HYCAMTIN- topotecan hydrochloride injection, powder, lyophilized, for solution
Novartis Pharmaceuticals Corporation
HYCAMTIN 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)].
HYCAMTIN® for 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.
HYCAMTIN for 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.
HYCAMTIN for 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.
Verify dosage using body surface area. Do not exceed a single dose of 4 mg intravenously.
The recommended dosage of HYCAMTIN for 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 HYCAMTIN for 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 HYCAMTIN for 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.
Do not administer subsequent cycles of HYCAMTIN for 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 HYCAMTIN for 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 HYCAMTIN for 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 HYCAMTIN for 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)].
- Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit.
- Reconstitute each 4 mg vial of HYCAMTIN for injection with 4 mL Sterile Water for Injection, USP.
- Dilute the appropriate volume of the reconstituted solution in either 0.9% Sodium Chloride Intravenous Infusion, USP or 5% Dextrose in Water Injection, USP.
- Because the vials contain no preservative, use contents immediately after reconstitution. Discard any unused portion.
- Store reconstituted product diluted for infusion at approximately 20°C to 25°C (68°F to 77°F) protected from light for no more than 24 hours. Discard after 24 hours.
HYCAMTIN for injection is a cytotoxic drug. Follow applicable handling and disposal procedures.1
For injection: 4 mg (free base) of topotecan as a light yellow to greenish lyophilized powder in single-dose vial for reconstitution.
HYCAMTIN is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. Reactions have included anaphylactoid reactions [see Adverse Reactions (6.2)].
HYCAMTIN 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 HYCAMTIN for 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 HYCAMTIN for 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 HYCAMTIN. 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 HYCAMTIN for injection if ILD is confirmed.
Extravasation, including severe cases, can occur with HYCAMTIN for injection. If signs or symptoms of extravasation occur, immediately stop administration of HYCAMTIN for injection and institute recommended management procedures [see Adverse Reactions (6.1)].
Based on animal data, HYCAMTIN 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 HYCAMTIN for injection. Advise males with a female partner of reproductive potential to use effective contraception during treatment with HYCAMTIN for 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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