Bendamustine Injection

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.

Bendamustine comes as a solution (liquid) or as a powder to be mixed with liquid and injected intravenously (into a vein) over 10 minutes or infused intravenously over 30 or 60 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.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving bendamustine injection,

• tell your doctor and pharmacist if you are allergic to bendamustine, any other medications, or any of the ingredients in bendamustine injection. Ask your pharmacist for a list of the ingredients.
• 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: ciprofloxacin (Cipro), fluvoxamine (Luvox, and omeprazole (Prilosec). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may interact with bendamustine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have or have ever had cytomegalovirus infection (CMV; a viral infection that may cause symptoms in patients with weak immune systems), hepatitis B virus infection (HBV; an ongoing liver infection), tuberculosis (TB; a serious infection that affects the lungs and sometimes other parts of the body), herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past), or kidney or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are receiving bendamustine injection. You should use birth control to prevent pregnancy in yourself or your partner during your treatment with bendamustine injection and for 3 months afterwards. Talk to your doctor about birth control methods that will work for you. If you or your partner becomes pregnant while receiving bendamustine injection, call your doctor. Bendamustine injection can harm the fetus.
• tell your doctor if you are breast-feeding. You should not breastfeed during your treatment with bendamustine.
• 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.

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

Call your doctor right away if you are unable to keep an appointment to receive a dose of bendamustine injection.

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

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

• pain in the place where the medication was injected
• 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
• nausea; vomiting; unusual bleeding or bruising; yellowing of the skin or eyes, dark urine, or light colored stool; tenderness on the right upper side of the stomach

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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• rapid, irregular, or pounding heartbeat

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to bendamustine injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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