Pronunciation:

ben-da-MUS-teen

Brand Names:

• Belrapzo
• Bendeka
• Treanda
• Vivimusta

Dosage Forms:

• Solution
• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Alkylating Agent

Chemical—

Nitrogen Mustard

Uses of This Medicine:

Bendamustine injection is used to treat chronic lymphocytic leukemia (CLL, cancer of white blood cells) and indolent B-cell non-Hodgkin's lymphoma (NHL) in patients who have already received other treatments. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Bendamustine belongs to a group of cancer medicines called alkylating agents.

Before you begin treatment with bendamustine, you and your doctor should talk about the benefits this medicine will have as well as the risks of using it.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of bendamustine injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bendamustine injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Amiodarone
• Bacillus of Calmette and Guerin Vaccine, Live
• Carbamazepine
• Cholera Vaccine, Live
• Ciprofloxacin
• Dengue Tetravalent Vaccine, Live
• Enoxacin
• Fluvoxamine
• Fosphenytoin
• Influenza Virus Vaccine, Live
• Interferon Alfa-2b
• Mexiletine
• Obeticholic Acid
• Peginterferon Alfa-2a
• Phenytoin
• Poliovirus Vaccine, Live
• Rifampin
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Vemurafenib
• Yellow Fever Vaccine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Tobacco

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cancer (eg, acute myeloid leukemia, myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, bronchial carcinoma, non-melanoma skin cancer)—Use with caution. May make this condition worse.

• Infection—May decrease your body’s ability to fight infections.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

You will receive this medicine in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control to keep from getting pregnant while you are receiving this medicine and for at least 6 months after stopping it. Men should continue to use birth control for at least 3 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Some men who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Bendamustine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection (eg, pneumonia). It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of an infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you have fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination, trouble breathing, or unusual bleeding or bruising.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor if you have weakness on one side of the body, clumsiness, blurred vision, changes in thinking, memory problems, confusion, or personality changes.

This medicine may cause serious allergic reactions, including anaphylaxis and infusion reactions, which can be life-threatening and require immediate medical attention. Tell your doctor or nurse right away if you have chest tightness, chills, cough, fast heartbeat, fever, hives, hoarseness, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, rash, trouble breathing, trouble swallowing, or unusual tiredness or weakness after you receive the medicine.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) may occur during treatment with bendamustine. Tell your doctor right away if you have black ,tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, fever, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness while receiving this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of getting other cancers, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, bronchial carcinoma, and non-melanoma skin cancer (eg, basal cell carcinoma and squamous cell carcinoma). Talk to your doctor if you have concerns about this risk.

This medicine may cause a permanent depression (necrosis) under the skin at the injection site. Contact your doctor right away if you have depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or peeling of the skin at the injection site.

Bendamustine may cause some people to feel unusually tired or weak. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not smoke tobacco while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

blood in the urine or stools

chest pain

chills

cough or hoarseness

diarrhea

fever

headache

joint pain, stiffness, or swelling

lack or loss of strength

lower back, side, or stomach pain

muscle aches

nausea

painful or difficult urination

pale skin

pinpoint red spots on the skin

sore throat

stuffy or runny nose

swelling of the feet or lower legs

swollen glands

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Less common

Burning or stinging of the skin

chest tightness

fast heartbeat

hives, itching, or rash

irritation

painful cold sores or blisters on the lips, nose, eyes, or genitals

redness of the skin

stiffness or swelling

swelling of the eyelids, face, lips, hands, or feet

trouble swallowing

Incidence not known

Back pain

blistering, flaking, or peeling of the skin

bluish color

blurred vision

changes in skin color

confusion

dizziness

drowsiness

pain, tenderness, or swelling of the foot or leg

pain or discomfort in the arms, jaw, back, or neck

persistent non-healing sore

pink growth

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

reddish patch or irritated area

seizures

shiny bump

sweating

thickening of bronchial secretions

weakness

white, yellow, or waxy scar-like area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Decreased weight

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.