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GEMCITABINE FOR is a brand name for Gemcitabine, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations This preparation is for intravenous use only. Gemcitabine for Injection should be administered by healthcare professionals experienced in the administration of chemotherapeutic drugs. Patients should be monitored prior to each dose for granulocyte and platelet counts.
Periodic physical examination and checks of renal and hepatic function should be made to detect non-hematologic toxicity. Dosage escalation or reduction should be based upon the degree of toxicities experienced by the patient. Treatment Discontinuation Acute shortness of breath in association with Gemcitabine for Injection administration may occur.
Bronchodilators, corticosteroids and/or oxygen produce symptomatic relief. Some reports of parenchymal lung toxicity were consistent with drug induced pneumonitis in association with the use of gemcitabine hydrochloride (see ADVERSE REACTIONS section).
The mechanism of this toxicity is not known. Patients suspected of experiencing drug-induced pneumonitis should be discontinued and not be re-challenged with the drug.
Recommended Dose Dosage – Pancreatic Cancer:
Gemcitabine for Injection should be used by IV infusion at a dose of 1000 mg/m2 over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by one week of rest from treatment.
Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks. For dose adjustment guidelines see Dosage Adjustment, Dose Modifications for Pancreatic Cancer, Non-Small Cell Lung Cancer, and TCC of the Bladder Patients section below.
Dosage – Non-Small Cell Lung Cancer:
Single-agent Gemcitabine for Injection should be administered by IV infusion at a dose of 1000 mg/m2 over 30 minutes once weekly for three consecutive weeks, followed by a one week rest period. This 4 week cycle is repeated. Gemcitabine for Injection has been given in combination with cisplatin on either a 4-week or a 3- week schedule.
With the 4-week schedule, Gemcitabine for Injection should be administered intravenously at 1000 mg/m2 over 30 minutes on Days 1, 8 and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 100 mg/m2 on day 1 after the infusion of Gemcitabine for Injection.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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With the 3-week schedule, Gemcitabine for Injection should be administered intravenously at 1250 mg/m2 over 30 minutes on days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m2 should be administered intravenously after the infusion of Gemcitabine for Injection on day 1.
See cisplatin prescribing information for administration and hydration guidelines. 0-Proposed PM Page 23 of 54 For dose adjustment guidelines, see Dosage Adjustment, Dose Modifications for Pancreatic Cancer, Non-Small Cell Lung Cancer, and TCC of the Bladder Patients section below.
Dosage – TCC of the Bladder:
Gemcitabine for Injection should be administered by IV infusion at a dose of 1,000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 70 mg/m2 on Day 1 of each 28-day cycle.
This 4-week schedule is then repeated. See cisplatin prescribing information for administration and hydration guidelines. A clinical trial showed more myelosuppression when cisplatin was used in doses of 100 mg/m2. For dose adjustment guidelines, see Dosage Adjustment, Dose Modifications for Pancreatic Cancer, Non-Small Cell Lung Cancer, and TCC of the Bladder Patients section below.
Dosage – Breast Cancer:
Gemcitabine for Injection has been given in combination with paclitaxel. It is recommended to administer paclitaxel (175 mg/m2) on Day 1 over approximately 3 hours as an intravenous infusion, followed by Gemcitabine for Injection (1,250 mg/m2) as a 30 minute intravenous infusion on Days 1 and 8 of each 21-Day cycle.
Patients should have an absolute granulocyte count ≥1,500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle. See paclitaxel prescribing information for administration guidelines.
For dose adjustment guidelines, see Dosage Adjustment:
Dose Modifications for Breast Cancer Patients section below. Dosage Adjustment Dose Modifications for Pancreatic Cancer, Non-Small Cell Lung Cancer, and TCC of the Bladder Patients: Patients receiving Gemcitabine for Injection should be monitored prior to each dose for granulocyte and platelet counts and, if necessary, the dose of Gemcitabine for Injection may be either reduced or withheld in the presence of hematological toxicity according to the guidelines in Table 5.
Table 5:
Dose Adjustments Based on Granulocyte and Platelet Counts Absolute granulocyte count (x 106 /L) Platelet count (x 106 /L) % of full dose > 1,000 and > 100,000 100 500 – 1,000 or 50,000 – 100,000 75 < 500 or < 50,000 hold Periodic physical examination and checks of renal and hepatic function should be made to detect non-hematologic toxicity.
Doses may be reduced or withheld based upon the level of toxicity. Doses should be reduced or withheld until toxicity has resolved in the opinion of the physician.
Dose Modifications for Breast Cancer Patients:
Patients should be monitored prior to each dose with a complete blood count, including differential counts. 0-Proposed PM Page 24 of 54 Gemcitabine for Injection dosage adjustments for hematological toxicity are based on the granulocyte and platelet counts taken on Day 8 of therapy.
If marrow suppression is detected, Gemcitabine for Injection dosage should be modified according to the guidelines in Table 6.
Table 6:
Day 8 Dosage Reduction Guidelines for Gemcitabine for Injection in Combination with Paclitaxel Absolute granulocyte count (x 106 /L) Platelet count (x 106 /L) % of full dose ≥ 1,200 and >75,000 100 1,000 – 1,199 or 50,000 – 75,000 75 700 – 999 and ≥ 50,000 50 < 700 or < 50,000 hold Periodic physical examination and checks of renal and hepatic function should be made to detect non-hematologic toxicity.
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