Gemtero Dosage/Direction for Use

Gemcitabine for injection is for intravenous use only. Gemcitabine for injection may be administered on an outpatient basis.
Breast Cancer: Gemcitabine for injection should be administered by intravenous infusion at a dose of 1250 mg/m² over 30 minutes on Days 1 and 8 of each 21-day cycle.
Paclitaxel should be administered at 175 mg/m² on Day 1 as a 3 hour intravenous infusion before gemcitabine for injection administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 x 10⁶/L and a platelet count ≥100,000 x 10⁶/L prior to each cycle.
Dose Modifications: Gemcitabine for injection dosage adjustment for hematological toxicity is 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 2. (See Table 2.)

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In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine for injection should be held or decreased by 50% depending on the judgment of the treating physician. For paclitaxel dosage adjustment, see manufacturer's prescribing information.
Non-Small Cell Lung Cancer: Two schedules have been investigated and the optimum schedule has not been determined. With the 4-week schedule, gemcitabine for injection should be administered by intravenous infusion 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. With the 3-week schedule, gemcitabine for injection should be administered by intravenous infusion 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 prescribing information for cisplatin administration and hydration guidelines.
Dose Modifications: Dosage adjustments for hematologic toxicity may be required for gemcitabine for injection and for cisplatin. Gemcitabine for injection dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving gemcitabine for injection should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3. For cisplatin dosage adjustment, see manufacturer's prescribing information.
In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine for injection plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored (Grade 3/4 serum creatinine toxicity for gemcitabine for injection plus cisplatin was 5% versus 2% for cisplatin alone).
Pancreatic Cancer: Gemcitabine for injection should be administered 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 a week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.
Dose Modifications: Dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient [see Precautions]. Clearance in women and the elderly is reduced and women were somewhat less able to progress to subsequent cycles [see Precautions and Pharmacology: Pharmacodynamics under Actions].
Patients receiving gemcitabine for injection should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3. (See Table 3.)

Click on icon to see table/diagram/image

Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine, should be performed prior to initiation of therapy and periodically thereafter. Gemcitabine for injection should be administered with caution in patients with evidence of significant renal or hepatic impairment as there is insufficient information from clinical studies to allow clear dose recommendation for these patient populations. Dose reduction is recommended in patients with elevated serum bilirubin concentration because such patients are at increased risk of toxicity. The dose modifications are based on a Phase 1 study of cancer patients with elevated serum bilirubin concentrations (median 50 µmol/L, range 30-100 µmol/L), who were administered gemcitabine monotherapy, 8 out of 10 patients experienced toxicity at a gemcitabine dose of 950 mg/m² compared with 3 out of 8 at 800 mg/m². The toxicity was mostly related to the liver. In the same study, patients with elevated serum creatinine concentration appeared to experience increased sensitivity to gemcitabine. However, the data based on 15 patients was not sufficient to make dosing recommendation.
Preparation and Administration Precautions: Caution should be exercised in handling and preparing gemcitabine for injection solutions. The use of gloves is recommended. If gemcitabine for injection solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water. Although acute dermal irritation has not been observed in animal studies, 2 of 3 rabbits exhibited drug-related systemic toxicities (death, hypoactivity, nasal discharge, shallow breathing) due to dermal absorption.
Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published.
Preparation for Intravenous Infusion Administration: The recommended diluent for reconstitution of gemcitabine for injection is 0.9% Sodium Chloride Injection without preservatives. Due to solubility considerations, the maximum concentration for gemcitabine for injection upon reconstitution is 40 mg/mL. Reconstitution at concentrations greater than 40 mg/mL may result in incomplete dissolution, and should be avoided.
To reconstitute, add 5 mL of 0.9% Sodium Chloride Injection to the 200-mg vial or 25 mL of 0.9% Sodium Chloride Injection to the 1-g vial. Shake to dissolve. These dilutions each yield a gemcitabine concentration of 38 mg/mL which includes accounting for the displacement volume of the lyophilized powder (0.26 mL for the 200-mg vial or 1.3 mL for the 1-g vial). The total volume upon reconstitution will be 5.26 mL or 26.3 mL, respectively. Complete withdrawal of the vial contents will provide 200 mg or 1 g of gemcitabine, respectively. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.
Reconstituted gemcitabine for injection is a clear, colorless to light straw-colored solution. After reconstitution with 0.9% Sodium Chloride Injection, the pH of the resulting solution lies in the range of 2.7 to 3.3. The solution should be inspected visually for particulate matter and discoloration prior to administration, whenever solution or container permit. If particulate matter or discoloration is found, do not administer.
When prepared as directed the reconstituted solution is stable for 24 hours when stored at 20-25°C. Discard unused portion. Solutions of reconstituted gemcitabine for injection should not be refrigerated, as crystallization may occur.
The compatibility of gemcitabine for injection with other drugs has not been studied. No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.