Embryo Fetal Toxicity

Exposure to Herceptin during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. [see Warnings and Precautions (5.3), Use in Specific Populations (8.1)]
1 INDICATIONS AND USAGE
1.1 Adjuvant Breast Cancer

Herceptin is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1)]) breast cancer

• as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
• with docetaxel and carboplatin
• as a single agent following multi-modality anthracycline based therapy.

1.2 Metastatic Breast Cancer

Herceptin is indicated:

• In combination with paclitaxel for 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.

1.3 Metastatic Gastric Cancer

Herceptin is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Doses and Schedules

Do not administer as an intravenous push or bolus. Do not mix Herceptin with other drugs.

Adjuvant Treatment, Breast Cancer:

Administer according to one of the following doses and schedules for a total of 52 weeks of Herceptin therapy:

During and following paclitaxel, docetaxel, or docetaxel/carboplatin:

• Initial dose of 4mg/kg as an intravenous infusion over 90minutes then at 2mg/kg as an intravenous infusion over 30minutes weekly during chemotherapy for the first 12weeks (paclitaxel or docetaxel) or 18weeks (docetaxel/carboplatin).
• One week following the last weekly dose of Herceptin, administer Herceptin at 6mg/kg as an intravenous infusion over 30–90minutes every three weeks.

As a single agent within three weeks following completion of multi‑modality, anthracycline‑based chemotherapy regimens:

• Initial dose at 8mg/kg as an intravenous infusion over 90minutes
• Subsequent doses at 6mg/kg as an intravenous infusion over 30–90minutes every three weeks.

[see Dose Modifications (2.2)]

Metastatic Treatment, Breast Cancer:

• Administer Herceptin, alone or in combination with paclitaxel, at an initial dose of 4mg/kg as a 90 minute intravenous infusion followed by subsequent once weekly doses of 2mg/kg as 30minute intravenous infusions until disease progression.

Metastatic Gastric Cancer

• Administer Herceptin at an initial dose of 8mg/kg as a 90 minute intravenous infusion followed by subsequent doses of 6mg/kg as an intravenous infusion over 30-90 minutes every threeweeks until disease progression [see Dose Modifications (2.2)].

2.2 Dose Modifications

Infusion Reactions

[see Boxed Warning, Warnings and Precautions (5.2)]