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  Ivermax | Areva Pharmaceuticals Inc.

  

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  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 for Injection USP in moderate hypercalcemia (corrected serum calcium* of approximately 12-13.5 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 for Injection USP 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.

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  *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 for Injection USP, 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 for Injection USP 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 for Injection USP 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 for Injection USP infusion.

  Limited information is available on the use of Pamidronate disodium for Injection USP in multiple myeloma patients with a serum creatinine ≥3.0 mg/dL.

  Patients who receive Pamidronate disodium for Injection USP 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 section).

  Osteolytic Bone Metastases of Breast Cancer

  The recommended dose of Pamidronate disodium for Injection USP in patients with osteolytic bone metastases is 90 mg administered over a 2-hour infusion given every 3-4 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 for Injection USP 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 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.

  Preparation of Solution Reconstitution

  Pamidronate disodium for Injection USP is reconstituted by adding 10 mL of Sterile Water for Injection, USP, to each vial, resulting in a solution of 30 mg/10 mL, 60mg/10mL or 90 mg/10 mL. The pH of the reconstituted solution is 6.0-7.4. The drug should be completely dissolved before the solution is withdrawn.

  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 FOR INJECTION USP SHOULD NOT EXCEED 90 MG. (SEE WARNINGS.)

  There must be strict adherence to the intravenous administration recommendations for Pamidronate disodium for Injection USP 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 3-4 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 for Injection USP 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.

  Pamidronate disodium for Injection USP reconstituted with Sterile Water for Injection may be stored under refrigeration at 2°C-8°C (36°F-46°F) for up to 24 hours.

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