BENDAMUSTINE

Please see Precautions section.

Common side effects:

• nausea
• vomiting
• diarrhea
• tiredness
• headache
• dizziness
• weakness
• mouth sores

Tell your doctor right away if you have any serious side effects, including:

• unusual tiredness
• pale skin
• signs of infection (such as persistent sore throat, cough, fever, chills)
• easy bruising/bleeding
• swelling ankles/feet/hands

Bendamustine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, drink plenty of fluids unless your doctor directs you otherwise. Also, your doctor may prescribe an additional medication. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), pink/bloody urine, change in the amount of urine, painful urination, muscle spasms/weakness.

This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.

Bendamustine can commonly cause a reaction with symptoms of rash, itching, fever, and chills. This reaction is usually not serious. However, you may not be able to tell it apart from a rare allergic reaction that could be severe. Therefore, get medical help right away if you develop any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Precautions

• Allergy: Before using bendamustine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
• Medical History: Before using this medication, tell your doctor or pharmacist if you had: blood/bone marrow disorders, kidney problems, liver problems, recent/current infection.
• Infections: Bendamustine can make you more likely to get infections or may worsen any current infections. Therefore, do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Also avoid contact with people who have infections that may spread to others (such as chickenpox, flu). Wash your hands well to prevent the spread of infections.
• Tumor Lysis syndrome: The onset tends to be within the first treatment cycle of Bendamustine and, without intervention, may lead to acute renal failure and death. Preventive measures include vigorous hydration and close monitoring of blood chemistry, particularly potassium and uric acid levels. Allopurinol has also been used during the beginning of Bendamustine therapy.

Pregnancy Risk: Category D. This drug is not recommended for use during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while using this medication and for 3 months after treatment. Therefore, males and females must use reliable forms of birth control (such as condoms, birth control pills) during treatment and for 3 months following the end of treatment with this drug.

Breastfeeding: It is not known whether this drug passes into breast milk. However, breast-feeding while using this drug is not recommended.

Interactions

• Some products that may interact with this drug include: live vaccines (e.g., typhoid vaccine taken by mouth, flu vaccine inhaled through the nose).

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes: Laboratory and/or medical tests (e.g., complete blood count, liver and kidney function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor immediately to establish a new dosing schedule.

Storage: Not applicable. This medication is given in a clinic and will not be stored at home.