bendamustine

What is the most important information I should know about bendamustine?

What is bendamustine?

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.

What should I discuss with my healthcare provider before I receive bendamustine?

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.

• 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.

How is bendamustine given?

Bendamustine is given as an infusion into a vein. A healthcare provider will give you this injection.

Bendamustine is usually given for 2 days in a row every 21 to 28 days. Your doctor will determine how long to treat you with this medicine.

You may be given other medications to help prevent certain side effects of bendamustine.

Bendamustine affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

If you've ever had hepatitis B, using bendamustine can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving bendamustine?

What are the possible side effects of bendamustine?

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.

• 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.

What other drugs will affect bendamustine?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• allopurinol.

This list is not complete. Other drugs may affect bendamustine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about bendamustine.