Simeprevir is used for:

Treating chronic hepatitis C (CHC) in certain patients. It must be used in combination with certain other medicines to treat CHC.

Simeprevir is a hepatitis C protease inhibitor. It reduces the amount of hepatitis C virus (HCV) in the body by preventing the spread of the HCV within the body.

Do NOT use simeprevir if:

  • you are allergic to any ingredient in simeprevir
  • you have severe liver problems
  • you are NOT taking other drugs to treat HCV infection
  • you are taking carbamazepine, cisapride, clarithromycin, cobicistat, cyclosporine, delavirdine, dexamethasone, efavirenz, erythromycin, etravirine, fluconazole, HIV protease inhibitors (eg, ritonavir), itraconazole, ketoconazole, milk thistle, nevirapine, oxcarbazepine, phenobarbital, phenytoin, posaconazole, rifabutin, rifampin, rifapentine, St. John’s wort, telithromycin, or voriconazole

Before using simeprevir:

Some medical conditions may interact with simeprevir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances, including sulfa drugs
  • if you have other liver problems (eg, cirrhosis, hepatitis B infection) or have had a liver transplant
  • if you are receiving phototherapy
  • if you have ever taken any medicine to treat HCV infection
  • if you are taking sofosbuvir with simeprevir to treat HCV infection and are also taking amiodarone. The risk of slow heartbeat may be increased, especially if you are taking a beta blocker (eg, metoprolol), have heart problems, or have certain liver problems

Some MEDICINES MAY INTERACT with simeprevir. Tell your health care provider if you are taking any other medicines, especially any of the following:

Many prescription and nonprescription medicines (eg, used for anxiety, asthma or other lung or breathing problems, blood thinning, cancer, depression or other mental or mood problems, erectile dysfunction, high blood pressure, high cholesterol, HIV, immune system suppression, infections, inflammation, irregular heartbeat or other heart problems, nausea and vomiting, pulmonary arterial hypertension (PAH), seizures, sleep, stomach or bowel problems), multivitamin products, and herbal or dietary supplements because they may interact with simeprevir. As

How to use simeprevir:

Use simeprevir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with simeprevir. Talk to your pharmacist if you have questions about this information.
  • Simeprevir must be taken with certain other medicines to treat CHC. Some of these medicines come with their own Medication Guides. If the other medicines have a Medication Guide, be sure to read it each time you get them filled.
  • Take simeprevir by mouth with food.
  • Swallow simeprevir whole. Do not break, crush, or chew before swallowing.
  • Simeprevir works best if it is taken at the same times each day.
  • Continue to take simeprevir even if you feel well. Do not miss any doses.
  • If you miss a dose of simeprevir, take it as soon as possible with food. If it is less than 12 hours before your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Important safety information:

  • Tell your doctor or dentist that you take simeprevir before you receive any medical or dental care, emergency care, or surgery.
  • Simeprevir may cause rashes and skin reactions to sunlight, which may be severe. Sometimes, this has led to the need to go to the hospital. This is most common during the first 4 weeks of treatment, but can happen at any time during treatment. This risk may be higher in patients of East Asian descent. Limit sunlight exposure and avoid the use of sunlamps, tanning beds, or other types of light therapy during treatment with simeprevir. Use a sunscreen, and wear a hat, sunglasses, and protective clothing if you must be outside for more than a short time. Call your doctor right away if you have burning, redness, swelling, or blisters on your skin; mouth sores or ulcers; or red or inflamed eyes.
  • Cases of slow heartbeat and the need to get a pacemaker have happened when an HCV medicine (sofosbuvir) was given with amiodarone and certain other HCV medicines (including simeprevir). Sometimes, this has been fatal. Slow heartbeat has happened up to 2 weeks after starting HCV treatment. You will need to be monitored closely if you will be taking amiodarone with HCV treatment. Follow what your doctor has told you to do. Call your doctor right away if you have symptoms of slow heartbeat (eg, chest pain, confusion, dizziness or lightheadedness, fainting or near-fainting, memory problems, shortness of breath, tiredness or weakness).
  • Simeprevir does not stop the spread of HCV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HCV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HCV to others.
  • Do not change your dose or stop taking simeprevir or any of your medicines without checking with your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking simeprevir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Simeprevir must be taken along with certain other medicines to treat CHC. Be sure you know about all of the warnings, benefits, and risks of the other medicines. Discuss any questions or concerns with your doctor.
  • If you stop taking any of your other medicines to treat CHC, talk with your doctor. You may need to stop taking simeprevir as well.
  • If you may become pregnant, you must use an effective form of birth control while you take simeprevir. If you have questions about effective birth control, talk with your doctor.
  • Lab tests may be performed while you use simeprevir and for several months after you stop simeprevir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: It is not known if simeprevir can cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using simeprevir while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking simeprevir.


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