corporation simeprevir Generic Name: simeprevir (sim E pre vir) Brand Name: Olysio Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A What is simeprevir? Simeprevir is an antiviral medicine that prevents certain viruses from multiplying in your body. Simeprevir is used in combination with peginterferon alfa and ribavirin, or with sofosbuvir to treat hepatitis C genotype 1 or 4 in adults. Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice. Every person with hepatitis C should remain under the care of a doctor. Simeprevir may also be used for purposes not listed in this medication guide. Slideshow 14 Essential Health Screenings That All Men Should Consider What is the most important information I should know about simeprevir? Simeprevir is used in combination with other medications. Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice. If you have ever had hepatitis B, simeprevir can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function. Call your doctor right away if you have symptoms of liver problems: vomiting, loss of appetite, feeling weak or tired, clay-colored stools, or jaundice (yellowing of the skin or eyes). If you take simeprevir with sofosbuvir and amiodarone, call your doctor or get emergency medical help if you have: slow heartbeats, chest pain, extreme weakness, confusion, memory problems, and feeling light-headed or short of breath. Avoid exposure to sunlight or tanning beds. Sunlight can cause a severe rash or skin reaction while you are using simeprevir combination treatment. Use sunscreen and wear a hat, sunglasses, and protective clothing when you are outdoors. Do not use simeprevir with peginterferon alfa and ribavirin if you are pregnant, or if you are a man and your female sexual partner is pregnant. Ribavirin can cause birth defects or death in an unborn baby. What should I discuss with my healthcare provider before taking simeprevir? You should not use simeprevir if you are allergic to it. Your doctor will perform blood tests to make sure simeprevir is the right treatment for your condition. To make sure this medicine is safe for you, tell your doctor if you have ever had: hepatitis B; liver problems other than hepatitis, or if you have had a liver transplant; or if you are receiving phototherapy (light therapy). Simeprevir is sometimes used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before using these medications together, and every month during your treatment. If you are a woman, do not use ribavirin if you are pregnant. If you are a man, do not use ribavirin if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin. Use at least 2 effective forms of birth control while either sexual partner is using ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using simeprevir with ribavirin. It is not known whether simeprevir passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine. Simeprevir is not approved for use by anyone younger than 18 years old. How should I take simeprevir? Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Simeprevir must be given in combination with other antiviral medications and it should not be used alone. Take with food. Do not crush, chew, break, or open a simeprevir capsule. Swallow it whole. You will need frequent blood tests to check your liver function. Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor. You should not stop using simeprevir suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine. If you have ever had hepatitis B, simeprevir can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine. Store at room temperature away from moisture, heat, and light. What happens if I miss a dose? Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking simeprevir? Avoid exposure to sunlight or tanning beds. Simeprevir combination treatment can make your skin more sensitive to sunlight, especially during the first 4 weeks of treatment. This may cause a severe sunburn or skin rash. Wear a hat, sunglasses, and protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Avoid taking an herbal supplement containing St. John's wort at the same time you are taking simeprevir. Simeprevir side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Read all of your medication guides to learn about possible side effects of other medications you use in combination with simeprevir. Ask your doctor or pharmacist if you have any questions. If you take simeprevir with sofosbuvir and amiodarone, call your doctor or get emergency medical help if you have: slow heartbeats, chest pain, extreme weakness, confusion, memory problems, and feeling light-headed or short of breath. Call your doctor at once if you have: new or worsening liver symptoms, such as vomiting, loss of appetite, feeling weak or tired, clay-colored stools, or yellowing of the skin or eyes; severe skin rash (redness, swelling, burning, blistering); eye redness or puffiness; mouth sores; shortness of breath; or (if you also take amiodarone)--confusion, chest pain, extreme weakness or drowsiness, feeling like you might pass out. Your treatment with simeprevir may be permanently discontinued if you have certain side effects. Common side effects may include: mild itching or rash; nausea; or headache. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Side Effects (complete list) Simeprevir dosing information Usual Adult Dose for Chronic Hepatitis C: 150 mg orally once a day with food Recommended Regimen and Duration of Therapy: Therapy-naive and therapy-experienced patients with HCV genotype 1 infection: -Without cirrhosis: Simeprevir plus sofosbuvir for 12 weeks -With compensated cirrhosis (Child-Pugh A): Simeprevir plus sofosbuvir for 24 weeks Therapy-naive patients and prior relapsers with HCV genotype 1 or 4 infection: -HCV mono-infected patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Simeprevir plus peginterferon alfa plus ribavirin for 12 weeks ---To be followed by: Peginterferon alfa plus ribavirin for 12 weeks ---Total duration of therapy: 24 weeks (unless patient meets stopping rules) -HCV/HIV-1-coinfected patients without cirrhosis: Simeprevir plus peginterferon alfa plus ribavirin for 12 weeks ---To be followed by: Peginterferon alfa plus ribavirin for 12 weeks ---Total duration of therapy: 24 weeks (unless patient meets stopping rules) -HCV/HIV-1-coinfected patients with compensated cirrhosis (Child-Pugh A): Simeprevir plus peginterferon alfa plus ribavirin for 12 weeks ---To be followed by: Peginterferon alfa plus ribavirin for 36 weeks ---Total duration of therapy: 48 weeks (unless patient meets stopping rules) Prior non-responders (including partial and null responders) with HCV genotype 1 or 4 infection: -HCV/HIV-1-coinfected or HCV mono-infected patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Simeprevir plus peginterferon alfa plus ribavirin for 12 weeks ---To be followed by: Peginterferon alfa plus ribavirin for 36 weeks ---Total duration of therapy: 48 weeks (unless patient meets stopping rules) Treatment Stopping Rules for Patients with Inadequate On-Treatment Virologic Response during Treatment with Simeprevir, Peginterferon alfa, and Ribavirin: -HCV-RNA level at least 25 international units/mL at treatment week 4: Discontinue simeprevir, peginterferon alfa, and ribavirin. -HCV-RNA level at least 25 international units/mL at treatment week 12 or 24: Discontinue peginterferon alfa and ribavirin (simeprevir finished at week 12). Comments: -Liver chemistry tests should be monitored before and during therapy. -Therapy-experienced patients include prior relapsers, prior partial responders, and prior null responders who failed prior interferon-based therapy. -Prior relapser: HCV RNA not detected at the end of prior interferon-based therapy and HCV RNA detected during follow-up. -Prior partial responder: Prior on-treatment reduction in HCV RNA at least 2 log10 international units/mL from baseline at week 12 and HCV RNA detected at end of prior interferon-based therapy. -Prior null responder: Prior on-treatment reduction in HCV RNA less than 2 log10 international units/mL from baseline at week 12 during prior interferon-based therapy. -Virologic treatment stopping rules not available for combination therapy with sofosbuvir. -HCV-RNA levels should be monitored during combination therapy with peginterferon alfa and ribavirin as clinically indicated. It is not likely that patients with inadequate on-treatment virologic response (i.e., HCV RNA at least 25 international units/mL) will achieve a sustained virologic response; therapy discontinuation recommended in such patients. Use: For the treatment of chronic HCV infection -In combination with sofosbuvir: For HCV genotype 1 without cirrhosis or with compensated cirrhosis -In combination with peginterferon alfa and ribavirin: For HCV genotype 1 or 4 without cirrhosis or with compensated cirrhosis What other drugs will affect simeprevir? Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Taking simeprevir together with sofosbuvir and amiodarone (a heart rhythm medication) may slow your heart rate which can lead to serious medical problems. Tell your doctor if you take amiodarone (Cordarone, Nexterone, Pacerone). Other drugs may interact with simeprevir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using. Next Side Effects Print this page Add to My Med List More about simeprevir Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 4 Reviews Add your own review/rating Drug class: protease inhibitors Consumer resources Simeprevir Simeprevir (Advanced Reading) Other brands: Olysio Professional resources Simeprevir (AHFS Monograph) Simeprevir (Wolters Kluwer) Related treatment guides Hepatitis C Where can I get more information? Your pharmacist can provide more information about simeprevir. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Date modified: December 03, 2017 Last reviewed: May 30, 2017} Drug Status Rx Availability Prescription only X Pregnancy Category Not for use in pregnancy N/A CSA Schedule Not a controlled drug Drug Class Protease inhibitors Related Drugs Hepatitis C Harvoni , Epclusa , ribavirin , Zepatier , Mavyret , Sovaldi , sofosbuvir , ledipasvir / sofosbuvir , Vosevi , Viekira Pak , daclatasvir , Daklinza , Pegasys , Intron A , Ribasphere , Olysio , sofosbuvir / velpatasvir , Rebetol , Moderiba , PegIntron , elbasvir / grazoprevir , glecaprevir / pibrentasvir , Victrelis , More... Simeprevir Rating 4 User Reviews 9.7 /10 4 User Reviews 9.7 Rate it! Related Questions & Answers Sovaldi - how long after my 12 week treatment do side effects last ? Read more questions} } a very
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