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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › ANTIMETABOLITES › Pyrimidine analogues
gemcitabine
L01BC05
Forms & Strengths
- Injectable powder for reconstitution: 200 mg, 1 g, 2 g vials
- Intravenous solution: 38 mg/mL
Adult Dosing
- Pancreatic cancer: 1000 mg/m2 IV over 30 minutes once weekly for 7 weeks, then 1 week rest, followed by weekly for 3 weeks out of every 4
- Non-small cell lung cancer: 1000 mg/m2 IV on days 1, 8, and 15 of a 28-day cycle, or 1250 mg/m2 IV on days 1 and 8 of a 21-day cycle
- Breast cancer: 1250 mg/m2 IV on days 1 and 8 of a 21-day cycle (in combination with paclitaxel)
- Bladder cancer: 1000 mg/m2 IV on days 1, 8, and 15 of a 28-day cycle (in combination with cisplatin)
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
Indications
- First-line treatment of locally advanced or metastatic pancreatic cancer
- First-line treatment of locally advanced or metastatic non-small cell lung cancer in combination with cisplatin
- First-line treatment of metastatic breast cancer in combination with paclitaxel
- Treatment of locally advanced or metastatic urothelial tract (bladder) cancer in combination with cisplatin
Mechanism of Action
- Pyrimidine antimetabolite that is metabolized intracellularly to active diphosphate and triphosphate nucleosides
- Diphosphate inhibits ribonucleotide reductase, depleting deoxynucleotide pools required for DNA synthesis
- Triphosphate competes with deoxycytidine triphosphate for incorporation into DNA, leading to inhibition of DNA synthesis and apoptotic cell death
Contraindications
- Hypersensitivity to gemcitabine or any of its components
- Severe bone marrow suppression
Adverse Reactions
- Myelosuppression (leukopenia, neutropenia, thrombocytopenia, anemia)
- Nausea, vomiting, diarrhea, constipation, stomatitis
- Elevated transaminases and alkaline phosphatase
- Proteinuria, hematuria, and elevated serum creatinine
- Flu-like symptoms (fever, asthenia, chills, headache)
- Rash, pruritus, and alopecia
- Peripheral edema, dyspnea, and cough
- Rare: Hemolytic uremic syndrome (HUS), capillary leak syndrome, posterior reversible encephalopathy syndrome (PRES)
Drug Interactions
- Radiation therapy: Concurrent administration can result in severe, potentially life-threatening radiation toxicity
- Live vaccines: Increased risk of systemic vaccine infection and reduced vaccine efficacy
- Myelosuppressive agents: Increased risk of severe bone marrow suppression
Curated Content: Needs Vetting Before Put to Clinical Use