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  • Generic Name: (simeprevir)
    Other Brands: N/A
  • Last Revised: 06/2016
    • What is this medication and its most common uses?

      Olysio is a medicine used in combination with other antiviral medicines (sofosbuvir or peginterferon and ribavirin) to treat chronic (long-term) hepatitis C infection. Olysio should not be taken alone.

    • What should I know when beginning and continuing on this medication?

      How does this medication work?

      Olysio works by decreasing the amount of hepatitis C virus in the body.

      What are the beneficial effects of this medication and when should I begin to have results?

      What: Studies have shown that people treated with Olysio in combination with sofosbuvir or peginterferon alfa and ribavirin achieved sustained virologic response, which means that the chronic hepatitis C virus was no longer found in the blood, as early as 12 weeks after the end of treatment.

      When: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's directions. It is important that you take Olysio exactly as your healthcare provider has prescribed.

      How do I know it is working?

      Your healthcare provider may order tests regularly to check how well this medication is working.

    • What are the possible side effects of this medication?

      The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.

      Used in Combination with Peginterferon Alfa and Ribavirin

      More common side effects may include: skin rash, itching, nausea.

      Used in Combination with Sofosbuvir

      More common side effects may include: tiredness, headache, nausea.

      Less common side effects of Olysio may include:

      Combination treatment with sofosbuvir may result in slowing of the heart rate along with other symptoms when taken with amiodarone. Symptoms may include fainting or near-fainting, dizziness, lightheadedness, weakness, extreme tiredness, chest pain, shortness of breath, confusion, or memory problems.

      Severe liver problems, with symptoms such as tiredness, weakness, lack of appetite, nausea, vomiting, yellowing of your skin or the whites of your eyes, or color changes in your stools. Your healthcare provider may do blood tests to check your liver function during treatment with Olysio.

      Skin reactions and rashes to sunlight, with symptoms such as burning, redness, swelling, or blisters on your skin; mouth sores or ulcers; red or inflamed eyes (like pink eye).

    • Who should not take this medication?

      Do not take Olysio if you are allergic to it or any of its ingredients.

    • What should I tell my healthcare provider before I take the first dose of this medication?

      Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Olysio. Also, talk to your healthcare provider about your complete medical history, especially if you have liver problems (other than hepatitis C infection), have ever taken any medicine to treat hepatitis C infection, have had a liver transplant, are receiving phototherapy, are of East Asian descent, or if you are pregnant, plan to become pregnant, or are breastfeeding.

    • What is the usual dosage?

      The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.

      Adults: The recommended dose is 1 capsule once a day. Your healthcare provide will determine the appropriate duration of treatment based on the extent of your liver scarring.

    • How should I take this medication?

      Take Olysio exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Olysio without first talking to your healthcare provider.

      Take Olysio with food and swallow the capsules whole.

      Women who can become pregnant 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.

      When taking Olysio in combination with peginterferon alfa and ribavirin you should also read those Medication Guides. When taking Olysio in combination with sofosbuvir, you should also read its Patient Information leaflet.

    • What should I avoid while taking this medication?

      Do not use tanning beds, sunlamps, or other types of light therapy, and limit your exposure to natural sunlight during treatment with Olysio. Use sunscreen, and wear a hat, sunglasses, and protective clothing when you will be exposed to sunlight while you are taking Olysio.

    • What are the possible food and drug interactions associated with this medication?

      If Olysio is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Olysio may interact with numerous medications. Therefore, it is very important that you tell your healthcare provider about any other medications you are taking.

    • May I receive this medication if I am pregnant or breastfeeding?

      The effects of Olysio during pregnancy and breastfeeding are unknown. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

      Do not take Olysio in combination with ribavirin if you or your sexual partner is pregnant. Females who take Olysio in combination with ribavirin should avoid becoming pregnant during treatment and for 6 months after stopping ribavirin.

    • What should I do if I miss a dose of this medication?

      If you miss a dose of Olysio, take it as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular dosing schedule. Do not take two doses at the same time to make up for a missed dose.

    • How should I store this medication?

      Store at room temperature. Store Olysio in the original bottle to protect it from light.

    • Who should I contact in case of emergency or overdose?
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      In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
      National Poison Control#: Call 1-800-222-1222

      This PDR+ drug information has been developed by the Physicians’ Desk Reference Network (PDRN), a source of medication information trusted by doctors for over 65 years.

      This monograph summarizes the most important information about your medication and does not cover all the information you may need. If you have any questions or concerns or want to learn more about your medication, ask your healthcare provider; he/she will be able to provide answers to your questions. This medication should only be used by the patient for whom it was prescribed and should not be shared with other people.
    • Additional patient resources.
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