Simeprevir

Simeprevir
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery

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Overview

Simeprevir is a protease inhibitor that is FDA approved for the treatment of chronic hepatitis C (CHC) genotype 1 infection as a component of a combination antiviral treatment regimen.. Common adverse reactions include pruritus, rash, nausea, hyperbilirubinemia, headache, insomnia and fatigue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

OLYSIO Combination Treatment

Administer OLYSIO in combination with other antiviral drugs for the treatment of CHC infection. For specific dosing recommendations for the antiviral drugs used in combination with OLYSIO, refer to their respective prescribing information. OLYSIO monotherapy is not recommended. Administer OLYSIO in combination with either:

Peg-IFN-alfa and RBV: Table 1 displays the recommended dosage regimen and treatment duration of OLYSIO in combination with Peg-IFN-alfa and RBV. Refer to Table 3 for treatment stopping rules for OLYSIO combination therapy with Peg-IFN-alfa and RBV; or Sofosbuvir: Table 2 displays the recommended dosage regimen and treatment duration of OLYSIO in combination with sofosbuvir. The recommended dosage of OLYSIO is one capsule taken orally once daily with food. The capsule should be swallowed as a whole.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Simeprevir in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Simeprevir in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Simeprevir FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Simeprevir in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Simeprevir in pediatric patients.

Contraindications

There are no specific contraindications to simeprevir. However, as simeprevir should always be administered in combination with other antiviral drugs for the treatment of chronic hepatitis C infection, prescribers should consult the complete prescribing information for these drugs for a description of contraindications.

Warnings

Risk of Serious Adverse Reactions Associated With Combination Treatment. simeprevir should be used in combination with other antiviral drugs for the treatment of CHC infection. Therefore, consult the prescribing information for these drugs before starting therapy with OLYSIO. Warnings and Precautions related to these drugs also apply to their use in simeprevir combination treatment.

Photosensitivity

Photosensitivity reactions have been observed with simeprevir combination therapy. Serious photosensitivity reactions resulting in hospitalization have been observed with simeprevir in combination with Peg-IFN-alfa and ribavirin. Photosensitivity reactions occurred most frequently in the first 4 weeks of treatment, but can occur at any time during treatment. Photosensitivity may present as an exaggerated sunburn reaction, usually affecting areas exposed to light (typically the face, "V" area of the neck, extensor surfaces of the forearms, and dorsa of the hands). Manifestations may include burning, erythema, exudation, blistering, and edema.

Use sun protective measures and limit sun exposure during treatment with OLYSIO. Avoid use of tanning devices during treatment with OLYSIO. Discontinuation of OLYSIO should be considered if a photosensitivity reaction occurs and patients should be monitored until the reaction has resolved. If a decision is made to continue OLYSIO in the setting of a photosensitivity reaction, expert consultation is advised.

Rash

Rash has been observed with OLYSIO combination therapy [see ADVERSE REACTIONS (6.1)]. Rash occurred most frequently in the first 4 weeks of treatment, but can occur at any time during treatment. Severe rash and rash requiring discontinuation of OLYSIO have been reported in subjects receiving OLYSIO in combination with Peg-IFN-alfa and RBV. Most of the rash events in OLYSIO-treated patients were of mild or moderate severity [see ADVERSE REACTIONS (6.1)]. Patients with mild to moderate rashes should be followed for possible progression of rash, including the development of mucosal signs (e.g., oral lesions, conjunctivitis) or systemic symptoms. If the rash becomes severe, OLYSIO should be discontinued. Patients should be monitored until the rash has resolved.

Sulfa Allergy

OLYSIO contains a sulfonamide moiety. In subjects with a history of sulfa allergy (n=16), no increased incidence of rash or photosensitivity reactions has been observed. However, there are insufficient data to exclude an association between sulfa allergy and the frequency or severity of adverse reactions observed with the use of OLYSIO.

5.5 Risk of Adverse Reactions or Reduced Therapeutic Effect Due to Drug Interactions Co-administration of OLYSIO with substances that are moderate or strong inducers or inhibitors of cytochrome P450 3A (CYP3A) is not recommended as this may lead to significantly lower or higher exposure of simeprevir, respectively, which may result in reduced therapeutic effect or adverse reactions

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Simeprevir Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Simeprevir Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Simeprevir Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Simeprevir in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Simeprevir in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Simeprevir during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Simeprevir in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Simeprevir in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Simeprevir in geriatric settings.

Gender

There is no FDA guidance on the use of Simeprevir with respect to specific gender populations.

Race

There is no FDA guidance on the use of Simeprevir with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Simeprevir in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Simeprevir in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Simeprevir in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Simeprevir in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Simeprevir Administration in the drug label.

Monitoring

There is limited information regarding Simeprevir Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Simeprevir and IV administrations.

Overdosage

There is limited information regarding Simeprevir overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Simeprevir Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Simeprevir Mechanism of Action in the drug label.

Structure

There is limited information regarding Simeprevir Structure in the drug label.

Pharmacodynamics

There is limited information regarding Simeprevir Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Simeprevir Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Simeprevir Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Simeprevir Clinical Studies in the drug label.

How Supplied

There is limited information regarding Simeprevir How Supplied in the drug label.

Storage

There is limited information regarding Simeprevir Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Simeprevir Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Simeprevir interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Simeprevir Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Simeprevir Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.