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BELRAPZO- bendamustine hydrochloride injection

Patient Information

Allergic (Hypersensitivity) Reactions
Inform patients of the possibility of serious or mild allergic reactions and to immediately report rash, facial swelling, or difficulty breathing during or soon after infusion.[see Warnings and Precautions (5.3)]

Inform patients of the likelihood that BELRAPZO will cause a decrease in white blood cells, platelets, and red blood cells and the need for frequent monitoring of blood counts. Advise patients to report shortness of breath, significant fatigue, bleeding, fever, or other signs of infection.[see Warnings and Precautions (5.1)]

Inform patients of the possibility of developing liver function abnormalities and serious hepatic toxicity. Advise patients to immediately contact their health care provider if signs of liver failure occur, including jaundice, anorexia, bleeding or bruising.[see Warnings and Precautions (5.6)].

Advise patients that BELRAPZO may cause tiredness and to avoid driving any vehicle or operating any dangerous tools or machinery if they experience this side effect.[see Adverse Reactions (6.1)]

Nausea and Vomiting
Advise patients that BELRAPZO may cause nausea and/or vomiting. Patients should report nausea and vomiting so that symptomatic treatment may be provided.[see Adverse Reactions (6.1)]

Advise patients that BELRAPZO may cause diarrhea. Patients should report diarrhea to the physician so that symptomatic treatment may be provided.[see Adverse Reactions (6.1)]

Advise patients that a rash or itching may occur during treatment with BELRAPZO. Advise patients to immediately report severe or worsening rash or itching.[see Adverse Reactions (5.5)]

Pregnancy and Nursing
BELRAPZO can cause fetal harm. Women should be advised to avoid becoming pregnant throughout treatment and for 3 months after bendamustine hydrochloride therapy has stopped. Men receiving BELRAPZO should use reliable contraception for the same time period. Advise patients to report pregnancy immediately. Advise patients to avoid nursing while receiving BELRAPZO.[see Use in Specific Populations (8.1)]

Marketed by
Eagle Pharmaceuticals, Inc.
Woodcliff Lake, NJ

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