#高警訊藥品

乳癌
Breast cancer, metastatic: Treatment of human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (in combination with trastuzumab and docetaxel) in patients who have not received prior anti-HER2 therapy or chemotherapy to treat metastatic disease.
Breast cancer, early (adjuvant): Adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence (in combination with trastuzumab and chemotherapy).
Breast cancer, early (neoadjuvant): Neoadjuvant treatment of locally advanced, inflammatory, or early stage HER2-positive, breast cancer (either greater than 2 cm in diameter or node positive) in combination with trastuzumab and chemotherapy (as part of a complete treatment regimen for early breast cancer).

Antineoplastic Agent, Anti-HER2; Monoclonal Antibody
Pertuzumab is a recombinant humanized monoclonal antibody which targets the extracellular human epidermal growth factor receptor 2 protein (HER2) dimerization domain. Inhibits HER2 dimerization and blocks HER downstream signaling halting cell growth and initiating apoptosis.

1. Distribution: Vd: 5.12 L
2. Half-life elimination: Terminal: 18 days

Known hypersensitivity to pertuzumab or any component of the formulation

According to the manufacturer, the decision to breastfeed during therapy should consider the risk and benefits.

1. Cardiovascular: Decreased left ventricular ejection fraction
2. Central nervous system: Fatigue, headache, insomnia, dizziness
3. Dermatologic: Alopecia, skin rash, pruritus, palmar-plantar erythrodysesthesia, xeroderma
4. Gastrointestinal: Diarrhea, nausea, vomiting, decreased appetite, mucositis, constipation, stomatitis, dysgeusia
5. Hematologic: Neutropenia, anemia, leukopenia, febrile neutropenia
6. Hypersensitivity: Hypersensitivity
7. Neuromuscular: Asthenia, myalgia, arthralgia
8. Respiratory: Upper respiratory tract infection, epistaxis
9. Miscellaneous: Fever, infusion reactions

Breast cancer, metastatic HER2+:
1. IV: 840 mg over 60 minutes followed by a maintenance dose of 420 mg over 30 to 60 minutes every 3 weeks until disease progression or unacceptable toxicity
2. In combination with trastuzumab [or trastuzumab/hyaluronidase] and docetaxel
Breast cancer, early HER2+ (adjuvant treatment):
1. IV: 840 mg over 60 minutes followed by a maintenance dose of 420 mg over 30 to 60 minutes every 3 weeks for a total of 1 year (up to 18 cycles) or until disease progression or unacceptable toxicity (whichever occurs first)
2. As part of a combination regimen containing trastuzumab (or trastuzumab/hyaluronidase) and including standard anthracycline- and/or taxane-based therapy; pertuzumab and trastuzumab (or trastuzumab/hyaluronidase) should begin on day 1 of the first taxane-containing cycle
Breast cancer, early HER2+ (neoadjuvant treatment):
IV: 840 mg over 60 minutes followed by a maintenance dose of 420 mg over 30 to 60 minutes every 3 weeks for 3 to 6 cycles; may be administered as one of the regimens below
1. Four preoperative cycles of pertuzumab, trastuzumab (or trastuzumab/hyaluronidase), and docetaxel, followed by 3 postoperative cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC)
2. Three or four preoperative cycles of FEC (alone) followed by 3 or 4 preoperative cycles of pertuzumab, trastuzumab (or trastuzumab/hyaluronidase), and docetaxel
3. Six preoperative cycles of pertuzumab, trastuzumab (or trastuzumab/hyaluronidase), docetaxel, and carboplatin
4. Four preoperative cycles of dose-dense doxorubicin and cyclophosphamide alone, followed by 4 preoperative cycles of pertuzumab, trastuzumab (or trastuzumab/hyaluronidase), and paclitaxel

1. CrCl 30 mL/minute: No dosage adjustment necessary.
2. CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).