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GoodFellow Pharma Corporation

ZEFEI (Gemcitabine Hydrochloride)

Zefei Powder for Injection 200 mg and 1 gram
Formulation
Each vial contains 200mg and 1g Gemcitabine (as hydrochloride).



Description
Gemcitabine HCl (Zefei) is a nucleoside analogue that exhibits antitumor activity. Gemcitabine HCl is 2'-deoxy-2',2'-difluorocytidine monohydrochloride (b-isomer). The empirical formula is C9H11F2N3O4 . HCl. It has a molecular weight of 299.66. Gemcitabine HCl is a white to off-white solid. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents.

Clinical Pharmacology
Gemcitabine exhibits cell phase specificity, primarily killing cells undergoing DNA synthesis (S-phase) and also blocking the progression of cells through the G1/S phase boundary. Gemcitabine is metabolized intracellularly by nucleoside kinases to the active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. The cytotoxic effect of gemcitabine is attributed to a combination of two actions of the diphosphate and the triphosphate nucleosides, which leads to the inhibition of DNA synthesis. First, gemcitabine diphosphate inhibits ribonucleotide reductase, which is responsible for catalyzing the reactions that generate the deoxynucleoside triphosphates for DNA synthesis. Inhibition of this enzyme by the diphosphate nucleoside causes a reduction in the concentrations of deoxynucleotides, including dCTP. Second, gemcitabine triphosphate competes with dCTP for incorporation into DNA. The reduction in the intracellular concentration of dCTP (by the action of the diphosphate) enhances the incorporation of gemcitabine triphosphate into DNA (self potentiation).

Reconstitution
To reconstitute, add 5 mL of 0.9% Sodium Chloride Injection to the 200 mg vial or 25 mL of Sodium Chloride Injection to the 1 gram vial.

When prepared as directed, solutions are stable for 24 hours at 25oC. Discard the unused portion.

How Supplied
Vial of 200 mg and Vial of 1 gram

Caution
"Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription"

Storage
Store at temperature not exceeding 25oC. Keep out of children's reach.

Indication
Therapeutic Indications Non-Small Cell Lung Cancer - Gemcitabine HCl (Zefei) is indicated 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 HCl (Zefei) is indicated as first line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. It is also indicated for patients previously treated with 5-FU.

Contraindications
Gemcitabine HCl (Zefei) is contraindicated in those patients with known hypersensitivity to the drug.

Adverse Reactions
Anaemia, leukocytopenia, thrombocytopenia, elevation of liver transaminase enzymes, or alkaline phosphatase, nausea and vomiting, diarrhea or mild constipation, moderate proteinuria and haematuria, dyspnoea, allergic skin reactions, anaphylactoid reaction, somnolence, flu-like symptoms, oedema, alopecia, oral soreness and erythema.

Precautions
Patients receiving Gemcitabine HCl (Zefei) should be monitored prior to each dose with complete blood count (CBC) including differential and platelet, leukocyte and granulocyte count. Suspension or modification of therapy should be considered when marrow suppression is detected.

Laboratory evaluation of renal and hepatic function should be performed prior to initiation of therapy and periodically thereafter.

Warning
Prolongation of the infusion time beyond 60 minutes and more frequent than weekly dosing have been shown to increase toxicity.

Pregnancy
Gemcitabine HCl can cause fetal harm when administered to a pregnant woman. If Gemcitabine HCl is used during pregnancy, or if the patient becomes pregnant while taking Gemcitabine HCl, the patient should be apprised of the potential hazard to the fetus.
Dosage and Administration
Gemcitabine HCl (Zefei) is for intravenous use only.

Adult Single-Agent for Pancreatic Cancer - should be administered by intravenous infusion at a dose of 1000mg/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.

Combination Use for Non-Small-Cell Lung Cancer - With the 4-week schedule, Gemcitabine HCl 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 HCl. With the 3 week schedule, Gemcitabine HCl should be administered intravenously at 1250 mg/m2 over 30 minutes on days 1and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m2 should be administered intravenously after the infusion of Gemcitabine HCl on day 1.

Dosage modification - Dosage adjustments for hematologic toxicity maybe required for Gemcitabine HCl and Cisplatin.

Manufactured By
Jiangsu Hansen Pharmaceutical, Co., Ltd
Lianyungang City, Jiangsu, P.R. China

Solely Distributed by
Goodfellow Pharma Corporation
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