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OLYSIO™ (simeprevir) capsules, for oral use

DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED WARNINGS
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Drug Updates:  OLYSIO (simeprevir) capsules, for oral use
[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2013

Mechanism of Action: Simeprevir is an inhibitor of the HCV NS3/4A protease which is essential for viral replication. In a biochemical assay simeprevir inhibited the proteolytic activity of recombinant genotype 1a and 1b HCV NS3/4A proteases, with median Ki values of 0.5 nM and 1.4 nM, respectively.

INDICATIONS AND USAGE:  OLYSIO® is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) genotype 1 or 4 infection as a component of a combination antiviral treatment regimen.


WARNINGS  top of page

See warnings and precautions below.

DESCRIPTION  top of page

OLYSIO (simeprevir) capsules, for oral use
Initial U.S. Approval -2013

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).

CLINICAL PHARMACOLOGY: top of page

Mechanism of Action:
Simeprevir is a direct-acting antiviral (DAA) agent against the hepatitis C virus

INDICATIONS AND USAGE  top of page

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.

CONTRAINDICATIONS top of page

 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.

PRECAUTIONS top of page

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.

ADVERSE REACTIONS top of page

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.

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.

DOSAGE AND ADMINISTRATION  top of page

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.

HOW SUPPLIED top of page

DOSAGE FORMS AND STRENGTHS

Capsule: 150 mg

REFERENCE

Package insert data:   [Accessed: Jan 2014].
Manufactured by:
Janssen-Cilag SpA, Latina, Italy

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
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