Nurses Compass
Drug Guide
Telbivudine
Classification
Therapeutic: Antiviral Agent
Pharmacological: Nucleoside Reverse Transcriptase Inhibitor (NRTI)
FDA Approved Indications
- Chronic hepatitis B virus (HBV) infection in adults
Mechanism of Action
Telbivudine is a thymidine nucleoside analog that inhibits HBV DNA replication by incorporating into viral DNA and causing chain termination, thereby reducing viral replication.
Dosage and Administration
Adult: 600 mg orally once daily, with or without food
Pediatric: Not approved for pediatric use
Geriatric: Uses should be cautious; adjust for renal impairment
Renal Impairment: Dose adjustment recommended based on renal function; see prescribing information
Hepatic Impairment: No specific adjustment, but monitor response
Pharmacokinetics
Absorption: Rapidly absorbed with peak plasma concentrations within 1 hour
Distribution: Limited data, presumed to distribute into body fluids
Metabolism: Not extensively metabolized
Excretion: Excreted primarily by the kidneys
Half Life: Approximately 15 hours
Contraindications
- Known hypersensitivity to telbivudine or any component of the formulation
Precautions
- Lactic acidosis and severe hepatomegaly with steatosis have been reported with nucleoside analogs
- Renal impairment requires dose adjustment
- Monitor renal function regularly
- Potential for resistance development
Adverse Reactions - Common
- Fatigue (Common)
- Headache (Common)
- Hepatitis B flare upon discontinuation (Common)
Adverse Reactions - Serious
- Lactic acidosis (Rare)
- Proximal muscle weakness (Rare)
- Serious renal impairment (Rare)
Drug-Drug Interactions
- Caution when used with other nucleoside analogs or nephrotoxic drugs
Drug-Food Interactions
- No significant food interactions reported
Drug-Herb Interactions
- Limited data; consult with healthcare provider before use with herbal supplements
Nursing Implications
Assessment: Monitor renal function, liver function, and for signs of lactic acidosis
Diagnoses:
- Risk for decreased renal perfusion
- Risk for lactic acidosis
Implementation: Administer as prescribed, ensure adherence, monitor labs
Evaluation: Assess viral load, liver function, and adverse effects regularly
Patient/Family Teaching
- Take medication exactly as prescribed, at the same time daily
- Report symptoms of muscle weakness, unusual fatigue, or signs of lactic acidosis
- Maintain regular follow-up appointments for lab monitoring
- Use contraception if applicable, as efficacy in pregnancy not fully established
Special Considerations
Black Box Warnings:
- Lactic acidosis and severe hepatomegaly with steatosis
Genetic Factors: No specific genetic factors identified
Lab Test Interference: May affect tests for hepatitis B viral load
Overdose Management
Signs/Symptoms: Nausea, vomiting, severe hepatic or renal impairment
Treatment: Supportive care, hemodialysis may be considered due to renal elimination
Storage and Handling
Storage: Store at room temperature 20°C to 25°C (68°F to 77°F); protect from moisture
Stability: Stable under recommended storage conditions; discard after expiration