Generic Name and Formulations:
Simeprevir 150mg; caps.
Company:
Janssen Therapeutics
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01/15/14 |
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Monograph added. |
Indications for OLYSIO:
Chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in patients with compensated liver disease, including cirrhosis. Not for use as monotherapy. Screen for presence of virus with NS3Q80K polymorphism at baseline; consider alternative therapy if Q80K polymorphism is present.
Adult Dose for OLYSIO:
Swallow whole. Take with food. 150mg once daily. Treat for 12 wks (with peginterferon + ribavirin). Treatment-naive and prior relapsers, including cirrhosis: give additional 12 wks of peginterferon + ribavirin (total treatment = 24 wks). Prior non-responders (partial and null), including cirrhosis: give additional 36 wks of peginterferon + ribavirin (total treatment = 48 wks). Do not reduce simeprevir dose or interrupt therapy; if discontinued, do not reinitiate. Discontinue if HCV-RNA levels indicate futility (see full labeling). If peginterferon or ribavirin is discontinued, simeprevir must also be discontinued.
Children's Dose for OLYSIO:
<18yrs: not established.
Pharmacological Class:
HCV NS3/4A protease inhibitor.
Contraindications:
Pregnant women and in men whose partners are pregnant (note: ribavirin is Cat. X). Peginterferon and ribavirin contraindications also apply to combination therapy with simeprevir.
Warnings/Precautions:
Female patients/partners of male patients must have (–) pregnancy test before therapy; use 2 effective forms of contraception during and 6 months after treatment completion; perform routine monthly pregnancy test. Avoid sun exposure, tanning devices; consider discontinuing if photosensitivity or rash occurs. Sulfa allergy. Monitor HCV-RNA levels as clinically indicated. East Asian ancestry. Severe renal impairment, ESRD or dialysis. Moderate or severe hepatic impairment. Liver transplant patients. Other HCV genotypes. Pregnancy (Cat. C). Nursing mothers: not recommended.
Interactions:
Concomitant moderate or strong CYP3A inducers/inhibitors: not recommended. Avoid use with macrolides, azole antifungals, milk thistle, cobicistat-containing products, delavirdine, darunavir, ritonavir, other HIV PIs. May be antagonized by anticonvulsants, rifabutin, rifampin, rifapentine, dexamethasone, efavirenz, etravirine, nevirapine, St. John's wort; avoid. May potentiate cisapride (avoid), antiarrhythmics (caution), digoxin, calcium channel blockers, statins (use lowest dose), PDE-5 inhibitors for PAH, oral midazolam or triazolam. Monitor warfarin, immunosuppressants.
Adverse Reactions:
Rash, photosensitivity, pruritus, nausea, myalgia, dyspnea.
Note:
For peginterferon alfa and ribavirin specific dosing and safety information, refer to their respective prescribing information.
How Supplied:
Caps—7, 28
