Amifostine
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Questions & Answers
Side Effects & Adverse Reactions
1. Effectiveness of the Cytotoxic Regimen
Limited data are currently available regarding the preservation of antitumor efficacy when Amifostine is administered prior to cisplatin therapy in settings other than advanced ovarian cancer. Although some animal data suggest interference is possible, in most tumor models the antitumor effects of chemotherapy are not altered by amifostine. Amifostine should not be used in patients receiving chemotherapy for other malignancies in which chemotherapy can produce a significant survival benefit or cure (e.g., certain malignancies of germ cell origin), except in the context of a clinical study.
2. Hypotension
Patients who are hypotensive or in a state of dehydration should not receive Amifostine. Patients receiving Amifostine at doses recommended for chemotherapy should have antihypertensive therapy interrupted 24 hours preceding administration of Amifostine. Patients receiving Amifostine at doses recommended for chemotherapy who are taking antihypertensive therapy that cannot be stopped for 24 hours preceding Amifostine treatment, should not receive Amifostine.
Prior to Amifostine infusion patients should be adequately hydrated. During Amifostine infusion patients should be kept in a supine position. Blood pressure should be monitored every 5 minutes during the infusion, and thereafter as clinically indicated. It is important that the duration of the 910 mg/m2 infusion not exceed 15 minutes, as administration of Amifostine as a longer infusion is associated with a higher incidence of side effects. For infusion durations less than 5 minutes, blood pressure should be monitored at least before and immediately after the infusion, and thereafter as clinically indicated. If hypotension occurs, patients should be placed in the Trendelenburg position and be given an infusion of normal saline using a separate i.v. line. During and after Amifostine infusion, care should be taken to monitor the blood pressure of patients whose antihypertensive medication has been interrupted since hypertension may be exacerbated by discontinuation of antihypertensive medication and other causes such as i.v. hydration.
Guidelines for interrupting and restarting Amifostine infusion if a decrease in systolic blood pressure should occur are provided in the
DOSAGE AND ADMINISTRATION section. Hypotension may occur during or shortly after Amifostine infusion, despite adequate hydration and positioning of the patient (see
ADVERSE REACTIONS and
PRECAUTIONS). Hypotension has been reported to be associated with dyspnea, apnea, hypoxia, and in rare cases seizures, unconsciousness, respiratory arrest and renal failure.
3. Cutaneous Reactions
Serious cutaneous reactions have been associated with Amifostine administration. Serious cutaneous reactions have included erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, toxoderma and exfoliative dermatitis. These reactions have been reported more frequently when Amifostine is used as a radioprotectant (see
ADVERSE REACTIONS). Some of these reactions have been fatal or have required hospitalization and/or discontinuance of therapy. Patients should be carefully monitored prior to, during and after Amifostine administration. Serious cutaneous reactions may develop weeks after initiation of Amifostine administration (see
PRECAUTIONS).
4. Hypersensitivity
Allergic manifestations including anaphylaxis and severe cutaneous reactions have been associated with Amifostine administration.
Nausea and Vomiting
Antiemetic medication should be administered prior to and in conjunction with Amifostine (see
DOSAGE AND ADMINISTRATION). When Amifostine is administered with highly emetogenic chemotherapy, the fluid balance of the patient should be carefully monitored.
5. Hypocalcemia
Serum calcium levels should be monitored in patients at risk of hypocalcemia, such as those with nephrotic syndrome or patients receiving multiple doses of Amifostine (see
ADVERSE REACTIONS). If necessary, calcium supplements can be administered.
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
Amifostine for injection is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer.
For the approved indications, the clinical data do not suggest that the effectiveness of cisplatin based chemotherapy regimens is altered by Amifostine for injection. There are at present only limited data on the effects of Amifostine for injection on the efficacy of chemotherapy. Amifostine for injection should not be administered to patients in other settings where chemotherapy can produce a significant survival benefit except in the context of a clinical study (see
WARNINGS).
History
There is currently no drug history available for this drug.
Other Information
Amifostine for injection is an organic thiophosphate cytoprotective agent known chemically as 2-[(3-aminopropyl) amino] ethanethiol dihydrogen phosphate (ester) and has the following structural formula:
Amifostine is a white crystalline powder, which is freely soluble in water. Its molecular formula is C5H15N2O3PS and it has a molecular weight of 214.22.
Amifostine for Injection is the trihydrate form of amifostine and is supplied as a sterile powder requiring reconstitution for intravenous infusion. Each single-use 10 mL vial contains 500 mg of amifostine on the anhydrous basis.
Sources
Amifostine Manufacturers
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Sun Pharmaceutical Industries Limited
![Amifostine Injection, Powder, Lyophilized, For Solution [Sun Pharmaceutical Industries Limited]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Amifostine | Sun Pharmaceutical Industries Limited
For Reduction of Cumulative Renal Toxicity with Chemotherapy: The recommended starting dose of Amifostine for injection is 910 mg/m 2 administered once daily as a 15-minute i.v. infusion, starting 30 minutes prior to chemotherapy.
The 15-minute infusion is better tolerated than more extended infusions. Further reductions in infusion times for chemotherapy regimens have not been systematically investigated.
Patients should be adequately hydrated prior to Amifostine for injection infusion and kept in a supine position during the infusion. Blood pressure should be monitored every 5 minutes during the infusion, and thereafter as clinically indicated.
The infusion of Amifostine for injection should be interrupted if the systolic blood pressure decreases significantly from the baseline value as listed in the guideline below:
Guideline for Interrupting Amifostine for injection Infusion Due to Decrease in Systolic Blood Pressure Baseline Systolic Blood Pressure (mm Hg) <100 100 to 119 120 to 139 140 to 179 ≥180 Decrease in systolic blood pressure during infusion of Amifostine for injection (mm Hg) 20 25 30 40 50
If the blood pressure returns to normal within 5 minutes and the patient is asymptomatic, the infusion may be restarted so that the full dose of Amifostine for injection may be administered. If the full dose of Amifostine for injection cannot be administered, the dose of Amifostine for injection for subsequent chemotherapy cycles should be 740 mg/m 2.
It is recommended that antiemetic medication, including dexamethasone 20 mg i.v. and a serotonin 5HT 3 receptor antagonist, be administered prior to and in conjunction with Amifostine for injection. Additional antiemetics may be required based on the chemotherapy drugs administered.
Reconstitution
Amifostine for Injection is supplied as a sterile powder requiring reconstitution for intravenous infusion. Each single-use vial contains 500 mg of amifostine on the anhydrous basis.
Prior to intravenous injection, Amifostine for injection is reconstituted with 9.7 mL of sterile 0.9% Sodium Chloride Injection, USP. The reconstituted solution (500 mg amifostine/10 mL) is chemically stable for up to 5 hours at room temperature (approximately 25°C) or up to 24 hours under refrigeration (2°C to 8°C).
Amifostine for injection prepared in polyvinylchloride (PVC) bags at concentrations ranging from 5 mg/mL to 40 mg/mL is chemically stable for up to 5 hours when stored at room temperature (approximately 25°C) or up to 24 hours when stored under refrigeration (2°C to 8°C). CAUTION: Parenteral products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if cloudiness or precipitate is observed.
Incompatibilities
The compatibility of Amifostine for injection with solutions other than 0.9% Sodium Chloride for Injection, or Sodium Chloride solutions with other additives, has not been examined. The use of other solutions is not recommended.
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Sun Pharma Global Fze
Amifostine | Target Corporation
• wash the affected area and dry thoroughly • apply a thin layer over affected area twice daily (morning and night) • supervise children in the use of this product • use daily for 2 weeks • if condition persists longer, ask a doctor • this product is not effective on the scalp or nails -
Bedford Laboratories
Amifostine | Bedford Laboratories
For Reduction of Cumulative Renal Toxicity with Chemotherapy:The recommended starting dose of Amifostine for Injection is 910 mg/m2 administered once daily as a 15-minute i.v. infusion, starting 30 minutes prior to chemotherapy.
The 15-minute infusion is better tolerated than more extended infusions. Further reductions in infusion times for chemotherapy regimens have not been systematically investigated.
Patients should be adequately hydrated prior to Amifostine for Injection infusion and kept in a supine position during the infusion. Blood pressure should be monitored every 5 minutes during the infusion, and thereafter as clinically indicated.
The infusion of Amifostine for Injection should be interrupted if the systolic blood pressure decreases significantly from the baseline value as listed in the guideline below:
Guideline for Interrupting Amifostine for Injection Infusion Due to Decrease in Systolic Blood Pressure Baseline Systolic Blood Pressure (mm Hg) <100 100-119 120-139 140-179 ≥180 Decrease in systolic blood pressure during infusion of Amifostine for Injection (mm Hg) 20 25 30 40 50If the blood pressure returns to normal within 5 minutes and the patient is asymptomatic, the infusion may be restarted so that the full dose of Amifostine for Injection may be administered. If the full dose of amifostine cannot be administered, the dose of amifostine for subsequent chemotherapy cycles should be 740 mg/m2.
It is recommended that antiemetic medication, including dexamethasone 20 mg i.v. and a serotonin 5HT3 receptor antagonist, be administered prior to and in conjunction with Amifostine for Injection. Additional antiemetics may be required based on the chemotherapy drugs administered.
For Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck:
The recommended dose of Amifostine for Injection is 200 mg/m2 administered once daily as a 3-minute i.v. infusion, starting 15-30 minutes prior to standard fraction radiation therapy (1.8-2.0 Gy).
Patients should be adequately hydrated prior to Amifostine for Injection infusion. Blood pressure should be monitored at least before and immediately after the infusion, and thereafter as clinically indicated.
It is recommended that antiemetic medication be administered prior to and in conjunction with Amifostine for Injection. Oral 5HT3 receptor antagonists, alone or in combination with other antiemetics, have been used effectively in the radiotherapy setting.
ReconstitutionAmifostine for Injection is supplied as a sterile lyophilized powder requiring reconstitution for intravenous infusion. Each single-use vial contains 500 mg of amifostine on the anhydrous basis.
Prior to intravenous injection, Amifostine for Injection is reconstituted with 9.7 mL of sterile 0.9% Sodium Chloride Injection, USP. The reconstituted solution (500 mg amifostine/10 mL) is chemically stable for up to 5 hours at room temperature (approximately 25°C) or up to 24 hours under refrigeration (2°C to 8°C).
Amifostine for Injection prepared in polyvinylchloride (PVC) bags at concentrations ranging from 5 mg/mL to 40 mg/mL is chemically stable for up to 5 hours when stored at room temperature (approximately 25°C) or up to 24 hours when stored under refrigeration (2°C to 8°C).
CAUTION: Parenteral products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if cloudiness or precipitate is observed.
IncompatibilitiesThe compatibility of Amifostine for Injection with solutions other than 0.9% Sodium Chloride for Injection, or Sodium Chloride solutions with other additives, has not been examined. The use of other solutions is not recommended.
![Amifostine Injection, Powder, Lyophilized, For Solution [Sun Pharma Global Fze]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f53d5418-5878-4c86-a2bb-b0ff61aec768&name=e6b552ee-8e5b-4e98-8a8c-60602a79c9a6-01.jpg)
![Amifostine Injection, Powder, Lyophilized, For Solution [Bedford Laboratories]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0a47114c-569c-40be-afd8-a22d2e99bb5d&name=amifostine-01.jpg)
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