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Hycamtin Capsules Generic Name & Formulations
Legal Class
Rx
General Description
Topotecan (as HCl) 0.25mg, 1mg; caps.
Pharmacological Class
Topoisomerase inhibitor.
See Also
How Supplied
Single-use vials—1; Caps—10
Manufacturer
Hycamtin Capsules Indications
Indications
Relapsed small cell lung cancer with prior complete or partial response and at least 45 days from the end of 1st line chemotherapy.
Hycamtin Capsules Dosage and Administration
Adult
Confirm baseline neutrophils ≥1,500cells/mm3 and platelets ≥100,000cells/mm3 prior to 1st course of therapy. Swallow whole. 2.3mg/m2/day once daily for 5 consecutive days, starting on Day 1 of a 21-day cycle. Renal impairment (CrCl 30–49mL/min): 1.5mg/m2/day; (CrCl <30mL/min): 0.6mg/m2/day. Dose modifications: see full labeling.
Children
Not established.
Hycamtin Capsules Contraindications
Not Applicable
Hycamtin Capsules Boxed Warnings
Boxed Warning
Myelosuppression.
Hycamtin Capsules Warnings/Precautions
Warnings/Precautions
Monitor blood counts frequently during therapy; hold subsequent doses until neutrophils >1,000cells/mm3, platelets >100,000cells/mm3, and hemoglobin ≥9g/dL. History of interstitial lung disease (ILD), pulmonary fibrosis, lung cancer, thoracic radiation, use of pneumotoxic drugs and/or colony stimulating factors. Monitor for pulmonary symptoms indicative of ILD; permanently discontinue if ILD is confirmed. Moderate to severe renal impairment (see Adults). Caps: severe diarrhea; may need to reduce dose. IV: avoid extravasation. Embryo-fetal toxicity. Advise use of effective contraception during and for 6 months (females) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Hycamtin Capsules Pharmacokinetics
See Literature
Hycamtin Capsules Interactions
Interactions
IV: myelosuppression potentiated with platinum agents. Caps: potentiated by P-gp (eg, cyclosporine) or BCRP inhibitors; avoid concomitant use.
Hycamtin Capsules Adverse Reactions
Adverse Reactions
Neutropenia, anemia, thrombocytopenia, febrile neutropenia, nausea, vomiting, fatigue, diarrhea, dyspnea, asthenia, pneumonia, abdominal pain, pain, infection, alopecia, anorexia; ILD, neutropenic colitis (may be fatal).
Hycamtin Capsules Clinical Trials
See Literature
Hycamtin Capsules Note
Not Applicable
Hycamtin Capsules Patient Counseling
See Literature
