Bendamustine Injection

Conditions Treated

Bendamustine injection is used to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells). Bendamustine injection is also used to treat a type of non-Hodgkins lymphoma (NHL: cancer that begins in a type of white blood cell that normally fights infection) that is slow spreading, but has continued to worsen during or after treatment with another medication. Bendamustine is in a class of medications called alkylating agents. It works by killing existing cancer cells and limiting the growth of new cancer cells.

Possible Side Effects

What Side Effects Can This Cause?

Bendamustine injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• heartburn
• constipation
• stomach pain or swelling
• sores or white patches in the mouth
• dry mouth
• bad taste in the mouth or difficulty tasting food
• loss of appetite
• weight loss
• headache
• anxiety
• depression
• difficulty falling asleep or staying asleep
• back, bone, joint, arm or leg pain
• dry skin
• sweating
• night sweats
• pain in the place where the medication was injected

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• hives
• rash
• itching
• blistering or peeling skin
• difficulty breathing or swallowing
• swelling of the eyes, face, lips, tongue, arms, hands, feet, ankles, or lower legs
• shortness of breath
• chest pain
• fast heartbeat
• excessive tiredness or weakness
• pale skin
• fever, chills, cough, or other signs of infection
• unusual bleeding or bruising

Bendamustine injection may cause infertility in some men. This infertility may end after treatment, may last for several years, or may be permanent. Talk to your doctor about the risks of receiving this medication.Some people developed other types of cancer while they were using bendamustine injection. There is not enough information to tell whether bendamustine injection caused these cancers to develop. Talk to your doctor about the risks of receiving this medication.Bendamustine injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

Bendamustine comes as a powder to be added to fluid and injected intravenously (into a vein) over 30 minutes by a doctor or nurse in a medical office or hospital outpatient clinic. When bendamustine injection is used to treat CLL, it is usually injected once a day for 2 days, followed by 26 days when the medication is not given. This treatment period is called a cycle, and the cycle may be repeated every 28 days for as long as 6 cycles. When bendamustine injection is used to treat NHL, it is usually injected once a day for 2 days, followed by 19 days when the medication is not given. This treatment cycle may be repeated every 21 days for up to 8 cycles. Your doctor may need to delay your treatment and adjust your dose if you experience certain side effects. Your doctor may also give you other medication(s) to prevent or treat certain side effects. Be sure to tell your doctor how you are feeling during your treatment with bendamustine injection.

What Dietary Instructions Should I Follow

Unless your doctor tells you otherwise, continue your normal diet.

Are There Any Special Instructions

Before receiving bendamustine injection, tell your doctor and pharmacist if you are allergic to bendamustine, mannitol (Osmitrol), or any other medications. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: cimetidine (Tagamet); fluoroquinolones such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin); fluvoxamine (Luvox); omeprazole (Prilosec); and ticlopidine (Ticlid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you have or have ever had kidney or liver disease. you should know that bendamustine injection may make you tired. Do not drive a car or operate machinery until you know how this medication affects you. tell your doctor if you use tobacco products. Smoking may decrease the effectiveness of this medication.