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Simeprevir is an antiviral drug used in combination with other medications (such as sofosbuvir or peginterferon/ribavirin) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Simeprevir belongs to a class of drugs known as protease inhibitors. It works by reducing the amount of hepatitis C virus in your body, which may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis) or liver cancer.
This combination treatment reduces the amount of hepatitis C virus in the body and helps the body's immune system fight the infection. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safe sex" (including the use of latex condoms) to lower the risk of passing the virus to others.
Simeprevir must be used in combination treatment to have the best effect. Taking it by itself can make your treatment less effective.
Read the Patient Information Leaflet if available from your pharmacist before you start taking simeprevir and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Also read the drug information for your other antiviral medication(s).
Take this medication by mouth with food as directed by your doctor, usually once daily. Swallow the capsules whole.
Simeprevir works best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
Continue to take simeprevir and the other medication(s) in the combination treatment for the full length of time prescribed, even if your symptoms disappear after a short time. Stopping any of the drugs too early may result in a return of the infection.
See also Warning section.
Nausea or skin itching may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Simeprevir can commonly cause a rash or skin reaction to sunlight that is usually not serious, especially during the first 4 weeks of treatment. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, get medical help right away if you develop any rash, especially a rash with blisters/swelling. Do not stop taking simeprevir if you develop a rash unless directed by your doctor. (See also Precautions section.) A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
See also Side Effects section.
Before taking simeprevir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: other liver problems (such as hepatitis B).
This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Get medical help right away if you get sunburned or have skin blisters/redness.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, simeprevir should be used only when clearly needed. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication.
Simeprevir, in combination with peginterferon and ribavirin, must not be used during pregnancy by either the pregnant woman or her male partner. The combination may harm an unborn baby. Two reliable forms of birth control (such as condoms, birth control pills) must be used whenever at least one sexual partner is using these medicines together, and for six months after stopping treatment. If you or your partner becomes pregnant, or if you think you or your partner may be pregnant, tell your doctor right away.
It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding. Breast-feeding is not recommended if simeprevir is used in combination with peginterferon and ribavirin.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Other medications can affect the removal of simeprevir from your body, which may affect how simeprevir works. Examples include azole antifungals (such as ketoconazole, itraconazole), cyclosporine, dexamethasone, macrolide antibiotics (such as erythromycin, clarithromycin), certain HIV NNRTIs (efavirenz, etravirine, nevirapine, delavirdine), HIV protease inhibitors (such as atazanavir, ritonavir), rifamycins (such as rifabutin, rifampin), St. John's wort, telithromycin, certain drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin), among others.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
If you miss a dose and it is more than 12 hours until your next dose, take it as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Do not share this medication with others.
Lab tests (such as liver function, tests for hepatitis B and C) should be done before you start using this medication, while you are using it, and after completing treatment. Keep all medical and lab appointments.
If you are taking this medication with ribavirin, it is recommended that female patients or female partners of male patients take a pregnancy test before starting this medication. A pregnancy test should also be taken every month while taking this medication and for 6 months after treatment ends to make sure no pregnancy occurs.
Selected from the Licensed Solutions data included with permission and copyrighted by FDB, inc., 2014. This copyrighted material has been downloaded and Licensed data provider and is not for distribution in professional healthcare settings. This information is generalized and not intended as specific medical advice. Consult your healthcare professional before taking any drug or commencing or discontinuing any course of treatment.