Active Ingredient: Gemcitabine
Gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2.
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 of gemcitabine is 1000 mg/m², given by 30-minute intravenous infusion. This should be repeated once weekly for 3 weeks, followed by a 1-week rest period. 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 intravenous infusion.
Intravenous
1,250 - 1,250 mg per m² of body surface area (BSA)
From 1,250 To 1,250 mg per m² of body surface area (BSA) once every 7 day(s) for 8 day(s)
The recommended dose for gemcitabine is 1250 mg/m² body surface area given as a 30-minute intravenous infusion on Day 1 and 8 of the treatment cycle (21 days). Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient. Cisplatin has been used at doses between 75-100 mg/m² once every 3 weeks.
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 intravenous infusion.
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