Active Ingredient: Gemcitabine
Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first-line therapy.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
1,000 - 1,000 mg per m² of body surface area (BSA)
From 1,000 To 1,000 mg per m² of body surface area (BSA) once every 7 day(s) for 8 day(s)
Gemcitabine in combination with carboplatin is recommended using gemcitabine 1000 mg/m² administered on Days 1 and 8 of each 21-day cycle as a 30-minute intravenous infusion. After gemcitabine, carboplatin will be given on Day 1 consistent with a target Area under curve (AUC) of 4.0 mg/ml·min. Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient.
Periodic physical examination and checks of renal and hepatic function should be made to detect non- haematological toxicity. Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient. In general, for severe (Grade 3 or 4) non-haematological toxicity, except nausea/vomiting, therapy with gemcitabine should be withheld or decreased depending on the judgement of the treating physician. Doses should be withheld until toxicity has resolved in the opinion of the physician.
For cisplatin, carboplatin, and paclitaxel dosage adjustment in combination therapy, please refer to the corresponding Summary of Product Characteristics.
For all indications, the patient must be monitored before each dose for platelet and granulocyte counts. Patients should have an absolute granulocyte count of at least 1,500 (x 106/l) and platelet count of 100,000 (x 106/l) prior to the initiation of a cycle.
Dose modifications of gemcitabine within a cycle should be performed according to the following tables:
Dose modification of gemcitabine within a cycle for ovarian cancer, given in combination with carboplatin:
| Absolute granulocyte count (x 106/l) | Platelet count (x 106/l) | Percentage of standard dose of gemcitabine (%) |
|---|---|---|
| >1,500 and | ≥100,000 | 100 |
| 1000-1,500 or | 75,000-100,000 | 50 |
| <1000 or | <75,000 | Omit dose* |
* Treatment omitted will not be re-instated within a cycle. Treatment will start on day 1 of the next cycle once the absolute granulocyte count reaches at least 1,500 (x106/l) and the platelet count reaches 100,000 (x106/l).
The gemcitabine dose should be reduced to 75% of the original cycle initiation dose, in the case of the following haematological toxicities:
30-minute intravenous infusion.
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