Drug Guide

Generic Name

Gemcitabine

Brand Names Gemzar

Classification

Therapeutic: Antineoplastic agent

Pharmacological: Antimetabolite (nucleoside analog)

FDA Approved Indications

  • Pancreatic cancer
  • Non-small cell lung cancer (NSCLC)
  • Bladder cancer
  • Breast cancer

Mechanism of Action

Gemcitabine is a nucleoside analog that inhibits DNA synthesis, leading to apoptosis of rapidly dividing tumor cells. It incorporates into DNA during replication and inhibits DNA chain elongation.

Dosage and Administration

Adult: Typically 1000 mg/m² IV weekly for 30-minute infusions, with treatment cycles repeated every 2-3 weeks based on specific indication and response.

Pediatric: Limited data; use with caution, and dosing should be individualized based on body surface area and clinical judgment.

Geriatric: Dose adjustments may be necessary; monitor renal and hepatic function closely.

Renal Impairment: Adjust dose based on renal function; severe impairment requires caution.

Hepatic Impairment: No specific adjustment recommended, but hepatic function should be monitored.

Pharmacokinetics

Absorption: Administered intravenously; not absorbed orally.

Distribution: Widely distributed in body tissues, crosses the blood-brain barrier minimally.

Metabolism: Primarily metabolized in the liver and plasma via cytidine deaminase to inactive metabolites.

Excretion: Excreted mainly in urine; renal function influences clearance.

Half Life: Approximately 42 minutes.

Contraindications

  • Hypersensitivity to gemcitabine or any component of the formulation.

Precautions

  • Patients with renal or hepatic impairment; use with caution.
  • Monitor blood counts regularly due to myelosuppression.
  • Pregnancy category D: risk of fetal harm; use effective contraception during treatment.

Adverse Reactions - Common

  • Myelosuppression (neutropenia, thrombocytopenia, anemia) (Very common)
  • Nausea and vomiting (Common)
  • Fatigue (Common)
  • Rash (Common)

Adverse Reactions - Serious

  • Severe myelosuppression leading to infection or bleeding (Serious)
  • Hepatotoxicity (Serious)
  • Interstitial lung disease (Rare)
  • Anaphylactic reactions (Rare)

Drug-Drug Interactions

  • CYP1A2 inhibitors or inducers may affect gemcitabine metabolism.
  • Other marrow suppressants may increase risk of myelosuppression.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor complete blood counts, hepatic and renal function before and during therapy; assess for signs of infection or bleeding.

Diagnoses:

  • Risk for bleeding
  • Impaired tissue perfusion related to myelosuppression

Implementation: Administer IV as prescribed; ensure hydration; monitor for adverse reactions; educate patient about infection risks.

Evaluation: Evaluate patient's blood counts, organ functions, and clinical response regularly.

Patient/Family Teaching

  • Report signs of infection (fever, chills), unusual bleeding, or bruising.
  • Follow instructions for blood tests.
  • Use effective contraception during treatment and for some time after.
  • Report any allergic reactions such as rash or difficulty breathing.

Special Considerations

Black Box Warnings:

  • Severe myelosuppression can lead to serious infections or bleeding.
  • Use with caution in patients with hepatitis B or C due to risk of reactivation.

Genetic Factors: Pharmacogenomic testing not routinely required.

Lab Test Interference: May cause falsely elevated serum bilirubin levels.

Overdose Management

Signs/Symptoms: Severe myelosuppression, mucositis, or organ toxicity.

Treatment: Supportive care; platelet transfusions, antibiotics for infections; no specific antidote available.

Storage and Handling

Storage: Store at 2-8°C. Protect from light.

Stability: Stable for up to 24 hours at room temperature after reconstitution.

This guide is for educational purposes only and is not intended for clinical use.