Adult Dosing
Metastatic ovarian carcinoma and small cell lung cancer
- 1.5 mg/m2 IV over 30 mins Daily on days 1-5 of 21 day cycle
- In the absence of tumor min 4 course is recommended
Advanced cervical cancer
- 0.75 mg/m2 IV over 30 mins Daily on days 1-3 of a 21 day cycle, followed by cisplatin 50 mg/m2 IV on day 1
Note:
- Refer to package inserts for toxicity related dose adjustments
- Prior to administration of the first course of therapy, patient must have a baseline neutrophil count of >1,500 cells/mm3 and a platelet count of >100,000 cells/mm3
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- Ovarian and small cell lung cancer
- 40-60 mL/min: No dose adjustments
- 20-39 mL/min: 0.75 mg/m2 IV qd
- <20 mL/min: Dose adjustments not defined
- Cervical cancer
- Administer standard doses only if serum creatinine
1.5 mg/dL - Do not administer if creatinine > 1.5 mg/dL
- Refer to package inserts for all toxicity related dose adjustments
Hepatic Dose Adjustment
- Hepatic impairment: No dose adjustments
See Supplemental Patient Information
- Bone marrow suppression (primarily neutropenia) has been reported with topotecan injection. Administer topotecan only to the patients with adequate bone marrow reserves, including baseline neutrophil count of at least 1,500 cells/mm3 and platelet count at least 100,000/mm3 [US Black Box Warning]
- Bone marrow suppression is the dose limiting toxicity of topotecan. Thrombocytopenia, anemia, and neutropenia have been reported. Monitor bone marrow function
- Topotecan-induced neutropenia leading to fatal neutropenic colitis has been reported. Consider the possibility of neutropenic colitis if patient presents with fever, neutropenia, and a compatible pattern of abdominal pain
- Fatal interstitial lung disease (ILD), can occur with topotecan injection. Patients with history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation, and use of pneumotoxic drugs or colony stimulating factors are at higher risk. Monitor the patient for pulmonary symptoms like cough, fever, dyspnea and discontinue the drug if diagnosis of ILD is confirmed
- Topotecan causes fetal harm when administered to a pregnant woman. if a patient becomes pregnant while during therapy, the patient should be apprised of the potential hazard to the fetus
- Topotecan injection can cause inadvertent extravasation
- Monitor Cr at baseline; CBC with differential count, platelets at baseline, then frequently during therapy
- Concomitant use with P-glycoprotein inhibitors should be avoided. i.e. cyclosporine A, elacridar, ketoconazole, ritonavir, saquinavir
Cautions: Use cautiously in
- Renal impairment
- Elderly patient
- Patients with child bearing potential
Supplemental Patient Information
- Advise patients to use effective contraceptive measures to prevent pregnancy and to avoid breastfeeding during treatment during therapy
- Advise patient to observe caution when driving or operating machinery as topotecan can cause asthenia or fatigue
Pregnancy Category:D
Breastfeeding: Contraindicated. Topotecan is excreted in breastmilk of lactating rats in high concentrations. It is not known whether it is excreted in human breastmilk. Discontinue breastfeeding when receiving topotecan therapy.
