Full Prescribing Information, including Boxed WARNINGS
Herceptin Dear Healthcare Provider Letter (198K/PDF)
Herceptin Vial Dear Healthcare Provider Letter (35K/PDF)

Herceptin® (Trastuzumab) is the first humanized antibody approved for the treatment of HER2-positive metastatic breast cancer. Herceptin is designed to target and block the function of HER2 protein overexpression.

Research has shown that HER2-positive breast cancer is a more aggressive disease with a greater likelihood of recurrence, a poorer prognosis, and a decreased chance of survival compared with HER2-negative breast cancer.

Adjuvant indications Herceptin is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature) breast cancer:

• As part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
• With docetaxel and carboplatin
• As a single agent following multi-modality anthracycline-based therapy

Metastatic indications Herceptin is indicated:

• In combination with paclitaxel for the first line treatment of HER2-overexpressing metastatic breast cancer
• As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

Status The U.S. Food and Drug Administration (FDA) approved Herceptin in September 1998. In November 2006, the FDA approved Herceptin as part of a treatment regimen containing doxorubicin, cyclophosphamide and paclitaxel, for the adjuvant treatment of patients with HER2-positive, node-positive breast cancer.

In January 2008, the FDA approved Herceptin as a single agent for the adjuvant treatment of HER2-overexpressing node-negative (ER/PR-negative or with one high-risk feature) or node-positive breast cancer, following multi-modality anthracycline-based therapy.

Important Safety Information, including Boxed WARNINGS

• Herceptin treatment can result in heart problems, including those without symptoms (reduced heart function) and those with symptoms (congestive heart failure). The risk and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). The doctor will stop or strongly consider stopping Herceptin if the patient has a significant drop in their heart function. Patients should be monitored for decreased heart function before their first dose of Herceptin, and frequently during the time they are receiving Herceptin and after their last dose of Herceptin. If patients must permanently or temporarily stop Herceptin due to heart problems, they should be monitored more frequently. In one study with Herceptin and certain types of chemotherapy, an inadequate blood supply to the heart occurred.
• Some patients have had serious infusion reactions and lung problems; fatal infusion reactions have been reported. In most cases, these reactions occurred during or within 24 hours of receiving Herceptin. The patient's Herceptin infusion should be temporarily stopped if shortness of breath or very low blood pressure occurs. The doctor will monitor the patient until these symptoms go away. If patients have a severe allergic reaction, swelling, lung problems, inflammation of the lung, or severe shortness of breath, their doctor may need to completely stop their Herceptin treatment. Patients receiving their first dose of Herceptin may have chills and fever as well as nausea, vomiting, pain, headache, dizziness, shortness of breath, low blood pressure, rash, and weakness.
• Worsening of low white blood cell counts associated with chemotherapy has also occurred.
• Herceptin can cause low amniotic fluid levels and harm to the fetus when taken by a pregnant woman. Patients should talk to their doctor if they are pregnant or become pregnant while taking Herceptin. Patients who are pregnant and receiving Herceptin should consider joining the MotHER Herceptin Pregnancy Registry by calling 1-800-690-6720.
• Patients should call their doctor immediately if they have any of the following: new or worsening shortness of breath; cough; swelling of the ankles or legs; swelling of the face; heartbeats that are unusually strong, fast, slow, or irregular in rhythm; weight gain of more than 5 pounds in 24 hours; dizziness; or loss of consciousness.

The most common side effects associated with Herceptin were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cells, and muscle pain.