What safety information do I need to know about HALAVEN?

HALAVEN can cause serious side effects, including

• Low white blood cell count (neutropenia). This can lead to serious infections that could lead to death. Your health care provider will check your blood cell counts. Call your health care provider right away if you develop fever (temperature above 100.5°F), chills, cough, or burning or pain when you urinate, as any of these can be symptoms of infection
• Numbness, tingling, or pain in your hands or feet (peripheral neuropathy). Peripheral neuropathy is common with HALAVEN and sometimes can be severe. Tell your health care provider if you have new or worsening symptoms of peripheral neuropathy
• Your health care provider may delay or decrease your dose or stop treatment with HALAVEN if you have side effects

Before you receive HALAVEN, tell your health care provider about all of your medical conditions, including if you

• have liver or kidney problems
• have heart problems, including a problem called congenital long QT syndrome
• have low potassium or low magnesium in your blood
• are pregnant or plan to become pregnant. HALAVEN can harm your unborn baby. Tell your health care provider right away if you become pregnant or think you are pregnant during treatment with HALAVEN. Females who are able to become pregnant should use an effective form of birth control during treatment with HALAVEN and for at least 2 weeks after the final dose of HALAVEN and males should use an effective form of birth control when having sex with female partners who are able to become pregnant during treatment with HALAVEN and for 3½ months (14 weeks) after the final dose of HALAVEN
• are breastfeeding or plan to breastfeed. It is not known if HALAVEN passes into your breast milk. Do not breastfeed during treatment with HALAVEN and for 2 weeks after the final dose of HALAVEN

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of HALAVEN?

HALAVEN can cause changes in your heartbeat (called QT prolongation). This can cause irregular heartbeats. Your health care provider may do heart monitoring (electrocardiogram or ECG) or blood tests during your treatment with HALAVEN to check for heart problems.

The most common side effects of HALAVEN in adults with breast cancer include low white blood cell count (neutropenia), low red blood cell count (anemia), weakness or tiredness, hair loss (alopecia), nausea, and constipation.

Your health care provider will do blood tests before and during treatment while you are taking HALAVEN.

For more information about HALAVEN, please see full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.