Adult Dosing

Small cell lung CA

• 2.3 mg/m²/day PO on days 1-5 of a 21 day cycle
• Repeat cycle q21 days

• Round calculated oral dose to nearest 0.25 mg and prescribe the minimum number of 1 mg and 0.25 mg capsules with the same number of capsules prescribed for each of the 5 days
• Do not crush/cut/chew
• Refer package inserts for toxicity related dose adjustments

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of relapsed small cell lung cancer in patients with a prior complete or partial response who are at least 45 days from the end of first-line chemotherapy

• Hypersensitivity to any of the ingredients of the products
• Pregnancy
• Breastfeeding
• Severe bone marrow depression
• ANC <1500
• Plt <100,000
• BCG live intravesical
• Live Influenza nasal vaccines
• Live Smallpox vaccine
• Live vaccines

• Administer only if baseline neutrophil count 1500 cells/mm³ and if platelet count 100,000 cells/mm³. Monitor peripheral blood counts frequently, to assess the occurrence of bone marrow suppression

Renal Dose Adjustment (Based on CrCl)

• 50-80 mL/min: No dose adjustments
• 30-49 mL/min: 1.8 mg/m² PO daily
• <30 mL/min: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustments

See Supplemental Patient Information

• Bone marrow suppression has been associated with topotecan therapy, monitor peripheral blood cell counts frequently and administered topotecan only in patients with adequate bone marrow reserves [US Black Box Warning]
• Severe diarrhea, requiring hospitalization, has been reported during treatment with oral topotecan. Manage diarrhea aggressively as per the guideline
• Interstitial lung disease (ILD), sometimes fatal has been reported with topotecan therapy. Patients with history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation, and use of pneumotoxic drugs and/or colony stimulating factors are at higher risk. Monitor the patients for pulmonary symptoms indicative of ILD (cough, fever, dyspnea, and/or hypoxia) and discontinue if diagnosis is confirmed
• Topotecan causes fetal harm when administered to a pregnant woman, Women should be warned to avoid pregnancy during the treatment and if becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus

Cautions: Use cautiously in

• Renal impairment
• Geriatric patients

Supplemental Patient Information

• Patients should be advised to use effective contraceptive measures to prevent pregnancy and to avoid breastfeeding during treatment

Pregnancy Category:D

Breastfeeding: Contraindicated. Topotecan is excreted in breastmilk of lactating rats in high concentrations. It is not known whether it is excreted in human breastmilk. Discontinue breastfeeding before starting therapy with topotecan.

• HEMA: Anemia, neutropenia, leukopenia, thrombocytopenia, febrile neutropenia
• GI: Nausea, diarrhea, vomiting
• CNS: Fatigue
• METABOLIC: Anorexia
• RESP: Interstitial lung disease
• DERM: Alopecia
• MISC: Asthenia, Pyrexia, infection, sepsis

• Antineoplastic agent; binds to the topoisomerase I-DNA complex and prevents religation of the single strand breaks, which was induced by topoisomerase I to relieves torsional strain in DNA
• Rapidly absorbed following oral administration
• Metabolized by pH dependent hydrolysis; minimally metabolized by liver
• Excreted in urine (20% unchanged and 2% as metabolite), feces (33% unchanged and 1.5% as metabolite)
• Half-life: 2-3 hrs; 5 hrs if CrCl 2-39

US Trade Name(s)

• Hycamtin

US Availability

Hycamtin

• CAPS: 0.25, 1 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Hycamtin

UK Availability

Hycamtin

• CAPS: 0.25, 1 mg

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Hematology/Oncology

Antineoplastics

Miscellaneous Agents

Drug Name: Hycamtin 0.25 MG Oral Capsule

Ingredient(s): Topotecan

Imprint: HYCAMTIN;0;25;mg

Color(s): White

Shape: Capsule

Size (mm): 18.00

Score: 1

Inactive Ingredient(s): glyceryl monostearate / gelatin / titanium dioxide

Drug Label Author:
SmithKline Beecham Corporation

DEA Schedule:
Non-Scheduled

Drug Name: Hycamtin 1 MG Oral Capsule

Ingredient(s): Topotecan

Imprint: HYCAMTIN;1;mg

Color(s): Pink

Shape: Capsule

Size (mm): 18.00

Score: 1

Inactive Ingredient(s): glyceryl monostearate / gelatin / titanium dioxide / ferric oxide red

Drug Label Author:
SmithKline Beecham Corporation

DEA Schedule:
Non-Scheduled