Gemcitabine


Generic Medicine Info
Indications and Dosage
Intravenous
Metastatic breast cancer
Adult: In patients with unresectable, locally recurrent cases who have relapsed following adjuvant/neoadjuvant chemotherapy: In combination with paclitaxel: 1,250 mg/m2 via infusion over 30 minutes on Days 1 and 8 of a 21-day cycle. Dose may be reduced with each cycle or within a cycle based on toxicity. Patients should have an absolute granulocyte count of at least 1,500 x 106/L and platelet count of 100,000 x 106/L prior to initiation of therapy.

Intravenous
Locally advanced bladder cancer, Metastatic bladder cancer
Adult: In combination with cisplatin: 1,000 mg/m2 via infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle, followed by a 1-week rest period. This 4-week cycle is then repeated. Dose may be reduced with each cycle or within a cycle based on the amount of toxicity. Patients should have an absolute granulocyte count of at least 1,500 x 106/L and platelet count of 100,000 x 106/L prior to initiation of therapy. Treatment recommendations may vary among countries and individual products (refer to specific product guidelines).

Intravenous
Locally advanced ovarian cancer, Metastatic ovarian cancer
Adult: In cases that have relapsed at least 6 months after completion of platinum-based therapy: In combination with carboplatin: 1,000 mg/m2 via infusion over 30 minutes on Days 1 and 8 of each 21-day cycle. Dose may be reduced with each cycle or within a cycle based on toxicity. Patients should have an absolute granulocyte count of at least 1,500 x 106/L and platelet count of 100,000 x 106/L prior to initiation of therapy.

Intravenous
Locally advanced non-small cell lung carcinoma, Metastatic non-small cell lung carcinoma
Adult: As monotherapy: 1,000 mg/m2 once weekly via infusion over 30 minutes for 3 weeks followed by a 1-week rest period. This 4-week cycle is then repeated. In combination with cisplatin: 1,250 mg/m2 via infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, followed by a 1-week rest period. This 3-week cycle is then repeated. Alternatively, 1,000 mg/m2 via infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle, followed by a 1-week rest period. This 4-week cycle is then repeated. Dose may be reduced with each cycle or within a cycle based on toxicity. Patients should have an absolute granulocyte count of at least 1,500 x 106/L and platelet count of 100,000 x 106/L prior to initiation of therapy.

Intravenous
Locally advanced adenocarcinoma of pancreas, Metastatic adenocarcinoma of pancreas
Adult: 1,000 mg/m2 once weekly via infusion over 30 minutes for 7 weeks, followed by a 1-week rest period. Subsequent cycles: 1,000 mg/m2 once weekly for 3 consecutive weeks out of every 4 weeks. Alternatively, 1,000 mg/m2 on Days 1, 8, and 15 of each 28-day cycle. Dose may be reduced with each cycle or within a cycle based on toxicity. Patients should have an absolute granulocyte count of at least 1,500 x 106/L and platelet count of 100,000 x 106/L prior to initiation of therapy. Treatment recommendations may vary among countries (refer to specific local guidelines).
What are the brands available for Gemcitabine in Thailand?
Other Known Brands
  • DBL Gemcitabine
  • Gemcitabine Actavis
  • Gemtin
Reconstitution
Reconstitute vial labelled as containing 200 mg or 1,000 mg with 5 mL or 25 mL of NaCl 0.9% inj, respectively, to provide a solution containing 38 mg/mL.
Contraindications
Co-administration of yellow fever and other live attenuated vaccines.
Special Precautions
Patient with liver metastases; history of liver cirrhosis, hepatitis, or alcoholism; history of CV events. Renal and hepatic impairment. Elderly. Pregnancy and lactation. Not recommended for use in combination with radiation therapy.
Adverse Reactions
Significant: Bone marrow suppression (e.g. neutropenia, thrombocytopenia, anaemia, grade 3 or 4 haematologic toxicity; capillary leak syndrome; hypersensitivity reactions (e.g. bronchospasm, anaphylactoid reactions); posterior reversible encephalopathy syndrome.
Blood and lymphatic system disorders: Febrile neutropenia.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, stomatitis, mouth ulceration, constipation.
General disorders and administration site conditions: Influenza-like symptoms, fever, asthenia, oedema, peripheral oedema.
Infections and infestations: Infections.
Investigations: Transient liver enzyme elevations (e.g. AST, ALT, alkaline phosphatase, bilirubin).
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Back pain, myalgia.
Nervous system disorders: Headache, insomnia, somnolence.
Renal and urinary disorders: Haematuria, proteinuria.
Respiratory, thoracic and mediastinal disorders: Dyspnoea, cough, rhinitis.
Skin and subcutaneous tissue disorders: Allergic skin rash associated with pruritus, alopecia, itching, sweating.
Potentially Fatal: Haemolytic uraemic syndrome leading to renal failure, serious hepatotoxicity (e.g. liver failure), pulmonary toxicity (e.g. adult respiratory distress syndrome, interstitial pneumonitis, pulmonary oedema, pulmonary fibrosis) leading to respiratory failure.
IV/Parenteral: D
Patient Counseling Information
This drug may cause somnolence, if affected, do not drive or operate machinery. Women of childbearing potential and men with female partner of childbearing potential must use effective contraception during and for 6 months after treatment.
Monitoring Parameters
Evaluate pregnancy status before treatment initiation in women of childbearing potential. Monitor CBC with differential and platelet count (prior to each dose); hepatic (e.g. LFTs) and renal (e.g. serum creatinine, BUN) function (prior to initiation and periodically); electrolytes (e.g. K, Mg, Ca) when in combination therapy with cisplatin; pulmonary function. Assess for signs and symptoms of capillary leak syndrome, haemolytic uraemic syndrome, posterior reversible encephalopathy syndrome.
Overdosage
Symptoms: Myelosuppression, paraesthesia, severe rash. Management: Supportive treatment. Monitor CBC.
Drug Interactions
Potentially Fatal: Increased risk of systemic disease with yellow fever and other live attenuated vaccines particularly in immunocompromised patients.
Action
Description:
Mechanism of Action: Gemcitabine, a synthetic pyrimidine nucleoside, is an antimetabolite antineoplastic agent. It blocks DNA polymerase and ribonucleotide reductase, thus inhibiting DNA synthesis. It specifically targets the S phase of the cell cycle and may also block the progression of cells at G1/S phase boundary.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: 30 minutes after completion of infusion.
Distribution: Widely distributed into the tissues, present in ascitic fluid. Volume of distribution: 50 L/m2 (<70 minutes infusion time); 370 L/m2 (70-285 minutes infusion time).
Metabolism: Undergoes intracellular metabolism by nucleoside kinases to form active gemcitabine diphosphate and triphosphate nucleoside metabolites; metabolites are then converted to inactive metabolite 2'-deoxy2',- 2'-difluorouridine (dFdU).
Excretion: Via urine (92-98%; mainly as dFdU); faeces (<1%). Elimination half-life: Gemcitabine: 42-94 minutes (≤70 minutes infusion time); 4-10.5 hours (3-4 hours infusion time). Gemcitabine triphosphate: 1.7-19.4 hours (terminal phase).
Chemical Structure

Chemical Structure Image
Gemcitabine

Source: National Center for Biotechnology Information. PubChem Database. Gemcitabine, CID=60750, https://pubchem.ncbi.nlm.nih.gov/compound/Gemcitabine (accessed on Jan. 22, 2020)

Storage
Powder for solution for infusion: Intact vial: Store between 15-30°C. Reconstituted solution: Store at 30°C; stable for 24 hours. Concentrate for solution for infusion: Store between 2-8°C. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC05 - gemcitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
References
Anon. Gemcitabine Hydrochloride. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 16/04/2024.

Buckingham R (ed). Gemcitabine Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 16/04/2024.

Gemcitabine 1,000 mg Powder for Solution for Infusion (Venus Pharma GmbH). MHRA. https://products.mhra.gov.uk. Accessed 16/04/2024.

Gemcitabine 38 mg/mL Concentrate for Solution for Infusion (Hospira UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 16/04/2024.

Gemcitabine Injection, Powder, Lyophilized, for Solution (Hospira, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 16/04/2024.

Gemcitabine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 16/04/2024.

Jocitam for Injection USP 1 g/vial (Healol Pharmaceuticals Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 16/04/2024.

Joint Formulary Committee. Gemcitabine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 16/04/2024.

Sandoz New Zealand Limited. Gemcitabine Ebewe Injection Vials data sheet 20 March 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 16/04/2024.

Disclaimer: This information is independently developed by MIMS based on Gemcitabine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com
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