#高警訊藥品

轉移性乳癌
Breast cancer, metastatic: In patients who have received at least 2 prior chemotherapy regimens for the treatment of metastatic disease (prior treatment should have included an anthracycline and a taxane in either the adjuvant or metastatic setting)

Antineoplastic Agent, Antimicrotubular
Eribulin is a non-taxane microtubule inhibitor which is a halichondrin B analog. It inhibits the growth phase of the microtubule by inhibiting formation of mitotic spindles causing mitotic blockage and arresting the cell cycle at the G2/M phase; suppresses microtubule polymerization yet does not affect depolymerization.

1. Elimination half-life: approximately 40 hours
2. Human plasma protein binding: 49% to 65%; No accumulation is observed with weekly administration

Hypersensitivity to eribulin mesylate, halichondrin B, or its chemical derivatives.

D

Discontinue drug or nursing, taking into consideration the importance of the drug to the mother.

1. Cardiovascular: Peripheral edema
2. Central nervous system: Fatigue, peripheral neuropathy, headache
3. Dermatologic: Alopecia
4. Endocrine & metabolic: Hypokalemia, hypocalcemia, weight loss, hypophosphatemia
5. Gastrointestinal: Nausea, constipation, abdominal pain, anorexia, decreased appetite, vomiting, diarrhea, stomatitis
6. Genitourinary: Urinary tract infection
7. Hematologic & oncologic: Neutropenia, anemia
8. Hepatic: Increased serum ALT or AST
9. Neuromuscular & skeletal: Weakness, arthralgia, myalgia, back pain, ostealgia, limb pain
10. Respiratory: Cough, dyspnea
11. Miscellaneous: Fever

Dosage:
IV 1.4 mg/m²/dose intravenously over 2 to 5 minutes on days 1 and 8 of a 21-day treatment cycle.
Administration:
1. May be administered undiluted or diluted.
2. Do not administer other medications through the same IV line, or through a line containing dextrose.

1. CrCl ≥50 mL/minute: No initial dosage adjustment necessary.
2. CrCl 15 to 49 mL/minute: Reduce initial dose to eribulin mesylate 1.1 mg/m2.
3. ESRD: Use is not recommended.
4. Hemodialysis: May consider administering 80% of the original dose.

1. Mild impairment (Child-Pugh class A): Reduce initial dose to eribulin mesylate 1.1 mg/m2.
2. Moderate impairment (Child-Pugh class B): Reduce initial dose to eribulin mesylate 0.7 mg/m2.
3. Severe impairment (Child-Pugh class C): Use is not recommended.