Olysio Dosage

Generic name: simeprevir
Dosage form: capsule

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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 (12.3)]. 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-naïve 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*
*
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 (14)].
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 (14)].
Treatment-naïve 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

HCV RNA levels should be monitored as clinically indicated [see Dosage and Administration (2.2)]. 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 (12.3)]. In clinical trials, higher simeprevir exposures have been associated with increased frequency of adverse reactions, including rash and photosensitivity [see Adverse Reactions (6.1)].

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 (12.3)]. In clinical trials, higher simeprevir exposures have been associated with increased frequency of adverse reactions, including rash and photosensitivity [see Adverse Reactions (6.1)]. 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.

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