BENDEKA® (bendamustine HCl) Injection | Understanding Serious Side Effects

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.

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 because it may cause fetal harm if you take BENDEKA while pregnant. Your doctor 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. For more information, see Important Safety Information.

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?

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.

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

Infuse in about 10 minutes

Learn how BENDEKA is given

Your doctor will monitor your response to treatment with BENDEKA

Learn what to expect from BENDEKA

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.