The OLYSIO® with sofosbuvir interferon- and ribavirin-free treatment option: An IFN*-free path is now available

The OLYSIO® with sofosbuvir interferon- and ribavirin-free treatment option: An IFN*-free path is now available

Adults with genotype 1 (G1) chronic hepatitis C (CHC) infection

OLYSIO® (simeprevir) is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection as a compenent of a combination antiviral treatment regimen.

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*Appropriate for both treatment-naïve and treatment-experienced patients (including prior relapsers, prior partial responders, and prior null responders who failed prior IFN-based therapy).

 

Important Safety Information

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Important Safety Information

Contraindications:

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

Warnings and Precautions:

Risk of Serious Adverse Reactions Associated With Combination Treatment: OLYSIO® 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®.

Photosensitivity: Photosensitivity reactions have been observed with OLYSIO® combination therapy. Serious photosensitivity reactions resulting in hospitalization have been observed with OLYSIO® in combination with Peg-IFN-alfa and RBV. 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. 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. 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®.

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:

Use with Peg-IFN-alfa and RBV: Adverse reactions (all grades, at least 3% higher frequency) for OLYSIO® with Peg-IFN-alfa and RBV vs. Peg-IFN-alfa and RBV alone in the first 12 weeks were rash (including photosensitivity) (28% vs. 20%), pruritus (22% vs. 15%), nausea (22% vs. 18%), myalgia (16% vs. 13%), and dyspnea (12% vs. 8%).

Use with sofosbuvir: The most common (> 10%) adverse reactions reported during 12 weeks treatment with OLYSIO® in combination with sofosbuvir without RBV were fatigue (25%), headache (21%), nausea (21%), insomnia (14%) and pruritus (11%). Rash and photosensitivity were reported in 11% and 7% of subjects, respectively. During 24 weeks treatment with OLYSIO® in combination with sofosbuvir, dizziness (16%), and diarrhea (16%) were also commonly reported.

Use in Specific Populations:

Pregnancy Category C: Adequate and well controlled trials with OLYSIO® have not been conducted in pregnant women. OLYSIO® should be used during pregnancy only if the potential benefit justifies the potential risk. Female patients of childbearing potential should use an effective contraceptive method.

Race: Patients of East Asian ancestry exhibit higher simeprevir exposures. In clinical trials, higher simeprevir exposures have been associated with increased frequency of adverse reactions, including rash and photosensitivity. There are insufficient safety data to recommend an appropriate dose for patients of East Asian ancestry. The potential risks and benefits of OLYSIO® should be carefully considered prior to use in patients of East Asian ancestry.

Renal Impairment: No dose adjustment of OLYSIO® is required in patients with mild, moderate or severe renal impairment. The safety and efficacy of OLYSIO® have not been studied in HCV-infected patients with severe renal impairment (creatinine clearance below 30 mL/min) or end-stage renal disease, including patients requiring dialysis. Simeprevir is highly protein-bound; therefore, dialysis is unlikely to result in significant removal of simeprevir.

Hepatic Impairment: No dose adjustment of OLYSIO® is required in patients with mild hepatic impairment (Child-Pugh Class A). The safety and efficacy of OLYSIO® have not been studied in HCV-infected patients with moderate or severe hepatic impairment (Child-Pugh Class B or C). No dosage recommendation can be given for patients with moderate hepatic impairment (Child-Pugh Class B) due to modest increases in simeprevir exposures. OLYSIO® is not recommended for patients with severe hepatic impairment (Child-Pugh Class C) due to substantially higher simeprevir exposures.

In clinical trials, higher simeprevir exposures have been associated with increased frequency of adverse reactions, including rash and photosensitivity. The potential risks and benefits of OLYSIO® should be carefully considered prior to use in patients with moderate hepatic impairment. The combination of OLYSIO® with Peg-IFN-alfa and RBV is contraindicated in patients with decompensated cirrhosis (moderate or severe hepatic impairment).

Other HCV Genotypes: The safety and efficacy of OLYSIO® have not been established in patients infected with other HCV genotypes.

Liver Transplantation: The safety and efficacy of OLYSIO® have not been studied in liver transplant patients.

Not a complete list of Uses in Specific Populations.

Consult the PI for Peg-IFN-alfa and RBV or sofosbuvir before starting therapy with OLYSIO®. Safety information related to these drugs also applies to their use in OLYSIO® combination treatment.

Please see full Prescribing Information and Patient Information for more details.

References: 1. Data on file. Janssen Therapeutics, Division of Janssen Products, LP. 2. Data on file through October 17, 2014. Janssen Therapeutics, Division of Janssen Products, LP. 3. Data on file. Janssen Therapeutics, Division of Janssen Products, LP. Based on managed markets insights and technology (MMIT), March 3, 2014.