Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK
Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin.
Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas.
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.
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.
Gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated.
Gemcitabine should only be prescribed by a physician qualified in the use of anti-cancer chemotherapy.
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.
The recommended dose of gemcitabine is 1000 mg/m², given by 30-minute intravenous infusion. This should be repeated once weekly for up to 7 weeks followed by a week of rest. Subsequent cycles should consist of injections once weekly for 3 consecutive weeks out of every 4 weeks. Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient.
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.
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.
Gemcitabine in combination with paclitaxel is recommended using paclitaxel (175 mg/m²) administered on Day 1 over approximately 3-hours as an intravenous infusion, followed by gemcitabine (1250 mg/m²) as a 30-minute intravenous infusion on Days 1 and 8 of each 21-day cycle. Dose reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient. Patients should have an absolute granulocyte count of at least 1,500 (x 106/l) prior to initiation of gemcitabine + paclitaxel combination.
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 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).
Dose modification of gemcitabine within a cycle for breast cancer, given in combination with paclitaxel:
| Absolute granulocyte count (x 106/l) | Platelet count (x 106/l) | Percentage of standard dose of gemcitabine (%) |
|---|---|---|
| ≥1,200 and | >75,000 | 100 |
| 1,000- <1,200 or | 50,000-75,000 | 75 |
| 700 - <1,000 and | ≥50,000 | 50 |
| <700 or | <50,000 | 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).
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:
Gemcitabine is tolerated well during infusion and may be administered ambulant. If extravasation occurs, generally the infusion must be stopped immediately and started again in another blood vessel. The patient should be monitored carefully after the administration.
For instructions on further dilution of the solution, see section 6.6.
Gemcitabine should be used with caution in patients with hepatic or renal impairment as there is insufficient information from clinical studies to allow for clear dose recommendations for these patient populations (see sections 4.4 and 5.2).
Gemcitabine has been well tolerated in patients over the age of 65. There is no evidence to suggest that dose adjustments, other than those already recommended for all patients, are necessary in the elderly (see section 5.2).
Gemcitabine is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.
There is no known antidote for overdose of gemcitabine. Doses as high as 5700 mg/m² have been administered by intravenous infusion over 30-minutes every 2 weeks with clinically acceptable toxicity. In the event of suspected overdose, the patient should be monitored with appropriate blood counts and receive supportive therapy, as necessary.
Unopened vial: 18 months.
In-Use: Further dilution:
After dilution, chemical and physical in-use stability has been demonstrated for:
| Diluent | Target Concentration | Storage Conditions | Time period |
|---|---|---|---|
| 0.9% sodium chloride solution for infusion | 0.1 mg/ml and 26 mg/ml | 2-8°C in the absence of light in non-PVC (polyolefin) infusion bags | 84 days |
| 0.9% sodium chloride solution for infusion | 0.1 mg/ml and 26 mg/ml | 2-8°C in the absence of light in PVC infusion bags | 24 hours |
| 0.9% sodium chloride solution for infusion | 0.1 mg/ml and 26 mg/ml | 25°C under normal lighting conditions in PVC infusion bags | 24 hours |
| 5% glucose solution for infusion | 0.1 mg/ml and 26 mg/ml | 25°C under normal lighting conditions in PVC infusion bags | 24 hours |
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Store in a refrigerator (2°C-8°C).
For storage conditions after dilution of the medicinal product, see section 6.3.
200 mg/5.3 ml presentation:
A 10ml, Type I clear glass vial, stoppered with a chlorobutyl closure and sealed with an aluminium seal and flip-off top.
Each vial of the 200mg presentation contains 5.3ml concentrate. Each pack contains 1 vial.
1 g/26.3 ml presentation:
A 30ml, Type I clear glass vial, stoppered with a chlorobutyl closure and sealed with an aluminium seal and flip-off top.
Each vial of the 1g presentation contains 26.3ml concentrate. Each pack contains 1 vial.
2 g/52.6 ml presentation:
A 100ml, Type I clear glass vial, stoppered with a chlorobutyl closure and sealed with an aluminium seal and flip-off top.
Each vial of the 2g presentation contains 52.6ml concentrate. Each pack contains 1 vial.
The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution. Handling of the concentrate should be done in a safety box and protective coats and gloves should be used. If no safety box is available, the equipment should be supplemented with a mask and protective glasses.
If the preparation comes into contact with the eyes, this may cause serious irritation. The eyes should be rinsed immediately and thoroughly with water. If there is lasting irritation, a doctor should be consulted. If the solution is spilled on the skin, rinse thoroughly with water.
An approved diluent for gemcitabine solution is sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative).
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