ETHYOL- amifostine injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMIFOSTINE (UNII: M487QF2F4V) (AMIFOSTINE ANHYDROUS - UNII:ILA426L95O)

Available from:

Cumberland Pharmaceuticals Inc.

INN (International Name):

AMIFOSTINE

Composition:

AMIFOSTINE ANHYDROUS 500 mg in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer [see Clinical Studies (14.1)] . ETHYOL 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 [see Clinical Studies (14.2)] . Limitation of Use Do not use ETHYOL in other settings where chemotherapy can produce a significant survival benefit or cure [see Warnings and Precautions (5.1)] , or in patients receiving definitive radiotherapy [see Warnings and Precautions (5.2)] , except in the context of a clinical study. ETHYOL is contraindicated in patients with known hypersensitivity to aminothiol compounds. When ETHYOL is used in combination with cisplatin, refer to the cisplatin full prescribing information for pregnancy information. Based on findings in animals, ETHYOL ca

Product summary:

ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized white powder in 10 mL single-dose vials (NDC 66220-017-03). Each vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows: Carton containing 3 vials (NDC 66220-017-03) Discard unused portion. Store the lyophilized dosage form at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Follow special handling and disposal procedures [see References (15)].

Authorization status:

New Drug Application

Summary of Product characteristics

ETHYOL- AMIFOSTINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
CUMBERLAND PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ETHYOL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ETHYOL.
ETHYOL (AMIFOSTINE) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
ETHYOL is a cytoprotective agent indicated for:
reduction of cumulative renal toxicity associated with repeated
administration of cisplatin in patients with advanced
ovarian cancer. (1.1)
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. (1.2)
Limitation of Use
Avoid the use of ETHYOL in settings where chemotherapy can produce a
significant survival benefit or cure, or in patients
receiving definitive radiotherapy. (1, 5.1, 5.2)
DOSAGE AND ADMINISTRATION
For reduction of cumulative renal toxicity with chemotherapy, the
recommended starting dose is 910 mg/m
administered once daily as a 15-minute intravenous infusion, starting
30 minutes prior to chemotherapy. (2.1)
For reduction of moderate to severe xerostomia from radiation of the
head and neck, the recommended dose is 200
mg/m administered once daily as a 3-minute intravenous infusion,
starting 15-30 minutes prior to standard fraction
radiation therapy (1.8-2.0 Gy). (2.2)
DOSAGE FORMS AND STRENGTHS
For injection: sterile lyophilized powder in 10 mL single vials.
Each single-use vial contains 500 mg of amifostine on the anhydrous
basis.
CONTRAINDICATIONS
ETHYOL is contraindicated in patients with known hypersensitivity to
aminothiol compounds. (4)
WARNINGS AND PRECAUTIONS
Hypotension and Cardiovascular Events: Patients who are hypotensive or
dehydrated should not receive ETHYOL. If
interruption of antihypertensive therapy is possible, interrupt
antihypertensive therapy 24 hours prior to ETHYOL
administration