bendamustine

Generic Name: bendamustine (BEN da MUS teen)Brand Names: Treanda

What is bendamustine?

Bendamustine is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

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

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

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

You should not receive this medication if you are allergic to bendamustine or mannitol (Osmitrol).

Before you receive bendamustine, tell your doctor if you have a weak immune system, fever or other signs of infection, a metabolic disorder or electrolyte imbalance, liver or kidney disease, or if you smoke.

Tell your doctor about all other medications you use, especially carbamazepine (Carbatrol, Equetro, Tegretol), cimetidine (Tagamet), ciprofloxacin (Cipro), fluvoxamine (Luvox), omeprazole (Prilosec), thiabendazole (Mintezol), or a barbiturate such as phenobarbital (Solfoton) and others.

Do not use this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Tell your caregiver right away if you have a fever, chills, itching, or skin rash during or shortly after the injection.

Other serious side effects to tell your doctor about include fever, chills, cough, sore throat, feeling short of breath, pale skin, easy bruising or bleeding, severe skin rash or itching, vomiting, diarrhea, pain, urinating less than usual, weak pulse, muscle weakness or stiffness, confusion, hallucinations, or white patches or sores inside your mouth or on your lips.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your blood pressure may also need to be checked. Do not miss any scheduled appointments.

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

You should not receive this medication if you are allergic to bendamustine or mannitol (Osmitrol).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive bendamustine:

• a weak immune system;

• fever or other signs of infection;

• a metabolic disorder or electrolyte imbalance;

• liver disease;
• kidney disease; or

• if you smoke.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Before you receive bendamustine, tell your doctor if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether bendamustine passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

Some people receiving bendamustine have developed certain types of cancers. It is not known whether this medication causes cancer. Talk with your doctor about the risks and benefits of using bendamustine.

How is bendamustine given?

Bendamustine is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take at least 30 minutes to complete.

Bendamustine is usually given for 2 days in a row every 21 to 28 days. You may receive up to 8 treatments total, depending on the condition being treated. Follow your doctor's instructions.

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

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your blood pressure may also need to be checked. Do not miss any scheduled appointments.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your bendamustine injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include drowsiness, tremors, slow or shallow breathing, loss of balance or coordination, or seizure (convulsions).

What should I avoid while receiving bendamustine?

Bendamustine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Bendamustine side effects

Some people receiving a bendamustine injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have fever, chills, itching, or skin rash during or shortly after the injection. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have a serious side effect such as:

• fever, chills, body aches, flu symptoms;

• cough with yellow or green mucus, stabbing chest pain, feeling short of breath;

• pale skin, easy bruising or bleeding, extreme weakness;

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• the first sign of any skin rash, no matter how mild;

• nausea, vomiting, diarrhea, loss of appetite, lower back pain, urinating less than usual;

• slow heart rate, weak pulse, muscle weakness or stiffness;

• confusion, hallucinations; or

• white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

• mild nausea, vomiting, constipation;

• dry mouth, decreased sensation of taste;

• drowsiness, tired feeling;

• headache;

• weight loss; or

• pain, itching, swelling or other irritation around the IV needle.

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.

Bendamustine Dosing Information

Usual Adult Dose for Chronic Lymphocytic Leukemia:

Recommended dose: 100 mg/m2 administered intravenously on days 1 and 2 of a 28 day cycle, up to 6 cycles. Bendamustine is intended for administration as an intravenous infusion over 30 minutes.Consider using allopurinol as prevention for patients at high risk of tumor lysis syndrome for the first few weeks of treatment.Bendamustine administration should be delayed in the event of grade 4 hematologic toxicity or clinically significant greater than or equal to grade 2 nonhematologic toxicity. Once nonhematologic toxicity has recovered to less than or equal to grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) greater than or equal to 1 x 10^9/L, platelets greater than or equal 75 x 10^9/L], bendamustine can be reinitiated at the discretion of the treating physician. Dose delays may be warranted.Dose modifications for hematologic toxicity: for grade 3 or greater toxicity, reduce the dose to 50 mg/m2 on days 1 and 2 of each cycle; if grade 3 or greater toxicity recurs, reduce the dose to 25 mg/m2 on days 1 and 2 of each cycle.Dose modifications for nonhematologic toxicity: for clinically significant grade 3 or greater toxicity, reduce the dose to 50 mg/m2 on days 1 and 2 of each cycle.Dose reescalation in subsequent cycles may be considered at the discretion of the treating physician.

Usual Adult Dose for non-Hodgkin's Lymphoma:

Recommended dose: 120 mg/m2 intravenously on days 1 and 2 of a 21 day cycle for up to 8 cycles. Bendamustine is intended for administration as an intravenous infusion over 60 minutes.Bendamustine administration should be delayed in the event of a grade 4 hematologic toxicity or clinically significant greater than or equal to grade 2 nonhematologic toxicity. Once nonhematologic toxicity has recovered to less than or equal to grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) greater than or equal to 1 x 10^9/L, platelets greater than or equal 75 x 10^9/L], bendamustine can be reinitiated at the discretion of the treating physician. In addition, dose reduction may be warranted.Dose modifications for hematologic toxicity: for grade 4 or greater toxicity, reduce the dose to 90 mg/m2 on days 1 and 2 of each cycle; if grade 4 or greater toxicity recurs, reduce the dose to 60 mg/m2 on days 1 and 2 of each cycle.Dose modifications for nonhematologic toxicity: for grade 3 or greater toxicity, reduce the dose to 90 mg/m2 on days 1 and 2 of each cycle; if grade 3 or greater toxicity recurs, reduce the dose to 60 mg/m2 on Days 1 and 2 of each cycle.

What other drugs will affect bendamustine?

Tell your doctor about all other medications you use, especially:

• carbamazepine (Carbatrol, Equetro, Tegretol);

• cimetidine (Tagamet);

• ciprofloxacin (Cipro);

• fluvoxamine (Luvox);

• omeprazole (Prilosec);

• thiabendazole (Mintezol); or

• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Solfoton).

This list is not complete and there may be other drugs that can interact with bendamustine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about bendamustine.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.05. Revision Date: 09/17/2009 2:14:55 PM.