Simeprevir

Brand Name(s): Olysio^®

IMPORTANT WARNING:

You may already be infected with hepatitis B (a virus that infects the liver and may cause severe liver damage) but not have any symptoms of the disease. In this case, taking simeprevir may increase the risk that your infection will become more serious or life-threatening and you will develop symptoms. Tell your doctor if you have or have ever had a hepatitis B virus infection. Your doctor will order a blood test to see if you have or have ever had hepatitis B infection. Your doctor will also monitor you for signs of hepatitis B infection during and for several months after your treatment. If necessary, your doctor may give you medication to treat this infection before and during your treatment with simeprevir. If you experience any of the following symptoms during or after your treatment, call your doctor immediately: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea or vomiting, pale stools, stomach pain, or dark urine.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests before, during, and after your treatment to check your body's response to simeprevir.

Talk to your doctor about the risk(s) of taking simeprevir.

IMPORTANT NOTICE:

Simeprevir is no longer available in the United States. If you are currently taking simeprevir, you should call your doctor to discuss switching to another treatment.

WHY is this medicine prescribed?

Simeprevir is used along with ribavirin (Copegus, Rebetol) and peginterferon alfa (Pegasys) to treat chronic hepatitis C (an ongoing viral infection that damages the liver). Simeprevir is in a class of medications called protease inhibitors. It works by decreasing the amount of hepatitis C virus (HCV) in the body. Simeprevir may not prevent the spread of hepatitis C to other people.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Simeprevir comes as a capsule to take by mouth. It is usually taken with food once a day. Take simeprevir at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take simeprevir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them.

You will take simeprevir with peginterferon alfa and ribavirin for 12 weeks. Then you will stop taking simeprevir and will take peginterferon and ribavirin for an additional 12 or 36 weeks. The length of your treatment depends on whether you have received prior treatment for hepatitis C, how you responded to prior treatment, how you respond to the medications, and whether you experience severe side effects. Continue to take simeprevir, peginterferon alfa, and ribavirin as long as they are prescribed by your doctor. Do not stop taking any of these medications without talking to your doctor even if you are feeling well.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking simeprevir,

• tell your doctor and pharmacist if you are allergic to simeprevir, sulfa drugs, any other medications, or any of the ingredients in simeprevir capsules. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain antifungal medications such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor XR, Tiazac), felodipine, nicardipine (Cardene), nifedipine (Adalat, Procardia), nisoldipine (Sular), or verapamil (Calan, Verelan, others); certain medications for high cholesterol such as atorvastatin (Lipitor, in Caduet), lovastatin (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Flolipid, Zocor, in Vytorin); cisapride (Propulsid) (not available in the U.S.); clarithromycin (Biaxin, in Prevpac); medications containing cobicistat (Stribild); erythromycin (E.E.S., Eryc, Ery-tab, others), certain medications for HIV such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), or tipranavir (Aptivus); certain medications for irregular heartbeat such as amiodarone (Nexterone, Pacerone), disopyramide (Norpace), flecainide (Tambocor), mexiletine , propafenone (Rythmol SR), or quinidine (in Nuedexta); cyclosporine (Gengraf, Neoral, Sandimmune); dexamethasone; digoxin (Lanoxin); ledipasvir (Harvoni); midazolam taken by mouth; rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); rifapentine (Priftin); certain medications for seizures such as carbamazepine (Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, or phenytoin (Dilantin, Phenytek); sildenafil (only Revatio brand used for lung disease); sirolimus (Rapamune); tacrolimus (Prograf); tadalafil (only Adcirca brand used for lung disease); telithromycin (Ketek); triazolam (Halcion) taken by mouth; vardenafil (Levitra, Staxyn), or warfarin (Coumadin, Jantoven). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with simeprevir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor what herbal products you are taking, especially milk thistle or St. John's wort. You should not take milk thistle or St. John's wort during your treatment with simeprevir.

• tell your doctor if you have had a liver transplant, if you are receiving phototherapy, if you are of East Asian descent, and if you have or have ever had any type of liver disease other than hepatitis C.

• tell your doctor if you are pregnant, plan to become pregnant, or can possibly become pregnant. If you are male, tell your doctor if your partner is pregnant, plans to become pregnant, or can possibly become pregnant. Simeprevir must be taken with ribavirin which can seriously harm the fetus. You must use two methods of birth control to prevent pregnancy in you or your partner during treatment with these medications and for 6 months after your treatment. Talk to your doctor about which methods you should use; hormonal contraceptives (birth control pills, patches, implants, rings, or injections) may not work well in women who are taking these medications. You or your partner must be tested for pregnancy prior to treatment, every month during your treatment, and for 6 months after your treatment. If you or your partner becomes pregnant while taking these medications, call your doctor immediately.

• tell your doctor if you are breastfeeding.

• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, a hat, and sunscreen during your treatment with simeprevir. Also avoid the use of tanning beds, sunlamps, or other types of light therapy during your treatment. Simeprevir may make your skin sensitive to sunlight. Call your doctor right away if you experience a severe sunburn or burning, redness, swelling, blisters on your skin, or red or inflamed eyes.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose with food as soon as you remember it. However, if it is less than 12 hours before the scheduled time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Simeprevir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• itching
• nausea
• muscle pain

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING and SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

• difficulty breathing
• rash
• mouth sores or ulcers
• red or swollen eyes ("pink eye")

Simeprevir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.