#高警訊藥品

乳癌、胃癌
Breast cancer, Adjuvant: Treatment of HER2-overexpressing node positive or node negative (estrogen receptor/progesterone receptor negative or with 1 high-risk feature) breast cancer
1. As part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
2. As part of a treatment regimen with docetaxel and carboplatin
3. As a single agent following multimodality anthracycline-based therapy.
Breast cancer, metastatic:
1. First-line treatment of HER2-overexpressing metastatic breast cancer (in combination with paclitaxel)
2. Single agent treatment of HER2-overexpressing breast cancer in patients who have received 1 or more chemotherapy regimens for metastatic disease.
Gastric cancer, Metastatic: Treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma (in combination with cisplatin and either capecitabine or 5-fluorouracil) in patients who have not received prior treatment for metastatic disease.

Antineoplastic Agent: Anti-HER2, Monoclonal Antibody
Trastuzumab is a monoclonal antibody which binds to the extracellular domain of the human epidermal growth factor receptor 2 protein (HER-2); it mediates antibody-dependent cellular cytotoxicity by inhibiting proliferation of cells which overexpress HER-2 protein.

Vd: 44 mL/ kg
Elimination Half Life: 5.8 days (range 1 to 32 days)

Patients with known hypersensitivity to trastuzumab or to any of its excipients.

D

Infant risk cannot be ruled out.

Common
1. Dermatologic: Rash
2. Endocrine metabolic: Weight decreased
3. Gastrointestinal: Diarrhea, Nausea, Stomatitis, Vomiting
4. Hematologic: Anemia, Neutropenia, Thrombocytopenia
5. Immunologic: Infectious disease
6. Neurologic: Headache, Insomnia
7. Respiratory: Cough
8. Other: Fatigue, Fever, Shivering
Serious
1. Cardiovascular: Cardiac dysrhythmia, Heart failure, Left ventricular cardiac dysfunction, Myocardial ischemia
2. Hematologic: Febrile neutropenia, Neutropenia, Thrombocytopenia, Thrombosis
3. Immunologic: Hypersensitivity reaction
4. Renal: Renal failure
5. Respiratory: Dyspnea, Interstitial pneumonia, Pulmonary hypertension, Pulmonary toxicity
6. Other: Infusion reaction, Tumor lysis syndrome

Breast cancer (adjuvant, HER2+): IV
1. With concurrent paclitaxel or docetaxel or docetaxel/carboplatin:
Initial 4 mg/kg infused over 90 minutes, followed by maintenance 2 mg/kg infused over 30 minutes weekly for total of 12 weeks, followed 1 week later (when concurrent chemotherapy completed) by 6 mg/kg infused over 30 to 90 minutes every 3 weeks for total therapy duration of 52 weeks
2. Following completion of multi-modality anthracycline-based chemotherapy:
Initial 8 mg/kg infused over 90 minutes, followed by maintenance 6 mg/kg infused over 30 to 90 minutes every 3 weeks for total therapy duration of 52 weeks
Breast cancer (metastatic, HER2+): IV
1. Dosage: Initial 4 mg/kg infused over 90 minutes, followed by maintenance 2 mg/kg infused over 30 minutes weekly until disease progression
2. Administration: either as a single agent or in combination with paclitaxel
Gastric cancer (metastatic, HER2+): IV
1. Dosage: Initial 8 mg/kg infused over 90 minutes, followed by maintenance 6 mg/kg infused over 30 to 90 minutes every 3 weeks until disease progression.
2. Administration: In combination with cisplatin and either capecitabine or fluorouracil for 6 cycles followed by trastuzumab monotherapy

The safety and effectiveness of trastuzumab have not been established in pediatric patients.

There are no dosage adjustments provided in the manufacturer's labeling.

There are no dosage adjustments provided in the manufacturer's labeling.

1. Store unopened vials between 2 and 8 degrees C.
2. After reconstitution with supplied bacteriostatic water for injection, solution may be stored in the refrigerator, between 2 and 8 degrees C, for up to 28 days.
3. Solutions prepared with unpreserved sterile water for injection should be used immediately. Discard any unused solution after 28 days; Do not freeze.