Product Description.:
TMC435 150
capsule , white , oblong oblong
Black ink
What is OLYSIO??
OLYSIO? (simeprevir) is one dose, once a day, and is part of a full treatment regimen, in combination with other antiviral medicines, peginterferon alfa and ribavirin, to help cure adult patients suffering from Genotype 1, Chronic (long lasting) Hepatitis C with stable liver problems.
OLYSIO? (simeprevir): CLINICAL RESULTS
For Appropriate Patients
What does it mean to be cured of chronic Hepatitis C? It means the Hepatitis C virus is not detectable (HCV RNA <25 IU/ml) in your blood for a period of time after treatment is complete. Treatment with OLYSIO?, in combination with peginterferon alfa and ribavirin, has been proven effective in clinical trials for:
Patients New to Treatment
Patients Who Have Undergone Past Treatment with the Virus Returning
Patients Who Partially Responded to Past Treatment
Patients Who Did Not Respond to Past Treatment
Scroll below to see how OLYSIO? triple therapy was effective in multiple clinical trials.
The efficacy of OLYSIO? in combination with peginterferon alfa and ribavirin is greatly decreased in patients who have Genotype 1a Q80K. Please talk to your doctor about testing for Genotype 1a Q80K and using a different therapy when Genotype 1a Q80K is present. *Past treatment with interferon-based therapy
Please read the Important Safety Information about OLYSIO?.
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What Is OLYSIO??
OLYSIO? (simeprevir) is a prescription medicine used with other antiviral medicines, peginterferon alfa and ribavirin, to treat genotype 1 chronic (lasting a long time) hepatitis C in adults with stable liver problems.
OLYSIO? must not be taken alone. The efficacy of OLYSIO? in combination with peginterferon and ribavirin is greatly decreased in patients who have genotype 1a Q80K. Please talk to your doctor about testing for genotype 1a Q80K and using a different therapy when genotype 1a Q80K is present.
It is not known if OLYSIO? is safe and effective in children under 18 years of age.
Important Safety Information
What is the most important information I should know and who should not take OLYSIO? (simeprevir)?
OLYSIO?, in combination with peginterferon alfa and ribavirin may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant, or plans to become pregnant, do not take these medicines. You or your sexual partner should not become pregnant while taking OLYSIO? with peginterferon alfa and ribavirin and for 6 months after treatment is over.
Females and males must use two effective forms of birth control during treatment and for 6 months after treatment with OLYSIO?, peginterferon alfa, and ribavirin combination therapy. Talk to your healthcare provider about forms of birth control that may be used during this time.
Females must have a pregnancy test before starting treatment with OLYSIO?, peginterferon alfa, and ribavirin combination therapy, every month while being treated, and every month for 6 months after your treatment with OLYSIO?, peginterferon alfa, and ribavirin combination therapy is over.
If you or your female sexual partner becomes pregnant while taking OLYSIO?, peginterferon alfa, and ribavirin combination therapy or within 6 months after you stop taking these medicines, tell your healthcare provider right away. You or your healthcare provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant.
OLYSIO? in combination with peginterferon alfa and ribavirin may cause rashes and skin reactions to sunlight. These rashes and skin reactions to sunlight can be severe and you may need to be treated in a hospital. Rashes and skin reactions to sunlight are most common during the first 4 weeks of treatment, but can happen at any time during treatment with OLYSIO?, peginterferon alfa, and ribavirin combination therapy.
Use sunscreen, and wear a hat, sunglasses, and protective clothing when you will be exposed to sunlight during treatment with OLYSIO?.
Limit sunlight exposure during treatment with OLYSIO?.
Avoid use of tanning beds, sunlamps, or other types of light therapy during treatment with OLYSIO?.
Call your healthcare provider right away if you get any of the following symptoms:
burning, redness, swelling or blisters on your skin
mouth sores or ulcers
red or inflamed eyes, like pink eye (conjunctivitis)
Do not take OLYSIO? alone. OLYSIO? should be used together with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.
What should I tell my healthcare provider before taking O
