#高警訊藥品

子宮頸癌、卵巢癌、小細胞肺癌
Cervical cancer: Treatment (in combination with cisplatin) of stage IVB, recurrent or persistent cervical cancer that is not amenable to curative treatment
Ovarian cancer: Treatment of metastatic ovarian cancer (as a single agent) after disease progression on or after initial or subsequent chemotherapy
Small cell lung cancer: Treatment of small cell lung cancer (as a single agent) in patients with platinum-sensitive disease which has progressed at least 60 days after initiation of first-line chemotherapy

Antineoplastic Agent, Camptothecin; Topoisomerase I Inhibitor
Topotecan binds to topoisomerase I and stabilizes the cleavable complex so that religation of the cleaved DNA strand cannot occur. This results in the accumulation of cleavable complexes and single-strand DNA breaks. Topotecan acts in S phase of the cell cycle.

Distribution
Protein binding: about 35%.
Metabolism
1. Plasma: pH dependent hydrolysis (alpha-beta-dihydroxycarboxylic acid (open-ring), inactive); topotecan lactone (active)
2. Hepatic: demethylation (N-desmethyl topotecan)
Excretion
Urine (51%; ~3% as N-desmethyl topotecan); feces (18%; ~2% as N-desmethyl topotecan)
Elimination Half Life
1. Adults: 2 hr to 3 hr
2. Pediatric: 2.58 hours ± 0.15

Severe hypersensitivity to topotecan or any other component of the product.

D

Infant risk cannot be ruled out.

Alopecia, Rash, Abdominal pain, Constipation, Diarrhea, Nausea, Stomatitis, Vomiting, Anemia, Neutropenia, Thrombocytopenia, Asthenia, Headache, Cough, Dyspnea, Fatigue, Fever

Administration:
Administer by IV infusion over 30 minutes.
Cervical cancer, recurrent or persistent: IV
1. Dosage: 0.75 mg/m2/day for 3 days (days 1, 2, and 3; in combination with cisplatin on day 1 [with hydration]) every 21 days
2. Duration: For a maximum of 6 cycles (in nonresponders) or until disease progression or unacceptable toxicity
Ovarian cancer, metastatic: IV
1.5 mg/m2/day for 5 consecutive days every 21 days, continue until disease progression or unacceptable toxicity
Small cell lung cancer, relapsed or progressive: IV
1.5 mg/m2/day for 5 consecutive days every 21 days

Safety and effectiveness not established in pediatric patients.

1. CrCl ≥40 mL/minute: No dosage adjustment necessary.
2. CrCl 20 to 39 mL/minute: Reduce dose to 0.75 mg/m2/dose.
3. CrCl <20 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (insufficient data available for dosing recommendation).

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

1. Reconstitution: Reconstitute each 4 mg vial with 4 mL of sterile water for injection and discard unused portion.
2. Dilution: Dilute immediately with NS or D5W; Once diluted, solution is stable for 24 hours under ambient lighting at 20 to 25 °C.