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OLYSIO™ simeprevir Receives FDA Approval ... 
Listing ID: 238
€1 EUR
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OLYSIO Rx
- Simeprevir 150mg; caps.


Therapeutic Use: Viral infections


Company:
Janssen Therapeutics

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





Price: €1 EUR
Listing ID: 238
Apoteket

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