Now AVAILABLE:

    NOW AVAILABLE:

    OLYSIO® + SOFOSBUVIR. AN INTERFERON-FREE TREATMENT OPTION.

    OLYSIO® (simeprevir) is a prescription medicine used with other antiviral medicines (sofosbuvir or peginterferon and ribavirin) to treat genotype 1, chronic (lasting a long time) hepatitis C infection in adults. Talk to your doctor to learn more about treatment with OLYSIO®.

    OLYSIO® SUPPORT: INTEGRATED TOOLS FOR YOUR TREATMENT JOURNEY.

    OLYSIO® SUPPORT: INTEGRATED TOOLS FOR YOUR TREATMENT JOURNEY.

    We didn’t stop with creating an interferon-free treatment option. We’ve also developed OLYSIO® Support, an easily accessible support program with tools and resources that can help you throughout your treatment journey.

     

    IMPORTANT SAFETY INFORMATION

    WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT OLYSIO®?

    • If you are pregnant, or plan to become pregnant, talk with your healthcare provider before taking OLYSIO®. It is not known if OLYSIO® will harm your unborn baby. Also read the Medication Guides for peginterferon alfa (Peg-IFN-alfa) and ribavirin (RBV) if your healthcare provider prescribes these medications for you in combination with OLYSIO®.
      • Females must use an effective form of birth control during treatment with OLYSIO®. Talk with your healthcare provider about birth control methods that you may use during treatment with OLYSIO®.
    • OLYSIO® combination treatment may cause rashes and skin reactions to sunlight. These rashes and skin reactions to sunlight can be severe and you may need to be treated in a hospital. Rashes and skin reactions to sunlight are most common during the first 4 weeks of treatment, but can happen at any time during combination treatment with OLYSIO®.
      • Use sunscreen, and wear a hat, sunglasses, and protective clothing when you will be exposed to sunlight during treatment with OLYSIO®.
      • Limit sunlight exposure during treatment with OLYSIO®.
      • Avoid use of tanning beds, sunlamps, or other types of light therapy during treatment with OLYSIO®.
      • Call your healthcare provider right away if you get any of the following symptoms:
        • burning, redness, swelling or blisters on your skin
        • mouth sores or ulcers
        • red or inflamed eyes, like "pink eye" (conjunctivitis)
    • You should not take OLYSIO® alone. OLYSIO® should be used together with other medicines to treat chronic hepatitis C infection.

    What should I tell my healthcare provider before taking OLYSIO®?
    Before taking OLYSIO®, tell your healthcare provider if you:

    • have liver problems other than hepatitis C virus infection
    • have ever taken any medicine to treat hepatitis C virus infection
    • had a liver transplant
    • are receiving phototherapy
    • have any other medical condition
    • are of East Asian descent
    • are breastfeeding. It is not known if OLYSIO® passes into your breast milk. You and your healthcare provider should decide if you will take OLYSIO® or breastfeed. You should not do both.
    • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
    • OLYSIO® and other medicines may affect each other. This can cause you to have too much or not enough OLYSIO® or other medicines in your body, which may affect the way OLYSIO® or your other medicines work, or may cause side effects. Do not start taking a new medicine without telling your healthcare provider or pharmacist.
    • Especially tell your healthcare provider if you take any of the following medicines (when taken by mouth or given by injection, where applicable): amiodarone (Cordarone®, Pacerone®) , amlodipine (Norvasc®), atazanavir (Reyataz®), atorvastatin (Lipitor®, Caduet®), carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®), cisapride (Propulsid®, Propulsid Quicksolv®), clarithromycin (Biaxin®, Prevpac®), cobicistat-containing medicine (Stribild®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), darunavir (Prezista®), delavirdine mesylate (Rescriptor®), dexamethasone, digoxin (Lanoxin®), diltiazem (Cardizem®, Dilacor XR®, Tiazac®), disopyramide (Norpace®), efavirenz (Sustiva®, Atripla®), erythromycin (E.E.S.®, Eryc®, Ery Tab®, Erythrocin®, Erythrocin Stearate®), etravirine (Intelence®), felodipine (Plendil®), flecainide (Tambocor®), fluconazole (Diflucan®), fosamprenavir (Lexiva®), indinavir (Crixivan®), itraconazole (Sporanox®, Onmel®), ketoconazole (Nizoral®), lopinavir (Kaletra®), lovastatin (Advicor®, Altoprev®, Mevacor®), mexiletine (Mexitil®), midazolam, milk thistle (Silybum marianum) or products containing milk thistle, nelfinavir (Viracept®), nevirapine (Viramune®, Viramune XR®), nicardipine (Cardene®), nifedipine (Adalat CC®, Afeditab CR®, Procardia®), nisoldipine (Sular®), oxcarbazepine (Oxtellar XR,Trileptal®), phenobarbital (Luminal®), phenytoin (Dilantin®, Phenytek®), pitavastatin (Livalo®), posaconazole (Noxafil®), pravastatin (Pravachol®), propafenone (Rythmol SR®), quinidine (Nuedexta®, Duraquin®, Quinaglute®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®), rifapentine (Priftin®), ritonavir (Norvir®), rosuvastatin (Crestor®), saquinavir mesylate (Invirase®), sildenafil (Revatio®, Viagra®), simvastatin (Zocor®, Vytorin®, Simcor®), sirolimus (Rapamune®), St. John's wort (Hypericum perforatum) or products containing St. John's wort, tadalafil (Adcirca®, Cialis®), telithromycin (Ketek®), tipranavir (Aptivus®), triazolam (Halcion®), verapamil (Calan®, Covera HS®, Isoptin®, Tarka®), voriconazole (Vfend®) .
    • This is not a complete list of medicines that could interact with OLYSIO®. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above.
    • Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

    What are the possible side effects of OLYSIO®?

    • The most common side effects in combination with Peg-IFN-alfa and RBV are skin rash, itching and nausea.
    • The most common side effects in combination with sofosbuvir are tiredness, headache and nausea.
    • Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of OLYSIO®. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    When taking OLYSIO® in combination with Peg-IFN-alfa and RBV, you should also read those Medication Guides. When taking OLYSIO® in combination with sofosbuvir, you should also read its Patient Information leaflet.

    Please see full Prescribing Information and Patient Information for more details.