TOPOTECAN- topotecan hydrochloride injection, solution, concentrate
Teva Parenteral Medicines, Inc.
Topotecan can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm3 and platelet counts greater than or equal to 100,000/mm3. Monitor blood cell counts [see Warnings and Precautions (5.1)].
Topotecan Injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy.
Topotecan Injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy.
Topotecan Injection, in combination with cisplatin, is indicated for the treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment.
Calculate dosage using body surface area. Do not exceed a single dose of 4 mg intravenously.
The recommended dosage of Topotecan Injection is 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21 day cycle until disease progression or unacceptable toxicity.
The recommended dosage of Topotecan Injection is 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21 day cycle.
The recommended dosage of Topotecan Injection is 0.75 mg/m2 by intravenous infusion over 30 minutes daily on Days 1, 2, and 3, in combination with cisplatin 50 mg/m2 on Day 1, of a 21 day cycle.
Withhold subsequent cycles of Topotecan Injection until neutrophils recover to greater than 1,000/mm3, platelets recover to greater than 100,000/mm3, and hemoglobin levels recover to greater than or equal to 9 g/dL (with transfusion if necessary).
For Topotecan Injection as a single agent, reduce the dose to 1.25 mg/m2/day for:
- neutrophil counts of less than 500/mm3 or administer granulocyte-colony stimulating factor (G-CSF) starting no sooner than 24 hours following the last dose
- platelet counts less than 25,000/mm3 during previous cycle
For Topotecan Injection in combination with cisplatin, reduce the dose to 0.6 mg/m2/day (and further to 0.45 mg/m2 if necessary) for:
- febrile neutropenia (defined as neutrophil counts less than 1,000/mm3 with temperature of greater than or equal to 38.0°C (100.4°F) or administer G-CSF starting no sooner than 24 hours following the last dose
- platelet counts less than 25,000/mm3 during previous cycle
For Topotecan Injection as a single agent, reduce the dose to 0.75 mg/m2/day for patients with creatinine clearance (CLcr) of 20 to 39 mL/min (calculated with the Cockcroft-Gault method using ideal body weight) [see Clinical Pharmacology (12.3)].
- Topotecan Injection is a cytotoxic. Follow applicable special handling and disposable procedures.1
- Withdraw the required volume from the vial and discard any unused portion.
- Dilute Topotecan Injection in either 0.9% Sodium Chloride, USP or 5% Dextrose in Water, USP prior to administration.
- Store diluted Topotecan Injection solutions at approximately 20°C to 25°C (68°F to 77°F) for no more than 4 hours or under refrigerated [2°C to 8°C (36°F to 46°F)] conditions for no more than 12 hours.
- Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if particulate matter or discoloration is observed.
Injection: 4 mg/4 mL (1 mg/mL topotecan free base) clear, light yellow to greenish solution in a single-dose vial.
Topotecan Injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. Reactions have included anaphylactoid reactions [see Adverse Reactions (6.2)].
Topotecan can cause severe myelosuppression.
Grade 4 neutropenia occurred in 78% of 879 patients, with a median duration of 7 days and was most common during Cycle 1 (58% of patients). Grade 4 neutropenia associated with infection occurred in 13% and febrile neutropenia occurred in 5%. Sepsis occurred in 4% of patients and was fatal in 1%. Grade 4 thrombocytopenia occurred in 27%, with a median duration of 5 days. Grade 3 or 4 anemia occurred in 37% of patients.
Combination with Cisplatin
Grade 4 neutropenia occurred in 48% and Grade 4 thrombocytopenia occurred in 7% of 147 patients. Grade 3 or 4 anemia occurred in 40% of patients.
Topotecan can cause fatal typhlitis (neutropenic enterocolitis). Consider the possibility of typhlitis in patients presenting with fever, neutropenia, and abdominal pain.
Administer the first cycle of Topotecan Injection only to patients with a baseline neutrophil count of greater than or equal to 1,500/mm3 and a platelet count greater than or equal to 100,000/mm3. Monitor blood counts frequently during treatment. Withhold and reduce dose of Topotecan Injection based on neutrophil counts, platelet counts and hemoglobin levels [see Dosage and Administration (2.5)].
Interstitial lung disease (ILD), including fatalities, can occur with topotecan. Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic radiation, and use of pneumotoxic drugs or colony stimulating factors. Monitor for pulmonary symptoms indicative of ILD. Permanently discontinue Topotecan Injection if ILD is confirmed.
Extravasation, including severe cases, can occur with topotecan. If signs or symptoms of extravasation occur, immediately stop administration of Topotecan Injection and institute recommended management procedures [see Adverse Reactions (6.1)].
Based on animal data, Topotecan Injection can cause fetal harm when administered to a pregnant woman. Topotecan caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose of Topotecan Injection. Advise males with a female partner of reproductive potential to use effective contraception during treatment with Topotecan Injection and for 3 months after the last dose [see Use in Specific Populations (8.1, 8.3), Nonclinical Toxicology (13.1)].
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