simeprevir

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

What is simeprevir?

Simeprevir is an antiviral medication 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) 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.

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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 boceprevir (Victrelis) or telaprevir (Incivek) in the past and they were not effective.

FDA Pregnancy Category X. Simeprevir is used in combination with other medications called peginterferon alfa and 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 simeprevir with peginterferon alfa and ribavirin if you are pregnant.

  • If you are a man, do not use this drug combination 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 these medications together. 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 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.

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;

  • nausea; or

  • muscle pain.

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

Duration of Therapy with Simeprevir: 12 weeks in combination with peginterferon alfa and ribavirin

Duration of Therapy with Simeprevir, Peginterferon Alfa, and Ribavirin (unless patient meets stopping rule):
In therapy-naive and prior relapse patients, including those with cirrhosis:
-Triple therapy (simeprevir, peginterferon alfa, and ribavirin): First 12 weeks
-Dual therapy (peginterferon alfa and ribavirin): Additional 12 weeks
-Total duration of therapy: 24 weeks

In prior non-responder patients (including partial and null responders), including those with cirrhosis:
-Triple therapy: First 12 weeks
-Dual therapy: Additional 36 weeks
-Total duration of therapy: 48 weeks

Treatment stopping rules for patients with inadequate on-treatment virologic response:
-HCV-RNA levels of 25 international units/mL or more at treatment week 4: Discontinue simeprevir, peginterferon alfa, and ribavirin
-HCV-RNA levels of 25 international units/mL or more at treatment week 12: Discontinue peginterferon alfa and ribavirin (simeprevir finished at week 12)
-HCV-RNA levels of 25 international units/mL or more at treatment week 24: Discontinue peginterferon alfa and ribavirin

Comments:
-Simeprevir must not be used as monotherapy.
-Efficacy of simeprevir combination therapy was established in HCV genotype 1 infected patients with compensated liver disease (including cirrhosis).
-In all patients, simeprevir should be started with peginterferon alfa and ribavirin and should be used for 12 weeks.
-It is not likely that patients with inadequate on-treatment virologic response will achieve a sustained virologic response; therapy discontinuation recommended in such patients.
-There are insufficient safety data to recommend an appropriate dose for patients of East Asian ancestry; risks/benefits should be considered carefully before use in such patients.

Approved indication: As a part of a combination antiviral treatment regimen, for the treatment of chronic hepatitis C infection

What other drugs will affect simeprevir?

Many drugs can interact with simeprevir. 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;

  • antifungal medication;

  • 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.

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: 1.02. Revision Date: 2014-01-13, 4:53:54 PM.

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