Home Drug Guide Simeprevir

Drug Guide

Generic Name

Simeprevir

Brand Names Olysio

Classification

Therapeutic: Antiviral

Pharmacological: Hepatitis C Virus (HCV) NS3/4A protease inhibitor

FDA Approved Indications

  • Treatment of chronic hepatitis C (HCV) genotype 1 infection in combination with peginterferon alfa and ribavirin

Mechanism of Action

Simeprevir inhibits the NS3/4A protease enzyme critical for HCV replication, thereby decreasing viral load.

Dosage and Administration

Adult: 150 mg orally once daily with food for 12-24 weeks, in combination with peginterferon alfa and ribavirin.

Pediatric: Not approved for pediatric use.

Geriatric: No specific dosage adjustments; monitor renal and hepatic function.

Renal Impairment: No dose adjustment needed for mild to moderate impairment; caution in severe impairment.

Hepatic Impairment: Use with caution in patients with decompensated cirrhosis; dose adjustments not established.

Pharmacokinetics

Absorption: Rapidly absorbed; food increases absorption.

Distribution: Widely distributed; high plasma protein binding (~99%).

Metabolism: Primarily metabolized by CYP3A4/5 enzymes.

Excretion: Primarily fecal excretion; minimal renal excretion.

Half Life: 15.8 ± 8.4 hours

Contraindications

  • Use with strong inducers of CYP3A4/5 (e.g., rifampin, carbamazepine, phenytoin)

Precautions

  • Use with caution in patients with hepatic impairment
  • Monitor for rash and hypersensitivity reactions
  • Assess for drug interactions, especially with CYP3A4 substrates

Adverse Reactions - Common

  • Fatigue (Common)
  • Pruritus (Common)
  • Rash (Common)
  • Headache (Common)

Adverse Reactions - Serious

  • Interstitial lung disease (Rare)
  • Photosensitivity reactions (Rare)
  • Hepatotoxicity (Rare)

Drug-Drug Interactions

  • CYP3A4 inducers or inhibitors (e.g., rifampin, ketoconazole)
  • Protease inhibitors (e.g., telaprevir, boceprevir)
  • CYP3A4 substrates with a narrow therapeutic index

Drug-Food Interactions

  • High-fat meals can increase absorption

Drug-Herb Interactions

  • St. John's Wort (induces CYP3A4)

Nursing Implications

Assessment: Monitor liver function tests, HCV viral load, and signs of adverse reactions.

Diagnoses:

  • Impaired liver function
  • Risk for adverse drug reactions

Implementation: Administer with food; monitor for rash, pruritus, and signs of hepatotoxicity.

Evaluation: Assess reduction in viral load and monitor for adverse effects.

Patient/Family Teaching

  • Take medication with food to enhance absorption.
  • Report any rash, difficulty breathing, or signs of liver problems immediately.
  • Use caution with sun exposure; photosensitivity reactions may occur.
  • Inform about potential drug interactions with other medications and supplements.

Special Considerations

Black Box Warnings:

  • Risk of hepatotoxicity; monitor hepatic function closely.

Genetic Factors: None established.

Lab Test Interference: May affect bilirubin levels.

Overdose Management

Signs/Symptoms: Nausea, vomiting, dizziness, or abnormal liver function tests.

Treatment: Supportive care; consider activated charcoal if ingestion is recent; monitor hepatic function.

Storage and Handling

Storage: Store at room temperature, away from moisture and light.

Stability: Stable up to the expiration date on the packaging when stored properly.

🛡️ 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.