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|See warnings and precautions below.|
| OLYSIO (simeprevir) capsules, for oral use
Initial U.S. Approval -2013
OLYSIO (simeprevir) is an inhibitor of the HCV NS3/4A protease.
OLYSIO (simeprevir) for oral administration is available as 150 mg strength hard gelatin capsules. Each capsule contains 154.4 mg of simeprevir sodium salt, which is equivalent to 150 mg of simeprevir. OLYSIO (simeprevir) capsules contain the following inactive ingredients: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, magnesium stearate and sodium lauryl sulphate. The white capsule contains gelatin and titanium dioxide (E171) and is printed with ink containing iron oxide black (E172) and shellac (E904).
| Mechanism of Action:
Simeprevir is a direct-acting antiviral (DAA) agent against the hepatitis C virus
| INDICATIONS AND USAGE:
OLYSIO is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
OLYSIO efficacy has been established in combination with peginterferon alfa and ribavirin in HCV genotype 1 infected subjects with compensated liver disease (including cirrhosis).
OLYSIO must not be used as monotherapy.
Screening patients with HCV genotype 1a infection for the presence of virus with the NS3 Q80K polymorphism at baseline is strongly recommended. Alternative therapy should be considered for patients infected with HCV genotype 1a containing the Q80K polymorphism.
| All contraindications to peginterferon alfa and ribavirin also apply to OLYSIO combination treatment with peginterferon alfa and ribavirin.
Because ribavirin may cause birth defects and fetal death, OLYSIO in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant.
WARNINGS AND PRECAUTIONS:
| ADVERSE REACTIONS
The most common reported adverse reactions (greater than 20% of subjects) in subjects receiving the combination of OLYSIO with peginterferon and ribavirin and occurring with at least 3% higher frequency compared to subjects receiving placebo in combination with peginterferon alfa and ribavirin during the first 12 weeks of treatment were: rash (including photosensitivity), pruritus and nausea.
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.
| DOSAGE AND ADMINISTRATION:
One 150 mg capsule taken once daily with food.
OLYSIO should be administered with both peginterferon alfa and ribavirin. The recommended treatment duration of OLYSIO with peginterferon alfa and ribavirin is 12 weeks, followed by either 12 or 36 additional weeks of peginterferon alfa and ribavirin depending on prior response status.
For specific dosage instructions for peginterferon alfa and ribavirin, see their respective prescribing information.
A dose recommendation cannot be made for patients of East Asian ancestry.
A dose recommendation cannot be made for patients with moderate to severe hepatic impairment.
| Package insert data: [Accessed: Jan 2014].
Janssen-Cilag SpA, Latina, Italy
Licensed from Medivir AB
OLYSIO™ is a trademark of Johnson & Johnson
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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