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HYCAMTIN
Gynecologic cancers
Respiratory and thoracic cancers
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Drug Name:

HYCAMTIN Rx

Generic Name and Formulations:
Topotecan (as HCl) 4mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains mannitol; preservative-free.

Company:
Novartis Pharmaceuticals Corp

Therapeutic Use:

Indications for HYCAMTIN:

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.

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.

Boxed Warning:

Myelosuppression.

Warnings/Precautions:

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). 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.

Pharmacological Class:

Topoisomerase inhibitor.

Interactions:

Myelosuppression potentiated with platinum agents.

Adverse Reactions:

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).

How Supplied:

Single-use vials—1

Indications for HYCAMTIN:

Small cell lung cancer (SCLC) with platinum-sensitive disease that progressed at least 60 days after initiation of 1st line chemotherapy.

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.

Boxed Warning:

Myelosuppression.

Warnings/Precautions:

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.

See Also:

HYCAMTIN CAPSULES

Pharmacological Class:

Topoisomerase inhibitor.

Interactions:

IV: myelosuppression potentiated with platinum agents. Caps: potentiated by P-gp (eg, cyclosporine) or BCRP inhibitors; avoid concomitant use.

Adverse Reactions:

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).

How Supplied:

Single-use vials—1; Caps—10

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