Carcinoma of cervix

Active Ingredient: Topotecan

Indication for Topotecan

Population group: women, only adults (18 years old or older)

Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination.

For this indication, competent medicine agencies globally authorize below treatments:

0.75 mg/m² body surface area per day for 3 days

Route of admnistration


Defined daily dose

0.75 - 0.75 mg per m² of body surface area (BSA)

Dosage regimen

From 0.75 To 0.75 mg per m² of body surface area (BSA) once every day for 3 day(s)

Detailed description

Initial dose

The recommended dose of topotecan is 0.75 mg/m²/day administered as a 30-minute intravenous infusion on days 1, 2 and 3. Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m²/day and following the topotecan dose. This treatment schedule is repeated every 21 days for six courses or until progressive disease.

Subsequent doses

Topotecan should not be re-administered unless the neutrophil count is ≥1.5 × 109/l, the platelet count is ≥100 × 109/l, and the haemoglobin level is ≥9 g/dl (after transfusion if necessary).

Standard oncology practice for the management of neutropenia is either to administer topotecan with other medicinal products (e.g. G-CSF) or to reduce the dose to maintain neutrophil counts.

If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count <0.5 × 109/l) for seven days or more or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 20% to 0.60 mg/m²/day for subsequent courses (or subsequently down to 0.45 mg/m²/day if necessary).

Doses should be similarly reduced if the platelet count falls below 25 × 109/l.

Dosage considerations

Intravenous infusion over 30 minutes.

Active ingredient


Topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication.

Read more about Topotecan

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