"The U.S. Food and Drug Administration today approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver"...
(oh li' see oh)
Read this Patient Information before you start taking OLYSIO and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
OLYSIO is used in combination with other antiviral medicines. When taking OLYSIO in combination with peginterferon alfa and ribavirin you should also read those Medication Guides.
The information in this Patient Information leaflet talks about OLYSIO when it is used in combination with peginterferon alfa and ribavirin.
What is the most important information I should know about OLYSIO?
OLYSIO, 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 OLYSIO 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 OLYSIO, 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 OLYSIO, peginterferon alfa, and ribavirin combination therapy, every month while being treated, and every month for 6 months after your treatment with OLYSIO, peginterferon alfa, and ribavirin combination therapy is over.
- If you or your female sexual partner becomes pregnant while taking OLYSIO, 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.
OLYSIO 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 OLYSIO, 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 OLYSIO.
- Limit sunlight exposure during treatment with OLYSIO.
- Avoid use of tanning beds, sunlamps, or other types of light therapy during treatment with OLYSIO.
- 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 OLYSIO alone. OLYSIO should be used together with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.
What is OLYSIO?
- OLYSIO is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C in adults.
- OLYSIO must not be taken alone.
It is not known if OLYSIO is safe and effective in children under 18 years of age.
Who should not take OLYSIO?
See “What is the most important information I should know about OLYSIO?”
What should I tell my healthcare provider before taking OLYSIO?
Before taking OLYSIO, tell your healthcare provider if you:
- have liver problems other than hepatitis C virus 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 OLYSIO passes into your breast milk. You and your healthcare provider should decide if you will take OLYSIO or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
OLYSIO and other medicines may affect each other. This can cause you to have too much or not enough OLYSIO or other medicines in your body, which may affect the way OLYSIO or your other medicines work, or may cause side effects. Do not start taking a new medicine without telling your healthcare provider or pharmacist.
Especially tell your healthcare provider if you take any of the following medicines:
- amiodarone (Cordarone®, Pacerone®)
- amlodipine (Norvasc®)
- atazanavir (Reyataz®)
- atorvastatin (Lipitor®, Caduet®)
- carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®)
- cisapride (Propulsid®, Propulsid Quicksolv®)
- clarithromycin (Biaxin®, Prevpac®)
- cobicistat-containing medicine (Stribild®)
- cyclosporine (Gengraf®, Neoral®, Sandimmune®)
- darunavir (Prezista®)
- delavirdine mesylate (Rescriptor®)
- dexamethasone (when administered by injection or when taken by mouth)
- digoxin (Lanoxin®)
- diltiazem (Cardizem®, Dilacor XR®, Tiazac®)
- disopyramide (Norpace®)
- efavirenz (Sustiva®, Atripla®)
- erythromycin (E.E.S.® , Eryc® , Ery-Tab® , Erythrocin® , Erythrocin Stearate®)
- etravirine (Intelence®)
- felodipine (Plendil®)
- flecainide (Tambocor®)
- fluconazole (when taken by mouth or when administered by injection) (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 (when taken by mouth)
- 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 (Nuedexta®, Duraquin®, Quinaglute®)
- 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 (when taken by mouth) (Halcion®)
- verapamil (Calan®, Covera-HS®, Isoptin®, Tarka®)
- voriconazole (when taken by mouth or when administered by injection) (Vfend®)
- warfarin (Coumadin®)
This is not a complete list of medicines that could interact with OLYSIO. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take OLYSIO?
- Take OLYSIO 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 OLYSIO unless your healthcare provider tells you to. If you think there is a reason to stop taking OLYSIO, talk to your healthcare provider before doing so.
- Take one OLYSIO capsule each day with food.
- Swallow OLYSIO capsules whole.
- If you miss a dose of OLYSIO 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 OLYSIO at your regular time.
- If you miss a dose of OLYSIO and it is less than 12 hours until your next dose, skip the missed dose. Take the next dose of OLYSIO at your regular time.
- Do not take two doses of OLYSIO at the same time to make up for a missed dose.
- If you take too much OLYSIO, call your healthcare provider right away or go to the nearest hospital emergency room.
What are the possible side effects of OLYSIO?
- See “What is the most important information I should know about OLYSIO?”
The most common side effects of OLYSIO when used in combination with peginterferon alfa and ribavirin include:
- skin rash. See “What is the most important information I should know about OLYSIO?” section of this leaflet.
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 OLYSIO. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store OLYSIO?
- Store OLYSIO at room temperature below 86°F (30°C).
- Store OLYSIO in the original bottle to protect it from light.
Keep OLYSIO and all medicines out of the reach of children.
General Information about the safe and effective use of OLYSIO
It is not known if treatment with OLYSIO will prevent you from infecting another person with the hepatitis C virus during your treatment. Talk with your healthcare provider about ways to prevent spreading the hepatitis C virus.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use OLYSIO for a condition for which it was not prescribed. Do not give your OLYSIO to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information about OLYSIO, talk with your pharmacist or healthcare provider. You can ask your pharmacist or healthcare provider for information about OLYSIO that is written for health professionals.
For more information about OLYSIO, go to www.OLYSIO.com or call 1-800-526-7736.
What are the ingredients in OLYSIO?
Active ingredient: simeprevir
Inactive ingredients: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, magnesium stearate, sodium lauryl sulphate. The white capsule contains gelatin and titanium dioxide (E171) and is printed with ink containing iron oxide black (E172) and shellac (E904).
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 1/23/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Olysio Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.