Ovarian cancer: Metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. Small cell lung cancer (SCLC): Relapsed SCLC in patients with a prior complete or partial response who are at least 45 days from the end of first-line chemotherapy; IV for patients with sensitive disease. Cervical cancer: Stage IV-B, recurrent, or persistent cervical carcinoma not amenable to curative treatment, in combination with cisplatin.
Ovarian cancer (IV): 1.5 mg/m² IV over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day cycle.
SCLC (IV): 1.5 mg/m² IV over 30 minutes daily for 5 days every 21 days.
SCLC (oral): 2.3 mg/m² orally once daily for 5 consecutive days, repeated every 21 days.
Cervical cancer: Topotecan 0.75 mg/m² IV Days 1–3 + cisplatin 50 mg/m² IV Day 1, every 21 days.
IV: Lyophilized powder for injection 4 mg/vial; solution for injection 1 mg/mL (4 mL vial).
Oral: Capsules: 0.25 mg, 1 mg
Severe hypersensitivity to topotecan. Severe myelosuppression (baseline neutrophils <1,500 cells/mm³ and platelets <100,000/mm³).
Neutropenia (97%), Anemia (98%), Thrombocytopenia (81%), Nausea (64%), Fatigue (29%), Diarrhea (42%), Alopecia (49%), Vomiting (45%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
G-CSF: If used to treat neutropenia, administer at least 24 hours after completion of topotecan.
Platinum compounds: Greater myelosuppression when combined with cisplatin/carboplatin; monitor carefully.
P-glycoprotein inhibitors: May increase topotecan exposure.
Can cause fetal harm. Advise females of reproductive potential to use effective contraception. Consult the full prescribing information for pregnancy risk details.
Advise women not to breastfeed during treatment and for a period after the last dose. Refer to prescribing information for duration guidance.
Safety and effectiveness in pediatric patients have not been established unless otherwise noted in the full prescribing information.
Dose modifications for organ impairment are specified in the complete prescribing information.
Topotecan is a semisynthetic derivative of camptothecin that inhibits topoisomerase I (Topo I). It forms a stable ternary complex with Topo I and DNA, preventing re-ligation of the DNA strand that Topo I has cut, resulting in persistent single-strand DNA breaks. These convert to lethal double-strand breaks during DNA replication, ultimately causing cell death in S-phase.
Route: IV or oral. Oral bioavailability: ~40%. Protein binding: ~35%. Volume of distribution: ~87.5 L/m². Minimal hepatic metabolism; hydrolysis of active lactone form to inactive hydroxy acid. Half-life: 2–3 hours (IV). Renal elimination: ~51%. Dose reduction required for CrCl 20–39 mL/min.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
Hycamtin has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:
Hycamtin (topotecan) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.
Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.
Topotecan is a semisynthetic derivative of camptothecin that inhibits topoisomerase I (Topo I). It forms a stable ternary complex with Topo I and DNA, preventing re-ligation of the DNA strand that Topo I has cut, resulting in persistent single-strand DNA breaks. These convert to lethal double-strand
Neutropenia (97%), Anemia (98%), Thrombocytopenia (81%), Nausea (64%), Fatigue (29%), Diarrhea (42%), Alopecia (49%), Vomiting (45%)