HYCAMTIN CAPSULES Rx
Generic Name and Formulations:
Topotecan (as HCl) 0.25mg, 1mg; caps.
Indications for HYCAMTIN CAPSULES:
Relapsed small cell lung cancer with prior complete or partial response and at least 45 days from the end of 1st line chemotherapy.
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.
Monitor peripheral blood cell counts during therapy; hold subsequent doses until neutrophils >1,000cells/mm3, platelets >100,000cells/mm3, and hemoglobin ≥9g/dL. History of interstitial lung disease, pulmonary fibrosis, lung cancer, thoracic exposure to radiation, use of pneumotoxic drugs and/or colony stimulating factors: increased risk of interstitial lung disease; monitor, discontinue if occurs. Moderate-to-severe renal impairment (see Adults). Caps: severe diarrhea; may need to reduce dose. IV: avoid extravasation. Embryo-fetal toxicity. Use effective contraception during and for 6 months (females) or 3 months (males w. female partners) after last dose. Pregnancy; exclude status prior to initiation. Nursing mothers: not recommended.
IV: myelosuppression potentiated with platinum agents. Caps: potentiated by P-gp (eg, cyclosporine) or BCRP inhibitors; avoid concomitant use.
Neutropenia, anemia, thrombocytopenia, febrile neutropenia, nausea, vomiting, fatigue, diarrhea, dyspnea, asthenia, pneumonia, abdominal pain, pain, infection, alopecia, anorexia; interstitial lung disease, neutropenic colitis (may be fatal).
Single-use vials—1; Caps—10