Genentech, the manufacturer of Herceptin^® (trastuzumab), has established this Pregnancy Registry to learn about pregnancy outcomes and the health of women who have taken Herceptin within six months prior to conception or during pregnancy. The information gathered in this Registry may supplement other sources of data and assist clinicians and patients in weighing the risks or benefits of being exposed to this medication around conception and during pregnancy. This drug is not approved for use during pregnancy and women of childbearing potential should be advised to avoid becoming pregnant or nursing while taking Herceptin.

 

The Herceptin Pregnancy Registry is a U.S.-based, prospective, observational study of women with HER2+ breast cancer who were treated with a Herceptin-containing regimen during pregnancy or within six months prior to conception. Women who are interested in enrolling may contact the Registry directly by calling 1-800-690-6720. This Registry is sponsored by Genentech and is managed by INC Research.

 

The primary objective of this Pregnancy Registry is to monitor pregnancies exposed to Herceptin in order to describe adverse pregnancy complications, pregnancy outcomes, fetal/infant outcomes among women with breast cancer treated with Herceptin either in combination with chemotherapies or with Herceptin alone during pregnancy or within six months prior to conception. The Registry also monitors if there is a potential increase in the risk of major birth defects.

 

Due to the observational nature of this Registry, participation in the Registry will not influence or interfere with the treatment plan recommended by the patient's healthcare provider.

 

If you are interested in additional information, click on contact us for the Registry Coordinating Center.

 

Full Indications for Herceptin

 

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

*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 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

Boxed WARNINGS and Additional Important Safety Information

• Herceptin administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Herceptin with anthracycline-containing chemotherapy regimens. In a pivotal adjuvant trial, one patient who developed CHF died of cardiomyopathy.
• Evaluate cardiac function prior to and during treatment. For adjuvant therapy, also evaluate cardiac function after completion of Herceptin. Discontinue Herceptin for cardiomyopathy.
• Herceptin can result in serious and fatal infusion reactions and pulmonary toxicity. Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
• Exposure to Herceptin during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death.
• Exacerbation of chemotherapy-induced neutropenia has also occurred.
• Detection of HER2 protein overexpression is necessary for selection of patients appropriate for Herceptin therapy.
• The most common adverse reactions associated with Herceptin use were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.

Please see the accompanying Herceptin full prescribing information including Boxed WARNINGS and additional important safety information.

For additional information about Herceptin, please click on the following link: www.Herceptin.com.

 

 

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The success of the Registry depends on the continued participation of healthcare providers and pregnant women who have been exposed to Genentech manufactured Herceptin. Participation from patients and healthcare providers is greatly appreciated.

 

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