#高警訊藥品

轉移性乳癌、早期乳癌
Breast cancer, adjuvant treatment: 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

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.

1. Protein binding: 93%
2. Metabolism: DM1 undergoes hepatic metabolism via CYP3A4/5
3. Elimination Half-life: ~4 days

Hypersensitivity to trastuzumab emtansine or any component of the formulation.

D

Excretion in breast milk unknown/not recommended

Common
1. Cardiovascular: Decreased left ventricular ejection fraction
2. Dermatologic: Skin rash
3. Gastrointestinal: Abdominal pain, anorexia, diarrhea, nausea, vomiting
4. Infection: Infection
5. Nervous system: Chills, dizziness, headache, insomnia, pain
6. Neuromuscular & skeletal: Asthenia, back pain
7. Respiratory: Cough, dyspnea, pharyngitis, rhinitis
8. Miscellaneous: Fever, infusion related reaction

Dosage:
1. Recommended dose: 3.6 mg/kg IVF every 3 weeks (21-day cycle) for a total of 14 cycles until disease progression or unacceptable toxicity.
2. Maximum dose: 3.6 mg/kg; do not exceed.
Administration:
1. Rate: For first time administration, infusion over 90 minutes, monitor infusion reaction; then adjust infusion ratet to 30 minutes
2. Missed or delayed doses: If a planned dose is missed or delayed, administer as soon as possible, do not wait until the next planned cycle. Then adjust schedule to maintain a 3-week interval between doses.

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

Hepatic impairment prior to treatment initiation:
1. Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary; use with caution.
2. Severe impairment (Child-Pugh class C): Has not been studied.
Hepatotoxicity during treatment:
Early breast cancer:
1. Grades 2 to 3 ALT elevations (>3 to ≤20 times ULN on the day of scheduled treatment): Withhold until ALT recovers to ≤grade 1
2. Grade 2 AST elevations (>3 to ≤5 times ULN on the day of scheduled treatment): Withhold until AST recovers to ≤grade 1
3. Grade 3 AST elevations (>5 to ≤20 times ULN on the day of scheduled treatment): Withhold until AST recovers to ≤grade 1
4. Grade 4 ALT or AST elevations (>20 times ULN at any time): Discontinue
5. Total bilirubin >1 to ≤2 times ULN: Withhold until bilirubin recovers to ≤1 times ULN
6. Total bilirubin >2 times ULN at any time: Discontinue
Metastatic breast cancer:
1. Grade 2 ALT, AST elevations (>2.5 to ≤5 times ULN): Continue at same dose level
2. Grade 3 ALT, AST elevations (>5 to ≤20 times ULN): Withhold until ALT, AST recover to ≤grade 2
3. Grade 4 ALT, AST elevations (>20 times ULN): Discontinue treatment
4. Grade 2 hyperbilirubinemia (>1.5 to ≤3 times ULN): Withhold until bilirubin recovers to ≤grade 1
5. Grade 3 hyperbilirubinemia (>3 to ≤10 times ULN): Withhold until bilirubin recovers to ≤grade 1
6. Grade 4 hyperbilirubinemia (>10 times ULN): Discontinue treatment

Store intact vials at 2°C to 8°C. Do not freeze or shake intact vials, reconstituted solution, or solutions diluted for infusion.