Classes
DEA Class; Rx
Common Brand Names; Hycamtin
- Antineoplastics, Topoisomerase Inhibitors;
- Antineoplastics, Camptothecin
Description
A camptothecin derivative, topoisomerase I inhibitor
Used for the treatment of small cell lung cancer, cervical cancer, and ovarian cancer
Can cause severe myelosuppression; closely monitor complete blood counts
Indications
Indicated for SCLC sensitive disease after failure of first-line chemotherapy
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
Indicated for metastatic ovarian cancer after failure of initial or subsequent chemotherapy
Contraindications
Hypersensitivity reactions to drug or any components
Adverse Effects
IV infusion
Ovarian cancer
Neutropenia, grade 4 (80%)
Anemia, grade 3 or 4 (41%)
Thrombocytopenia, grade 4 (27%)
Febrile neutropenia (23%)
Small cell lung cancer
Neutropenia, grade 4 (70%)
Anemia, grade 3 or 4 (42%)
Thrombocytopenia. grade 4 (29%)
Cervical cancer (Combination therapy with cisplatin)
Constitutional, grade 3 or 4 (69%)
Pain, grade 3 or 4 (59%)
Neutropenia, grade 4 (48%)
Vomiting, grade 3 or 4 (40%)
Anemia, grade 3 (34%)
Thrombocytopenia, grade 3 (26%)
Neutropenia, grade 3 (26%)
Capsule
All grades
Anemia (98%)
Sepsis (43%)
Nausea (33%)
Thrombocytopenia (29%)
Neutropenia (24%)
Grade 3 or 4
Neutropenia (24-32%)
Thrombocytopenia (6-29%)
Anemia (7-18%)
Warnings
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<=”” p=””></mm³;>
Avoid use in pregnancy; can cause fetal harm; advise women of potential risk to fetus
Neutropenia: pancytopenia has been reported
Grade 4 thrombocytopenia and grade 3-4 anemia reported; withhold and reduce dose based on neutrophil counts, platelet counts and hemoglobin levels
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 history of lung disease as fatalities due to interstitial lung disease have been reported
Pregnancy and Lactation
Based on animal data and its mechanism of action, therapy can cause fetal harm when administered to a pregnant woman
There are no data on presence of drug or its metabolites in human milk or their effects on breastfed infant or on milk production; lactating rats excrete high concentrations of drug in milk
Maximum Dosage
Intravenous: 4 mg IV
Oral: 2.3 mg/m2 per day PO
Intravenous: 4 mg IV
Oral: 2.3 mg/m2 per day PO
How supplied
Topoteca
powder for injection
- 4mg/vial
capsule
- 0.25mg
- 1mg