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 patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.

Treatment With BENDEKA

Chronic lymphocytic leukemia (CLL) is a type of leukemia

If you have been diagnosed with CLL, your doctor may order or prescribe BENDEKA for you. CLL is a slow-growing (chronic) type of leukemia that starts in lymphoid stem cells (in the bone marrow). Most CLL affects B-cell lymphocytes (specialized white blood cells) by preventing their normal development.

These partially mature cells live longer than normal white blood cells. They build up over a long time in the bone marrow and blood. As they grow in number, they keep normal red blood cells, all types of white blood cells, and platelets from developing.

Slow-growing B-cell non-Hodgkin lymphoma (NHL) is a cancer of the lymphatic system

If you have been previously treated for a slow-growing NHL that has continued to worsen during or after treatment with another medication, your doctor may switch you to BENDEKA.

NHL occurs when mature cells in the lymphatic system become abnormal and multiply. These abnormal cells don’t die when they should, and they don’t protect the body against infection. As the cells build up, they often form tumors.

These abnormal cells can go to virtually every part of the body through the lymphatic system. In fact, NHL is often in more than one part of the body by the time it is found.

Approved Use:

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.
· Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.

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:
-Signs of allergic reactions including; rash, facial swelling, or difficulty breathing during or soon after your infusion with BENDEKA injection.
-Signs of infection including; shortness of breath, significant fatigue, bleeding, bruising, fever, or other signs of infection and or any suspicious skin changes.
-Confusion, memory loss, trouble thinking, difficulty talking or walking, vision loss or other neurological or cognitive symptoms.
-Nausea, vomiting, diarrhea, loss of appetite, or a yellow skin tone.

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 can cause fetal harm if taken while pregnant. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with BENDEKA. Females of reproductive potential should use effective contraception during treatment with BENDEKA and for 6 months after the last dose and for males with female partners for 3 months after the last dose. BENDEKA may also impair male fertility. Females should not breastfeed during treatment with BENDEKA and for 1
week after the last dose.

Most common side effects include: fatigue, fever, nausea, and vomiting, diarrhea, constipation, loss of appetite, cough, headache, weight loss, difficulty breathing, rash, mouth irritation, 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 or call 1-800-FDA-1088.

Please read the Full Prescribing Information.


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Medical Information

For healthcare professionals or patients with specific medical questions about BENDEKA® (bendamustine HCl) injection, 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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