simeprevir

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Pronunciation: sim E pre vir

Brand: Olysio

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.

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.

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.

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.

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:

  • a history of hepatitis B;
  • 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;
  • if you also take amiodarone (Cordarone, Pacerone);
  • 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.

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.

What are the possible side effects of simeprevir?

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.

Call your doctor at once if you have:

  • new or worsening liver symptoms, such as nausea, tiredness, loss of appetite, clay-colored stools, or yellowing of your 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.

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 current medicines and any you start or stop using, 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.

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