Active Ingredient: Gemcitabine
Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
1 - 1 g per m² of body surface area (BSA)
From 1 To 1 g per m² of body surface area (BSA) once every 7 day(s) for 21 day(s)
The recommended dose for gemcitabine is 1000 mg/m², given by 30-minute infusion. The dose should be given on Days 1, 8 and 15 of each 28-day cycle in combination with cisplatin. Cisplatin is given at a recommended dose of 70 mg/m² on Day 1 following gemcitabine or day 2 of each 28-day cycle. This 4-week cycle is then repeated. 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 bladder cancer, NSCLC and pancreatic cancer, given in monotherapy or in combination with cisplatin:
| Absolute granulocyte count (x 106/l) | Platelet count (x 106/l) | Percentage of standard dose of gemcitabine (%) |
|---|---|---|
| >1,000 and | >100,000 | 100 |
| 500-1,000 or | 50,000-100,000 | 75 |
| <500 or | <50,000 | Omit dose* |
* Treatment omitted will not be re-instated within a cycle before the absolute granulocyte count reaches at least 500 (x106/l) and the platelet count reaches 50,000 (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 infusion.
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