Simeprevir, Oral

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KEY POINTS

• This medicine is taken by mouth, along with another medicine, to treat chronic hepatitis C. Take it exactly as directed.
• When taken with certain other medicines, this medicine can cause severe birth defects. It must not be used by women who are pregnant or by the male partners of women who are pregnant.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may cause life-threatening problems if you take this medicine with certain other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: HCV protease inhibitor

Generic and brand names: simeprevir, oral; Olysio

What is this medicine used for?

This medicine is taken by mouth to treat continuing (chronic) hepatitis C virus infections in adults. This medicine alone is not effective in the treatment of hepatitis C. Peginterferon and ribavirin must also be given in order for the treatment to be effective.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to sulfa
• An organ transplant
• Kidney disease
• Liver disease other than hepatitis C

Tell your provider if you are of Asian ancestry. You may need a dosage adjustment. Also, tell your healthcare provider if you are getting phototherapy (light therapy) treatments.

Taking this medicine with certain other medicines may be life-threatening. Tell your provider about ALL of the medicines and natural remedies you take, especially antibiotics, antipsychotics, sedatives, St. John's Wort, medicines for migraine headaches, birth control hormones, and medicines to treat cholesterol, an enlarged prostate, pulmonary hypertension, or seizures.

Females of childbearing age: This medicine, taken along with peginterferon and ribavirin, can cause birth defects. Read the information that comes in the medicine package. Your healthcare provider will check that you are not pregnant before starting this treatment, each month during treatment, and for 6 months after stopping treatment. Use 2 or more forms of an effective birth control method while you are taking this medicine and for 6 months after stopping it. Hormonal forms of birth control may not work as well during treatment with this medicine. Talk to your healthcare provider about effective forms of birth control. Stop taking this medicine at the first sign that you may be pregnant. If you think you may be pregnant while taking this medicine or within 6 months after stopping this medicine, contact your healthcare provider right away. Do not breast-feed while taking this medicine.

Males: Use 2 or more forms of an effective birth control method while you are taking this medicine and for 6 months after stopping it. Talk to your healthcare provider about effective forms of birth control. Do not use this medicine if your female partner is pregnant.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Your symptoms may get worse if you stop taking this medicine too soon.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine with food. Swallow the capsule whole. Do not break, crush, or chew the capsule. Take it 1 time per day, along with the other medicines. Do not take this medicine by itself. It must be taken with other medicines. Make sure you understand how to take all medicines. Ask your healthcare provider or pharmacist if you have any questions.

What if I miss a dose?

If you miss a dose, take it (with food) as soon as you remember, unless it is less than 12 hours before the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose or you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments.

This medicine may cause rashes or make your skin more sensitive to the sun, which may lead to severe reactions. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. If you get a severe sunburn, red or swollen eyes, or mouth sores after sun exposure, contact your healthcare provider right away.

This medicine does not cure hepatitis C or keep you from spreading it to other people. Do not share needles, toothbrushes, or razor blades with others.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or a Medic Alert bracelet. If you become unconscious, the ID tells emergency healthcare providers that you may need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Trouble breathing; shortness of breath; any skin rash, redness, burning, swelling, or blistering; mouth sores; red or swollen eyes.

Other: Nausea, muscle pain, mild itching.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alpha blockers such as alfuzosin (Uroxatral), silodosin (Rapaflo), and tamsulosin (Flomax)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, chlordiazepoxide, clorazepate (Gen-Xene, Tranxene), diazepam (Valium), estazolam, flurazepam, lorazepam (Ativan), and oxazepam
• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), isoniazid, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), nefazodone, trazodone, trimipramine (Surmontil), and venlafaxine (Effexor)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), haloperidol (Haldol), iloperidone (Fanapt), lurasidone (Latuda), and pimozide (Orap)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), clonazepam (Klonopin), ethosuximide (Zarontin), fosphenytoin (Cerebyx), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aprepitant (Emend)
• Cancer medicines such as abiraterone (Zytiga), afatinib (Gilotrif), bosutinib (Bosulif), crizotinib (Xalkori), dasatinib (Sprycel), doxorubicin (Doxil), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), nilotinib (Tasigna), osimertinib (Tagrisso), palbociclib (Ibrance), pazopanib (Votrient), and vincristine (Marqibo)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lovastatin (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Cimetidine (Tagamet)
• Colchicine (Colcrys)
• Corticosteroids such as dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), and prednisone (Prednisone Intensol)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Heart medicines such as amiodarone (Cordarone, Pacerone), amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dronedarone (Multaq), eplerenone (Inspra), felodipine, flecainide, isradipine (DynaCirc), lidocaine (Lidoderm, Xylocaine), mexiletine, nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), propafenone (Rythmol), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), ledipasvir/sofosbuvir (Harvoni), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), raltegravir (Isentress), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase), tenofovir (Viread), and tipranavir (Aptivus)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat breathing or lung problems such as budesonide (Entocort, Rhinocort, Uceris), fluticasone (Flonase, Flovent, Veramyst), fluticasone/salmeterol (Advair), mometasone (Asmanex, Nasonex), and salmeterol (Serevent)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), dabigatran (Pradaxa), edoxaban (Savaysa), rivaroxaban (Xarelto), and warfarin (Coumadin)
• Medicines to treat pulmonary hypertension such as bosentan (Tracleer), sildenafil (Revatio), and tadalafil (Adcirca)
• Methylergonovine
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal) and ergotamine (Ergomar)
• Naloxegol (Movantik)
• Natural remedies such as milk thistle, red yeast rice, and St. John’s wort
• Pain medicines such as buprenorphine (Buprenex, Butrans), fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), and methadone (Dolophine, Methadose)
• Sleeping pills such as eszopiclone (Lunesta), triazolam (Halcion), and zolpidem (Ambien, Edluar, Intermezzo)
• Sofosbuvir (Sovaldi)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the original bottle at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.