Treanda (Bendamustine Hydrochloride Injection) Drug Information: Medication Guide and Patient Information

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May 27, 2012

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Leukemia »

Leukemia facts

Leukemia is a cancer of the blood cells.
While the exact cause(s) of leukemia is not known, risk factors have been identified.
Leukemias are grouped by how quickly the disease develops (acute or chronic) as well as by the type of blood cell that is affected (lymphocytes or myelocytes). The four main types of leukemia include acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), acute myelocytic leukemia (AML), and chronic myelocytic leukemia (CML).
People with leukemia are at significantly increased risk for developing infections, anemia, and bleeding. Other symptoms and signs include easy bruising, weight loss, night sweats, and unexplained fevers.
The diagnosis of leukemia is supported by findings of the medical history and examination, and examining blood and bone marrow samples under a microscope.
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PATIENT INFORMATION

Allergic (Hypersensitivity) Reactions
Patients should be informed of the possibility of mild or serious allergic reactions and to immediately report rash, facial swelling, or difficulty breathing during or soon after infusion.
Myelosuppression
Patients should be informed of the likelihood that TREANDA (bendamustine hydrochloride injection) will cause a decrease in white blood cells, platelets, and red blood cells. They will need frequent monitoring of these parameters. They should be instructed to report shortness of breath, significant fatigue, bleeding, fever, or other signs of infection.
Pregnancy and Nursing
TREANDA (bendamustine hydrochloride injection) can cause fetal harm. Women should be advised to avoid becoming pregnant throughout treatment and for 3 months after TREANDA (bendamustine hydrochloride injection) therapy has stopped. Men receiving TREANDA (bendamustine hydrochloride injection) should use reliable contraception for the same time period. Advise patients to report pregnancy immediately. Advise patients to avoid nursing while receiving TREANDA (bendamustine hydrochloride injection) .
Fatigue
Advise patients that TREANDA (bendamustine hydrochloride injection) may cause tiredness and to avoid driving any vehicle or operating any dangerous tools or machinery if they experience this side effect.
Nausea and Vomiting
Advise patients that TREANDA (bendamustine hydrochloride injection) may cause nausea and/or vomiting. Patients should report nausea and vomiting so that symptomatic treatment may be provided.
Diarrhea
Advise patients that TREANDA (bendamustine hydrochloride injection) may cause diarrhea. Patients should report diarrhea to the physician so that symptomatic treatment may be provided.
Rash
Advise patients that a mild rash or itching may occur during treatment with TREANDA (bendamustine hydrochloride injection) . Advise patients to immediately report severe or worsening rash or itching