OLYSIO™ (simeprevir) capsules

OLYSIO (simeprevir) is an inhibitor of the HCV NS3/4A protease.
Simeprevir drug substance is a white to almost white powder. Simeprevir is practically insoluble in water over a wide pH range. It is practically insoluble in propylene glycol, very slightly soluble in ethanol, and slightly soluble in acetone. It is soluble in dichloromethane and freely soluble in some organic solvents (e.g., tetrahydrofuran and N,N-dimethylformamide).

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).

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.

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:

1. Embryofetal Toxicity (Use with Ribavirin and Peginterferon Alfa): Ribavirin may cause birth defects and fetal death and animal studies have shown interferons have abortifacient effects; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to initiating therapy, use at least two effective methods of contraception during treatment, and undergo monthly pregnancy tests.
2. Photosensitivity: Serious photosensitivity reactions have been observed during combination therapy with OLYSIO, peginterferon alfa and ribavirin. Use sun protection measures and limit sun exposure. Consider discontinuation if a photosensitivity reaction occurs.
3. Rash: Rash has been observed during combination therapy with OLYSIO, peginterferon alfa and ribavirin. Discontinue OLYSIO if severe rash occurs.

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.

DRUG INTERACTIONS
Co-administration of OLYSIO with drugs that are moderate or strong inducers or inhibitors of CYP3A may significantly affect the plasma concentrations of simeprevir. The potential for drug-drug interactions must be considered prior to and during treatment.

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.

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.

Manufactured for:
Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560

Licensed from Medivir AB
Issued: November 2013

OLYSIO™ is a trademark of Johnson & Johnson
© Janssen Products, LP 2013