Dosing & Uses
Dosage Forms & Strengths
powder for injection
Small Cell Lung Cancer
Indicated for SCLC sensitive disease after failure of first-line chemotherapy
Dosage Modifications (SCLC)
- CrCl 30-49 mL/min: Decrease dose to 1.5 mg/m² PO qDay
- CrCl <30 mL/min: Decrease dose to 0.6 mg/m² PO qDay
- Renal impairment dosage modification: Dose can be increased after the first course by 0.4 mg/m²/day if no severe hematologic or GI toxicities occur
- Do not administer subsequent courses of until neutrophils recover to >1,000 cells/mm³, platelets recover to >100,000 cells/mm³, hemoglobin levels recover to ≥9.0 g/dL (with transfusion if necessary)
- Reduce dose by 0.4 mg/m²/day PO (0.25 mg/m² IV) if: - neutrophil counts <500 cells/mm³ with fever or infection or lasting for ≥7 days - neutrophil counts of 500-1,000 cells/mm³ lasting beyond day 21 of treatment cycle - platelet counts <25,000 cells/mm³
- Also, consider G-CSF for severe neutropenia
- Do not administer to patients with Grade 3 or 4 diarrhea
- After recovery to ≤Grade 1, reduce the dose by 0.4 mg/m²/day PO for subsequent courses
Indicated for combination therapy with cisplatin for stage IV-B, recurrent or persistent cervical carcinoma which cannot be treated with surgery and/or radiation therapy
Severe febrile neutropenia (<1000 cells/mm³) or thrombocytopenia (Plt <25K/mm³)
- Reduce all subsequent doses to 0.6 mg/m²
- Alternatively, G-CSF may be administered for febrile neutropenia starting on Day 4 of the course (24 hours after toptecan administration has been completed)
Indicated for metastatic ovarian cancer after failure of initial or subsequent chemotherapy
Absence of tumor progresssion: ≥4 courses is recommended
Severe neutropenia or thrombocytopenia (Plt <25K/mm³): Reduce to 1.25 mg/m² for subsequent courses
Verify dose using body surface area prior to dispensing
Recommended dosage should generally not exceed 4 mg IV
Prior to administration of the first treatment course, baseline counts for neutrophils should be >1,500/mm³ and platelets >100,000/mm³
Safety and effectiveness not established
Serious - Use Alternative
Significant - Monitor Closely
Sepsis or pyrexia/ infection with neutropenia (43%)
Body/ back/ skeletal pain (23%)
Abdominal pain (22%)
Black Box Warnings
Administer only to patients with baseline neutrophil counts of 1500 cells/mm³or higher and a platelet count of 100,000 cells/mm³ or higher
To assess the occurrence of bone marrow suppression, blood cell counts should be monitored
Hypersensitivity reactions to drug or any components
Administer to patients with bone marrow suppression only if patient has adequate bone marrow reserves; monitor peripheral blood counts and adjust dose as needed
PO: Do NOT redose if ANC <1500/mm³; Plt 100,000 <mm³; Hgb <9 g/dL
Avoid use in pregnancy; can cause fetal harm; advise women of potential risk to fetus
Neutropenia: pancytopenia has been reported
Fatal cases of interstitial lung disease have occurred; permanently discontinue for confirmed ILD
If extravasation occurs, immediately stop administration and institute recommended management procedures; severe cases reported
PO: If patient vomits after taking capsule, do NOT repeat dose
PO: If diarrhea occurs, treat aggressively, potentially life-threatening
Monitor patients presenting with neutropenia, fever and abdominal pain; fatal typhlitis reported in patients with neutropenic enterocolitisas
Monitor patients presenting with cough, fever, dyspnea and/or hypoxia and a histroy of lung disease as fatalities due to interstitial lung disease have been reported
Pregnancy & Lactation
Pregnancy Category: D
Lactation: not known if excreted in breast milk, do not breast feed
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Binds to topoisomerase I to produce double-strand breaks in DNA
Bioavailability: 40% (PO)
Peak plasma time: 1-2 hr (PO)
Protein Bound: 35%
Half-life, terminal: 2-3 hr (IV); 3-6 hr (PO)
Excretion, PO: 35% feces; 22% urine
Excretion, IV: 20% feces; 54% urine
Y-site: dexamethasone sodium phosphate, fluorouracil, mitomycin, ticarcillin-clavulanate(?)
Solution: D5W, NS
Y-site: carbopolatin, cisplatin, cimetidine, cyclophosphamide, doxorubicin, etoposide, gemcitabine, granisetron, ifosfamide, methylprednisolone Na-succinate, metoclopramide, ondansetro, paclitaxel, prochlorperazine, vincristine
No preservatives-reconstitute immediately prior to use
Reconstitute in 4 mL SWI to obtain a 1 mg/mL solution
No preservatives-use immediately
Dilute in 50-250 mL NS or D5W; stability is pH dependent although topotecan may be further diluted in NS
Infuse over 30 min
Store intact vials at room temp protected from light
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