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Olysio

"The U.S. Food and Drug Administration today approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver"...

Olysio

INDICATIONS

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.

The following points should be considered when initiating OLYSIO for treatment of chronic hepatitis C infection:

  • OLYSIO must not be used as monotherapy [see WARNING AND PRECAUTIONS].
  • OLYSIO efficacy in combination with peginterferon alfa and ribavirin is influenced by baseline host and viral factors [see CLINICAL PHARMACOLOGY and Clinical Studies].
  • OLYSIO efficacy in combination with peginterferon alfa and ribavirin is substantially reduced in patients infected with HCV genotype 1a with an NS3 Q80K polymorphism at baseline compared to patients infected with hepatitis C virus (HCV) genotype 1a without the Q80K polymorphism [see Microbiology and Clinical Studies]. 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.
  • OLYSIO efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes OLYSIO or other HCV protease inhibitors [see Microbiology].

DOSAGE AND ADMINISTRATION

OLYSIO/Peginterferon alfa/Ribavirin Combination Treatment

The recommended dose of OLYSIO is one capsule of 150 mg taken orally once daily with food. The type of food does not affect exposure to simeprevir [see CLINICAL PHARMACOLOGY]. The capsule should be swallowed as a whole.

OLYSIO should be used in combination with peginterferon alfa and ribavirin. For peginterferon alfa and ribavirin specific dosage instructions, refer to their respective prescribing information.

Duration of Treatment

The recommended duration of treatment with OLYSIO is 12 weeks in combination with peginterferon alfa and ribavirin.

In all patients, treatment with OLYSIO should be initiated in combination with peginterferon alfa and ribavirin and should be administered for 12 weeks.

All treatment-na´ve and prior relapser patients, including those with cirrhosis, should receive an additional 12 weeks of peginterferon alfa and ribavirin after completing 12 weeks of treatment with OLYSIO, peginterferon alfa and ribavirin (total treatment duration of 24 weeks).

All prior non-responder patients (including partial and null-responders), including those with cirrhosis, should receive an additional 36 weeks of peginterferon alfa and ribavirin after completing 12 weeks of treatment with OLYSIO, peginterferon alfa and ribavirin (total treatment duration of 48 weeks).

The recommended duration of treatment with OLYSIO, peginterferon alfa and ribavirin is also presented in Table 1. Refer to Table 2 for treatment stopping rules.

Table 1: Duration of Treatment with OLYSIO, Peginterferon Alfa and Ribavirin

  Treatment with OLYSIO, Peginterferon alfa and Ribavirin* Treatment with Peginterferon alfa and Ribavirin* Total Treatment Duration*
Treatment-naive and prior relapser patients†, including those with cirrhosis First 12 weeks Additional 12 weeks 24 weeks
Prior non-responder patients‡ (including partial and null responders) including those with cirrhosis First 12 weeks Additional 36 weeks 48 weeks
* Recommended duration of treatment if patient does not meet stopping rule (see Table 2).
† Prior relapser: undetectable HCV RNA at the end of prior interferon-based therapy and detectable HCV RNA during follow-up [see Clinical Studies].
‡ Prior partial responder: prior on-treatment ≥ 2 log10 IU/mL reduction in HCV RNA from baseline at Week 12 and detectable HCV RNA at end of prior interferon-based therapy. Prior null responder: prior on-treatment < 2 log10 reduction in HCV RNA from baseline at Week 12 during prior interferon-based therapy [see Clinical Studies].

HCV RNA levels should be monitored as clinically indicated [see Discontinuation of Dosing]. Use of a sensitive assay with a lower limit of quantification of at least 25 IU/mL for monitoring HCV RNA levels during treatment is recommended. Refer to the respective prescribing information for peginterferon alfa and ribavirin for baseline, on-treatment and post-treatment laboratory testing recommendations including hematology, biochemistry (including hepatic enzymes and bilirubin), and pregnancy testing.

Discontinuation Of Dosing

It is unlikely that patients with inadequate on-treatment virologic response will achieve a sustained virologic response (SVR), therefore discontinuation of treatment is recommended in these patients. The HCV RNA thresholds that trigger discontinuation of treatment (i.e., treatment stopping rules) are presented in Table 2.

Table 2: Treatment Stopping Rules in Any Patient with Inadequate On-Treatment Virologic Response

HCV RNA Action
Treatment Week 4: greater than or equal to 25 IU/mL Discontinue OLYSIO, peginterferon alfa and ribavirin
Treatment Week 12: greater than or equal to 25 IU/mL Discontinue peginterferon alfa and ribavirin (treatment with OLYSIO is complete at Week 12)
Treatment Week 24: greater than or equal to 25 IU/mL Discontinue peginterferon alfa and ribavirin

If peginterferon alfa or ribavirin is discontinued for any reason, OLYSIO must also be discontinued.

Dosage Adjustment Or Interruption

To prevent treatment failure, the dose of OLYSIO must not be reduced or interrupted. If treatment with OLYSIO is discontinued because of adverse reactions or inadequate on-treatment virologic response, OLYSIO treatment must not be reinitiated.

If adverse reactions potentially related to peginterferon alfa and/or ribavirin occur which require dosage adjustment or interruption of either medicine, refer to the instructions outlined in the respective prescribing information for these medicines.

Hepatic Impairment

No dose recommendation can be given for patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) due to higher simeprevir exposures [see CLINICAL PHARMACOLOGY]. In clinical trials, higher simeprevir exposures have been associated with increased frequency of adverse reactions, including rash and photosensitivity [see ADVERSE REACTIONS].

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). The combination of peginterferon alfa and ribavirin is contraindicated in patients with decompensated cirrhosis (moderate or severe hepatic impairment). The potential risks and benefits of OLYSIO should be carefully considered prior to use in patients with moderate or severe hepatic impairment.

Race

Patients of East Asian ancestry exhibit higher simeprevir exposures [see CLINICAL PHARMACOLOGY]. In clinical trials, higher simeprevir exposures have been associated with increased frequency of adverse reactions, including rash and photosensitivity [see ADVERSE REACTIONS]. 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.

HOW SUPPLIED

Dosage Forms And Strengths

Each capsule contains 150 mg simeprevir. Capsules are white and marked with “TMC435 150” in black ink.

Storage And Handling

OLYSIO (simeprevir) 150 mg capsules are white, marked with “TMC435 150” in black ink. The capsules are packaged into a bottle containing 28 capsules (NDC 59676-225-28) or a bottle of 7 capsules (emergency supply; NDC 59676-225-07).

Store OLYSIO capsules in the original bottle in order to protect from light. Store OLYSIO capsules at room temperature below 30°C (86°F).

Manufactured by: Janssen-Cilag SpA, Latina, Italy. Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560. Revised: September 2014

Last reviewed on RxList: 9/18/2014
This monograph has been modified to include the generic and brand name in many instances.

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