Fresenius Kabi Introduces Bortezomib for Injection

Important Safety Information

Bortezomib for Injection is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boric acid or glycine, including anaphylactic reactions; contraindicated for intrathecal administration - fatal events have occurred.

Peripheral neuropathy: Manage peripheral neuropathy with dose modification or discontinuation.

Hypotension: Use caution when treating patients taking antihypertensives, with a history of syncope, or with dehydration.

Cardiac Toxicity: Worsening of and development of cardiac failure has occurred. Closely monitor patients with existing heart disease or risk factors for heart disease.

Pulmonary Toxicity: Acute respiratory syndromes have occurred. Monitor closely for new or worsening symptoms.

Posterior Reversible Encephalopathy Syndrome: Consider MRI imaging for onset of visual or neurological symptoms; discontinue bortezomib if suspected.

Gastrointestinal Toxicity: Nausea, diarrhea, constipation, and vomiting may require use of antiemetic and antidiarrheal medications or fluid replacement.

Thrombocytopenia or Neutropenia: Monitor complete blood counts regularly throughout treatment.

Tumor Lysis Syndrome: Closely monitor patients with high tumor burden.

Hepatic Toxicity: Monitor hepatic enzymes during treatment.

Embryo-Fetal Toxicity: Bortezomib can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to avoid pregnancy.

Herpes Virus Infection: Consider using antiviral prophylaxis.

After reconstitution, the dose of Bortezomib for Injection must be individualized to prevent overdose. Most commonly reported adverse reactions (incidence ≥20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia.

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 Bortezomib for Injection safely and effectively. Please click on the following link https://tinyurl.com/yd7d2g7d for the full prescribing information for Bortezomib for Injection.

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