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In the pursuit to cure* chronic hepatitis C virus (HCV) genotype 1 infection…Consider once-daily OLYSIO® in combination with sofosbuvir (SOF) for your individual patient needs

OLYSIO® has a demonstrated safety profile

Coadministration of OLYSIO® with substances that are moderate or strong inducers or inhibitors of cytochrome P450 3A (CYP3A) is not recommended, as this may lead to significantly lower or higher exposure of OLYSIO®, respectively, which may result in reduced therapeutic effect or adverse reactions.

Potentially significant drug interactions—drug-drug interactions (DDIs)

The following drugs are not recommended to be coadministered with OLYSIO®

Anti-infectives

  • Antibiotics (systemic administration)
    • Erythromycin
    • Clarithromycin
    • Telithromycin
  • Antifungals (systemic administration)
    • Itraconazole, ketoconazole, posaconazole, fluconazole, voriconazole
  • Antimycobacterials
    • Rifampin, rifabutin, rifapentine

HIV products

  • Cobicistat-containing products
  • NNRTI
    • Efavirenz
  • Other NNRTIs
    • Delavirdine, etravirine, nevirapine
  • PI
    • Darunavir/ritonavir†§
    • Ritonavir†‖
  • Other HIV products (boosted or unboosted)
    • Atazanavir, fosamprenavir, lopinavir, indinavir, nelfinavir, saquinavir, tipranavir

Antiarrhythmics

  • Amiodarone (coadministered with sofosbuvir)

Herbal products

  • Milk thistle
  • St. John’s wort

Other drugs

  • Anticonvulsants
    • Carbamazepine, oxcarbazepine, phenobarbital, phenytoin
  • Dexamethasone (Corticosteroid)
  • Cisapride (Propulsive)
  • Cyclosporine†¶(Immunosuppresant)

The following require caution and/or clinical monitoring when coadministered with OLYSIO®

Cardiovascular agents

  • ↑ Digoxin
  • Antiarrhythmics (oral administration) (↑ drugs)
    • Amiodarone (coadministered without sofosbuvir), disopyramide, flecainide, mexiletine, propafenone, quinidine
  • Calcium channel blockers (oral administration) (↑ drugs)
    • Amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil
  • Statins (↑ drugs)
    • Pitavastatin, pravastatin, rosuvastatin, atorvastatin, simvastatin, lovastatin

Immunosuppressants

  • ↑or↓sirolimus

Other drugs

  • Phosphodiesterase type 5 inhibitors for pulmonary arterial hypertension (↑ drugs)
    • Sildenafil, tadalafil, vardenafil
  • Midazolam (Sedatives/Anxiolytics), triazolam (↑ drugs; oral administration)

*Virologic cure (SVR12) was defined as sustained virologic response 12 weeks after actual (OPTIMIST-1) or planned (COSMOS) end of treatment (EOT).

These interactions have been studied in healthy adults with the recommended dose of OLYSIO® 150 mg once daily unless otherwise noted.

The dose of OLYSIO® in this interaction study was 200 mg once daily, both when given alone and when coadministered with rifampin 600 mg once daily.

§The dose of OLYSIO® in this interaction study was 50 mg once daily when coadministered in combination with darunavir/ritonavir, compared with 150 mg once daily in the OLYSIO®-alone treatment group.

The dose of OLYSIO® in this interaction study was 200 mg once daily, both when given alone and when coadministered in combination with ritonavir 100 mg twice daily.

Studied in combination with an investigational drug and RBV in a Phase 2 trial in HCV-infected post-liver transplant patients.

Additional Drug-Drug information—No expected clinically relevant DDIs

Interactions between OLYSIO® and the following drugs were evaluated in clinical studies. No dose adjustments are needed for either drug.

  • Caffeine
  • Dextromethorphan
  • Escitalopram
  • Ethinyl estradiol/norethindrone
  • Methadone
  • Midazolam (intravenous administration)
  • Omeprazole
  • Raltegravir
  • Rilpivirine
  • Sofosbuvir
  • Tacrolimus
  • Tenofovir disoproxil fumarate
  • Warfarin

No clinically relevant drug interactions expected when OLYSIO® is coadministered with

  • Antacids
  • Azithromycin
  • Bedaquiline
  • Corticosteroids (budesonide, fluticasone, methylprednisolone, prednisone)
  • Dolutegravir
  • Fluvastatin
  • H2-receptor antagonists
  • Narcotic analgesics (buprenorphine, naloxone)
  • NRTIs (eg, abacavir, didanosine, emtricitabine, lamivudine, stavudine, zidovudine)
  • Maraviroc
  • Methylphenidate
  • Proton pump inhibitors

 

 

NNRTI=non-nucleoside reverse-transcriptase inhibitor; NRTI=nucleoside reverse-transcriptase inhibitor; PI=protease inhibitor; PPI=proton pump inhibitor.