Simeprevir (Oral Route)

Simeprevir works by decreasing hepatitis C virus levels in the body, which can help the liver recover.

Overview

Simeprevir (Olysio) is a prescription medicine combined with other antiviral drugs to help treat long-lasting hepatitis C. Hepatitis C is a viral infection that inflames the liver and may cause liver failure or diminished liver function.

Simeprevir is in a category of drugs known as protease inhibitors that stop a certain protein that hepatitis C virus requires in order to replicate.

Simeprevir comes as a capsule and is taken with food once a day. Swallow the capsules whole. Doctors recommend 12 weeks of treatment with Olysio in combination with ribavirin and peginterferon alfa.

Simeprevir may also be administered with sofosbuvir to treat long-lasting hepatitis C virus disease.

Before using Olysio, tell your healthcare specialist:

  • If you have other liver conditions apart from hepatitis C
  • If have had hepatitis B before
  • If you have taken the following medicines: boceprevir (victrelis) or telaprevir (incivek)
  • If you underwent a liver transplant
  • If you’re receiving phototherapy
  • If you’re originally from East Asia
  • If you have any other disease
  • If you’re breastfeeding (it’s unclear whether Simeprevir gets into human milk)

You’ll have to decide between breastfeeding and taking Simeprevir with your doctor. You shouldn’t do both.

The most common Simeprevir side effects when combined with ribavirin and peginterferon alfa include nausea, itching, and rash (including photosensitivity). Limit your exposure to the sun and make use of sun-proof equipment during treatment.

Conditions Treated

  • Hepatitis C virus (Genotype 1 and 4)

Type of Medicine

  • Protease inhibitor

Side Effects

The most common Olysio side effects in combination with ribavirin and peginterferon alfa include:

  • Skin rash
  • Nausea
  • Muscle pain
  • Itching
  • Trouble breathing

The most common Olysio side effects when combined with sofosbuvir include:

  • Skin rash
  • Diarrhea
  • Tiredness
  • Headache
  • Nausea
  • Dizziness
  • Sensitivity to light

If you develop any of the following serious Simeprevir side effects, give your doctor a call immediately. If you have potentially life-threatening symptoms, or you’re having a medical emergency, dial 911.

Drastic slow down of heart rate

If you’re taking a heart medication like amiodarone, the Simeprevir and Sofosbuvir combination can make your heart rate slow down drastically. This may cause death.

Symptoms may include:

  • Tiredness
  • Lightheadedness
  • Fainting/feeling like fainting
  • Trouble breathing
  • Overall feeling of weakness
  • Chest pain
  • Difficulty with your memory
  • Confusion
  • End-stage liver disease and liver failure: symptoms may include weakness, general tiredness, loss of appetite, vomiting, nausea, yellowing of eyes or skin, color changes in stools, rash, photosensitivity
  • Skin reaction with symptoms like mouth ulcers or sores, inflamed or red eyes that appear pink (conjunctivitis)

Dosage

Olysio is available in capsule form. You’ll usually take one capsule by mouth with food once a day. Don’t crush, chew, or split the capsules. Swallow them whole. Take Olysio at the same intervals daily.

You’ll usually take Simeprevir with ribavirin and peginterferon alfa for 12 weeks. You’ll then take ribavirin and peginterferon alfa alone for an extra 12-36 weeks.

How long you should take these drugs depends on any prior treatment you’ve received for hepatitis C virus, how you responded to that therapy, and whether you had any serious effects from these drugs.

Take Simeprevir exactly as your physician prescribed. Not more or less.

There’s not much research available on the consequences of a Simeprevir overdose. If you suspect you’ve taken too much Simeprevir, call up your doctor immediately.

If you or somebody else has any serious symptoms after using Simeprevir, dial 911 or visit the emergency room near you.

Don’t stop using Simeprevir without consulting your doctor. Stopping treatment early or skipping doses can make the drug less effective.

If you’ve missed an Olysio dose and your next dose is more than 12 hours away, take that missed dose with food right away. Then go back to your usual dosing schedule.

Don’t take two Olysio capsules at once to offset your missed dose.

If you’ve got any questions about Simeprevir or how to use it, seek guidance from your doctor or pharmacist.

Interactions

Simeprevir may interact with other herbs, vitamins, or medications you may be using. That’s why your physician should carefully control all your medicines. If you want to know how Simeprevir might interact with whatever you’re taking, consult your doctor/pharmacist.

Note: You can decrease the chances of medication interactions by filling all your prescriptions at one pharmacy. That way, your pharmacist can try to find out possible medication interactions.

Alcohol interaction - if you have hepatitis C, don’t take alcohol. It may cause more harm to your liver. In addition, drinking alcohol can make your body get rid of Simeprevir too soon and your treatment may be ineffective.

Medications that could interact with Olysio

Heart medications:

  • Digoxin (Lanoxin)
  • Amiodarone (Pacerone, Cordarone, Nexterone)
  • Quinidine (Quinaglute, Duraquin, Nuedexta), oral route
  • Mexiletine (Mexitil), oral route
  • Disopyramide (Norpace), oral route
  • Propafenone (Rythmol SR), oral route
  • Flecainide (Tambocor), oral route

Seizure medications:

  • Phenytoin (Phenytek, Dilantin)
  • Phenobarbital (Luminal)
  • Carbamazepine (Epitol, Equetro, Carbatrol, Tegretol)
  • Oxcarbazepine (Trileptal, Oxtellar XR)

Antibiotics:

  • Telithromycin (Ketek)
  • Clarithromycin (Prevpac, Biaxin)
  • Erythromycin (Erythrocin Stearate, Erythrocin, Ery-Tab, E.E.S, Eryc)

Antifungal drugs:

  • Ketoconazole (Nizoral)
  • Itraconazole (Onmel, Sporanox)
  • Voriconazole (Vfend)
  • Posaconazole (Noxafil)
  • Fluconazole (Diflucan)

Tuberculosis (TB) drugs:

  • Rifapentine (Priftin)
  • Rifabutin (Mycobutin)
  • Rifampin (Rimactane, Rifamate, Rifadin, Rifater)

Calcium channel blockers:

  • Verapamil (Tarka, Isoptin, Calan, Covera-HS)
  • Amlodipine (Norvasc), oral route
  • Felopidine (Plendil), oral route
  • Nifepidine (Adalat CC, Procardia, Afeditab CR), oral route
  • Diltiazem (Cardizem, Tiazac, Dilacor XR), oral route
  • Nisolpidine (Sular), oral route
  • Nicarpidine (Cardene), oral route

Steroid medications:

  • Dexamethasone (injection or oral route)

Gastrointestinal medications:

  • Cisapride (Propulsid Quicksolv, Propulsid)

Herbal supplements:

  • St. John’s Wort or products that contain St. John’s Wort
  • Milk thistle or products that contain milk thistle

HIV medications:

  • Nelfinavir (Viracept)
  • Nevirapine (Viramune XR, Viramune)
  • Efavirenz (Atripla, Sustiva)

Medicines containing Cobicistat (Stribild):

  • Atazanavir (Reyataz)
  • Darunavir (Prezista)
  • Delavirdinen mesylate (Rescriptor)
  • Ritonavir (Norvir)
  • Etravirine (Intelence)
  • Indinavir (Crixivan)
  • Fosamprenavir (Lexiva)
  • Saquinavir mesylate (Invirase)
  • Lopinavir (Kaletra)
  • Tipranavir (Aptivus)

Cholesterol medications:

  • Lovastatin (Advicor, Mevacor, Altoprev)
  • Atorvastatin (Caduet, Lipitor)
  • Pravastatin (Pravachol)
  • Simvastatin (Zocor, Simcor, Vytorin)
  • Rosuvastatin (Crestor)
  • Pitavastatin (Livalo)

Immunity suppressing drugs:

  • Sirolimus (Rapamune)
  • Cyclosporine (Neoral, Gengraf, Sandimmune)

Pulmonary arterial hypertension, erectile dysfunction drugs:

  • Vardenafil (Staxyn, Levitra)
  • Sildenafil (Viagra, Revatio)
  • Tadalafil (Cialis, Adcirca)

Anti-anxiety and sedative drugs:

  • Triazolam (Halcion), oral route
  • Midazolam, oral route

Other Simeprevir interactions:

Simeprevir may make the skin highly sensitive to sunlight. Don’t try light therapy or a tanning bed, and minimize your exposure to the sun while using Simeprevir.

Take the following precautions when you’re exposed to the sun:

  • Apply sunscreen
  • Wear sunglasses, a hat, and protective clothing
  • Remain in the shade whenever possible

Warnings

If you’re allergic to Olysio, tell your doctor. Also tell him or her if you’re allergic to any of Olysio’s ingredients, sulfa medications, or any other drugs. Check out the maker’s patient information or ask your pharmacist about Simeprevir ingredients.

If you’re using any of these medications, inform your doctor.

Antifungal medications:

  • Ketoconazole (Nizoral)
  • Fluconazole (Diflucan)
  • Itraconazole (Sporanox, Onmel)
  • Voriconazole (Vfend)
  • Posaconazole (Noxafil)

HIV medications:

  • Atazanavir (Reyataz)
  • Delavirdine (Rescriptor)
  • Darunavir (Prezista)
  • Etravirine (Intelence)
  • Indinavir (Crixivan)
  • Nelfinavir (Viracept)
  • Nevirapine (Viramune)
  • Fosamprenavir (Lexiva)
  • Lopinavir (Kaletra)
  • Ritonavir (Norvir)
  • Saquinavir (Invirase)
  • Tipranavir (Aptivus)

Seizure medications:

  • Carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
  • Phenytoin (Phenytek, Dilantin)
  • Oxcarbazepine (Trileptal)
  • Phenobarbital

Medications containing cobicistat (Stribild):

  • Rifabutin (Mycobutin)
  • Rifapentine (Priftin)
  • Rifampin (Rimactane, Rifadin, In Rifater, In Rifamate)
  • Telithromycin (Ketek)

Other medications:

  • Cisapride (Propulsid)
  • Clarithromycin (In Prevpac, Biaxin)
  • Erythromycin (E.E.S, Ery-tab, Eryc, etc.)
  • Dexamethasone

Your doctor will likely tell you to avoid Simeprevir if you’re using one or some of these drugs. Also inform your doctor if you’ve ever used Telaprevir (Incivek) or Boceprevir (Victrelis).

Tell your health care specialists (nurse, doctor, pharmacist, etc.) what other prescription and over-the-counter medications, herbal products, vitamins, and nutritional supplements you’re using or plan to use. Make sure to state any of these:

Calcium channel blockers:

  • Amlodipine (Norvasc)
  • Nifepidine (Procardia, Adalat)
  • Nicardipine (Cardene)
  • Felopidine (Plendil)
  • Verapamil (Calan, Isoptin, Covera HS)
  • Nisoldipine (Sular)
  • Diltiazem (Dilacor XR, Cardizem, Tiazac)

High cholesterol medications:

  • Atorvastatin (in Cadulet, Lipitor)
  • Rosuvastatin (Crestor)
  • Lovastatin (Altoprev, in Advicor, Mevacor)
  • Pravastatin (Pravachol)
  • Pitavastatin (Livalo)
  • Simvastatin (Zocor, in Vytorin, in Simcor)

Medicines for irregular heartbeat:

  • Amiodarone (Pacerone,Cordarone)
  • Flecainide (Tambocor)
  • Propafenone (Rythmol SR)
  • Disopyramide (Norpace)
  • Mexiletine (Mexitil)
  • Quinidine
  • Digoxin (Lanoxin)

Immunity suppressing drugs:

  • Cyclosporine (Neoral, Sandimmune)
  • Sirolimus (Rapamune)

Pulmonary arterial hypertension/erectile dysfunction drugs:

  • Sildenafil (Viagra, Revatio)
  • Tadalafil (Cialis, Adcirca)

Anti-anxiety and sedative drugs:

  • Triazolam (Halcion), oral route
  • Midazolam, oral route

Other drugs:

  • Tacrolimus (Prograf)
  • Warfarin (Coumadin)

Your doctor may have to change your dose of medicines or carefully monitor you for side effects. Simeprevir can also interact with so many other medications, so make sure to inform your physician about other medicines you’re using, even those not mentioned on this list.

Tell your physician what herbs you are using, especially St. John’s Wort or milk thistle. You shouldn’t take St. John’s Wort or milk thistle during your Simeprevir treatment.

Tell your physician if you’ve ever received a liver transplant, if you’re originally from East Asia, if you’re having phototherapy, and if you’ve ever had any kind of liver problem except hepatitis C.

Tell your healthcare specialist if you’re having a baby, plan to conceive, or may possibly get pregnant. If you’re a man, tell your health care provider if your spouse is pregnant, trying to get pregnant, or may possibly get pregnant. Simeprevir must be used together with ribavirin, which may seriously harm your unborn child. To prevent pregnancy during your Simeprevir treatment and six months after treatment, make sure to use two birth control methods. Talk to your physician about which methods to use. Hormonal contraceptives (such as birth control pills, injections, rings, implants, or patches) may not be effective in women using Simeprevir.

You or your spouse must have a pregnancy test before treatment, each month during treatment, as well as six months after treatment. If your partner or yourself fall pregnant while using Simeprevir together with peginterferon alfa and ribavirin, call up your physician right away.

Inform your healthcare giver if you’re breastfeeding.

Plan to avoid prolonged or unnecessary exposure to the sun and wear protective clothes, a hat, sunscreen, and sunglasses. Also don’t use sunlamps, tanning beds, or other kinds of light therapy during your treatment. Olysio can make the skin very sensitive to the sun. Call up your physician promptly if you have severe burning or a sunburn, redness, blisters, or swelling on your skin.

Storage

Keep Olysio at room temperature (under 30 degrees Celsius) and in its original bottle to shield it from direct light. Be sure to keep Olysio and all other medications away from children.

Summary

You may pass the hepatitis C infection to others when you are using Simeprevir. Make sure to ask your healthcare specialist how to avoid spreading the viral infection to others.

This medication together with other medications for treating hepatitis C virus may impair your ability to safely drive or use machinery. Make sure to not operate machinery or drive until you understand how Simeprevir affects you and you’re certain it won’t impact your performance.

While taking Simeprevir, please have your liver function and level of hepatitis C infection regularly monitored by your doctor. This will include having blood tests prior to, during and after Simeprevir treatment. In addition, your blood will be tested to see whether you have genotype 1 hepatitis C virus with a mutation known as Q80K. This mutation may make Simeprevir less effective.

This medication may make the skin highly sensitive to the sun. Therefore, you should avoid unnecessary or prolonged exposure to the sun, sunlamps, or sunbeds while taking Simeprevir. If you cannot avoid being exposed to the sun, please take measures like wearing protective clothing or applying sun creams. Your physician may prescribe a high factor sun cream for you.

This medication is commonly known to cause an itchy rash. This rash is normally moderate or mild, but sometimes it can progress and become very serious or spread to other areas of your body. Make sure to tell your doctor as soon as you develop a rash during Simeprevir treatment, or if your existing rash starts to get worse. Also let your physician know if you see any ulceration or blistering on your skin, genitals, eyes, or mouth, or if you develop a fever, swollen glands or swollen face with a rash. In this case, your doctor may ask you to stop taking Simeprevir.

The efficacy and safety of Simeprevir has not been determined in patients who have had any organ transplant, including a liver transplant, or in patients who have hepatitis B as well.

 

Resources
Last Reviewed:
January 30, 2018
Last Updated:
January 27, 2018