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GEMCITABINE is a brand name for Gemcitabine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PrGemcitabine Injection (gemcitabine hydrochloride) is indicated for the: • Treatment of patients with locally advanced (non-resectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas to achieve a Clinical Benefit Response (a composite measure of clinical improvement). • Treatment of…
Verbatim from this product's HC label. Tap a section to expand.
) are necessary in patients over the age of 65. 2 CONTRAINDICATIONS • Gemcitabine Injection is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
and 4 DOSAGE AND ADMINISTRATION). • This preparation is for intravenous administration only. 1 Dosing Considerations • This preparation is for intravenous use only. • Gemcitabine 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.
2 Recommended Dose and Dosage Adjustment Dosage - Pancreatic Cancer Gemcitabine Injection should be used by intravenous 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 Product Monograph Pr GEMCITABINE INJECTION (gemcitabine hydrochloride) Page 6 of 52 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 Dose Adjustment:
Dose Modifications for Pancreatic Cancer, Non- Small Cell Lung Cancer, and TCC of the Bladder section below. Dosage - Non-Small Cell Lung Cancer Single-agent Gemcitabine Injection should be administered by intravenous 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 hydrochloride has been given in combination with cisplatin on either a 4-week or a 3- week schedule. With the 4-week schedule, Gemcitabine Injection should be administered intravenously at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General In all instances where the use of Gemcitabine Injection is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse events.
If severe adverse events occur, the drug should be reduced in dosage, omitted, or discontinued and appropriate corrective measures should be taken based on the clinical judgment of the physician (see 4 DOSAGE AND ADMINISTRATION). Most drug-related adverse reactions observed with gemcitabine hydrochloride therapy are reversible (see
• Gemcitabine Injection is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Gemcitabine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Cisplatin should be administered intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine Injection. With the 3-week schedule, Gemcitabine 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 Injection on Day 1. See cisplatin prescribing information for administration and hydration guidelines.
For dose adjustment guidelines, see Dose Adjustment:
Dose Modifications for Pancreatic Cancer, Non- Small Cell Lung Cancer, and TCC of the Bladder section below. Dosage - TCC of the Bladder Gemcitabine Injection should be administered by intravenous infusion at a dose of 1000 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 Dose Adjustment:
Dose Modifications for Pancreatic Cancer, Non- Small Cell Lung Cancer, and TCC of the Bladder section below. Dosage - Breast Cancer Gemcitabine 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 Injection (1250 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 ≥ 1500 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 Dose Adjustment:
Dose Modifications for Breast Cancer section below. Dosage Adjustment for Pancreatic Cancer, Non-Small Cell Lung Cancer, and TCC of the Bladder Patients receiving Gemcitabine Injection should be monitored prior to each dose for granulocyte and platelet counts and, if necessary, the dose of Gemcitabine Injection may be either reduced or withheld in the presence of hematological toxicity according to the guidelines in Table 1.
Product Monograph Pr GEMCITABINE INJECTION (gemcitabine hydrochloride) Page 7 of 52 Table 1:Dose Adjustments Based on Granulocyte and Platelet Counts Absolute granulocyte count (x 106/L) Platelet count (x 106/L) % of full dose > 1000 and > 100,000 100 500 – 1000 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. Dosage Adjustment for Breast Cancer Patients should be monitored prior to each dose with a complete blood count, including differential counts.
Gemcitabine 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 Injection dosage should be modified according to the guidelines in Table 2.
Table 2:
Day 8 Dosage Reduction Guidelines for Gemcitabine Injection in Combination with Paclitaxel Absolute granulocyte count (x 106/L) Platelet count (x 106/L) % of full dose ≥ 1200 and > 75,000 100 1000 – 1199 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.
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. For severe (Grade 3 or 4) non-hematological toxicity, therapy should be held or decreased by 50% depending on the judgment of the treating physician.
Treatment Discontinuation Acute shortness of breath in association with Gemcitabine Injection administration may occur. […]