration in renal function.
Hypercalcemia of Malignancy
The daily dose must be administered as an intravenous infusion over at least 2 to 24 hours for the 60 mg dose and the 90 mg doses. The recommended dose should be diluted in 1000 mL of sterile 0.45% or 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP. This infusion solution is stable for up to 24 hours at room temperature.
Paget’s Disease
The recommended daily dose of 30 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, and administered over a 4-hour period for 3 consecutive days.
Osteolytic Bone Metastases of Breast Cancer
The recommended dose of 90 mg should be diluted in 250 mL of sterile 0.45% or 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, and administered over a 2-hour period every 3 to 4 weeks.
Osteolytic Bone Lesions of Multiple Myeloma
The recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, and administered over a 4-hour period on a monthly basis.
Pamidronate disodium must not be mixed with calcium-containing infusion solutions, such as Ringer’s solution, and should be given in a single intravenous solution and line separate from all other drugs.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Hypercalcemia of Malignancy
Consideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia. Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hematologic malignancies, the use of glucocorticoid therapy may be helpful.
Moderate Hypercalcemia
The recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium* of approximately 12 to 13.5 mg/dL) is 60 to 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency.
Severe Hypercalcemia
The recommended dose of pamidronate disodium in severe hypercalcemia (corrected serum calcium* >13.5 mg/dL) is 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency.
_______________________
*Albumin-corrected serum calcium (CCa, mg/dL) = serum calcium, mg/dL + 0.8 (4-serum albumin, g/dL).
Retreatment
A limited number of patients have received more than one treatment with pamidronate disodium for hypercalcemia. Retreatment with pamidronate disodium, in patients who show complete or partial response initially, may be carried out if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.
Paget's Disease
The recommended dose of pamidronate disodium in patients with moderate to severe Paget’s disease of bone is 30 mg daily, administered as a 4-hour infusion on 3 consecutive days for a total dose of 90 mg.
Retreatment
A limited number of patients with Paget’s disease have received more than one treatment of pamidronate disodium in clinical trials. When clinically indicated, patients should be retreated at the dose of initial therapy.
Osteolytic Bone Lesions of Multiple Myeloma
The recommended dose of pamidronate disodium in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4-hour infusion given on a monthly basis.
Patients with marked Bence-Jones proteinuria and dehydration should receive adequate hydration prior to pamidronate disodium infusion.
Limited information is available on the use of pamidronate disodium in multiple myeloma patients with a serum creatinine ≥ 3 mg/dL.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
• For patients with normal baseline creatinine, increase of 0.5 mg/dL.
• For patients with abnormal baseline creatinine, increase of 1 mg/dL.
In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not yet known, however, in a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits (see Clinical Trials).
Osteolytic Bone Metastases of Breast Cancer
The recommended dose of pamidronate disodium in patients with osteolytic bone metastases is 90 mg administered over a 2-hour infusion given every 3 to 4 weeks.
Pamidronate disodium has been frequently used with doxorubicin, fluorouracil, cyclophosphamide, methotrexate, mitoxantrone, vinblastine, dexamethasone, prednisone, melphalan, vincristine, megesterol, and tamoxifen. It has been given less frequently with etoposide, cisplatin, cytarabine, paclitaxel, and aminoglutethimide.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
• For patients with normal baseline creatinine, increase of 0.5 mg/dL.
• For patients with abnormal baseline creatinine, increase of 1 mg/dL.
In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not known, however, in two breast cancer studies, final analyses performed after 24 months of therapy demonstrated overall benefits (see Clinical Trials).
Calcium and Vitamin D Supplementation
In the absence of hypercalcemia, patients with predominantly lytic bone metastases or multiple myeloma, who are at risk of calcium or vitamin D deficiency, and patients with Paget’s disease of the bone, should be given oral calcium and vitamin D supplementation in order to minimize the risk of hypocalcemia.
Preparation of Infusion
Method of Administration
DUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG (see WARNINGS).
There must be strict adherence to the intravenous administration recommendations for pamidronate disodium in order to decrease the risk of deterioration in renal function.
Hypercalcemia of Malignancy
The daily dose must be administered as an intravenous infusion over at least 2 to 24 hours for the 60 mg dose and the 90 mg doses. The recommended dose should be diluted in 1000 mL of sterile 0.45% or 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP. This infusion solution is stable for up to 24 hours at room temperature.
Paget’s Disease
The recommended daily dose of 30 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, and administered over a 4-hour period for 3 consecutive days.
Osteolytic Bone Metastases of Breast Cancer
The recommended dose of 90 mg should be diluted in 250 mL of sterile 0.45% or 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, and administered over a 2-hour period every 3 to 4 weeks.
Osteolytic Bone Lesions of Multiple Myeloma
The recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, and administered over a 4-hour period on a monthly basis.
Pamidronate disodium must not be mixed with calcium-containing infusion solutions, such as Ringer’s solution, and should be given in a single intravenous solution and line separate from all other drugs.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
American Regent, Inc.
Pamidronate Disodium | American Regent, Inc.
Hypercalcemia of MalignancyConsideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia. Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hematologic malignancies, the use of glucocorticoid therapy may be helpful.
Moderate HypercalcemiaThe recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium* of approximately 12 to 13.5 mg/dL) is 60 to 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., > 2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency.
Severe HypercalcemiaThe recommended dose of pamidronate disodium in severe hypercalcemia (corrected serum calcium* > 13.5 mg/dL) is 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., > 2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency.
*Albumin-corrected serum calcium (CCa, mg/dL) = serum calcium, mg/dL + 0.8 (4.0-serum albumin, g/dL).
RetreatmentA limited number of patients have received more than one treatment with pamidronate disodium for hypercalcemia. Retreatment with pamidronate disodium, in patients who show complete or partial response initially, may be carried out if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.
Paget’s DiseaseThe recommended dose of pamidronate disodium in patients with moderate to severe Paget’s disease of bone is 30 mg daily, administered as a 4-hour infusion on 3 consecutive days for a total dose of 90 mg.
RetreatmentA limited number of patients with Paget’s disease have received more than one treatment of pamidronate disodium in clinical trials. When clinically indicated, patients should be retreated at the dose of initial therapy.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of pamidronate disodium in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4-hour infusion given on a monthly basis.
Patients with marked Bence-Jones proteinuria and dehydration should receive adequate hydration prior to pamidronate disodium infusion.
Limited information is available on the use of pamidronate disodium in multiple myeloma patients with a serum creatinine ≥ 3.0 mg/dL.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not yet known, however, in a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits (see Clinical Trials section).
Osteolytic Bone Metastases of Breast CancerThe recommended dose of pamidronate disodium in patients with osteolytic bone metastases is 90 mg administered over a 2-hour infusion given every 3 to 4 weeks.
Pamidronate disodium has been frequently used with doxorubicin, fluorouracil, cyclophosphamide, methotrexate, mitoxantrone, vinblastine, dexamethasone, prednisone, melphalan, vincristine, megesterol, and tamoxifen. It has been given less frequently with etoposide, cisplatin, cytarabine, paclitaxel, and aminoglutethimide.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not known, however, in two breast cancer studies, final analyses performed after 24 months of therapy demonstrated overall benefits (see Clinical Trials section).
Calcium and Vitamin D SupplementationIn the absence of hypercalcemia, patients with predominantly lytic bone metastases or multiple myeloma, who are at risk of calcium or vitamin D deficiency, and patients with Paget’s disease of the bone, should be given oral calcium and vitamin D supplementation in order to minimize the risk of hypocalcemia.
Method of AdministrationDUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG. (SEE WARNINGS.)
There must be strict adherence to the intravenous administration recommendations for pamidronate disodium in order to decrease the risk of deterioration in renal function.
Hypercalcemia of MalignancyThe daily dose must be administered as an intravenous infusion over at least 2 to 24 hours for the 60 mg and 90 mg doses. The recommended dose should be diluted in 1000 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP. This infusion solution is stable for up to 24 hours at room temperature.
Paget’s DiseaseThe recommended daily dose of 30 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4-hour period for 3 consecutive days.
Osteolytic Bone Metastases of Breast CancerThe recommended dose of 90 mg should be diluted in 250 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 2-hour period every 3 to 4 weeks.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4-hour period on a monthly basis.
Pamidronate disodium must not be mixed with calcium-containing infusion solutions, such as Ringer’s solution, and should be given in a single intravenous solution and line separate from all other drugs.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Teva Parenteral Medicines, Inc.
Pamidronate Disodium | Teva Parenteral Medicines, Inc.
2.1 Hypercalcemia of MalignancyVigorous saline hydration, should be initiated promptly along with pamidronate therapy and if possible the urine output should be about 2 L/day throughout treatment [see Warnings and Precautions (5.2)].
Patients who receive pamidronate disodium injection should have serum creatinine assessed prior to each treatment [see Warnings and Precautions (5.1)]. Treatment should be withheld for renal deterioration.
Moderate Hypercalcemia
The recommended dose of pamidronate disodium injection in moderate hypercalcemia (corrected serum calcium* of approximately 12 mg/dL to 13.5 mg/dL) is 60 mg to 90 mg given as a single-dose, intravenous infusion over 2 hours to 24 hours. Longer infusions (i.e., greater than 2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal impairment.
Severe Hypercalcemia
The recommended dose of pamidronate disodium injection in severe hypercalcemia (corrected serum calcium* >13.5 mg/dL) is 90 mg given as a single-dose, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., greater than 2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency/impairment.
*Albumin-corrected serum calcium = serum calcium, mg/dL + 0.8 (4-serum albumin, g/dL).
Retreatment
Retreatment with pamidronate disodium injection in patients who show complete or partial response initially may be carried out if serum calcium does not return to normal or remain normal after initial treatment. A minimum of 7 days between treatments is recommended to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.
2.2 Paget’s DiseaseThe recommended dose of pamidronate disodium injection in patients with moderate to severe Paget’s disease of bone is 30 mg daily, administered as a 4-hour infusion on 3 consecutive days for a total dose of 90 mg. When clinically indicated, patients should be retreated at the dose of initial therapy.
2.3 Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple MyelomaOsteolytic Bone Metastases of Breast Cancer
The recommended dose of pamidronate disodium injection in patients with osteolytic bone metastases is 90 mg administered over a 2-hour infusion given every 3 to 4 weeks.
In a clinical study, renal deterioration was defined as follows:
• With normal baseline creatinine, an increase of 0.5 mg/dL. • With abnormal baseline creatinine, an increase of 1 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not known; however, in two breast cancer studies, final analyses performed after 24 months of therapy demonstrated overall benefits [see Clinical Studies (14.3)].
Osteolytic Bone Lesions of Multiple Myeloma
The recommended dose of pamidronate disodium injection in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4-hour infusion administered every four weeks.
Patients with marked Bence-Jones proteinuria and dehydration should receive adequate hydration prior to pamidronate disodium injection infusion.
Limited information is available on the use of pamidronate disodium injection in multiple myeloma patients with a serum creatinine greater than or equal to 3 mg/dL.
Patients who receive pamidronate disodium injection should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration.
In a clinical study, renal deterioration was defined as follows:
• With normal baseline creatinine, an increase of 0.5 mg/dL. • With abnormal baseline creatinine, an increase of 1 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not known. However, in a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits [see Clinical Studies (14.3)].
2.5 Dilution for AdministrationHypercalcemia of Malignancy
The daily dose must be administered as an intravenous infusion over at least 2 hours and up to 24 hours for the 60 mg and 90 mg doses. The recommended dose should be diluted in 1000 mL of sterile 0.45% or 0.9% sodium chloride injection or 5% dextrose injection. This infusion solution is stable for up to 24 hours at room temperature.
Paget’s Disease
The recommended daily dose of 30 mg should be diluted in 500 mL of sterile 0.45% or 0.9% sodium chloride injection, or 5% dextrose injection and administered over a 4-hour period daily for 3 consecutive days.
Osteolytic Bone Metastases of Breast Cancer
The recommended dose of 90 mg should be diluted in 250 mL of sterile 0.45% or 0.9% sodium chloride injection or 5% dextrose injection and administered over a 2-hour period once every 3 to 4 weeks.
Osteolytic Bone Lesions of Multiple Myeloma
The recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% sodium chloride injection, or 5% dextrose injection, and administered over a 4-hour period every four weeks.
2.6 Incompatibilities, Inspection before UsePamidronate disodium injection must not be mixed with calcium-containing infusion solutions such as Ringer’s solution. Administer as a single intravenous solution and infuse using an intravenous line reserved for pamidronate alone.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Sagent Pharmaceuticals
Pamidronate Disodium | Sagent Pharmaceuticals
Hypercalcemia of MalignancyConsideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia. Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hematologic malignancies, the use of glucocorticoid therapy may be helpful.
Moderate HypercalcemiaThe recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium* of approximately 12 to 13.5 mg/dL) is 60 to 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency.
Severe HypercalcemiaThe recommended dose of pamidronate disodium in severe hypercalcemia (corrected serum calcium* >13.5 mg/dL) is 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency.
*Albumin-corrected serum calcium (CCa, mg/dL)= serum calcium, mg/dL + 0.8 (4.0-serum albumin, g/dL).
RetreatmentA limited number of patients have received more than one treatment with pamidronate disodium for hypercalcemia. Retreatment with pamidronate disodium, in patients who show complete or partial response initially, may be carried out if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.
Paget's DiseaseThe recommended dose of pamidronate disodium in patients with moderate to severe Paget's disease of bone is 30 mg daily, administered as a 4 hour infusion on 3 consecutive days for a total dose of 90 mg.
RetreatmentA limited number of patients with Paget's disease have received more than one treatment of pamidronate disodium in clinical trials. When clinically indicated, patients should be retreated at the dose of initial therapy.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of pamidronate disodium in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4 hour infusion given on a monthly basis.
Patients with marked Bence-Jones proteinuria and dehydration should receive adequate hydration prior to pamidronate disodium infusion.
Limited information is available on the use of pamidronate disodium in multiple myeloma patients with a serum creatinine ≥3 mg/dL.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not yet known, however, in a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits (see Clinical Trials).
Osteolytic Bone Metastases of Breast CancerThe recommended dose of pamidronate disodium in patients with osteolytic bone metastases is 90 mg administered over a 2 hour infusion given every 3 to 4 weeks.
Pamidronate disodium has been frequently used with doxorubicin, fluorouracil, cyclophosphamide, methotrexate, mitoxantrone, vinblastine, dexamethasone, prednisone, melphalan, vincristine, megesterol, and tamoxifen. It has been given less frequently with etoposide, cisplatin, cytarabine, paclitaxel, and aminoglutethimide.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration.
In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not known, however, in two breast cancer studies, final analyses performed after 24 months of therapy demonstrated overall benefits (see Clinical Trials).
Calcium and Vitamin D SupplementationIn the absence of hypercalcemia, patients with predominantly lytic bone metastases or multiple myeloma, who are at risk of calcium or vitamin D deficiency, and patients with Paget's disease of the bone, should be given oral calcium and vitamin D supplementation in order to minimize the risk of hypocalcemia.
Method of AdministrationDUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG (SEE WARNINGS).
There must be strict adherence to the intravenous administration recommendations for pamidronate disodium in order to decrease the risk of deterioration in renal function.
Hypercalcemia of MalignancyThe daily dose must be administered as an intravenous infusion over at least 2 to 24 hours for the 60 mg and 90 mg doses. The recommended dose should be diluted in 1000 mL of sterile 0.45% or 0.9% sodium chloride injection, or 5% dextrose injection. This infusion solution is stable for up to 24 hours at room temperature.
Paget's DiseaseThe recommended daily dose of 30 mg should be diluted in 500 mL of sterile 0.45% or 0.9% sodium chloride injection, or 5% dextrose injection, and administered over a 4 hour period for 3 consecutive days.
Osteolytic Bone Metastases of Breast CancerThe recommended dose of 90 mg should be diluted in 250 mL of sterile 0.45% or 0.9% sodium chloride injection, or 5% dextrose injection, and administered over a 2 hour period every 3 to 4 weeks.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% sodium chloride injection, or 5% dextrose injection, and administered over a 4 hour period on a monthly basis.
Pamidronate disodium must not be mixed with calcium-containing infusion solutions, such as Ringer's solution, and should be given in a single intravenous solution and line separate from all other drugs.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Areva Pharmaceuticals Inc.
Pamidronate Disodium | Rxhomeo Private Limited D.b.a. Rxhomeo, Inc
Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.
-
Pfizer Laboratories Div Pfizer Inc
Pamidronate Disodium | Pfizer Laboratories Div Pfizer Inc
Hypercalcemia of MalignancyConsideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia. Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hemotologic malignancies, the use of glucocorticoid therapy may be helpful.
Moderate HypercalcemiaThe recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium1 of approximately 12 to 13.5 mg/dL) is 60 to 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency.
Severe HypercalcemiaThe recommended dose of pamidronate disodium in severe hypercalcemia (corrected serum calcium1 >13.5 mg/dL) is 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency.
1 Albumin-corrected serum calcium (CCa, mg/dL) = serum calcium, mg/dL + 0.8 (4.0-serum albumin, g/dL). RetreatmentA limited number of patients have received more than one treatment with pamidronate disodium for hypercalcemia. Retreatment with pamidronate disodium, in patients who show complete or partial response initially, may be carried out if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.
Paget's DiseaseThe recommended dose of pamidronate disodium in patients with moderate to severe Paget's disease of bone is 30 mg daily, administered as a 4 hour infusion on 3 consecutive days for a total dose of 90 mg.
RetreatmentA limited number of patients with Paget's disease have received more than one treatment of pamidronate disodium in clinical trials. When clinically indicated, patients should be retreated at the dose of initial therapy.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of pamidronate disodium in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4 hour infusion given on a monthly basis.
Patients with marked Bence-Jones proteinuria and dehydration should receive adequate hydration prior to pamidronate disodium infusion.
Limited information is available on the use of pamidronate disodium in multiple myeloma patients with a serum creatinine ≥3.0 mg/dL.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not yet known, however, in a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits (see Clinical Trials section).
Osteolytic Bone Metastases of Breast CancerThe recommended dose of pamidronate disodium in patients with osteolytic bone metastases is 90 mg administered over a 2 hour infusion given every 3 to 4 weeks.
Pamidronate disodium has been frequently used with doxorubicin, fluorouracil, cyclophosphamide, methotrexate, mitoxantrone, vinblastine, dexamethasone, prednisone, melphalan, vincristine, megesterol, and tamoxifen. It has been given less frequently with etoposide, cisplatin, cytarabine, paclitaxel, and aminoglutethimide.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not known, however, in two breast cancer studies, final analyses performed after 24 months of therapy demonstrated overall benefit (see Clinical Trials section).
Calcium and Vitamin D SupplementationIn the absence of hypercalcemia, patients with predominantly lytic bone metastases or multiple myeloma, who are at risk of calcium or vitamin D deficiency, and patients with Paget's disease of the bone, should be given oral calcium and vitamin D supplementation in order to minimize the risk of hypocalcemia.
Method of AdministrationDUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG. (SEE WARNINGS.)
There must be strict adherence to the intravenous administration recommendations for pamidronate disodium in order to decrease the risk of deterioration in renal function.
Hypercalcemia of MalignancyThe daily dose must be administered as an intravenous infusion over at least 2 to 24 hours for the 60 mg and 90 mg doses. The recommended dose should be diluted in 1000 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP. This infusion solution is stable for up to 24 hours at room temperature.
Paget's DiseaseThe recommended daily dose of 30 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4 hour period for 3 consecutive days.
Osteolytic Bone Metastases of Breast CancerThe recommended dose of 90 mg should be diluted in 250 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 2 hour period every 3 to 4 weeks.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4 hour period on a monthly basis.
Pamidronate disodium must not be mixed with calcium-containing infusion solutions, such as Ringer's solution, and should be given in a single intravenous solution and line separate from all other drugs.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Mylan Institutional Llc
Pamidronate Disodium | Mylan Institutional Llc
Hypercalcemia of MalignancyConsideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia. Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hemotologic malignancies, the use of glucocorticoid therapy may be helpful.
Moderate HypercalcemiaThe recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium* of approximately 12 to 13.5 mg/dL) is 60 to 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency.
Severe HypercalcemiaThe recommended dose of pamidronate disodium in severe hypercalcemia (corrected serum calcium* >13.5 mg/dL) is 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency.
*Albumin-corrected serum calcium (CCa, mg/dL) = serum calcium, mg/dL + 0.8 (4.0-serum albumin, g/dL).
RetreatmentA limited number of patients have received more than one treatment with pamidronate disodium for hypercalcemia. Retreatment with pamidronate disodium, in patients who show complete or partial response initially, may be carried out if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.
Paget’s DiseaseThe recommended dose of pamidronate disodium in patients with moderate to severe Paget’s disease of bone is 30 mg daily, administered as a 4 hour infusion on 3 consecutive days for a total dose of 90 mg.
RetreatmentA limited number of patients with Paget’s disease have received more than one treatment of pamidronate disodium in clinical trials. When clinically indicated, patients should be retreated at the dose of initial therapy.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of pamidronate disodium in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4 hour infusion given on a monthly basis.
Patients with marked Bence-Jones proteinuria and dehydration should receive adequate hydration prior to pamidronate disodium infusion.
Limited information is available on the use of pamidronate disodium in multiple myeloma patients with a serum creatinine ≥3.0 mg/dL.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not yet known, however, in a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits (see Clinical Trials section).
Osteolytic Bone Metastases of Breast CancerThe recommended dose of pamidronate disodium in patients with osteolytic bone metastases is 90 mg administered over a 2 hour infusion given every 3 to 4 weeks.
Pamidronate disodium has been frequently used with doxorubicin, fluorouracil, cyclophosphamide, methotrexate, mitoxantrone, vinblastine, dexamethasone, prednisone, melphalan, vincristine, megesterol, and tamoxifen. It has been given less frequently with etoposide, cisplatin, cytarabine, paclitaxel, and aminoglutethimide.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL. For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not known, however, in two breast cancer studies, final analyses performed after 24 months of therapy demonstrated overall benefit (see Clinical Trials section).
Calcium and Vitamin D SupplementationIn the absence of hypercalcemia, patients with predominantly lytic bone metastases or multiple myeloma, who are at risk of calcium or vitamin D deficiency, and patients with Paget’s disease of the bone, should be given oral calcium and vitamin D supplementation in order to minimize the risk of hypocalcemia.
Method of AdministrationDUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG. (SEE WARNINGS.)
There must be strict adherence to the intravenous administration recommendations for pamidronate disodium in order to decrease the risk of deterioration in renal function.
Hypercalcemia of MalignancyThe daily dose must be administered as an intravenous infusion over at least 2 to 24 hours for the 60 mg and 90 mg doses. The recommended dose should be diluted in 1000 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP. This infusion solution is stable for up to 24 hours at room temperature.
Paget’s DiseaseThe recommended daily dose of 30 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4 hour period for 3 consecutive days.
Osteolytic Bone Metastases of Breast CancerThe recommended dose of 90 mg should be diluted in 250 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 2 hour period every 3 to 4 weeks.
Osteolytic Bone Lesions of Multiple MyelomaThe recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4 hour period on a monthly basis.
Pamidronate disodium must not be mixed with calcium-containing infusion solutions, such as Ringer’s solution, and should be given in a single intravenous solution and line separate from all other drugs.
Note : Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Hospira Worldwide, Inc.
Pamidronate Disodium | Hospira Worldwide, Inc.
Hypercalcemia of Malignancy
Consideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia.
Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hematologic malignancies, the use of glucocorticoid therapy may be helpful.
Moderate Hypercalcemia
The recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium* of approximately 12 to 13.5 mg/dL) is 60 to 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency.
Severe Hypercalcemia
The recommended dose of pamidronate disodium in severe hypercalcemia (corrected serum calcium* >13.5 mg/dL) is 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency.
* Albumin-corrected serum calcium (CCa, mg/dL) = serum calcium, mg/dL + 0.8 (4.0-serum albumin, g/dL).
Retreatment
A limited number of patients have received more than one treatment with pamidronate disodium for hypercalcemia. Retreatment with pamidronate disodium, in patients who show complete or partial response initially, may be carried out if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.
Paget’s Disease
The recommended dose of pamidronate disodium in patients with moderate to severe Paget’s disease of bone is 30 mg daily, administered as a 4-hour infusion on 3 consecutive days for a total dose of 90 mg.
Retreatment
A limited number of patients with Paget’s disease have received more than one treatment of pamidronate disodium in clinical trials. When clinically indicated, patients should be retreated at the dose of initial therapy.
Osteolytic Bone Lesions of Multiple Myeloma
The recommended dose of pamidronate disodium in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4-hour infusion given on a monthly basis.
Patients with marked Bence-Jones proteinuria and dehydration should receive adequate hydration prior to pamidronate disodium infusion.
Limited information is available on the use of pamidronate disodium in multiple myeloma patients with a serum creatinine ≥ 3.0 mg/dL.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL.
For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.
In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not yet known, however, in a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits (see Clinical Trials section).
Osteolytic Bone Metastases of Breast Cancer
The recommended dose of pamidronate disodium in patients with osteolytic bone metastases is 90 mg administered over a 2-hour infusion given every 3 to 4 weeks.
Pamidronate disodium has been frequently used with doxorubicin, fluorouracil, cyclophosphamide, methotrexate, mitoxantrone, vinblastine, dexamethasone, prednisone, melphalan, vincristine, megesterol, and tamoxifen. It has been given less frequently with etoposide, cisplatin, cytarabine, paclitaxel, and aminoglutethimide.
Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL.
For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.
In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not known, however, in two breast cancer studies, final analyses performed after 24 months of therapy demonstrated overall benefits (see Clinical Trials section).
Calcium and Vitamin D Supplementation
In the absence of hypercalcemia, patients with predominantly lytic bone metastases or multiple myeloma, who are at risk of calcium or vitamin D deficiency, and patients with Paget’s disease of the bone, should be given oral calcium and vitamin D supplementation in order to minimize the risk of hypocalcemia.
Method of Administration
DUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG. (SEE WARNINGS.)
There must be strict adherence to the intravenous administration recommendations for pamidronate disodium in order to decrease the risk of deterioration in renal function.
Hypercalcemia of Malignancy
The daily dose must be administered as an intravenous infusion over at least 2 to 24 hours for the 60-mg and 90-mg doses. The recommended dose should be diluted in 1000 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP. This infusion solution is stable for up to 24 hours at room temperature.
Paget’s Disease
The recommended daily dose of 30 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4-hour period for 3 consecutive days.
Osteolytic Bone Metastases of Breast Cancer
The recommended dose of 90 mg should be diluted in 250 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 2-hour period every 3 to 4 weeks.
Osteolytic Bone Lesions of Multiple Myeloma
The recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4-hour period on a monthly basis.
Pamidronate disodium must not be mixed with calcium-containing infusion solutions, such as Ringer’s solution, and should be given in a single intravenous solution and line separate from all other drugs. Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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