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Hycamtin Generic Name & Formulations
Legal Class
Rx
General Description
Topotecan (as HCl) 4mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains mannitol; preservative-free.
Pharmacological Class
Topoisomerase inhibitor.
See Also
How Supplied
Single-use vials—1
Manufacturer
Hycamtin Indications
Indications
Metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy. In combination with cisplatin for Stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment.
Hycamtin Dosage and Administration
Adult
Verify dose using BSA. Usual max dose 4mg IV. Confirm baseline neutrophils ≥1,500cells/mm3 and platelets ≥100,000cells/mm3 prior to 1st course of therapy. Give by IV infusion over 30mins. Ovarian cancer: 1.5mg/m2 daily for 5 consecutive days, starting on Day 1 of a 21-day cycle; continue until disease progression or unacceptable toxicity. Cervical cancer: 0.75mg/m2 on Days 1 (with cisplatin), 2, and 3 of a 21-day cycle. Renal impairment (CrCl 20–39mL/min): 0.75mg/m2/day. Dose modifications: see full labeling.
Children
Not established.
Hycamtin Contraindications
Not Applicable
Hycamtin Boxed Warnings
Boxed Warning
Myelosuppression.
Hycamtin 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). 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 Pharmacokinetics
See Literature
Hycamtin Interactions
Interactions
Myelosuppression potentiated with platinum agents.
Hycamtin 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 Clinical Trials
See Literature
Hycamtin Note
Not Applicable
Hycamtin Patient Counseling
See Literature
Hycamtin Generic Name & Formulations
Legal Class
Rx
General Description
Topotecan (as HCl) 4mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains mannitol; preservative-free.
Pharmacological Class
Topoisomerase inhibitor.
See Also
How Supplied
Single-use vials—1; Caps—10
Manufacturer
Hycamtin Indications
Indications
Small cell lung cancer (SCLC) with platinum-sensitive disease that progressed at least 60 days after initiation of 1st line chemotherapy.
Hycamtin Dosage and Administration
Adult
Verify dose using BSA. Usual max dose 4mg IV. Confirm baseline neutrophils ≥1,500cells/mm3 and platelets ≥100,000cells/mm3 prior to 1st course of therapy. Give by IV infusion over 30mins. 1.5mg/m2 daily for 5 consecutive days, starting on Day 1 of a 21-day cycle. Renal impairment (CrCl 20–39mL/min): 0.75mg/m2/day. Dose modifications: see full labeling.
Children
Not established.
Hycamtin Contraindications
Not Applicable
Hycamtin Boxed Warnings
Boxed Warning
Myelosuppression.
Hycamtin 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 Pharmacokinetics
See Literature
Hycamtin Interactions
Interactions
IV: myelosuppression potentiated with platinum agents. Caps: potentiated by P-gp (eg, cyclosporine) or BCRP inhibitors; avoid concomitant use.
Hycamtin 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 Clinical Trials
See Literature
Hycamtin Note
Not Applicable
Hycamtin Patient Counseling
See Literature
