Drug Guide
Gemcitabine
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/ADrug-Herb Interactions
N/ANursing 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.