July 23, 2016
Recommended Topic Related To:

Olysio

"The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.

Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infecti"...

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Olysio

Indications
Dosage
How Supplied

INDICATIONS

OLYSIO® is indicated for the treatment of adults with chronic hepatitis C virus (HCV) infection [see DOSAGE AND ADMINISTRATION and Clinical Studies]:

  • in combination with sofosbuvir in patients with HCV genotype 1 without cirrhosis or with compensated cirrhosis
  • in combination with peginterferon alfa (Peg-IFN-alfa) and ribavirin (RBV) in patients with HCV genotype 1 or 4 without cirrhosis or with compensated cirrhosis.

Limitations Of Use

  • Efficacy of OLYSIO in combination with Peg-IFN-alfa and RBV 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 DOSAGE AND ADMINISTRATION and Microbiology].
  • OLYSIO is not recommended in patients who have previously failed therapy with a treatment regimen that included OLYSIO or other HCV protease inhibitors [see Microbiology].

DOSAGE AND ADMINISTRATION

Testing Prior To Initiation Of Therapy

Q80K Testing in HCV Genotype 1a-Infected Patients

OLYSIO in Combination with Sofosbuvir

In HCV genotype 1a-infected patients with compensated cirrhosis, screening for the presence of virus with the NS3 Q80K polymorphism may be considered prior to initiation of treatment with OLYSIO with sofosbuvir [see Clinical Studies].

OLYSIO in Combination with Peg-IFN-alfa and RBV

Prior to initiation of treatment with OLYSIO in combination with Peg-IFN-alfa and RBV, screening patients with HCV genotype 1a infection for the presence of virus with the NS3 Q80K polymorphism is strongly recommended and alternative therapy should be considered for patients infected with HCV genotype 1a containing the Q80K polymorphism [see INDICATIONS AND USAGE and Microbiology].

Hepatic Laboratory Testing

Monitor liver chemistry tests before and during OLYSIO combination therapy [see WARNINGS AND PRECAUTIONS].

OLYSIO Combination Treatment

Administer OLYSIO in combination with other antiviral drugs for the treatment of chronic HCV infection. OLYSIO monotherapy is not recommended. The recommended dosage of OLYSIO is one 150 mg capsule taken orally once daily with food [see CLINICAL PHARMACOLOGY]. The capsule should be swallowed as a whole. For specific dosing recommendations for the antiviral drugs used in combination with OLYSIO, refer to their respective prescribing information.

OLYSIO can be taken in combination with sofosbuvir or in combination with Peg-IFN-alfa and RBV.

OLYSIO In Combination With Sofosbuvir

Table 1 displays the recommended treatment regimen and duration of OLYSIO in combination with sofosbuvir in patients with chronic HCV genotype 1 infection.

Table 1: Recommended Treatment Regimen and Duration for OLYSIO and Sofosbuvir Combination Therapy in Patients with Chronic HCV Genotype 1 Infection

Patient Population (HCV Genotype 1) Treatment Regimen and Duration
Treatment-naive and treatment-experienced* patients:
without cirrhosis 12 weeks of OLYSIO + sofosbuvir
with compensated cirrhosis (Child-Pugh A) 24 weeks of OLYSIO + sofosbuvir
* Treatment-experienced patients include prior relapsers, prior partial responders and prior null responders who failed prior IFN-based therapy [see Clinical Studies].

OLYSIO In Combination With Peg-IFN-alfa And RBV

Table 2 displays the recommended treatment regimen and duration of OLYSIO in combination with Peg-IFN-alfa and RBV in mono-infected and HCV/HIV-1 co-infected patients with HCV genotype 1 or 4 infection. Refer to Table 3 for treatment stopping rules for OLYSIO combination therapy with Peg-IFN-alfa and RBV.

Table 2: Recommended Treatment Regimen and Duration for OLYSIO, Peg-IFN-alfa, and RBV Combination Therapy in Patients with Chronic HCV Genotype 1 or 4 Infection

Patient Population (HCV Genotype 1 or 4) Treatment Regimen and Duration
Treatment-naive patients and prior relapsers*:
  HCV mono-infected patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) 12 weeks of OLYSIO + Peg-IFN-alfa + RBV followed by additional 12 weeks of Peg-IFN-alfa + RBV (total treatment duration of 24 weeks)†
  HCV/HIV-1 co-infected patients without cirrhosis
  HCV/HIV-1 co-infected patients with compensated cirrhosis (Child-Pugh A) 12 weeks of OLYSIO + Peg-IFN-alfa + RBV followed by additional 36 weeks of Peg-IFN-alfa + RBV (total treatment duration of 48 weeks)†
Prior non-responders (including partial‡ and null responders#):
  HCV/HIV-1 co-infected or HCV monoinfected patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) 12 weeks of OLYSIO + Peg-IFN-alfa + RBV followed by additional 36 weeks of Peg-IFN-alfa + RBV (total treatment duration of 48 weeks)†
HIV = human immunodeficiency virus.
* Prior relapser: HCV RNA not detected at the end of prior IFN-based therapy and HCV RNA detected during follow-up [see Clinical Studies].
† Recommended duration of treatment if patient does not meet stopping rules (see Table 3).
‡ Prior partial responder: prior on-treatment ≥ 2 log10 IU/mL reduction in HCV RNA from baseline at Week 12 and HCV RNA detected at end of prior IFN-based therapy [see Clinical Studies].
#Prior null responder: prior on-treatment < 2 log10 IU/mL reduction in HCV RNA from baseline at Week 12 during prior IFN-based therapy [see Clinical Studies].

Discontinuation Of Dosing

OLYSIO In Combination With Sofosbuvir

No treatment stopping rules apply to the combination of OLYSIO with sofosbuvir [see Clinical Studies].

OLYSIO In Combination With Peg-IFN-alfa And RBV

During treatment, HCV RNA levels should be monitored as clinically indicated using a sensitive assay with a lower limit of quantification of at least 25 IU/mL. Because patients with an inadequate on-treatment virologic response (i.e., HCV RNA greater or equal to 25 IU/mL) are not likely to achieve a sustained virologic response (SVR), discontinuation of treatment is recommended in these patients. Table 3 presents treatment stopping rules for patients who experience an inadequate on-treatment virologic response at Weeks 4, 12, and 24.

Table 3: Treatment Stopping Rules in Patients Receiving OLYSIO in Combination with Peg-IFN-alfa and RBV with Inadequate On-Treatment Virologic Response

Treatment Week HCV RNA Action
Week 4 ≥ 25 IU/mL Discontinue OLYSIO, Peg-IFN-alfa, and RBV
Week 12 Discontinue Peg-IFN-alfa, and RBV (treatment with OLYSIO is complete at Week 12)
Week 24 Discontinue Peg-IFN-alfa, and RBV (treatment with OLYSIO is complete at Week 12)

Dosage Adjustment Or Interruption

To prevent treatment failure, avoid reducing the dosage of OLYSIO or interrupting treatment. If treatment with OLYSIO is discontinued because of adverse reactions or inadequate on-treatment virologic response, OLYSIO treatment must not be reinitiated [see WARNINGS AND PRECAUTIONS].

If adverse reactions potentially related to the antiviral drug(s) used in combination with OLYSIO occur, refer to the instructions outlined in their respective prescribing information for recommendations on dosage adjustment or interruption.

If any of the other antiviral drug(s) used in combination with OLYSIO for the treatment of chronic HCV infection are permanently discontinued for any reason, OLYSIO should also be discontinued.

Not Recommended In Patients With Moderate Or Severe Hepatic Impairment

OLYSIO is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

OLYSIO is available as a white gelatin capsule marked with “TMC435 150” in black ink. Each capsule contains 150 mg simeprevir.

Storage And Handling

OLYSIO 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 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 May 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/6/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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