Bendamustine Injection

What is this medication?

BENDAMUSTINE (BEN da MUS teen) is a chemotherapy drug. It is used to treat chronic lymphocytic leukemia and non-Hodgkin lymphoma.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): BELRAPZO, BENDEKA, Treanda

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)
• kidney disease
• liver disease
• an unusual or allergic reaction to bendamustine, mannitol, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• clozapine

This medicine may also interact with the following medications:

• atazanavir
• cimetidine
• ciprofloxacin
• enoxacin
• fluvoxamine
• medicines for seizures like carbamazepine and phenobarbital
• mexiletine
• rifampin
• tacrine
• thiabendazole
• zileuton

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

You may need blood work done while you are taking this medicine.

Call your doctor or healthcare provider for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your healthcare provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

In some patients, this medicine may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your health care provider right away. If you cannot reach your health care provider, urgently seek other source of medical care.

This medicine may increase your risk to bruise or bleed. Call your doctor or healthcare provider if you notice any unusual bleeding.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

This medicine may increase your risk of skin cancer. Check your skin for changes to moles or for new growths while taking this medicine. Call your health care provider if you notice any of these skin changes.

Do not become pregnant while taking this medicine or for at least 6 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for at least 3 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your healthcare provider or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for at least 1 week after stopping it.

This medicine may make it more difficult to father a child. You should talk with your doctor or healthcare provider if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
• rash, fever, and swollen lymph nodes
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• signs of infection like fever or chills, cough, sore throat, pain or difficulty passing urine
• signs of decreased platelets or bleeding like bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
• signs of decreased red blood cells like being unusually weak or tired, fainting spells, lightheadedness
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation
• decreased appetite
• diarrhea
• headache
• mouth sores
• nausea, vomiting
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.