Fresenius Kabi Introduces Leukemia Drug Arsenic Trioxide Injection in 10 mg per 10 mL vial

Arsenic Trioxide injection is contraindicated in patients with hypersensitivity to arsenic.

Hepatotoxicity: Monitor hepatic function tests at least twice weekly during arsenic trioxide injection therapy.

Carcinogenesis: Arsenic trioxide is a human carcinogen. Monitor patients for the development of second primary malignancies.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.

Serious adverse reactions reported include: Differentiation Syndrome, cardiac conduction abnormalities, hepatotoxicity, carcinogenesis, and embryo-fetal toxicity. The most common adverse reactions (greater than 30%) were leukocytosis, neutropenia, thrombocytopenia, nausea, vomiting, diarrhea, abdominal pain, hepatic toxicity, fever, rigors, fatigue, insomnia, tachycardia, QTc prolongation, edema, hyperglycemia, hypokalemia, hypomagnesemia, dyspnea, cough, rash or itching, sore throat, arthralgia, headaches, paresthesia and dizziness.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This Important Safety Information does not include all the information needed to use Arsenic Trioxide Injection safely and effectively. Please see accompanying full prescribing information (https://tinyurl.com/yaacqq8v) for ARSENIC TRIOXIDE INJECTION, including BOXED WARNING. Full prescribing information is also available at www.fresenius-kabi.co/us.