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.

Finding support

Talk with your doctor

Your doctor is your best resource when it comes to understanding treatment and will be able to help answer most of the questions you may have. Your doctor will help guide you along your journey and will be with you every step of the way.

Talk with your loved ones

Discussing your illness may be harder with a loved one than it is with someone you’re not close to. But this is a step you should consider taking. It’s also a step that can help you accept the reality of your situation and then move forward. Sometimes, relationships can even grow stronger in times like these. Try to be honest and open.

Share your emotions

Sharing your feelings with others can help you be more comfortable with those feelings. Reach out to those who know effective ways to help you cope. These people might include:

Members of your health care team
Health psychologists
Oncology social workers
Other mental health experts
Faith or spiritual counselors

Join a support group

As alone as you may feel sometimes, remember that many other people are facing similar challenges. You can connect with these people by joining a support group. Some groups meet in person, by phone, or over the Internet. Hearing other people’s stories can give you valuable insight into how to cope with your emotions. Some group members prefer to simply listen and not talk. And that’s fine. Your health care team may be able to direct you to a local support group.

Teva offers a resource called CORE^® (Comprehensive Reimbursement Expertise).

CORE provides tools to help make it easier to understand the reimbursement process

The CORE hotline (1-888-587-3263) can help:

Verify benefits and coverage
Offer precertification and prior authorization support
Explain coverage guidelines
Provide personalized support through the claims and appeals process
Identify programs that may be able to help you pay for treatment

Visit

www.TevaCORE.com

Phone

Call 1-888-587-3263

Patient assistance program

The Teva Cares Foundation Patient Assistance Program provides certain Teva medications at no cost to eligible patients in the United States. Eligibility is based on patients’ income and prescription insurance status. To learn more visit TevaCares.org or call 1-877-237-4881.

Insurance

Here are some commonly used terms and considerations regarding insurance:

Reimbursement is the process of getting payment from an insurance plan for drugs already paid for
Prior authorization is the process of getting approval from an insurance plan for a medication or service before receiving it. Some insurance plans may require prior authorization for Teva Oncology products
Make sure that your doctor's office has your most current insurance information
Typically, your doctor’s office submits all paperwork, but you may need to update your patient information at your doctor's office
If you don’t have insurance coverage, and have difficulty affording your treatment, contact the CORE hotline at 1-888-587-3263
CORE (Comprehensive Oncology Reimbursement Expertise) is a convenient reimbursement resource for patients and their health care providers. CORE provides a reimbursement support program along with online tools and resources. You can find information on the CORE website or by calling the CORE hotline at 1-888-587-3263
There are many reasons why insurance plans issue denials. Whatever the reason, you may be able to file an appeal. See the Reimbursement Process page for an example of how the process works
An appeal is a request for reconsideration of services that were denied reimbursement by an insurance plan. An appeal is filed if the insurance plan does not pay or does not pay enough for a procedure or service. The appeal is made to the insurance plan and there are usually specific guidelines
The amount of time an insurance plan has to respond to an appeal request varies by plan, but insurance plans usually have 30 to 45 days to respond to an appeal request

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.