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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)]

Myelosuppression
Inform patients of the likelihood that bendamustine hydrochloride 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)]

Hepatotoxicity
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)].

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

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

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

Pregnancy and Nursing
Bendamustine hydrochloride 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 bendamustine hydrochloride should use reliable contraception for the same time period. Advise patients to report pregnancy immediately. Advise patients to avoid nursing while receiving bendamustine hydrochloride.[see Use in Specific Populations (8.1)]


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Woodcliff Lake, NJ

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