II. Indications

  1. FDA Approved
    1. Pancreatic Adenocarcinoma
    2. Non-Small Cell Lung Cancer
    3. Metastatic Breast Cancer
    4. Advanced Ovarian Cancer
  2. Off-Label Use: Advanced Cancers, Recurrent, Metastatic or Persistent
    1. Bladder Cancer
    2. Cervical Cancer
    3. Ewing Sarcoma
    4. Hepatobiliary Cancer
    5. Lymphoma (Hodgkin Lymphoma, Non-Hodgkin Lymphoma)
    6. Nasopharyngeal Cancer
    7. Osteosarcoma
    8. Renal Cell Carcinoma
    9. Small Cell Lung Cancer
    10. Soft Tissue Sarcoma
    11. Testicular Cancer (germ cell tumors)
    12. Thymic Cancer
    13. Uterine Sarcoma

III. Mechanism

  1. See Antimetabolite Chemotherapy
  2. Broad Spectrum, antineoplastic antimetabolite
    1. PyrimidineNucleoside analog of deoxycytidine
  3. Gemcitabine is a prodrug, metabolized to active metabolites by deoxycytidine kinase on infusion
    1. dFdCDP (difluorodeoxycytidine diphosphate)
      1. Inhibits ribonucleotide reductase
      2. Decreases the Nucleotide source for DNA synthesis, and potentiates dFdCTP uptake by DNA
    2. dFdCTP (difluorodeoxycytidine triphosphate)
      1. Competes with dCTP (deoxycytidine triphosphate)
      2. Incorporated into DNA, blocking DNA Polymerase and DNA Replication

IV. Medications

  1. Gemcitabine IV Solution in 200, 1000 and 2000 mg vials

V. Dosing

  1. See other references for disease specific dosing protocols

VI. Pharmacokinetics

  1. Hepatic and peripheral blood deamination to inactive metabolite (difluorouridine)

VII. Adverse Effects

  1. Alopecia
  2. Fever
  3. Hematuria or Proteinuria
  4. Hepatotoxicity
  5. Myelosuppression
  6. Rash
  7. Other uncommon, but serious adverse effects
    1. Pulmonary Eosinophilia
    2. Thrombotic Thrombocytopenic Purpura
    3. Hemolytic-Uremic Syndrome
    4. Thrombotic Microangiopathy

VIII. Safety

  1. Avoid in Lactation
  2. Avoid in pregnancy (all trimesters)
    1. Use reliable Contraception
    2. Men should also not father children while taking Decitabine, and for 2 months after
  3. Monitoring
    1. Complete Blood Count with Platelets
    2. Liver Function Test
    3. Renal Function test

X. References

  1. Hamilton (2020) Tarascon Pocket Pharmacopoeia

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