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Treanda Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, tiredness, weakness, or mouth sores may occur. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: unusual tiredness, pale skin, signs of infection (e.g., persistent sore throat, cough, fever, chills), easy bruising/bleeding.

Bendamustine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, drink plenty of fluids unless your doctor directs you otherwise. Also, your doctor may prescribe an additional medication. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), pink/bloody urine, change in the amount of urine, painful urination, muscle spasms/weakness.

This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.

Bendamustine can commonly cause a reaction with symptoms of rash, itching, fever, and chills. This reaction is usually not serious. However, you may not be able to tell it apart from a rare allergic reaction that could be severe. Therefore, get medical help right away if you develop any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist promptly.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Treanda (bendamustine hydrochloride injection) Side Effects Center for a complete guide to possible side effects

PRECAUTIONS: Before using bendamustine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as mannitol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow disorders, kidney problems, liver problems, recent/current infection.

Bendamustine can make you more likely to get infections or may worsen any current infections. Therefore, do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Also avoid contact with people who have infections that may spread to others (e.g., chickenpox, flu). Wash your hands well to prevent the spread of infections.

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may cause tiredness. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This drug is not recommended for use during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while using this medication and for 3 months after treatment. Therefore, males and females must use reliable forms of birth control (e.g., condoms, birth control pills) during treatment and for 3 months following the end of treatment with this drug. If you become pregnant or think you may be pregnant, or if your partner becomes pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. However, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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