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Antimetabolite Chemotherapy Pregnancy: No adequate data in pregnant women; animal studies show reproductive toxicity. Should not be used during pregnancy unless clearly necessary; women advised not to become pregnant during treatment. Breast-feeding must be discontinued during therapy.

Gemcitabine

Brand names: Gemzar

Gemcitabine is a nucleoside analogue cytotoxic agent used in urological cancers, particularly bladder cancer, both intravenously for advanced disease and as intravesical therapy, often combined with other agents such as cisplatin.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Bladder cancer: 1,000 mg/m2 by 30-minute infusion on Days 1, 8 and 15 of each 28-day cycle, in combination with cisplatin
Route: intravenous infusion (over 30 minutes)
Frequency: Days 1, 8 and 15 of each 28-day cycle
Should only be prescribed by a physician qualified in anti-cancer chemotherapy. Bladder cancer (combination): gemcitabine 1,000 mg/m2 over 30 min on Days 1, 8 and 15 of each 28-day cycle; cisplatin 70 mg/m2 on Day 1 (following gemcitabine) or Day 2. Other licensed indications in the SPC: pancreatic cancer 1,000 mg/m2 weekly for up to 7 weeks then 1 week rest, subsequently weekly for 3 of every 4 weeks; NSCLC monotherapy 1,000 mg/m2 weekly for 3 weeks then 1 week rest (4-week cycle), or combination 1,250 mg/m2 on Days 1 and 8 of a 21-day cycle; breast cancer (with paclitaxel) 1,250 mg/m2 on Days 1 and 8 of each 21-day cycle; ovarian cancer (with carboplatin) 1,000 mg/m2 on Days 1 and 8 of each 21-day cycle. Dose reduction within or between cycles is applied per the grade of haematological/non-haematological toxicity; monitor platelet and granulocyte counts before each dose. Not established in paediatric patients.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any excipient
  • Breast-feeding

Side effects

  • Leucopenia/neutropenia, thrombocytopenia, anaemia (very common)
  • Elevation of liver transaminases (AST/ALT) and alkaline phosphatase (very common)
  • Nausea and vomiting (very common)
  • Dyspnoea (very common); allergic skin rash (very common)
  • Proteinuria and haematuria (very common)

Interactions

  • Concomitant radiotherapy (given together or within 7 days) — toxicity reported
  • Yellow fever vaccine and other live attenuated vaccines not recommended

Clinical monograph

How it works

After intracellular phosphorylation its active metabolites are incorporated into DNA and inhibit ribonucleotide reductase, halting DNA synthesis and triggering apoptosis.

Prescribing in practice

  • Myelosuppression is the principal dose-limiting toxicity, so blood counts must be checked and febrile neutropenia treated urgently.
  • Rare but serious haemolytic uraemic syndrome and pulmonary toxicity can occur and warrant prompt assessment.
  • Prolonging the infusion duration beyond that recommended increases toxicity and should be avoided.

Monitoring

Monitor full blood count before each dose and review renal, hepatic and respiratory status during treatment.

Counselling the patient

  • Seek urgent help for fever, signs of infection, unusual bruising or bleeding.
  • Report breathlessness, reduced urine output or swelling, which need prompt review.
  • Mild flu-like symptoms after infusion are common and usually settle.

Evidence & guidelines

Gemcitabine combined with cisplatin is an established standard chemotherapy regimen for advanced urothelial carcinoma supported by randomised trial evidence.

Reference: NICE NG2 (Bladder Cancer); Von der Maase et al. (2000) GC vs MVAC trial; EAU Bladder Cancer Guidelines 2024; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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