Bendamustine is used to treat chronic lymphocytic leukemia. Bendamustine is also used to treat indolent B-cell non-Hodgkin lymphoma after other medicines have been tried without successful treatment of this condition.

Bendamustine may also be used for purposes not listed in this medication guide.

You should not be treated with this medicine if you are allergic to bendamustine, polyethylene glycol, propylene glycol, or mannitol (Osmitrol).

Tell your doctor if you have ever had:

• a weak immune system;
• fever or other signs of infection;
• tuberculosis;
• herpes zoster (also called shingles)
• a metabolic disorder or electrolyte imbalance;
• liver disease;
• kidney disease; or
• if you smoke.

Using bendamustine may increase your risk of developing certain types of cancer. Ask your doctor about this risk.

Bendamustine can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use bendamustine if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using bendamustine.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because bendamustine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Use Vivimusta (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Bendamustine may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Call your doctor at once if you have:

• fever, chills, or itching during or shortly after the injection;
• pain, swelling, redness, skin changes, or signs of infection where the medicine was injected;
• severe ongoing nausea, vomiting, or diarrhea;
• liver problems--right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well;
• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
• signs of tumor cell breakdown--confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

Your cancer treatments may be delayed if you have certain side effects.

Common side effects may include:

• fever, cough, mouth sores, trouble breathing;
• low blood cell counts;
• nausea, vomiting, diarrhea, constipation;
• headache, tiredness;
• rash; or
• loss of appetite, weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.