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Simeprevir (By mouth)

Simeprevir (sim-E-pre-vir)

Treats hepatitis C. Used together with peginterferon alfa and ribavirin, or with sofosbuvir.

Brand Name(s):


There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you had an allergic reaction to simeprevir, you are pregnant, or your sexual partner is pregnant.

How to Use This Medicine:


  • Take your medicine as directed.
  • Simeprevir is always taken together with ribavirin and peginterferon-alfa, or with sofosbuvir. Take all of the medicines your doctor prescribed and make sure you understand when to take them during the day.
  • Swallow the capsule whole. Do not crush, break, or chew it.
  • It is best to take this medicine with food or milk.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
  • Missed dose: If it is less than 12 hours from the time your dose was scheduled, take the capsule as soon as you can. If you miss a dose and it is more than 12 hours from the time your dose was scheduled, skip the missed dose and take your next dose at the regular time. Do not take extra medicine to make up for a missed dose. Call your doctor if you have questions.
  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • There are many other drugs that can interact with simeprevir. Make sure your doctor knows about all other medicines you are using.
  • Do not use this medicine together with milk thistle, St John's wort, carbamazepine, cisapride, clarithromycin, cobicistat, cyclosporine, dexamethasone, erythromycin, fluconazole, itraconazole, ketoconazole, oxcarbazepine, phenobarbital, phenytoin, posaconazole, rifabutin, rifampin, rifapentine, telithromycin, voriconazole, or certain medicines to treat HIV/AIDS.
  • Tell your doctor if you are using digoxin, midazolam, sirolimus, triazolam, blood pressure medicine (a calcium channel blocker [CCB]), medicine to treat heart rhythm problems, a blood thinner (such as warfarin), medicine to lower cholesterol, or medicine to treat pulmonary arterial hypertension.

Warnings While Using This Medicine:

  • This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. You must use 2 forms of birth control during treatment and for 6 months after treatment ends.
  • Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease other than hepatitis C, you had an organ transplant, or you have a sulfa allergy.
  • This medicine may cause severe sunburn and rash. Stay out of the sun as much as possible. Wear sunscreen, a hat, and protective clothing when you are outside. Do not use sunlamps or tanning beds.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Blisters, swelling, redness, or other signs of sunburn
  • Red or swollen irritated eyes
  • Severe skin rash
  • Sores or ulcers in the mouth
  • Trouble breathing

If you notice these less serious side effects, talk with your doctor:

  • Joint or muscle pain
  • Nausea

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 7/4/2015

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