Odynia-u

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• Ursh Pharmaceutical Inc.
  

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  2.1 OLYSIO Combination Treatment

  Administer OLYSIO in combination with other antiviral drugs for the treatment of CHC infection. Monitor liver chemistry tests before and during OLYSIO combination therapy [see Warnings and Precautions (5.2)]. OLYSIO monotherapy is not recommended. For specific dosing recommendations for the antiviral drugs used in combination with OLYSIO, refer to their respective prescribing information. 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.

  Table 1: Recommended Dosage Regimens and Treatment Duration for OLYSIO, Peg-IFN-alfa, and RBV Combination Therapy for Treatment of CHC Infection in HCV Genotype 1 or 4 Mono-infected and HCV/HIV-1 Co-infected Patients Patient Population Treatment Regimen and Duration 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 (14)]. † 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 (14)]. § Prior null responder: prior on-treatment < 2 log10 reduction in HCV RNA from baseline at Week 12 during prior IFN-based therapy [see Clinical Studies (14)]. Treatment-naïve patients and prior relapsers*   with or without cirrhosis, who are not co-infected with HIV 12 weeks of OLYSIO in combination with Peg-IFN-alfa and RBV followed by an additional 12 weeks of Peg-IFN-alfa and RBV (total treatment duration of 24 weeks)†   without cirrhosis, who are co-infected with HIV   with cirrhosis, who are co-infected with HIV 12 weeks of OLYSIO in combination with Peg-IFN-alfa and RBV followed by an additional 36 weeks of Peg-IFN-alfa and RBV (total treatment duration of 48 weeks)† Prior non-responders (including partial‡ and null responders§), with or without cirrhosis, with or without HIV co-infection 12 weeks of OLYSIO in combination with Peg-IFN-alfa and RBV followed by an additional 36 weeks of Peg-IFN-alfa and RBV (total treatment duration of 48 weeks)† Table 2: Recommended Dosage Regimen and Treatment Duration for OLYSIO and Sofosbuvir Combination Therapy for Treatment of CHC Infection in HCV Genotype 1 Mono-infected Patients Patient Population Treatment Regimen and Duration * Treatment-experienced patients include prior relapsers, prior partial responders and prior null responders who failed prior IFN-based therapy. Treatment-naïve and treatment-experienced* patients without cirrhosis 12 weeks of OLYSIO + sofosbuvir Treatment-naïve and treatment-experienced* patients with cirrhosis 24 weeks of OLYSIO + sofosbuvir 2.2 Testing Prior to Initiation of OLYSIO in HCV Genotype 1a-Infected Patients

  Prior to initiation of treatment with OLYSIO 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. Prior to initiation of treatment with OLYSIO with sofosbuvir, screening patients infected with HCV genotype 1a for the presence of virus with the NS3 Q80K polymorphism is not strongly recommended but may be considered [see Indications and Usage (1)].

  2.3 Discontinuation of Dosing

  Use 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 ≥ 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)

  Use with Sofosbuvir

  No treatment stopping rules apply to the combination of OLYSIO with sofosbuvir [see Clinical Studies (14)].

  2.4 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.

  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 drugs used in combination with OLYSIO for the treatment of CHC infection are permanently discontinued for any reason, OLYSIO should also be discontinued.

  2.5 Hepatic Impairment

  OLYSIO is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) [see Use in Specific Populations (8.8)]. There have been postmarketing reports of hepatic decompensation, hepatic failure, and death in patients with advanced or decompensated cirrhosis receiving OLYSIO combination therapy [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)]. Simeprevir exposures are increased in patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) [see Clinical Pharmacology (12.3)].

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

  OLYSIO in combination with Peg-IFN-alfa and RBV is contraindicated in patients with decompensated cirrhosis (moderate or severe hepatic impairment) [see Peg-IFN-alfa prescribing information].

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