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Simeprevir

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

Simeprevir is used for:

Treating chronic hepatitis C (CHC) in certain patients. It must be used in combination with certain other medicines to treat CHC.

Simeprevir is a hepatitis C protease inhibitor. It reduces the amount of hepatitis C virus (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 have severe liver problems
  • you are NOT taking other drugs to treat HCV infection
  • you are taking carbamazepine, cisapride, clarithromycin, cobicistat, cyclosporine, delavirdine, dexamethasone, efavirenz, erythromycin, etravirine, fluconazole, HIV protease inhibitors (eg, ritonavir), 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.

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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 ever taken any medicine to treat HCV infection
  • if you are taking sofosbuvir with simeprevir to treat HCV infection and are also taking amiodarone. The risk of slow heartbeat may be increased, especially if you are taking a beta blocker (eg, metoprolol), have heart problems, or have certain liver problems

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, pulmonary arterial hypertension (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 certain other medicines to treat CHC. Some of these medicines come with their own Medication Guides. If the other medicines have a Medication Guide, be sure to read it 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, take it as soon as possible with food. If 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:

  • Tell your doctor or dentist that you take simeprevir before you receive any medical or dental care, emergency care, or surgery.
  • Simeprevir may cause rashes and skin reactions to sunlight, which may be severe. Sometimes, this has led to the need to go to the hospital. 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.
  • Cases of slow heartbeat and the need to get a pacemaker have happened when an HCV medicine (sofosbuvir) was given with amiodarone and certain other HCV medicines (including simeprevir). Sometimes, this has been fatal. Slow heartbeat has happened up to 2 weeks after starting HCV treatment. You will need to be monitored closely if you will be taking amiodarone with HCV treatment. Follow what your doctor has told you to do. Call your doctor right away if you have symptoms of slow heartbeat (eg, chest pain, confusion, dizziness or lightheadedness, fainting or near-fainting, memory problems, shortness of breath, tiredness or weakness).
  • 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.
  • Simeprevir must be taken along with certain other medicines to treat CHC. Be sure you know about all of the warnings, benefits, and risks of the other medicines. Discuss any questions or concerns with your doctor.
  • If you stop taking any of your other medicines to treat CHC, talk with your doctor. You may need to stop taking simeprevir as well.
  • If you may become pregnant, you must use an effective form of birth control while you take simeprevir. If you have questions about effective birth control, talk with your doctor.
  • Lab tests 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.
  • PREGNANCY and BREAST-FEEDING: It is not known if simeprevir can cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using simeprevir while you are pregnant. It is not known if this medicine 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:

Diarrhea; dizziness; headache; itching; muscle pain; nausea; tiredness; trouble sleeping.

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 health care provider for complete information about the risks and benefits of using simeprevir.

Issue Date: June 3, 2015
Database Edition 15.2.1.003
Copyright © 2015 Clinical Drug Information, LLC

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.

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