QUESTIONS FOR YOUR HEALTH CARE TEAM

Who is Halaven for?

Halaven is a prescription medicine used to treat patients with breast cancer who have received at least 2 other types of anticancer medicines for their breast cancer once it has spread. Previous therapy should have included an anthracycline and a taxane for either early or advanced breast cancer.

What important safety information do I need to know about Halaven?

Decreased White Blood Cells (Neutropenia)

• Your doctor should do a blood test to monitor your blood cells before you receive each dose of Halaven, and should monitor you more often if you develop lower white blood cells
• If you develop severe neutropenia lasting longer than 7 days or neutropenia with a fever, your next dose of Halaven should be delayed and reduced. Severe neutropenia occurred in 57% (287/503) of patients who received Halaven and lasted more than 1 week in 12% (62/503) of patients
• Neutropenia with a fever occurred in 5% (23/503) of patients; 2 patients died from complications of neutropenia with a fever
• Neutropenia with a fever can result in serious infections that could lead to hospitalization or death. Call your health care provider immediately if you have any of the following symptoms: fever (temperature above 100.5˚F), chills, coughing, and burning or pain when you urinate

Nerve Disorders (Peripheral Neuropathy)

• Halaven can cause numbness, tingling, or burning in your hands and feet (peripheral neuropathy). You should be monitored closely for signs of neuropathy. If you develop severe neuropathy, treatment with Halaven should be delayed until the neuropathy improves and the next dose of Halaven should be reduced
• Severe peripheral neuropathy occurred in 8% (42/503) of patients who received Halaven. Neuropathy lasting more than 1 year occurred in 5% of patients. Twenty-two percent (109/503) of patients developed a new or worsening neuropathy that had not recovered after an average of 269 days
• Peripheral neuropathy was the most common side effect that caused patients to stop receiving Halaven

Pregnancy and Nursing

• Halaven may harm your unborn baby. Avoid becoming pregnant while you are receiving Halaven. Tell your health care provider right away if you become pregnant or think you are pregnant while you are receiving Halaven
• You and your health care provider should decide if you will take Halaven or breast-feed. You should not do both

Heartbeat Changes

• Halaven can cause changes in your heartbeat (called QTc prolongation). This can cause irregular heartbeats that may lead to death
• Your health care provider will decide if you need heart monitoring (electrocardiogram or ECG) or blood tests during your treatment with Halaven to watch for this problem

What should I be sure to tell my doctor before getting Halaven?

It is important to share all of your medical information with your doctor. Tell your doctor about all of your medical conditions, including:

• If you have ever had low white blood cell counts or low platelet counts
• Liver or kidney problems
• Heart problems, including a problem called “congenital long QT syndrome"
• If you are pregnant or plan to become pregnant. Talk with your doctor about birth control methods
• If you are breast-feeding or planning to breast-feed
• All the medicines you are taking, or if you are planning to take new medicines, such as:
  • — Prescription medication
  • — Medicines that you buy without a prescription
  • — Vitamins
  • — Herbal supplements

How will Halaven be given to me?

Halaven is given as a short intravenous (IV) infusion into the vein that lasts 2 to 5 minutes.

• You will need blood tests before each treatment with Halaven and monitoring for signs of peripheral neuropathy (numbness, tingling, or burning in your hands and feet)
• In patients with mild or moderate liver problems, and/or moderate kidney problems, a lower starting dose of Halaven is recommended

How often will Halaven be given to me?

Halaven is injected once per week for 2 weeks in a row (Day 1 of Week 1 and Day 1 of Week 2), followed by a week with no treatment (Week 3).

• This 3-week period is known as 1 cycle of treatment
• Your doctor may need to decrease your dose of Halaven or change how often you receive it, depending on your blood tests

What are the most common side effects I might experience while being treated with Halaven?

The most common side effects reported in more than 25% of patients who received Halaven in a clinical trial were:

• Low white blood cells (82%)
• Low red blood cells (58%)
• Weakness/tiredness (54%)
• Hair loss (45%)
• Numbness, tingling, or burning in the hands and feet (35%)
• Nausea (35%)
• Constipation (25%)

The most common serious side effects reported with Halaven were neutropenia with or without a fever (4% and 2%, respectively).

When should I call my doctor?

You should alert your health care team immediately if you notice any changes in your body or experience any of the following symptoms:

• Fever (temperature above 100.5°F)
• Chills
• Cough
• Burning or pain when you urinate

Tell your doctor about any side effect that bothers you or does not go away.

This Q&A does not include all the possible side effects of Halaven.

For more information, ask your doctor. You may also report side effects to the Food and Drug Administration at 1-800-FDA-1088.

Questions about insurance coverage and possible patient assistance?

For information about reimbursement, patient assistance programs, and all other questions, ask your health care team about the Eisai Assistance Program or visit www.eisaireimbursement.com.

To speak to a dedicated reimbursement consultant, please call 1-866-61-EISAI (1-866-613-4724).

Download your own copy of the Halaven Q&A.