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ETHYOL- amifostine injection, powder, lyophilized, for solution


Patient Information

Hypotension and Cardiovascular Events
Inform the patient that he or she may experience hypotension after ETHYOL infusion[see Adverse Reactions (6.1)]. Advise the patient to inform the prescriber if he or she is receiving anti-hypertensive medications or other drugs that could cause or potentiate hypotension[see Warnings and Precautions (5.3), Drug Interactions (7)].

Severe Cutaneous Reactions
Inform the patient that severe cutaneous reactions may develop during or weeks after initiation of ETHYOL administration. Advise the patient to inform the prescriber if they experience any cutaneous reactions or mucosal lesions outside of the injection site or radiation port, or on the palms or soles, as discontinuation of the drug may be necessary[see Warnings and Precautions (5.4)].

Hypersensitivity
Inform the patient that he or she may experience allergic reactions after ETHYOL infusion[see Adverse Reactions (6.1)]. ETHYOL might need to be discontinued for severe acute allergic reactions and the patient receive other treatments[See Warnings and Precautions (5.5)].

Nausea and Vomiting
Inform the patient that he or she may experience severe nausea and/or vomiting after ETHYOL infusion[see Adverse Reactions (6.1)].

Hypocalcemia
Inform the patient that calcium supplements may be necessary if hypocalcemia is identified[see Warnings and Precautions (5.7)]. Blood tests may be needed to identify this, and correct the condition.

Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy[see Warnings and Precautions (5.8) and Use in Specific Populations (8.1)]. Refer to the cisplatin full prescribing information for pregnancy and contraception information.

Lactation
Advise lactating women not to breastfed during treatment with ETHYOL[see Use in Specific Populations (8.2)]. Refer to the cisplatin full prescribing information for lactation information.

Infertility
Advise males of reproductive potential that ETHYOL may impair fertility[see Use in Specific Populations (8.3)]. Refer to the cisplatin full prescribing information for infertility information.

U.S. Patent 5,994,409

Manufactured for:
Cumberland Pharmaceuticals Inc.
Nashville, TN 37203

Cumberland Logo

Clinigen LogoETHYOL is a registered trademark owned by the Clinigen Group.

For product information, please call Cumberland Pharmaceuticals Inc. Medical Information at 1 877 484 2700

Revision Date: 07/2019



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