Myelosuppression: Common and dose-limiting (neutropenia, thrombocytopenia, anaemia) → check FBC before each dose
Severe pulmonary toxicity: Interstitial pneumonitis, pulmonary oedema, ARDS (rare but potentially fatal)
Renal toxicity / HUS: Rapidly falling Hb + thrombocytopenia + rising creatinine → stop immediately
Radiotherapy interaction: Potent radiosensitiser → high risk of severe mucositis, pneumonitis, radiation recall
Capillary leak syndrome: Sudden oedema, hypotension, hypoalbuminaemia → discontinue
PRES: Headache, seizures, confusion, hypertension → permanent discontinuation
Severe skin reactions: SJS/TEN/AGEP reported → stop drug immediately
Live vaccines contraindicated (e.g. yellow fever)
Generic name: Gemcitabine
Brand name (example): MYLAN Gemcitabine
Drug class: Antimetabolite (pyrimidine analogue)
Formulation: Powder for solution for IV infusion
Strengths: 200 mg vial, 1 g vial
Route: Intravenous infusion only
Lung Cancer
Locally advanced or metastatic non-small cell lung cancer (NSCLC)
Monotherapy or in combination with cisplatin
Pancreatic Cancer
Locally advanced or metastatic pancreatic adenocarcinoma
First-line treatment
Bladder Cancer
Transitional cell carcinoma
Alone or with cisplatin
Breast Cancer
Metastatic or locally recurrent disease
In combination with paclitaxel after prior anthracycline
Ovarian Cancer
Recurrent epithelial ovarian carcinoma
Monotherapy or with carboplatin
General
IV infusion over 30 minutes
Dose based on body surface area (mg/m²)
Cycles repeated every 3–4 weeks depending on regimen
Typical dosing examples
Monotherapy: 1,000–1,250 mg/m² weekly (days 1, 8, ±15)
With cisplatin: Gemcitabine on days 1 and 8 (or 1, 8, 15 depending on schedule)
Important
Prolonged infusion times ↑ toxicity
Dose reductions common based on haematologic toxicity
Haematologic toxicity
ANC < 500 or platelets < 50 ×10⁶/L → hold dose
Moderate cytopenias → dose reduction (e.g. 75%)
Non-haematologic toxicity
Severe pulmonary, renal, neurological, or skin toxicity → permanent discontinuation
Cisplatin, paclitaxel, carboplatin commonly used combinations
Radiotherapy: High risk of severe toxicity (avoid concurrent use where possible)
Live vaccines: Contraindicated
Hypersensitivity to gemcitabine or excipients
Pregnancy and breastfeeding
Paediatric use (safety not established)
Before each dose
Full blood count (ANC, platelets, Hb)
Baseline and periodically
Renal function (creatinine, urea)
Liver function (AST, ALT, bilirubin, ALP)
Clinical assessment for pulmonary symptoms
Additional
Monitor BP and neurological symptoms (PRES risk)
Monitor weight and oedema (capillary leak syndrome)
Very common / Common
Neutropenia, thrombocytopenia, anaemia
Nausea, vomiting, diarrhoea, stomatitis
Fatigue, fever, flu-like symptoms
Rash, pruritus
Raised liver enzymes
Dyspnoea, cough
Serious / Rare
Interstitial pneumonitis, ARDS
Renal failure, haemolytic uraemic syndrome
Capillary leak syndrome
PRES
Severe cutaneous adverse reactions (SJS/TEN)
Sepsis
Elderly
Generally well tolerated; no routine dose adjustment
Renal impairment
Use with caution
Discontinue if signs of HUS or acute renal failure
Hepatic impairment
Use with caution, especially with liver metastases
Fertility
May impair male fertility; sperm preservation should be discussed
Continue treatment until
Disease progression, or
Unacceptable toxicity
Permanently discontinue if
Life-threatening pulmonary toxicity
HUS or irreversible renal failure
PRES
Severe skin reactions
Capillary leak syndrome
https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2024/03/Approved-PI-Gemcitabine-1.pdf
| Trade Name | |
|---|---|
| Drug Class | Antimetabolites |
| Cost | |
| Company | |
|---|---|
| Drug Rep | Admin |
| Indications | Lung Cancer |
| Dosage |