Home Drug Guide Sofosbuvir

Drug Guide

Generic Name

Sofosbuvir

Brand Names Sovaldi

Classification

Therapeutic: Antiviral for hepatitis C

Pharmacological: RNA polymerase inhibitor

FDA Approved Indications

  • Chronic hepatitis C virus (HCV) infection, genotype 1, 2, 3, 4, 5, and 6

Mechanism of Action

Sofosbuvir is a nucleotide analog inhibitor of hepatitis C virus (HCV) NS5B RNA-dependent RNA polymerase, which inhibits viral replication.

Dosage and Administration

Adult: 400 mg once daily with or without food, often in combination with other antivirals.

Pediatric: Not approved for pediatric use.

Geriatric: No specific dose adjustment required, but assess renal and hepatic function.

Renal Impairment: Use caution; dose adjustment may be necessary, especially in severe impairment.

Hepatic Impairment: Use in patients with decompensated cirrhosis only as part of combination therapy under specialist supervision.

Pharmacokinetics

Absorption: High oral bioavailability, peak plasma concentration in about 0.8 hours.

Distribution: Wide tissue distribution.

Metabolism: Primarily hepatic via CYP2B and CYP2C8 pathways to active metabolites.

Excretion: Primarily via feces, with some renal excretion.

Half Life: Approximately 0.4 hours for the parent drug, but active metabolites have half-lives of 27 hours.

Contraindications

  • Hypersensitivity to sofosbuvir or any component.
  • Concurrent use with dasabuvir or with potent organic anion transporting polypeptide (OATP) inhibitors, unless guidance indicates safety.

Precautions

  • Monitor for liver function, and be cautious in patients with severe renal impairment or ESRD. Use cautiously in renal impairment.

Adverse Reactions - Common

  • Fatigue (Likely)
  • Headache (Likely)
  • Nausea (Likely)
  • Insomnia (Uncommon)

Adverse Reactions - Serious

  • Cardiovascular events (rare) (Rare)
  • Lactic acidosis (rare) (Rare)
  • Hepatic decompensation or worsening liver function (especially in decompensated cirrhosis) (Rare)

Drug-Drug Interactions

  • Ribavirin, ledipasvir, daclatasvir, simeprevir, other NS5B inhibitors.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor liver function tests, renal function, and for side effects.

Diagnoses:

  • Risk for hepatic decompensation
  • Knowledge deficit regarding medication administration

Implementation: Ensure adherence to combination regimens, assess for drug interactions.

Evaluation: Monitor viral load and liver function tests to assess efficacy.

Patient/Family Teaching

  • Take medication as prescribed, with or without food.
  • Report symptoms of fatigue, nausea, or worsening jaundice.
  • Attend regular follow-up appointments.

Special Considerations

Black Box Warnings:

  • Use with caution in patients with severe renal impairment or ESRD. Not approved for use in patients with decompensated cirrhosis in monotherapy.

Genetic Factors: None specified.

Lab Test Interference: May cause transient elevations in liver enzymes; monitor accordingly.

Overdose Management

Signs/Symptoms: N/A — limited data, but overdose may cause increased side effects.

Treatment: Supportive care; no specific antidote.

Storage and Handling

Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F).

Stability: Stable under recommended storage conditions up to the expiration date.

🛡️ 5 Critical Medication Safety Tips for Nurses

1

Triple-Check High-Risk Medications

Always have another nurse verify insulin, heparin, warfarin, and chemotherapy drugs. These "high-alert" medications cause the most serious errors. Check concentration, dose calculation, and pump settings twice.

2

Know Look-Alike, Sound-Alike Drugs

Common mix-ups: hydromorphone/morphine, Celebrex/Celexa, Zyprexa/Zyrtec. Always use BOTH generic and brand names, read labels twice, and use barcode scanning when available. One wrong letter can be fatal.

3

Assess Before AND After Giving Meds

Check vitals before cardiac meds, pain levels before analgesics, and blood glucose before insulin. Always reassess within 30 minutes to evaluate effectiveness and watch for adverse reactions.

4

Watch for Drug Interactions

Common dangerous combinations: warfarin + aspirin (bleeding), ACE inhibitors + potassium (hyperkalemia), digoxin + diuretics (toxicity). Always check drug interactions before administering new medications.

5

Educate Your Patients

Teach patients medication names, purposes, major side effects, and what to report. Informed patients catch errors and improve compliance. Always encourage questions - an educated patient is a safer patient.

⚡ Remember: When in doubt, don't give it out! It's always safer to double-check than regret later.

⚠️ Medical Disclaimer

This drug guide is for educational purposes only and is NOT intended for clinical use. Always consult current prescribing information, healthcare providers, and institutional protocols before administering any medication. Do not use this information for patient care decisions.