Introduction
The Gemtor 1 g (Gemcitabine) Injection is a high-dose nucleoside analog chemotherapy agent designed for the treatment of advanced ovarian, breast, non-small cell lung (NSCLC), pancreatic, and bladder cancers. Manufactured by Eskayef Pharmaceuticals Ltd., a leader in oncology innovation, and supplied globally by Onco Solution, this 1g formulation delivers potent DNA synthesis inhibition, offering enhanced efficacy and convenience for aggressive cancer regimens. By disrupting tumor cell proliferation and inducing apoptosis, the Gemtor 1 g (Gemcitabine) Injection is a pivotal tool for oncologists managing complex malignancies.
Key Benefits
- High-Dose Efficacy: 1g formulation enables precise dosing for advanced or bulky tumors.
- Dual Mechanism: Inhibits DNA polymerase and ribonucleotide reductase, halting cancer cell replication.
- Combination Flexibility: Synergizes with carboplatin, paclitaxel, or cisplatin for optimized outcomes.
- Streamlined Administration: Reduces the number of vials required per dose, improving clinical efficiency.
- Global Accessibility: Supplied by Onco Solution, ensuring reliable access to critical therapies.
Indications
The Gemtor 1 g (Gemcitabine) Injection is indicated for:
- Ovarian Cancer: Combined with carboplatin for relapsed cases ≥6 months post-platinum therapy.
- Breast Cancer: First-line metastatic treatment with paclitaxel after anthracycline failure.
- Non-Small Cell Lung Cancer (NSCLC): Combined with cisplatin for inoperable or metastatic cases.
- Pancreatic Cancer: First-line therapy for locally advanced or metastatic adenocarcinoma.
- Bladder Cancer: Used with cisplatin in advanced stages.
Pharmacology
- Mechanism of Action:
Gemcitabine, the active ingredient in Gemtor 1 g (Gemcitabine) Injection, is metabolized into diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. These metabolites:- Block DNA Synthesis: Inhibit ribonucleotide reductase and DNA polymerase.
- Trigger Apoptosis: Induce programmed cell death in S-phase cancer cells.
- Cell Cycle Specificity: Targets cells in the S-phase and arrests growth at the G1-S border.
Dosage & Administration
Standard Regimens
| Indication | Dosage |
|---|---|
| NSCLC | 1000 mg/m² on days 1, 8, 15 (28-day cycle) or 1250 mg/m² on days 1, 8 (21-day cycle). Example: For a 1.8 m² patient, one 1g vial (1000 mg) covers standard dosing. |
| Pancreatic Cancer | 1000 mg/m² weekly for 7 weeks, then 3 weeks on/1 week off. |
| Ovarian Cancer | 1000 mg/m² on days 1, 8 + carboplatin (21-day cycle). |
| Breast Cancer | 1250 mg/m² on days 1, 8 + paclitaxel (21-day cycle). Example: Requires two 1g vials for a 1.8 m² patient. |
| Bladder Cancer | 1000 mg/m² on days 1, 8, 15 + cisplatin (28-day cycle). |
Administration Guidelines
- Administer via 30-minute intravenous infusion; avoid exceeding 60 minutes to minimize toxicity.
- Reconstitution: Dilute with 0.9% sodium chloride to a concentration ≤40 mg/mL.
Drug Interactions
- Warfarin: Potentiates anticoagulant effects; monitor INR closely.
Contraindications
- Hypersensitivity to gemcitabine or components.
- Concurrent radical radiotherapy.
- Pregnancy or lactation.
Side Effects
Common Reactions:
- Hematologic: Leukopenia (65%), anemia (55%), thrombocytopenia (35%).
- Gastrointestinal: Nausea (45%), vomiting (25%), elevated transaminases (20%).
- Flu-like Symptoms: Fever (35%), fatigue (30%), myalgia (15%).
Severe Risks:
- Myelosuppression: Life-threatening infections or bleeding (monitor CBC).
- Pulmonary Toxicity: Interstitial pneumonia, pulmonary edema (discontinue if dyspnea occurs).
- Renal Toxicity: Hemolytic uremic syndrome (HUS), proteinuria.
Pregnancy & Lactation
- Pregnancy Category D: Contraindicated due to fetal harm risk.
- Lactation: Avoid breastfeeding; potential infant toxicity.
Precautions & Warnings
- Hematologic Monitoring: Check CBC before each dose; withhold if neutrophils <1,500/mm³ or platelets <100,000/mm³.
- Renal/Hepatic Impairment: Adjust dose in severe cases; monitor creatinine/LFTs.
- Microangiopathic Anemia: Discontinue at first sign of HUS or thrombotic thrombocytopenic purpura (TTP).
Storage Conditions
- Store at 25°C; protect from light and moisture.
- Reconstituted Solution: Use immediately; discard unused portions.
Why Choose Gemtor 1 g (Gemcitabine) Injection?
- High-Dose Precision: Optimizes dosing efficiency for large body surface areas or aggressive regimens.
- Trusted Quality: Produced by Eskayef Pharmaceuticals Ltd., adhering to WHO-GMP standards.
- Global Supply Chain: Supplied by Onco Solution, ensuring equitable access across Asia, Africa, and Europe.
Conclusion
The Gemtor 1 g (Gemcitabine) Injection is a cornerstone of modern oncology, offering potent DNA disruption for aggressive cancers with the convenience of high-dose formulation. By integrating this therapy, clinicians leverage Eskayef Pharmaceuticals Ltd.’s commitment to innovation and Onco Solution’s mission to deliver affordable, high-quality therapies worldwide.
