BENDEKA® (bendamustine HCl) Injection

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.

Frequently asked questions (FAQs)

Your healthcare provider will be able to answer most of the questions you may have. Having a lot of questions about your treatment is normal. We hope you’ll find some answers here.

At the treatment center, you’ll meet nurses and support staff who will also be able to answer your questions before you begin treatment.

Talk with your doctor about any medications you are taking or plan to take. Some types of medication may impact the way BENDEKA works in the body.

A healthy diet is important when you're being treated for cancer. The right diet can help you keep up your strength and energy level. But getting the right nutrition can be hard if you don’t feel well. Some people lose their appetite or have trouble eating because of side effects from chemotherapy.

Tell your healthcare team about any concerns you have about eating. They can help you make diet changes that will help you cope with certain side effects.

That will depend on how you respond to your treatment. Each person responds differently. Ask your doctor what is best for you.

As you return to your daily activities, let your caregiver and friends help you. Allowing friends and family to give moral and emotional support can be very helpful during your treatment.

Get in touch with your doctor or nurse right away if you have any side effects. Don’t wait to share this information at your next office visit.

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 and or any suspicious skin changes. Also, tell your doctor if you experience 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. 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.

In a safety evaluation from a clinical study for CLL, hair loss occurred in 1 of the 153 patients treated with bendamustine hydrochloride compared to 0 (zero) of the 143 patients treated with chlorambucil. In an NHL study, hair loss occurred in 3 of the 100 patients treated with bendamustine hydrochloride.

Try these tips to make sure you are getting the right nutrition:

Eat several snacks during the day, rather than 3 large meals
Eat protein-rich foods, such as yogurt, cereal, half a sandwich, a bowl of soup, cheese and crackers
Avoid foods that make side effects worse. If you have diarrhea, for example, do not eat raw fruits and vegetables. If you have a sore throat, do not eat dry snacks or acidic foods

Understanding common side effects

Learn more about potential

side effects of BENDEKA

Get to know your treatment schedule

Learn how BENDEKA is given

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 www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the Full Prescribing Information.

Frequently asked questions (FAQs)

Try these tips to make sure you are getting the right nutrition:

Approved Use:

Important Safety Information

Medical Information

Teva Medical Information