amifostine (Rx)

Brand and Other Names:Ethyol
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 500mg/vial

Nephrotoxicity

Indicated to reduce cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer

910 mg/m² IV (15-minute infusion), 30 minutes before chemotherapy  

Blood pressure should be followed following its administration and interrupted if systolic blood pressure decreases significantly from baseline as described below

Interrupt Therapy If Systolic Blood Pressure Baseline Decreased

  • Decreased by 20 mm Hg if baseline <100
  • Decreased by 25 mm Hg if baseline <100-119
  • Decreased by 30 mm Hg if baseline <120-139
  • Decreased by 40 mm Hg if baseline <140-179
  • Decreases by 50 mm Hg if baseline ≥180

Xerostomia

Indicated to reduce incidence of moderate-to-severe xerostomia in patients undergoing postoperative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands

200 mg/m² IV (3-minute infusion), 15-30 minutes before radiation therapy  

500 mg SC qDay prior to radiation therapy

Chemoprotective Agent (Orphan)

Orphan indications

  • Chemoprotection for cisplatin in the treatment of metastatic melanoma
  • Reduction of incidence and severity of toxicities associated with cisplatin administration
  • Chemoprotection for cyclophosphamide in the treatment of advanced ovarian carcinoma
  • Treatment of myelodysplastic syndromes

Orphan indications sponsor

  • Medimmune Oncology, Inc; One MedImmune Way; Gaithersburg, MD 20878

Administration

Ensure adequate hydration and premedicate with antiemetic treatment

Safety and efficacy not established

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Interactions

Interaction Checker

and amifostine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Nausea/vomiting (96%)

            Hypotension (61%) - discontinue infusion if significant BP drop

            1-10%

            Hypocalcemia (1%)

            Stevens-Johnson syndrome (1%)

            Frequency Not Defined

            Chills/feeling of coldness

            Flushing/feeling of warmth

            Dizziness

            Fever

            Somnolence

            Rash

            Malaise

            Hiccups

            Sneezing

            Postmarketing Reports

            Immune system disorders: Hypersensitivity reactions including pruritus, urticaria, laryngeal edema, anaphylactic reactions, anaphylactoid reactions

            Nervous system disorders: Seizures and syncope (loss of consciousness)

            Cardiac disorders: Myocardial ischemia, myocardial infarction, cardiac arrest, arrhythmias including tachycardia, bradycardia, atrial fibrillation/flutter, supraventricular tachycardia, extrasystoles

            Vascular disorders: Transient hypertension and exacerbations of preexisting hypertension

            Respiratory, thoracic and mediastinal disorders: Apnea, dyspnea, hypoxia, respiratory arrest

            Skin and subcutaneous tissue disorders: Erythema multiforme, dermatitis exfoliative, Stevens-Johnson syndrome, toxic epidermal necrolysis

            Renal and urinary disorders: Renal failure.

            General disorders and administration site conditions: Chest discomfort and chest pain

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            Warnings

            Contraindications

            Hypersensitivity to aminothiol, monitor closely during and after IV

            Cautions

            Cardiovascular disease, hypocalcemia, hypotension, cutaneous reactions, or nausea/vomiting may occur

            Administer antiemetic medication prior to and in conjunction with therapy; monitor fluid balance when administered with highly emetogenic chemotherapy

            Monitor serum calcium levels in patients at risk of hypocalcemia; if necessary, administer calcium supplements

            Ensure adequate hydration

            Antitumor interference

            • Drug may interfere with antitumor activity of chemotherapy regimens
            • Do not use 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 drug is administered prior to cisplatin therapy in settings other than advanced ovarian cancer

            Radiotherapy interference

            • Drug may interfere with antitumor activity of radiotherapy regimens; do not use in patients receiving definitive radiotherapy, except in the context of a clinical trial; there are insufficient data to exclude a tumor-protective effect in this setting
            • Safety and efficacy of ETHYOL 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

            Cardiovascular events

            • Patients who are hypotensive or dehydrated should not receive therapy
            • If interruption of antihypertensive therapy is possible, interrupt antihypertensive therapy 24 hours prior to therapy administration
            • Hypotensive patients unable to safely interrupt antihypertensive therapy should not receive therapy
            • Monitor blood pressure during infusion; interrupt and restart infusion if decrease in systolic blood pressure observed

            Severe cutaneous reactions

            • Fatal and serious cutaneous reactions reported with therapy, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, toxicoderma, exfoliative dermatitis and drug reaction with biopsy-confirmed eosinophilia and systemic symptoms (DRESS)
            • Reactions have been reported more frequently when drug is used as a radioprotectant
            • Monitor patients carefully prior to, during and after therapy administration; discontinue therapy for cutaneous reactions or mucosal lesions appearing outside of injection site or radiation port and for erythematous, edematous or bullous lesions on palms or soles
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            Pregnancy & Lactation

            Pregnancy

            When used in combination with cisplatin, refer to cisplatin full prescribing information

            Verify pregnancy status in females of reproductive potential prior to initiating therapy

            Based on findings in animals, therapy can cause fetal harm when administered to a pregnant woman

            There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

            Advise pregnant women and females of reproductive potential of the potential risk to a fetus

            Animal data

            • In animal reproduction studies, intravenous administration to pregnant rabbits during organogenesis was embryotoxic at doses approximately sixty percent of recommended dose in humans based on body surface area

            Infertility

            • Based on findings from animal studies, therapy may impair fertility in males of reproductive potential

            Lactation

            When used in combination with cisplatin, refer to cisplatin full prescribing information for lactation information

            There are no data on presence of amifostine or metabolites in human milk, effects on breastfed child, or on milk production

            Because of potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Thiol metabolite binds to reactive metabolites of cisplatin and scavenges free radicals

            Pharmacokinetics

            Half-Life: 8 min

            Metabolite: Free thiol

            Metabolism: Liver

            Vd: 3.5 L

            Half-life: 8-9 min

            Excretion: Urine

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            Administration

            IV Incompatibilities

            Y-site: acyclovir, amphotericin B, cefoperazone, chlorpromazine, cisplatin, ganciclovir, hydroxyzine, minocycline, prochlorperazine

            IV Compatibilities

            Y-site (partial list): amikacin, ampicillin, carboplatin, cefazolin, ceftriaxone, cefoxitin, clindamycin, dopamine, furosemide, heparin, lorazepam, MgSO4, metoclopramide, morphine, ondansetron, NaHCO3, trimethoprim/sulfamethoxazole, vancomycin

            IV Preparation

            Reconstitute with 9.5 mL 0.9% NaCl

            Amifostine should be further diluted in 0.9% NaCl to a concentration of 5-40 mcg/mL

            IV Administration

            Infuse over 15 min before chemotherapy

            Infuse over 3 min before radiation treatment

            Administration as a longer infusion is associated with a higher incidence of adverse effects

            Storage

            Refrigerate lyophilized powder

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.