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Generic Name:

simeprevir, Oral capsule

All Brands

  • Olysio
SECTION 1 of 5

Highlights for simeprevir

Oral capsule
1

Simeprevir is an oral drug used to treat chronic hepatitis C virus infection. It’s for people with HCV genotype 1.

2

This drug must be used in combination with other medications to treat your infection. Simeprevir should be taken with sofosbuvir or peginterferon alfa and ribavirin.

3

The recommended dose of simeprevir is one 150-mg capsule taken once per day with food.

4

Common side effects include skin rash, nausea, lightheadedness, itching, headache, fatigue, and muscle pain.

5

You may be able to pass the hepatitis C virus to other people when you’re taking this medication. Ask your doctor how you can prevent spreading the virus to others.

IMPORTANT INFORMATION

Amiodarone warning

If you’re taking the drug amiodarone for your heart, let your doctor know before you start taking simeprevir and sofosbuvir. This combination can slow down your heart rate to a low level and be fatal. Call your doctor right away if you have these symptoms:

  • fainting or feeling like you may faint
  • lightheadedness
  • weakness
  • tiredness
  • trouble breathing
  • chest pain
  • confusion
  • trouble with your memory

Liver failure warning

Simeprevir may raise your risk of liver failure and end-stage liver disease (decompensated liver). This risk may be higher if you already have severe liver problems. Your doctor may do blood tests to check how well your liver works before and during treatment. Call your doctor right away if you have any symptoms of liver failure, such as:

  • tiredness
  • weakness
  • loss of appetite
  • nausea
  • vomiting
  • yellowing of your skin or the whites of your eyes
  • color changes to your stool

Photosensitivity and rash risk

Simeprevir may cause skin reactions and rashes when your skin is exposed to sunlight. These reactions may be severe and may require treatment in a hospital. They're most likely to occur during the first four weeks of treatment, but they can happen at any time. Your doctor will watch you closely and may stop treatment if you develop a rash. Call your doctor right away if you have any of these symptoms:

  • extreme sunburn-like reactions, such as burning, redness, blistering, and swelling of your skin
  • mouth sores or ulcers
  • red or inflamed eyes that look like “pink eye” (conjunctivitis)

What is simeprevir?

Simeprevir is a prescription drug. It’s available as an oral capsule.

Simeprevir is available in its generic form. Generic drugs usually cost less. In some cases they may not be available in every strength or form as the brand. Talk to your healthcare provider to see if the generic will work for you.

Don’t take simeprevir alone. Take it as a part of a combination therapy with sofosbuvir or peginterferon alfa and ribavirin.

Why it's used

Simeprevir is used to treat chronic hepatitis C virus infection. It’s effective for people with HCV genotype 1. It’s used in combination with sofosbuvir or peginterferon alfa and ribavirin.

How it works

Simeprevir is an antiviral drug that inhibits enzymes and prevents the hepatitis C virus from making copies of itself. This stops the virus from spreading and may cure your infection.

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SECTION 2 of 5

simeprevir Side Effects

Oral capsule

Most Common Side Effects

  • The most common side effects that occur with simeprevir in combination with peginterferon alfa and ribavirin include:

    • skin rash
    • itching
    • nausea
    • muscle pain
    • trouble breathing
  • The most common side effects that occur with simeprevir in combination with sofosbuvir include:

    • tiredness
    • headache
    • nausea
    • trouble sleeping
    • dizziness
    • diarrhea
    • skin rash
    • sensitivity to light

Serious Side Effects

If you experience any of these serious side effects, call your doctor right away. If your symptoms are potentially life threatening, or if you think you’re experiencing a medical emergency, call 9-1-1.

  • severe slowing of your heart rate. If you take amiodarone for your heart, the combination of simeprevir and sofosbuvir can slow down your heart rate to a very low level. This can be fatal. Symptoms may include:

    • fainting or feeling like you may faint
    • lightheadedness
    • a general feeling of weakness
    • tiredness
    • trouble breathing
    • chest pain
    • confusion
    • trouble with your memory
  • liver failure and end-stage liver disease. Symptoms may include:

    • general tiredness
    • weakness
    • loss of appetite
    • nausea
    • vomiting
    • yellowing of your skin or the whites of your eyes
    • color changes in your stools
  • photosensitivity skin reaction and rash. Symptoms may include:

    • extreme sunburn-like reactions, such as burning, redness, blistering, and swelling of your skin
    • mouth sores or ulcers
    • red or inflamed eyes that look like “pink eye” (conjunctivitis)
Pharmacist's Advice
Clinical Associate Professor, University of Illinois at Chicago College of Pharmacy

Simeprevir does not cause drowsiness.

Mild side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
SECTION 3 of 5

simeprevir May Interact with Other Medications

Oral capsule

Simeprevir can interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Alcohol Interaction

Don’t drink alcohol if you have the hepatitis C virus infection. It may cause more damage to your liver. If you drink alcohol, your body may remove this drug more quickly and the treatment may not work.

Medications That Might Interact with This Drug

Heart medications
  • amiodarone (Cordarone, Nexterone, Pacerone)
  • digoxin (Lanoxin)
  • disopyramide (Norpace), when taken by mouth
  • flecainide (Tambocor), when taken by mouth
  • mexiletine (Mexitil), when taken by mouth
  • propafenone (Rythmol SR), when taken by mouth
  • quinidine (Nuedexta, Duraquin, Quinaglute), when taken by mouth

Seizure medications
  • carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
  • oxcarbazepine (Oxtellar XR, Trileptal)
  • phenobarbital (Luminal)
  • phenytoin (Dilantin, Phenytek)

Antibiotics
  • erythromycin (E.E.S., Eryc, Ery-Tab, Erythrocin, Erythrocin Stearate)
  • clarithromycin (Biaxin, Prevpac)
  • telithromycin (Ketek)

Antifungal drugs
  • itraconazole (Sporanox, Onmel)
  • ketoconazole (Nizoral)
  • posaconazole (Noxafil)
  • fluconazole (Diflucan)
  • voriconazole (Vfend)

Tuberculosis drugs
  • rifabutin (Mycobutin)
  • rifampin (Rifadin, Rifamate, Rifater, Rimactane)
  • rifapentine (Priftin)

Calcium channel blockers
  • amlodipine (Norvasc), when taken by mouth
  • diltiazem (Cardizem, Dilacor XR, Tiazac), when taken by mouth
  • felodipine (Plendil), when taken by mouth
  • nicardipine (Cardene), when taken by mouth
  • nifedipine (Adalat CC, Afeditab CR, Procardia), when taken by mouth
  • nisoldipine (Sular), when taken by mouth
  • verapamil (Calan, Covera-HS, Isoptin, Tarka), when taken by mouth

Steroid medications
  • dexamethasone, when taken by mouth or given by injection

Gastrointestinal medications
  • cisapride (Propulsid, Propulsid Quicksolv)

Herbal supplements
  • milk thistle (Silybum marianum) or products that contain milk thistle
  • St. John’s wort (Hypericum perforatum) or products containing St. John’s wort

Human immunodeficiency virus (HIV) medications
  • cobicistat-containing medicine (Stribild)
  • efavirenz (Sustiva, Atripla)
  • delavirdine mesylate (Rescriptor)
  • etravirine (Intelence)
  • nevirapine (Viramune, Viramune XR)
  • darunavir (Prezista)
  • ritonavir (Norvir)
  • atazanavir (Reyataz)
  • fosamprenavir (Lexiva)
  • indinavir (Crixivan)
  • lopinavir (Kaletra)
  • nelfinavir (Viracept)
  • saquinavir mesylate (Invirase)
  • tipranavir (Aptivus)

Cholesterol medications
  • atorvastatin (Lipitor, Caduet)
  • lovastatin (Advicor, Altoprev, Mevacor)
  • pitavastatin (Livalo)
  • pravastatin (Pravachol)
  • rosuvastatin (Crestor)
  • simvastatin (Zocor, Vytorin, Simcor)

Immunity suppressing drugs
  • cyclosporine (Gengraf, Neoral, Sandimmune)
  • sirolimus (Rapamune)

Erectile dysfunction, pulmonary arterial hypertension drugs
  • sildenafil (Revatio, Viagra)
  • tadalafil (Adcirca, Cialis)

Sedative and anti-anxiety drugs
  • midazolam, when taken by mouth
  • triazolam (Halcion), when taken by mouth

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
Simeprevir Warnings
People with heart conditions
People with heart conditions who take amiodarone

If you take amiodarone for your heart, the combination of simeprevir and sofosbuvir can slow down your heart rate to a very low level. This can be fatal. You have an even greater risk for this problem if you take beta blockers or have severe liver disease.

 liver problems
People with liver problems

Simeprevir may raise your risk of liver failure and end-stage liver disease (decompensated liver). This risk may be higher if you have severe liver problems. If you’ve had a liver transplant, it’s not known if this drug will work or be safe for you.

 kidney problems
People with kidney problems

If you have severe or end-stage kidney disease, or if you’re on dialysis, it’s not known if simeprevir will work or be safe for you.

Allergy
People with a sulfa allergy

This medication has a sulfonamide component. If you have a sulfa allergy, you may have an allergic reaction to simeprevir. Tell your doctor if you’re allergic to sulfa drugs. Your doctor may watch you closely for signs of an allergic reaction.

People of East Asian ancestry
People of East Asian ancestry

People of East Asian descent may have higher levels of simeprevir in their blood. This may raise your risk of side effects, such as skin rash and photosensitivity.

People with a certain gene
People with a certain gene

Before starting simeprevir, your doctor may do genetic testing to see if you have the polymorphism NS3 Q80K in your genes. If you have this genetic difference, simeprevir taken in combination with peginterferon alfa and ribavirin won’t work as well for you. Your doctor will choose a different treatment.

Pregnant women
Pregnant women

Simeprevir is a category C pregnancy drug. That means two things:

  1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
  2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

It isn’t known if simeprevir alone will harm an unborn baby. However, simeprevir in combination with peginterferon alfa and ribavirin can cause birth defects or death of a fetus.

This can happen if either you or your partner uses ribavirin during conception, or if you or your partner takes the drug during pregnancy. Don’t become pregnant while taking ribavirin and for 6 months after treatment ends.

  • Use two effective forms of birth control during and for 6 months after treatment if you’re a man or a woman being treated with ribavirin. Talk to your healthcare provider about birth control.
  • Women must have a negative pregnancy test before starting treatment, every month while being treated, and for 6 months after treatment ends.
  • If you or your female partner becomes pregnant during or within 6 months after treatment with simeprevir, peginterferon alfa, and ribavirin, 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’s pregnant.
Women who are nursing
Women who are nursing

It isn’t known if simeprevir passes through breast milk. If it does, it may cause serious effects in a breastfeeding child.

You and your doctor may need to decide if you’ll take simeprevir or breastfeed.

Seniors
For Seniors

It isn’t known if seniors respond differently to simeprevir. However, as you age, your organs, such as your liver and kidneys, don’t work as well as they once did. This may cause your body to respond differently to this drug.

Children
For Children

It isn’t known if simeprevir is safe and effective in children younger than 18 years old.

Keep simeprevir and all medicines out of the reach of children.

When to call the doctor
When to call the doctor

Talk to your doctor if you or your partner are pregnant or plan to become pregnant. Taking simeprevir in combination with ribavirin and peginterferon alfa can cause harm to an unborn baby.

Allergies
Allergies

Simeprevir can cause a severe allergic reaction. Symptoms may include:

  • trouble breathing
  • swelling of your throat or tongue
  • hives

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal.

If you have a sulfa allergy, tell your doctor. This medication has a sulfonamide component. You may have an allergic reaction to simeprevir. Tell your doctor if you’re allergic to sulfa drugs. Your doctor may watch you closely for signs of an allergic reaction.

SECTION 4 of 5

How to Take simeprevir (Dosage)

Oral capsule

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

What Are You Taking This Medication For?

Chronic hepatitis C virus infection
Form: Oral capsule
Strength: 150 mg
Adult Dosage (ages 18 years and older)

The recommended dosage of simeprevir is one 150-mg capsule taken by mouth once per day with food. Swallow the capsule whole.

Simeprevir in combination with peginterferon alfa and ribavirin:

  • If you’ve never been treated for the hepatitis C virus (HCV) infection before, or if you were treated successfully but your infection came back, your treatment will be the following:
    • You’ll take simeprevir with peginterferon alfa and ribavirin for the first 12 weeks. Then you’ll stop taking simeprevir, but you’ll continue to take peginterferon alfa and ribavirin for another 12 weeks. The total treatment time is 24 weeks.
  • If you’ve been treated for your HCV infection in the past but your treatment didn’t work, your treatment will be the following:
    • You’ll take simeprevir with peginterferon alfa and ribavirin for the first 12 weeks. Then you’ll stop taking simeprevir, but you’ll continue to take peginterferon alfa and ribavirin for another 36 weeks. The total treatment time is 48 weeks.

Simeprevir in combination with sofosbuvir (with or without a history of HCV treatment):

  • If you don’t have a history of cirrhosis (severe scarring of liver tissue):
    • You’ll take simeprevir and sofosbuvir for 12 weeks.
  • If you have a history of cirrhosis:
    • You’ll take simeprevir and sofosbuvir for 24 weeks.
Child Dosage (ages 0–17 years)

It isn’t known if simeprevir is safe and effective in children younger than 18 years old.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Pharmacist's Advice
Clinical Associate Professor, University of Illinois at Chicago College of Pharmacy

Simeprevir comes with serious risks if you don't take it as prescribed.

If You Don't Take It at All

If you don’t take this medication, the infection will continue to progress and cause more damage to your liver. This infection may be fatal if it’s not treated properly.

If You Don't Take It On Schedule

You may become resistant to this drug and it will no longer work for you. The infection will continue to progress and cause more damage to your liver. Take your medication every day as directed.

If You Take Too Much

If you think you’ve taken too much of this drug, call your doctor or go to the emergency room right away.

What to Do If You Miss a Dose

If you miss a dose and it’s 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 and it’s fewer than 12 hours until your next dose, skip the missed dose. Take the next dose of simeprevir at your regular time.

Don’t take two doses of simeprevir at the same time to try to make up for a missed dose.

How to Tell the Drug is Working

Your doctor will do blood tests to check the amount of virus in your body. If simeprevir is working, the amount of virus in your body should decrease. These blood tests may be done before, during, and after treatment with simeprevir.

Simeprevir is a short-term drug treatment.

Important Considerations for Taking Simeprevir
with food
Take simeprevir with food. This will help your body absorb the drug better
timing
Take this drug at the right times for best effects
Don’t cut
Don’t cut or crush this medication
Storage
Store simeprevir at room temperature
See Details
Refillable
Prescription is refillable
Travel
Travel
See Details
Clinical Monitoring
Clinical Monitoring
See Details
Sun Sensitivity
Sun Sensitivity
See Details
Not Stocked
Not every pharmacy stocks this drug, so call ahead
Prior authorization
Insurance
See Details

Store simeprevir at room temperature

Keep it below 86°F (30°C). Don’t freeze simeprevir.

Keep it in its original bottle to protect it from light.

Keep this drug away from areas where they could get wet, such as bathrooms. Store this drug away from moisture and damp locations.

Travel

When traveling with your medication:

  • Always carry your medication with you or in your carry-on bag.
  • Don’t worry about airport X-ray machines. They can’t hurt this medication.
  • You may need to show your pharmacy’s label to clearly identify the medication. Keep the original prescription label with you when traveling.
  • Don’t leave this drug in the car, especially when the temperature is hot or freezing.
  • Be sure that you have enough medication before you leave on your trip. It may be difficult to fill this prescription since not every pharmacy has it in stock.

Clinical Monitoring

Your doctor may check you for the following during your treatment with simeprevir:

  • genetics. Before starting simeprevir, your doctor may do genetic testing to check if you have the polymorphism NS3 Q80K in your genes. If you have this genetic difference, simeprevir taken in combination with peginterferon alfa and ribavirin won’t work as well for you. Your doctor will choose a different treatment.
  • blood tests. Your doctor will do blood tests to check for the amount of virus in your body. If simeprevir is working, the amount of virus in your body should decrease. These blood tests may be done before, during, and after treatment with simeprevir.
  • liver function. Since this medication can damage your liver, your doctor will check how well your liver is working. This will also tell your doctor if this drug is still safe for you to take.
  • pregnancy. Simeprevir, taken in combination with peginterferon alfa and ribavirin, may cause birth defects or death of an unborn baby. If you’re pregnant or your partner is pregnant or plans to become pregnant, don’t take these medicines. Women must have a negative pregnancy test before starting treatment, every month while being treated, and for 6 months after treatment ends.

Sun Sensitivity

Simeprevir causes sun sensitivity.

To protect yourself:

  • Limit exposure to sunlight.
  • Use sunscreen when you’re outside.
  • Wear a hat, sunglasses, and protective clothing when you’re exposed to sunlight.
  • Avoid tanning beds, sunlamps, or other types of light therapy while you’re taking simeprevir.
  • Call your doctor right away if you have extreme sunburn-like reactions, such as burning, redness, blistering, and swelling of your skin.

Insurance

Many insurance companies will require a prior authorization before they approve the prescription and pay for simeprevir.

Are There Any Alternatives?

There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.

SECTION 5 of 5

How Much Does simeprevir Cost?

Oral capsule

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Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on June 11, 2015

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
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