Simeprevir

Generic Name: simeprevir (sim-E-pre-vir)
Brand Name: Olysio

Simeprevir is used for:

Treating chronic hepatitis C virus (HCV) infection in certain patients. It must be used in combination with peginterferon alfa and ribavirin.

Simeprevir is a hepatitis C protease inhibitor. It reduces the amount of HCV in the body by preventing the spread of the HCV within the body.

Do NOT use simeprevir if:

  • you are allergic to any ingredient in simeprevir
  • you are pregnant
  • your sexual partner is pregnant
  • you are taking carbamazepine, certain HIV protease inhibitor and ritonavir combinations (eg, atazanavir/ritonavir, darunavir/ritonavir, lopinavir/ritonavir), cisapride, clarithromycin, cobicistat, delavirdine, dexamethasone, efavirenz, erythromycin, etravirine, fluconazole, itraconazole, ketoconazole, milk thistle, nevirapine, oxcarbazepine, phenobarbital, phenytoin, posaconazole, rifabutin, rifampin, rifapentine, St. John's wort, telithromycin, or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using simeprevir:

Some medical conditions may interact with simeprevir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances, including sulfa drugs
  • if you have other liver problems (eg, cirrhosis, hepatitis B infection) or have had a liver transplant
  • if you are receiving phototherapy
  • if you have taken boceprevir or telaprevir

Some MEDICINES MAY INTERACT with simeprevir. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for anxiety, asthma or other lung or breathing problems, blood thinning, cancer, depression or other mental or mood problems, erectile dysfunction, high blood pressure, high cholesterol, HIV, immune system suppression, infections, inflammation, irregular heartbeat or other heart problems, nausea and vomiting, PAH, seizures, sleep, stomach or bowel problems), multivitamin products, and herbal or dietary supplements because they may interact with simeprevir. Ask your doctor or pharmacist if you are unsure if any of your medicines may interact with simeprevir

This may not be a complete list of all interactions that may occur. Ask your health care provider if simeprevir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use simeprevir:

Use simeprevir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with simeprevir. Talk to your pharmacist if you have questions about this information.
  • Simeprevir must be taken with peginterferon alfa and ribavirin, which come with their own Medication Guides. Be sure to read those Medication Guides each time you get them filled.
  • Take simeprevir by mouth with food.
  • Swallow simeprevir whole. Do not break, crush, or chew before swallowing.
  • Simeprevir works best if it is taken at the same times each day.
  • Continue to take simeprevir even if you feel well. Do not miss any doses.
  • If you miss a dose of simeprevir and it is more than 12 hours before your next dose, take the missed dose with food and go back to your regular dosing schedule. If you miss a dose of simeprevir and it is less than 12 hours before your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use simeprevir.

Important safety information:

  • Simeprevir may cause rashes and skin reactions to sunlight, which may be severe. This is most common during the first 4 weeks of treatment, but can happen at any time during treatment. This risk may be higher in patients of East Asian descent. Limit sunlight exposure and avoid the use of sunlamps, tanning beds, or other types of light therapy during treatment with simeprevir. Use a sunscreen, and wear a hat, sunglasses, and protective clothing if you must be outside for more than a short time. Call your doctor right away if you have burning, redness, swelling, or blisters on your skin; mouth sores or ulcers; or red or inflamed eyes.
  • Simeprevir does not stop the spread of HCV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HCV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HCV to others.
  • Do not change your dose or stop taking simeprevir or any of your medicines without checking with your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking simeprevir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Women who may become pregnant and men who use simeprevir must use 2 effective forms of birth control while they take simeprevir with ribavirin and for at least 6 months after treatment is stopped. Talk with your doctor if you have questions about effective birth control. If you or your sexual partner become pregnant while taking simeprevir or within 6 months after you stop taking it, contact your doctor immediately.
  • Women of childbearing potential who either take simeprevir with ribavirin or are sexual partners of men who take simeprevir with ribavirin must have a pregnancy test before treatment is started, monthly during treatment, and monthly for 6 months after treatment is stopped.
  • Tell your doctor or dentist that you take simeprevir before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including HCV levels, may be performed while you use simeprevir and for several months after you stop simeprevir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Simeprevir should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Simeprevir must be used with ribavirin. Ribavirin use during pregnancy has resulted in birth defects and fetal death. If you are able to become pregnant, talk with your doctor or pharmacist about the use of effective birth control while using simeprevir. If you become pregnant while taking simeprevir or within 6 months after you stop taking it, contact your doctor immediately. You will need to discuss the benefits and risks of using simeprevir while you are pregnant. It is not known if simeprevir is found in breast milk. Do not breast-feed while taking simeprevir.

Possible side effects of simeprevir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Itching; muscle pain; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); shortness of breath; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of simeprevir:

Store simeprevir at room temperature up to 86 degrees F (30 degrees C). Keep simeprevir in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep simeprevir out of the reach of children and away from pets.

General information:

  • If you have any questions about simeprevir, please talk with your doctor, pharmacist, or other health care provider.
  • Simeprevir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take simeprevir or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about simeprevir. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to simeprevir. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using simeprevir.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Hide
(web1)