pharmacopeia
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/api/v1/drug/gemcitabine

Mechanism of action

Sourced from openFDA

Gemcitabine kills cells undergoing DNA synthesis and blocks the progression of cells through the G1/S-phase boundary. Gemcitabine is metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides.

Nucleic Acid Synthesis

Indications

Sourced from openFDA
  • Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: • in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) • in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.ICD-10: C50.919, C56.9

Contraindications

Sourced from openFDA
  • Gemcitabine Injection is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis [see Adverse Reactions (6.1) ] .contraindicated

Dosage & administration

Sourced from openFDA

Gemcitabine Injection is for intravenous use only. • Ovarian Cancer: 1000 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.1 ) • Breast Cancer: 1250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.2 ) • Non-Small Cell Lung Cancer: 1000 mg/m 2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.3 ) • Pancreatic Cancer: 1000 mg/m 2 over 30 minutes once weekly for the first 7 weeks, then one-week rest, then once weekly for 3 weeks of each 28-day cycle. ( 2.4 ) 2.1 Ovarian Cancer Recommended Dose and Schedule The recommended dosage of Gemcitabine Injection is 1000 mg/m 2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 administered intravenously on Day 1 after Gemcitabine Injection administration. Refer to carboplatin prescribing information for additional information. Dosage Modifications Recommended dosage modifications for Gemcitabine Injection for myelosuppression are described in Tables 1 and 2 [see Warnings and Precautions (5.2) ] . Refer to the recommended dosage modifications for non-hematologic adverse reactions [see Dosage and Administration (2.5) ] .

Warnings & precautions

Sourced from openFDA

• Schedule-Dependent Toxicity: Increased toxicity with infusion time greater than 60 minutes or dosing more frequently than once weekly. ( 5.1 ) • Myelosuppression: Monitor for myelosuppression prior to each cycle and reduce or withhold dose for severe myelosuppression. ( 5.2 ) • Severe Cutaneous Adverse Reactions (SCARs): Permanently discontinue Gemcitabine Injection if SCARs occur. ( 5.3 ) • Pulmonary Toxicity and Respiratory Failure: Discontinue Gemcitabine Injection for unexplained dyspnea or other evidence of severe pulmonary toxicity. ( 5.4 ) • Hemolytic Uremic Syndrome (HUS): Monitor renal function prior to initiation and during treatment. Discontinue Gemcitabine Injection for HUS or severe renal impairment. ( 5.5 ) • Hepatic Toxicity: Monitor hepatic function prior to initiation and during treatment. Discontinue Gemcitabine Injection for severe hepatic toxicity. ( 5.6 ) • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females and males of reproductive potential to use effective contraception. ( 5.7 , 8.1 ) • Exacerbation of Radiation Therapy Toxicity: May cause severe and life-threatening toxicity when administered during or within 7 days of radiation therapy. ( 5.8 ) • Capillary Leak Syndrome: Discontinue Gemcitabine Injection. ( 5.9 ) • Posterior Reversible Encephalopathy Syndrome (PRES): Discontinue Gemcitabine Injection.

Adverse reactions

Sourced from openFDA

The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity [see Contraindications (4) ] • Schedule-Dependent Toxicity [see Warnings and Precautions (5.1) ] • Myelosuppression [see Warnings and Precautions (5.2) ] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.3) ] • Pulmonary Toxicity and Respiratory Failure [see Warnings and Precautions (5.4) ] • Hemolytic Uremic Syndrome [see Warnings and Precautions (5.5) ] • Hepatic Toxicity [see Warnings and Precautions (5.6) ] • Exacerbation of Radiation Therapy Toxicity [see Warnings and Precautions (5.8) ] • Capillary Leak Syndrome [see Warnings and Precautions (5.9) ] • Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.10) ] The most common adverse reactions for the single agent (≥20%) are nausea/vomiting, anemia, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Use in specific populations

Sourced from openFDA

Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on animal data and its mechanism of action, Gemcitabine Injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of gemcitabine in pregnant women. In animal reproduction studies, gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits (see Data ) . Advise pregnant women of the potential risk to a fetus [see Use in Specific Populations (8.3) ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Gemcitabine is embryotoxic in mice. Daily dosing of gemcitabine to pregnant mice increased the incidence of fetal malformations (cleft palate, incomplete ossification) at doses of 1.5 mg/kg/day [about 0.005 times the 1000 mg/m 2 clinical dose based on body surface area (BSA)]. Gemcitabine is embryotoxic and fetotoxic in rabbits. Daily dosing of gemcitabine to pregnant rabbits resulted in fetotoxicity (decreased fetal viability, reduced litter sizes and developmental delays) and increased the incidence of fetal malformations (fused pulmonary artery, absence of gall bladder) at doses of 0.1 mg/kg/day (about 0.002 times the 1000 mg/m 2 clinical dose based on BSA).

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetics of gemcitabine were examined in 353 patients, with various solid tumors. Pharmacokinetic parameters were derived using data from patients treated for varying durations of therapy given weekly with periodic rest weeks and using both short infusions (<70 minutes) and long infusions (70 to 285 minutes).

Overdosage

Sourced from openFDA

There is no known antidote for overdoses of gemcitabine. Myelosuppression, paresthesias, and severe rash were the principal toxicities seen when a single dose as high as 5700 mg/m 2 was administered by intravenous infusion over 30 minutes every 2 weeks to several patients in a dose-escalation study. In the event of suspected overdose, monitor with appropriate blood counts and provide supportive therapy, as necessary.

Approval history

Sourced from openFDA
  • Nov 15, 2010ANDAANDA079183Hospira Inc
  • May 16, 2011ANDAANDA090799Fresenius Kabi Usa
  • Jul 25, 2011ANDAANDA091365Dr Reddys Labs Ltd
  • Jul 25, 2011ANDAANDA078759Teyro Labs
  • Aug 4, 2011NDANDA200795Hospira Inc
  • Aug 3, 2017NDANDA209604Accord Hlthcare
  • Jun 27, 2025NDANDA219920Avyxa Holdings
  • Sep 9, 2025NDANDA219683Janssen Biotech

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Gemcitabine Hydrochloride, Injection, 1 g/26.3 mL (38 mg/mL), sterile solution in a single-dose glass vial NovaPlus (NDC 0409-0181-25)To be discontinued
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Gemcitabine Hydrochloride, Injection, 2 g/52.6 mL (38 mg/mL), sterile solution in a single-dose glass vial NovaPlus (NDC 0409-0182-25)To be discontinued
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Gemcitabine Hydrochloride, Injection, 200 mg/5.26 mL (38 mg/mL), sterile solution in a single-dose glass vial NovaPlus (NDC 0409-0183-25)To be discontinued
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
51,587 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Disease Progression4,7539.2%
  2. 2Off Label Use3,9837.7%
  3. 3Thrombocytopenia3,6267.0%
  4. 4Neutropenia3,2306.3%
  5. 5Anaemia3,0325.9%
  6. 6Malignant Neoplasm Progression2,8215.5%
  7. 7Drug Ineffective2,6935.2%
  8. 8Nausea2,5665.0%
  9. 9Pyrexia2,5665.0%
  10. 10Diarrhoea2,0744.0%
  11. 11Vomiting2,0674.0%
  12. 12Fatigue2,0554.0%
  13. 13Death1,9383.8%
  14. 14Febrile Neutropenia1,8023.5%
  15. 15Dyspnoea1,5913.1%

Literature

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Recent PubMed references pinned to Gemcitabine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 3,653 ClinicalTrials.gov registrations naming Gemcitabine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Gemcitabine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • NT5C2CPIC D (provisional)ClinPGx 3

Frequently asked questions

How does Gemcitabine work?
Gemcitabine kills cells undergoing DNA synthesis and blocks the progression of cells through the G1/S-phase boundary. Gemcitabine is metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides.
What is Gemcitabine used for?
According to FDA labeling, Gemcitabine carries indications including: Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: • in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) • in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Gemcitabine?
Gemcitabine is classified as Pyrimidine analogues, Nucleoside Metabolic Inhibitor, Nucleic Acid Synthesis Inhibitors, Decreased DNA Integrity, Increased Cellular Death.
What are the brand names for Gemcitabine?
Gemcitabine is marketed under brand names including Avgemsi, Infugem, Inlexzo.
What are the contraindications for Gemcitabine?
Gemcitabine labeling lists contraindications including: Gemcitabine Injection is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis [see Adverse Reactions (6.1) ] .. Always consult the full prescribing information and a clinician.
Note. Data for gemcitabine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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