Topotecan
Cytostatic · Topoisomerase 1 inhibitor
Indications
Metastatic ovarian cancer where other therapies have failed. Treatment of recurrent or resistant (stage IVB) cervical cancer (in combination with cisplatin) which is not amenable to curative treatment. Relapsed small cell lung cancer.
Dosage
Injection: Adults: Ovarian cancer, metastatic: 1.5 mg/m² daily by IV infusion over 30 min for 5 consecutive days. Repeat every 3 wk for minimum of 4 courses. Cervical cancer, recurrent or resistant: 0.75 mg/m²/day for 3 days via IV route (in combination with cisplatin on day 1 only, [with hydration]) every 21 days. Small cell lung cancer, relapsed: 1.5 mg/m²/day via IV route for 5 consecutive days every 21 days. Oral: Adults: Ovarian cancer, metastatic: 2.3 mg/m² daily for 5 consecutive days every 21 days. Small cell lung cancer, relapsed: 2.3 mg/m²/day for 5 consecutive days every 21 days (round dose to the nearest 0.25 mg); if patient vomits after dose is administered, do not give a replacement dose. Children: Not recommended.
Administration
Administer IVP Bolus over 30 min or by 24 hours continuous inf. Reconstitution: Reconstitute vials with 4 mL SWFI, D5W or NS; may be further diluted in 50-100 mL D5W or NS for inf. Stability: Store intact vials at 20°C-25°C (68°F- 77°F). Protect vials from direct sunlight. Single-used vials should be discarded after initial vial entry. Solution for infusion is stable for 24 hours at room temperature or up to 7 days under refrigeration after dilution in at least 50 mL D5W or NS.
Adverse Effects
Neutropenia, thrombocytopenia, anaemia, abdominal pain, fatigue, asthaenia, infection, sepsis, blood dyscrasias, rash, GI upset, mucositis, anorexia, hyperbilirubinaemia, alopecia, pruritus, pyrexia, malaise.
Risk Factor (Pregnancy/Lactation)
Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: Haemoglobin <9g/dl. Severe renal (CrCl <20m1/min) or hepatic impairment. Severe myelosuppression (baseline neutrophils <1.5 x 109/l and/or platelets <100 x 109/1). Precautions: Renal or hepatic impairment. Mild to moderate renal impairment. Ensure baseline neutrophils as necessary prior to treatment. Monitor blood regularly. Risk factors for interstitial lung disease (ILD). Monitor for symptoms of ILD; discontinue if diagnosis confirmed.
Advice to Patient
Take oral forms with or without meals. Do not chew or crush or open capsules. Swallow whole. Report immediately swelling/redness/burning or pain at infusion site. Contact prescriber if there is severe constant fever, chills, cough, odd-smelling urine, pain on urination, unhealed mouth or vaginal sores, easy bruising or bleeding, unusual constant weakness or lethargy, difficulty in breathing, numbness or tingling in fingers and toes, diarrhoea that remains for more than 3 days, diarrhoea with fever or abdominal pain. Take sufficient amount of fluids (2-3 litres per day) to maintain hydration, unless restricted by the prescriber. Maintain good oral hygiene by rinsing mouth regularly and using soft toothbrush, cotton applicators few times a day. Avoid highly crowded places to prevent infection. People around you should wear mask and gloves. Do not get vaccinated without consulting…
Pharmacokinetics
Absorption: Oral: Rapid. Metabolism: Hepatic. Bioavailability: Oral: Capsule: Adults: Approx. 40%; data from pediatric patients (1 to 18 years of age) showed that while highly variable, the reported median oral bioavailability with oral administration of the reconstituted parenteral solution is similar to adults. Half-life elimination: Pediatric patients (0 to 18 years of age): Lactone moiety: 2.58 hours ± 0.15 (range: 0.2 to 7.1 hours). Adults: IV: 2 to 3 hours; renal impairment: Approx. 5 hours. Oral: 3 to 6 hours. Time to peak, plasma: Pediatric patients (1 to 18 years of age): Parenteral formulation (reconstituted lyophilized formulation): 0.75 to 2 hours. Adults: Oral: 1 to 2 hours; delayed with high-fat-meal ( 3 to 4 hours). Excretion: IV: Urine (51%; approx. 3% as N-desmethyl topotecan); feces (18%; approx. 2% as N-desmethyl topotecan). Oral: Urine (20%; 2% as N-desmethyl…
Brands with this active ingredient
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