simeprevir, Olysio

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GENERIC NAME: simeprevir

BRAND NAME: Olysio

DRUG CLASS AND MECHANISM: Simeprevir is an oral, direct-acting an-tiviral agent used for treating infections with the hepatitis C virus (HCV). boceprevir (Victrelis), telaprevir (Incivek), and sofosbuvir (Sovaldi) are other direct-acting drugs for treating HCV. Simeprevir blocks the effect of pro-teases which are enzymes that HCV needs for making new viruses, leading to reduced numbers of HCV in the body. Simeprevir is effective for treating people infected with HCV genotype 1, including those with liver disease. The FDA approved simeprevir in November 2013.

PRESCRIPTION: Yes

GENERIC AVAILABLE: No

PREPARATIONS: Capsules: 150 mg

STORAGE: Capsules should be stored at room temperature below 30 C (86 F).

PRESCRIBED FOR: Simeprevir is used in combination with ribavirin (Rebetol, Copegus) and peginterferon to treat infections with HCV.

DOSING: The recommended dose of simeprevir is one 150 mg capsule once daily with or without food for 12 weeks in combination with peginter-feron and ribavarin.

DRUG INTERACTIONS: Rifampin and St. John's wort may reduce blood levels of simeprevir by increasing its metabolism (break-down) in the intestine. Therefore, simeprevir should not be combined with rifampin or St. John's wort. Other drugs that also may reduce blood levels of simeprevir include carbamazepine (Tegretol, Tegretol XR , Equetro, Carbatrol), phenytoin (Dilantin, Dilantin-125),  phenobarbital, oxcarbazepine (Tripetal), rifabutin, rifampin, rifapentine (Prifitin), efavirenz (Sustiva), nevirapine (Viramune, Viramune XR), and etravirine (Intelence).

Antibiotics such as erythromycin and clarithromycin reduce breakdown of simeprevir in the liver, increasing blood levels of simeprevir and its side effects. The antifungal drugs ketoconazole (Nizoral, Extina, Xolegel, Kuric) and itraconazole (Sporanox) also have a similar effect.

PREGNANCY: Simeprevir has not been adequately evaluated in pregnant women. However, ribavarin which is combined with simeprevir should not be used by pregnant women or their male partners.

NURSING MOTHERS: It is not known if simeprevir is secreted into breast milk.

SIDE EFFECTS: The most common side effects associated with simeprevir treatment are rash, itching, sun sensitivity, muscle pain, shortness of breath, and nausea.

REFERENCE: FDA.gov prescribing information. simeprevir.


Medically Reviewed by a Doctor on 1/23/2014



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