Each single dose vial contains Sterile Iyophilized Gemcitabine Hydrochloride equivalent to Gemcitabine 200 mg Suitably buffered
Each single dose vial contains Sterile Iyophilized Gemcitabine Hydrochloride equivalent to Gemcitabine 1000 mg Suitably buffered
Gemcitabine is prescribed for:
Non-Small Cell Lung Cancer: Gemcitabine is prescribed in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer.
Pancreatic Cancer: Gemcitabine is prescribed as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine is prescribed for patients previously treated with 5-FU.
Gemcitabine is for intravenous use only.
Pancreatic Cancer - Gemcitabine should be administered by intravenous infusion at a dose of 1000 /m 2 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 hematological toxicity experienced by the patient ( see Warnings ).
Patients receiving Gemcitabine should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count.
Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine, should be performed prior to initiation of therapy and periodically thereafter.
Gemcitabine should be administered with caution in patients with evidence of significant renal or hepatic impairment.
Patients treated with Gemcitabine who complete an entire cycle of therapy may have the dose for subsequent cycles increased by 25%, provided that the absolute granulocyte count (AGC) and platelet nadirs exceed 1500 x 10 6 /L and 100,000 x 10 6 /L, respectively, and if non-hematologic toxicity has not been greater than WHO grade 1.
If patients tolerate the subsequent course of Gemcitabine at the increased dose, the dose for the next cycle can be further increased by 20%, provided again that the AGC and platelet nadirs exceed 1500 x 10 6 /L and 100,000 x 10 6 /L, respectively, and that non-hematologic toxicity has not been greater than WHO grade 1.
Non-Small Cell Lung Cancer -Two schedules have been investigated and the optimum schedule has not been determined.
With the 4-week schedule, Gemcitabine should be administered intravenously at 1000 /m 2 over 30 minutes on days 1, 8, and 15 of each 28-day cycle.
Cisplatin should be administered intravenously at 100 /m 2 on day 1 after the infusion of Gemcitabine. With the 3-week schedule, Gemcitabine should be administered intravenously at 1250 mg/m 2 over 30 minutes on days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m 2 should be administered intravenously after the infusion of Gemcitabine on day 1.
See prescribing information for cisplatin administration and hydration guidelines.
Dose Modifications -Dosage adjustments for hematologic toxicity may be required for Gemcitabine and for cisplatin.
Gemcitabine dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy.
Patients receiving Gemcitabine should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts.
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 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 plus cisplatin was 5% versus 2% for cisplatin alone).
Gemcitabine may be administered on an outpatient basis.
Instructions for Use/Handling -The recommended diluent for reconstitution of Gemcitabine is 0.9% Sodium Chloride Injection without preservatives.
Due to solubility considerations, the maximum concentration for Gemcitabine upon reconstitution is 40 /mL.
Reconstitution at concentrations greater than 40 /mL may result in incomplete dissolution, and should be avoided.
To reconstitute, add 5 mL of 0.9% Sodium Chloride Injection to the 200 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 /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 or 1 g of gemcitabine, respectively.
The appropriate amount of drug may be administered as prepared or further diluted with 0.9% Sodium Chloride Injection to concentrations as low as 0.1 /mL.
Reconstituted Gemcitabine 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 permits.
If particulate matter or discoloration is found, do not administer.
When prepared as directed, Gemcitabine solutions are stable for 24 hours at controlled room temperature 20° to 25°C (68° to 77°F).
Discard unused portion. Solutions of reconstituted Gemcitabine should not be refrigerated, as crystallization may occur.
The compatibility of Gemcitabine with other drugs has not been studied.
No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.
Caution should be exercised in handling and preparing Gemcitabine solutions.
The use of gloves is recommended. If Gemcitabine 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, two of three rabbits exhibited drug-related systemic toxicities (death, hypoactivity, nasal discharge, shallow breathing) due to dermal absorption.
Gemcitabine is contraindicated if you have any of the following conditions:
Gemcitabine is contraindicated in those patients with a known hypersensitivity to the drug.
- Vial of 10 ml;
- Vial of 50 ml;