BENDEKA is indicated for the treatment of patients with a Chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established or a Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Understanding serious side effects

Many people worry about serious side effects from their cancer treatment. The serious side effects listed below have been seen in some studies with bendamustine hydrochloride. That is why it is important to talk with your doctor about your treatment and any symptoms you may have.

Who should not take BENDEKA?

If you have a known allergic response to bendamustine polyethylene glycol 400, propylene glycol or monothioglycerol, you should not take BENDEKA. Tell your doctor about any other known allergic responses.

Should pregnant women take BENDEKA?

Women should avoid becoming pregnant while receiving BENDEKA and for three months after treatment. BENDEKA may cause fetal harm if you take it while pregnant.

BENDEKA MAY CAUSE BLOOD-RELATED SERIOUS SIDE EFFECTS

Lower than normal blood cell counts

  • A low red blood cell count can make you feel tired easily or short of breath

  • A low white blood cell count can make you more likely to get an infection

  • A low platelet count can make you more likely to have bleeding that is not normal for you

Infections

  • Tell your doctor if you have shortness of breath, significant fatigue, bleeding, fever or other signs of infection

BENDEKA MAY CAUSE NON–BLOOD-RELATED SERIOUS SIDE EFFECTS

  • Infections and recurrence of infections

  • Infusion reactions

  • Sudden and severe allergic responses

  • Kidney failure due to fast breakdown of cancer cells

  • Other cancers

  • Leaking of BENDEKA out of your vein and into your surrounding skin

  • Liver injury

Can getting an infusion of BENDEKA cause a reaction?

Yes, tell your doctor if you have any side effects including: rash, facial swelling, or difficulty breathing during or soon after your infusion with BENDEKA injection. These are signs of an allergic reaction. You also should tell your doctor if you have shortness of breath, significant fatigue, bleeding, bruising, fever, or other signs of infection. Also, tell your doctor if you experience nausea, vomiting, diarrhea, loss of appetite, or a yellow skin tone. In addition, your doctor will perform blood tests to see if you have low blood counts. These are lower-than-normal numbers of red blood cells, white blood cells, or platelets.

Warning
Tell your doctor or nurse right away if you have any of these side effects associated with BENDEKA because some of these effects may become serious and could be fatal if they are not treated in time.

Changes in treatment

Some serious side effects may require changes in your treatment, such as:

  • Lowering the amount of BENDEKA given

  • Waiting longer between doses of BENDEKA

  • Stopping the use of BENDEKA

Important Safety Information

BENDEKA is not right for everyone, including patients with a known allergic response to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol.

BENDEKA may cause serious side effects including: low blood cell counts, infections or recurrence of infections, unexpected responses to BENDEKA when placed in your blood, sudden and severe allergic responses, kidney failure due to fast breakdown of cancer cells, other cancers, and leaking of BENDEKA out of your vein and into your surrounding skin. Some of these side effects, such as low blood counts, infections, liver injury, and severe allergic skin responses (when bendamustine HCL was given alone and in combination with other anticancer medications or allopurinol), have caused death.

Tell your doctor if you have any side effects including: rash, facial swelling, or difficulty breathing during or soon after your infusion with BENDEKA injection. These are signs of an allergic reaction. You also should tell your doctor if you have shortness of breath, significant fatigue, bleeding, bruising, fever, or other signs of infection. Also, tell your doctor if you experience nausea, vomiting, diarrhea, loss of appetite, or a yellow skin tone. In addition, your doctor will perform blood tests to see if you have low blood counts. These are lower-than-normal numbers of red blood cells, white blood cells, or platelets.

Some serious side effects may require changes in therapy, such as lowering the amount of BENDEKA given, stopping the use of BENDEKA, or waiting longer than expected between doses of BENDEKA.

BENDEKA may cause fetal harm if taken while pregnant. Women should avoid becoming pregnant or nursing while receiving BENDEKA.

Non–blood-related side effects may occur including: fever, nausea, and vomiting, diarrhea, constipation, loss of appetite, cough, headache, weight loss, difficulty breathing, rash, and mouth irritation.

Blood-related side effects may occur including: low red blood cells (oxygen-carrying cells), low platelets (blood-clotting cells), and decreased number of three different types of white blood cells (infection-fighting cells).

These are not all of the possible side effects of BENDEKA. For more information ask your healthcare provider.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication

BENDEKA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL)—efficacy relative to first-line therapies other than chlorambucil has not been established—or indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Please read the Full Prescribing Information.

 

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The information on this site is intended for healthcare professsionals
in the United States. Are you a healthcare professional in the United States?

 

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Medical Information

For healthcare professionals or patients with specific medical questions about BENDEKA®, please contact:

Teva Medical Information

1-888-4-TEVARX (1-888-483-8279)
To request more information about BENDEKA, click here.

 

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