IMPORTANT SAFETY INFORMATION AND INDICATIONS
IMPORTANT SAFETY INFORMATION
Possible Serious Side Effects With TRAZIMERA
Not all people have serious side effects, but side effects with trastuzumab-product therapy are common.
Although some people may have a life-threatening side effect, most do not.
Your doctor will stop treatment if any serious side effects occur.
TRAZIMERA is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:
HEART PROBLEMS
These include 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 trastuzumab and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. Your doctor will check for signs of heart problems before, during, and after treatment with TRAZIMERA.
Contact your doctor immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness, or loss of consciousness.
INFUSION REACTIONS, including:
These signs usually happen within 24 hours after receiving trastuzumab products.
Be sure to contact your doctor if you:
Are a woman who could become pregnant, or may be pregnant
Use of trastuzumab products may result in the death of an unborn baby or birth defects. Contraception should be used while receiving TRAZIMERA and for 7 months after your last dose of TRAZIMERA.
Have any signs of SEVERE LUNG PROBLEMS, including:
Your doctor may check for signs of severe lung problems when he or she examines you.
Have LOW WHITE BLOOD CELL COUNTS
Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving trastuzumab plus chemotherapy than in patients receiving chemotherapy alone.
Your doctor may check for signs of low white blood cell counts when he or she examines you.
Side Effects Seen Most Often With Trastuzumab Products
Some patients receiving trastuzumab for breast cancer had the following side effects:
Some patients receiving trastuzumab for metastatic stomach cancer had the following side effects:
You should contact your doctor immediately if you have any of the side effects listed above.
INDICATIONS
Adjuvant Breast Cancer
TRAZIMERA is approved 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+ 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.* TRAZIMERA can be used in several different ways:
Patients are selected for therapy based on an FDA-approved test for trastuzumab products.
*High risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.
Metastatic Breast Cancer
TRAZIMERA has 2 approved uses in metastatic breast cancer:
Patients are selected for therapy based on an FDA-approved test for trastuzumab products.
Gastric Cancer
TRAZIMERA is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2+ 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.
Patients are selected for therapy based on an FDA-approved test for trastuzumab products.
Patients should always ask their doctors for medical advice about adverse events.
You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.
TRAZIMERA is a registered trademark of Pfizer Inc.
Herceptin is a registered trademark of Genentech, Inc.
