SIMEPREVIR - ORAL

SIMEPREVIR - ORAL

PHONETIC PRONUNCIATION: (sim-E-pre-vir)

COMMON BRAND NAME(S): Olysio

GENERIC NAME(S): simeprevir sodium

Uses

USES: 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.


How to use SIMEPREVIR - ORAL

HOW TO USE: 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.

Side Effects

SIDE EFFECTS: 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.

Precautions

PRECAUTIONS: 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.

Interactions

DRUG INTERACTIONS: 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.

Overdose

OVERDOSE: 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.

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Faq for SIMEPREVIR - ORAL

Simeprevir is an oral medication used in combination with other drugs to treat chronic hepatitis C virus infection.

Simeprevir belongs to a class of drugs called direct-acting antivirals. It works by inhibiting a specific protein (NS3/4A protease) in the hepatitis C virus, which is essential for the virus to replicate and survive.

The standard dosage of Simeprevir is 150 mg taken orally once daily in combination with other antiviral medications.

The common side effects of Simeprevir include headache, fatigue, itching, nausea, and skin rash. It is important to report any severe or persistent side effects to your healthcare provider.

Simeprevir, when used in combination with other antiviral drugs, has shown high cure rates (sustained virologic response) in patients with chronic hepatitis C infection. However, individual cases may vary, and it is important to consult with your doctor for the best treatment options.

The duration of Simeprevir treatment depends on various factors such as the genotype of the hepatitis C virus and the specific treatment regimen prescribed by the healthcare provider. It typically ranges from 12 to 24 weeks.

Simeprevir is approved for use in adults with genotype 1 hepatitis C infection. However, its use may be contraindicated or require dose adjustments in patients with certain medical conditions or taking specific medications. Consultation with a healthcare provider is essential for individualized treatment recommendations.

Simeprevir is not recommended for use during pregnancy or breastfeeding, as its safety in these populations has not been adequately studied. It is important to discuss alternative treatment options with a healthcare provider if you are pregnant or breastfeeding.

Yes, Simeprevir can interact with certain medications, including those that act on the liver, such as certain anticonvulsants, antibiotics, and antifungals. It is important to inform your doctor about all the medications, supplements, and herbal products you are currently taking to avoid potential drug interactions.


Warning

WARNING: Although this medication helps many people with hepatitis C, it may rarely cause serious liver problems. Also, people who have another liver problem called hepatitis B may get worse. Before starting this medication, tell your doctor if you have ever had hepatitis B. Tell your doctor right away if you have new or worsening symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, dark urine or yellowing eyes/skin.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.