Who is Halaven for?

Halaven is for patients with breast cancer who have received at least two 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 taking 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

Liver and Kidney Problems

• In patients with mild or moderate liver problems, and/or moderate kidney problems, a lower starting dose of Halaven is recommended

Most Common Side Effects

• The most common side effects reported in ≥25% of patients receiving Halaven 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%); and constipation (25%)
• The most common serious side effects reported in patients receiving Halaven were neutropenia with or without a fever (4% and 2%, respectively)