APPROVED USES

Patients are selected for therapy with HERZUMA based on an FDA-approved test.

Adjuvant Breast Cancer

HERZUMA is a prescription medicine used in adults for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature. HERZUMA can be used in several different ways:

• As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as “AC → TH”
• With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as “TCH”
• Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy)

Metastatic Breast Cancer

HERZUMA has 2 approved uses in metastatic breast cancer in adults:

• HERZUMA in combination with the chemotherapy drug paclitaxel is approved for the first-line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer
• HERZUMA alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease

Metastatic Gastric Cancer

HERZUMA is approved in adults, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2-positive metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease

IMPORTANT SAFETY INFORMATION

HERZUMA can cause serious side effects, including:

• HEART PROBLEMS: Trastuzumab products can cause heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both a trastuzumab product and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. Your healthcare provider will check for signs of heart problems before, during, and after treatment with HERZUMA
• INFUSION REACTIONS: Infusion reactions, sometimes serious or fatal, have occurred. Symptoms may include: fever, chills, feeling sick to your stomach (nausea), throwing up (vomiting), pain (in some cases at tumor site), headache, dizziness, and shortness of breath. These symptoms usually happen within 24 hours after receiving HERZUMA
• SEVERE LUNG PROBLEMS: Trastuzumab product use can result in serious and fatal lung problems. Symptoms may include: severe shortness of breath, fluid in or around the lungs, weakening of the valve between the heart and lungs, not enough oxygen in the body, swelling of the lungs, and scarring of the lungs. Your healthcare provider may check for signs of severe lung problems
• HARM TO UNBORN BABIES OR BIRTH DEFECTS: Trastuzumab products may result in birth defects or the death of an unborn baby. Contraception should be used while receiving HERZUMA and for 7 months after your last dose of HERZUMA. If you are or become pregnant while receiving HERZUMA or within 7 months after your last dose of HERZUMA, you should immediately contact your doctor. Patients should contact their healthcare professional with a known or suspected pregnancy
• LOW WHITE BLOOD CELL COUNTS: Low white blood cell counts (which may be life-threatening) were seen more often in patients receiving trastuzumab plus chemotherapy than in patients receiving chemotherapy alone. Your healthcare provider may check for signs of low white blood cell counts

Your healthcare provider will stop treatment with HERZUMA if you have severe, serious, or life-threatening side effects.

The most common side effects for patients receiving HERZUMA for breast cancer include: headache, diarrhea, feeling sick to your stomach (nausea), chills, fever, infection, weakened heart muscle, unable to sleep, cough, and rash.

The most common side effects for patients receiving HERZUMA for metastatic gastric cancer include: low white blood cell counts, diarrhea, feeling tired, low red blood cell counts, swelling of the mouth lining, weight loss, upper respiratory infections, fever, low platelet counts, swelling of the mucous membranes, swelling of the nose and throat, and change in taste.

These are not all of the possible side effects with HERZUMA. 

Please click here for full Prescribing Information for HERZUMA, including BOXED WARNINGS.

Talk to your doctor about any side effects you may experience.

You may report side effects to Teva at 1-888-483-8279. You may also report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.