Amfosted 500mg Injection

Amifostine is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. – reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. Limitation of Use Avoid the use of Amifostine in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy. Reduction of Cumulative Renal Toxicity with Chemotherapy Amifostine (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck Amifostine is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. Limitation of Use Do not use Amifostine in other settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy, except in the context of a clinical study.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

– Hypotension and Cardiovascular Events: Patients who are hypotensive or dehydrated should not receive Amifostine. If interruption of antihypertensive therapy is possible, interrupt antihypertensive therapy 24 hours prior to Amifostine administration. Monitor blood pressure during infusion; interrupt and restart infusion if decrease in systolic blood pressure is observed. Do not administer Amifostine to hypotensive patients who are taking antihypertensive therapy that cannot be stopped for 24 hours prior to Amifostine administration. – Severe Cutaneous Reactions: Monitor patients prior to, during, and weeks after administration for severe cutaneous reactions. Discontinue for cutaneous reactions or lesions appearing outside of the injection site/radiation port or on the palms or soles. – Hypersensitivity: Discontinue for severe acute allergic reactions. Administer treatment for serious allergic events. – Nausea and Vomiting: Administer antiemetic medication prior to and in conjunction with Amifostine. Monitor fluid balance when administered with highly emetogenic chemotherapy. – Hypocalcemia: Monitor serum calcium levels in patients at risk of hypocalcemia. If necessary, administer calcium supplements. – Embryo-Fetal Toxicity: Amifostine can cause fetal harm. Advise patients of the potential risk to a fetus. Also, refer to the cisplatin full prescribing information for pregnancy and contraception information. Effectiveness of the Chemotherapy Regimen Amifostine may interfere with the antitumor activity of chemotherapy regimens. Do not use Amifostine 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. Limited data are currently available regarding interference with antitumor efficacy when Amifostine is administered prior to cisplatin therapy in settings other than advanced ovarian cancer. Effectiveness of Radiotherapy Amifostine may interfere with the antitumor activity of the radiotherapy regimens. Do not use Amifostine in patients receiving definitive radiotherapy, except in the context of a clinical trial, since there are insufficient data to exclude a tumor-protective effect in this setting. Amifostine was studied with standard fractionated radiotherapy and when ≥75% of both parotid glands were exposed to radiation. The safety and efficacy of Amifostine on the incidence of xerostomia in the setting of combined chemotherapy and radiotherapy, and in the setting of accelerated or hyperfractionated therapy, have not been established. Hypotension and Cardiovascular Events Severe hypotension with serious sequelae have been reported in clinical studies and post-marketing experience in patients treated with Amifostine. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: – Hypotension and Cardiovascular Events – Severe Cutaneous Reactions – Hypersensitivity – Nausea and Vomiting – Hypocalcemia Most common adverse reactions are hypotension, nausea and vomiting. Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Amifostine was administered to patients receiving chemotherapeutic agents for advanced ovarian cancer (WR-1 study) or who were receiving standard fractionated radiotherapy for head and neck cancer (WR-38 study). In the WR-38 study of patients with head and neck cancer, 17% (26/150) discontinued Amifostine due to adverse reactions. All but one of these patients continued to receive radiation treatment until completion. Table 2 summarizes adverse reactions reported in patients from the WR-1 and WR-38 clinical trials. Table 2: Incidence of Common Adverse Reactions in Patients Receiving Amifostine Ovarian Cancer (WR-1 Trial) 910 mg/m 2 Head and Neck Cancer (WR-38 Trial) 200 mg/m 2 Per Patient Per Infusion Nausea/Vomiting ≥Grade 3 36/122 (30%) 53/592 (9%) 12/150 (8%) 13/4314 (<1%) All Grades 117/122 (96%) 520/592 (88%) 80/150 (53%) 233/4314 (5%) Hypotension ≥Grade 3 10/122 (8%) 4/150 (3%) All Grades 75/122 (62%) 159/592 (27%) 22/150 (15%) 46/4314 (1%) Other clinically relevant adverse reactions reported in patients in the WR-1 and WR-38 trials include the following: Infusion-related Reactions: flushing/feeling of warmth, chills/feeling of coldness, malaise, pyrexia, rash, dizziness, somnolence, hiccups, diarrhea, sneezing, diplopia and blurred vision. These effects have not generally precluded the completion of therapy. Injection site reactions (including rash/erythema, pruritus, urticaria, pain, inflammation, bruising and local swelling) were also observed. Post-Marketing Experience The following adverse reactions have been identified during post-approval use of Amifostine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.