Generic Name

Ganciclovir Sodium

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Classification

FDA Approved Indications

• Cytomegalovirus (CMV) retinitis in immunocompromised patients
• Prevention of CMV disease in transplant recipients

Mechanism of Action

Ganciclovir inhibits viral DNA synthesis by incorporating into the DNA strand and causing chain termination, thereby inhibiting viral replication.

Dosage and Administration

Adult: Typically 5 mg/kg IV every 12 hours for 14-21 days, then maintenance doses; dosage adjustments may be necessary based on renal function.

Pediatric: Dosing similar to adults based on body weight, with adjustments for renal function; specific protocols should be followed.

Geriatric: Use caution; renal function should be carefully monitored due to increased risk of toxicity.

Renal Impairment: Reduce dose and increase interval based on creatinine clearance.

Hepatic Impairment: No specific adjustment recommended, but caution advised.

Pharmacokinetics

Absorption: Not absorbed orally; given intravenously.

Distribution: Widely distributed; crosses the blood-brain barrier and the placenta.

Metabolism: Minimal metabolism; primarily excreted unchanged.

Excretion: Renally excreted via glomerular filtration and tubular secretion.

Half Life: Approx. 3 hours in individuals with normal renal function.

Contraindications

• Hypersensitivity to ganciclovir or valganciclovir.

Precautions

• Use with caution in pregnant or breastfeeding women, in patients with renal impairment, or active bone marrow suppression.

Adverse Reactions - Common

• Granulocytopenia (Common)
• Thrombocytopenia (Common)
• Elevated liver enzymes (Common)
• Renal impairment (Common)

Adverse Reactions - Serious

• Severe bone marrow suppression leading to neutropenia, anemia, thrombocytopenia (Serious but less common)
• Potential carcinogenicity and teratogenicity in animal studies (Warning for pregnant women) (Serious)

Drug-Drug Interactions

• Myelosuppressive agents such as zidovudine, immunosuppressants

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Report fever, chills, sore throat, unusual bleeding, or bruising.
• Understand the importance of regular blood tests.
• Report signs of kidney problems or allergic reactions.

Special Considerations

Black Box Warnings:

• Potential for reproductive toxicity; effective contraception should be used during treatment and for at least 30 days after the last dose.
• Use caution in pregnant women; only use if clearly needed. Dilution and infusion should be prepared carefully to avoid extravasation.

Genetic Factors: N/A

Lab Test Interference: May cause transient elevations of serum creatinine and liver enzymes.

Overdose Management

Signs/Symptoms: Bone marrow suppression, nephrotoxicity.

Treatment: Discontinue drug, provide supportive care, and consider hematopoietic growth factors or dialysis if necessary.

Storage and Handling

Storage: Store vials at room temperature, protected from light.

Stability: Stable until expiration date on the package.