Bendamustine Injection

What is this medication?

BENDAMUSTINE (BEN da MUS teen) treats leukemia and lymphoma. It works by slowing down the growth of cancer cells.

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, VIVIMUSTA

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 viral infection, such as chickenpox, cold sores, herpes
• Kidney disease
• Liver disease
• An unusual or allergic reaction to bendamustine, mannitol, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication 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?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medication with any of the following:

• Clozapine

This medication may also interact with the following:

• Atazanavir
• Cimetidine
• Ciprofloxacin
• Enoxacin
• Fluvoxamine
• Medications for seizures, such as carbamazepine, 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?

Visit your care team for regular checks on your progress. This medication 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 care team tells you to stop.

You may need blood work while taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team 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. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

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

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.

Talk to your care team about your risk of skin cancer. You may be more at risk for skin cancer if you take this medication.

Talk to your care team if you or your partner wish to become pregnant or think either of you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for up to 6 months after the last dose. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 6 months after the last dose. Talk to your care team about reliable forms of contraception. Wear a condom while taking this medication and for at least 3 months after the last dose.

Do not breast-feed while taking this medication or for at least 1 week after the last dose.

This medication may cause infertility. Talk to your care team 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 care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Painful swelling, warmth, or redness of the skin, blisters or sores at the infusion site
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain
• Unusual bruising or bleeding

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

• Diarrhea
• Fatigue
• Headache
• Loss of appetite
• Nausea
• Vomiting

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 medication is given in a hospital or clinic. It 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.