Simeprevir

Simeprevir is a prescription medication used with other antiviral medicines to treat chronic hepatitis C virus infection (a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure). 

Simeprevir belongs to a group of drugs called protease inhibitors that block a specific protein needed by the hepatitis C virus to replicate.

This medication comes in capsule form and is taken once daily with food. Swallow simeprevir capsules whole. The recommended duration of treatment with simeprevir is 12 weeks in combination with peginterferon alfa and ribavirin. 

Simeprevir can also be given with sofosbuvir for the treatment of chronic hepatitis C virus infection.

The most common side effects of simeprevir in combination with peginterferon-alfa and ribavirin are rash (including photosensitivity), itching and nausea. Limit sun exposure and use sun protective measures during treatment.

Simeprevir is a prescription medication used with other antiviral medications to treat chronic hepatitis C (CHC) infection. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Simeprevir may be found in some form under the following brand names:

• Olysio

The most common side effects of simeprevir when used in combination with peginterferon alfa and ribavirin include

• skin rash
• itching
• 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 simeprevir. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your healthcare provider about the medications you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

• amiodarone (Cordarone, Pacerone)
• amlodipine (Norvasc)
• atazanavir (Reyataz)
• atorvastatin (Lipitor, Caduet)
• carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
• clarithromycin (Biaxin)
• cobicistat-containing medicine: (Stribild)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• darunavir (Prezista)
• delavirdine mesylate (Rescriptor)
• dexamethasone 
• digoxin (Lanoxin)
• diltiazem (Cardizem, 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 (when taken by mouth) (Sporanox, Onmel)
• ketoconazole (when taken by mouth) (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 (Trileptal)
• phenobarbital (Luminal)
• phenytoin (Dilantin, Phenytek)
• pitavastatin (Livalo)
• posaconazole (when taken by mouth) (Noxafil)
• pravastatin (Pravachol)
• propafenone (Rythmol SR)
• quinidine
• rifabutin (Mycobutin)
• rifampin (Rifadin, Rifamate, Rifater)
• 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
• tacrolimus (Prograf)
• tadalafil (Adcirca, Cialis)
• telithromycin (Ketek)
• tipranavir (Aptivus)
• triazolam (Halcion)
• verapamil (Calan, Covera-HS, Isoptin, Tarka)
• voriconazole (Vfend)
• warfarin (Coumadin)

This is not a complete list of simeprevir drug interactions. Ask your healthcare provider or pharmacist for more information.

• Simeprevir, in combination with peginterferon alfa and ribavirin may cause birth defects or death of your unborn baby. See "Pregnancy" section.
• Simeprevir in combination with peginterferon alfa and ribavirin 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 treatment with simeprevir, peginterferon alfa, and ribavirin combination therapy.
  • Use sunscreen, and wear a hat, sunglasses, and protective clothing when you will be exposed to sunlight during treatment with simeprevir.
  • Limit sunlight exposure during treatment with simeprevir.
  • Avoid use of tanning beds, sunlamps, or other types of light therapy during treatment with simeprevir.
  • 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)

• Do not take simeprevir alone. Simeprevir should be used together with peginterferon alfa and ribavirin or used in combination with sofosbuvir to treat chronic hepatitis C infection.

Contact your healthcare provider immediately if you develop weakness, fatigue, nausea, vomiting, yellow eyes or skin, loss of appetite, or light-colored stools. These may be signs and symptoms of a serious liver problem. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of simeprevir there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking simeprevir, tell your healthcare provider if you:

• have liver problems other than hepatitis C virus infection
• if you have a history of hepatitis B infection
• have taken the medicines telaprevir (Incivek) or boceprevir (Victrelis)
• had a liver transplant
• are receiving phototherapy
• have any other medical condition
• are of East Asian descent
• are breastfeeding. It is not known if simeprevir passes into your breast milk. You and your healthcare provider should decide if you will take simeprevir or breastfeed. You should not do both.

• Simeprevir, in combination with peginterferon alfa and ribavirin may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant, or plans to become pregnant, do not take these medicines. You or your sexual partner should not become pregnant while taking simeprevir with peginterferon alfa and ribavirin and for 6 months after treatment is over.
  • Females and males must use two effective forms of birth control during treatment and for 6 months after treatment with simeprevir, peginterferon alfa, and ribavirin combination therapy. Talk to your healthcare provider about forms of birth control that may be used during this time.
  • Females must have a pregnancy test before starting treatment with simeprevir, peginterferon alfa, and ribavirin combination therapy, every month while being treated, and every month for 6 months after your treatment with simeprevir, peginterferon alfa, and ribavirin combination therapy is over.
  • If you or your female sexual partner becomes pregnant while taking simeprevir, peginterferon alfa, and ribavirin combination therapy or within 6 months after you stop taking these medicines, tell your healthcare provider right away. You or your healthcare provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant.

Tell your healthcare provider if you are breastfeeding. It is not known if simeprevir passes into your breast milk. You and your healthcare provider should decide if you will take simeprevir or breastfeed. You should not do both.

• Take simeprevir exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to. 
• Do not stop taking simeprevir unless your healthcare provider tells you to. If you think there is a reason to stop taking simeprevir, talk to your healthcare provider before doing so. 
• Take one simeprevir capsule each day with food. 
• Swallow simeprevir capsules whole. 
• If you miss a dose of simeprevir and it is more than 12 hours until your next dose, take the missed dose as soon as possible with food. Take the next dose of simeprevir at your regular time. 
• If you miss a dose of simeprevir and it is less than 12 hours until your next dose, skip the missed dose. Take the next dose of simeprevir at your regular time. 
• Do not take two doses of simeprevir at the same time to make up for a missed dose. 

The recommended dose of simeprevir is one capsule of 150 mg taken orally once daily with food.

If you take too much simeprevir, call your healthcare provider right away or go to the nearest hospital emergency room.

• Store simeprevir at room temperature below 86°F (30°C). 
• Store simeprevir in the original bottle to protect it from light. 
• Keep simeprevir and all medicines out of the reach of children.

There is a risk of hepatitis B virus (HBV) becoming an active infection in those who have a current or previous infection with HBV and is treated with a certain antiviral medication (a direct-acting antiviral) to treat hepatitis C virus. Your healthcare provider will screen and monitor for HBV in those taking a direct-acting antiviral. Tell your healthcare provider if you have a history of hepatitis B infection or other liver problems before you are treated for hepatitis C.