Olysio Side Effects
Generic Name: simeprevir
Note: This document contains side effect information about simeprevir. Some of the dosage forms listed on this page may not apply to the brand name Olysio.
Some side effects of Olysio may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to simeprevir: oral capsule
Get emergency medical help if you have any of these signs of an allergic reaction while taking simeprevir (the active ingredient contained in Olysio) hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
severe skin rash (redness, swelling, burning, blistering);
eye redness or puffiness;
mouth sores; or
shortness of breath.
Common side effects may include:
mild itching or rash;
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to simeprevir: oral capsule
In clinical trials, most side effects reported during 12 weeks therapy with simeprevir (the active ingredient contained in Olysio) combination therapy (simeprevir, peginterferon alfa, and ribavirin) were Grade 1 to 2 in severity. Grade 3 or 4 side effects were reported in 23% of subjects using simeprevir combination therapy and in 25% using placebo with peginterferon alfa and ribavirin. Serious side effects were reported with simeprevir combination therapy (2%) and with placebo, peginterferon alfa, and ribavirin (3%). Simeprevir or placebo was discontinued due to side effects in 2% and 1% of subjects using simeprevir combination therapy and subjects using placebo with peginterferon alfa and ribavirin, respectively.
Fifty-six percent (56%) of rash events occurred in the first 4 weeks; 42% in the first 2 weeks. Most rash events were of mild or moderate severity. Severe rash was reported in 1% of subjects. Simeprevir was discontinued due to rash in 1% of subjects. The frequencies of rash and photosensitivity reactions were higher in subjects with higher simeprevir (the active ingredient contained in Olysio) exposures.
All trial subjects were directed to use sun protection measures. Most photosensitivity reactions were of mild or moderate severity. Two subjects had photosensitivity reactions that required hospitalization.
Very common (10% or more): Rash (including photosensitivity; term includes rash, erythema, eczema, maculopapular rash, macular rash, dermatitis, papular rash, skin exfoliation, pruritic rash, erythematous rash, urticaria, generalized rash, drug eruption, allergic dermatitis, dermatosis, vasculitic rash, toxic skin eruption, exfoliative rash, generalized erythema, dermatitis exfoliative, cutaneous vasculitis, photosensitivity reaction, polymorphic light eruption, solar dermatitis, photodermatosis, sunburn; 28%), pruritus (term includes pruritus, generalized pruritus; 22%)
Common (1% to 10%): Photosensitivity (5%)
Very common (10% or more): Hyperbilirubinemia (Grade 1: 27%; Grade 2: 18%)
Common (1% to 10%): Hyperbilirubinemia (Grade 3: 4%), increased alkaline phosphatase (Grade 1: 3%)
Uncommon (0.1% to 1%): Hyperbilirubinemia (Grade 4: less than 1%), increased alkaline phosphatase (Grade 2: less than 1%)
Bilirubin elevations were mostly mild to moderate in severity, and included elevation of both direct and indirect bilirubin. Bilirubin elevations occurred soon after therapy started, peaked by the second week, and reversed quickly after simeprevir was stopped. In general, bilirubin elevations were not associated with liver transaminase elevations.
Very common (10% or more): Nausea (22%)
Very common (10% or more): Myalgia (16%)
Very common (10% or more): Dyspnea (term includes dyspnea, exertional dyspnea; 12%)
All dyspnea events were of mild or moderate severity. Sixty-one percent (61%) of dyspnea events occurred in the first 4 weeks.
More about Olysio (simeprevir)
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