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- Simeprevir 150mg; caps.
Therapeutic Use: Viral infections
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.
HCV NS3/4A protease inhibitor.
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.
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.
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.
Rash, photosensitivity, pruritus, nausea, myalgia, dyspnea.
For peginterferon alfa and ribavirin specific dosing and safety information, refer to their respective prescribing information.
Price: €1 EUR
Listing ID: 238