Generic Name: simeprevir (sim E pre vir)
Brand Name: Olysio
What is simeprevir?
Simeprevir is an antiviral medicine that prevents certain virus cells from multiplying in your body. Simeprevir is used in combination with peginterferon alfa (Pegasys, PegIntron) and ribavirin (Copegus, Rebetol, Ribasphere, RibaTab), or with sofosbuvir (Sovaldi) to treat hepatitis C 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.
What is the most important information I should know about simeprevir?
Simeprevir is used in combination with other medications called peginterferon alfa and ribavirin.
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.
Ribavirin can cause birth defects or death in an unborn baby. 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.
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 you do not have conditions that would prevent you from safely using simeprevir.
To make sure this medicine is safe for you, tell your doctor if you have:
liver problems other than hepatitis, or if you have had a liver transplant;
kidney disease (or if you are on dialysis);
an allergy to sulfa drugs;
a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia;
if you also take didanosine;
if you are East Asian descent;
if you are receiving phototherapy (light therapy); or
if you have taken simeprevir, boceprevir (Victrelis), or telaprevir (Incivek) in the past and they were not effective.
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 peginterferon alfa and 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.
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.
Do not take simeprevir as your only medication to treat hepatitis C. Simeprevir must be used in combination with peginterferon alfa and ribavirin. Your disease may become resistant if you do not take it in combination with other medicines your doctor has prescribed.
Take with food.
Do not crush, chew, break, or open a simeprevir capsule. Swallow it whole.
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 any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
severe skin rash (redness, swelling, burning, blistering);
eye redness or puffiness;
mouth sores; or
shortness of breath.
Common side effects may include:
mild itching or rash;
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.
See also: Side effects (in more detail)
Simeprevir dosing information
Usual Adult Dose for Chronic Hepatitis C:
150 mg orally once a day with food
Recommended Regimen and Duration of Therapy for Simeprevir, Peginterferon alfa, and Ribavirin (unless patient meets stopping rules):
Therapy-naive patients and prior relapsers:
-First 12 weeks: Simeprevir, peginterferon alfa, and ribavirin
-Additional 12 weeks: Peginterferon alfa and ribavirin
-Total duration of therapy: 24 weeks
Prior non-responders (including partial and null responders):
-First 12 weeks: Simeprevir, peginterferon alfa, and ribavirin
-Additional 36 weeks: Peginterferon alfa and ribavirin
-Total duration of therapy: 48 weeks
Treatment Stopping Rules for Patients with Inadequate On-Treatment Virologic Response during Treatment with Simeprevir, Peginterferon alfa, and Ribavirin:
-HCV-RNA levels at least 25 international units/mL at treatment week 4: Discontinue simeprevir, peginterferon alfa, and ribavirin.
-HCV-RNA levels at least 25 international units/mL at treatment week 12 or 24: Discontinue peginterferon alfa and ribavirin (simeprevir finished at week 12).
-Patient population includes patients with or without cirrhosis.
-Before starting therapy with simeprevir and peginterferon alfa/ribavirin, screening patients with HCV genotype 1a infection for virus with the NS3 Q80K polymorphism at baseline is strongly recommended; alternative therapy should be considered if the Q80K polymorphism is present.
-Prior relapsers: 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 from baseline at week 12 during prior interferon-based therapy.
-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.
Recommended Regimen and Duration of Therapy for Simeprevir and Sofosbuvir:
-Therapy-naive and therapy-experienced patients without cirrhosis: Simeprevir and sofosbuvir for 12 weeks
-Therapy-naive and therapy-experienced patients with cirrhosis: Simeprevir and sofosbuvir for 24 weeks
-Therapy-experienced patients include prior responders, prior partial responders, and prior null responders who failed prior interferon-based therapy.
-Before starting therapy with simeprevir and sofosbuvir, screening patients with HCV genotype 1a infection for virus with the NS3 Q80K polymorphism may be considered (not strongly recommended).
-Virologic treatment stopping rules not available for this combination.
Use: In combination with other antivirals, for the treatment of chronic hepatitis C (CHC) genotype 1 infection
What other drugs will affect simeprevir?
Many drugs can interact with combination treatment. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with simeprevir, especially:
an antibiotic medicine, including medicine to treat tuberculosis;
heart or blood pressure medicine;
HIV or AIDS medications;
seizure medication; or
"statin" medication to treat high cholesterol.
This list is not complete and many other drugs can interact with simeprevir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
More about simeprevir
- Other brands: Olysio
Related treatment guides
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: 1.03. Revision Date: 2014-11-20, 5:09:56 PM.