"The U.S. Food and Drug Administration today approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver"...
- Clinician Information:
Olysio Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Olysio (simeprevir) is a protease inhibitor used to treat chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. Common side effects include rash, itching, nausea, muscle pain, and indigestion.
The recommended dose of Olysio is one capsule of 150 mg taken orally once daily with food. Olysio may interact with amiodarone, amlodipine, antibiotics, azole antifungals, statins, medications to treat erectile dysfunction, antiviral medications, carbamazepine, cisapride, cobicistat-containing medicine, cyclosporine, dexamethasone, digoxin, diltiazem, disopyramide, felodipine, flecainide, mexiletine, midazolam, milk thistle, nicardipine, nifedipine, nisoldipine, oxcarbazepine, phenobarbital, phenytoin, propafenone, quinidine, sirolimus, St. John's wort, tacrolimus, telithromycin, triazolam, verapamil , or warfarin. Tell your doctor all medications and supplements you use. Olysio must not be used by women who are pregnant or by men whose partners are pregnant. Women should have a negative pregnancy test before stating this medication. Consult your doctor about using two forms of birth control while taking Olysio. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Olysio (simeprevir) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Olysio FDA Prescribing Information: Side Effects
OLYSIO should be administered with peginterferon alfa and ribavirin. Refer to the prescribing information of peginterferon alfa and ribavirin for a description of adverse reactions associated with their use.
The following serious and otherwise important adverse drug reactions (ADRs) are discussed in detail in another section of the labeling:
- Embryo-Fetal Toxicity (Use with Ribavirin and Peginterferon alfa) [see WARNING AND PRECAUTIONS and Use In Specific Populations]
- Photosensitivity [see WARNING AND PRECAUTIONS]
- Rash [see WARNING AND PRECAUTIONS]
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
The safety profile of OLYSIO in combination with peginterferon alfa and ribavirin in patients with HCV genotype 1 infection who were treatment-na´ve or who had previously relapsed following interferon therapy with or without ribavirin is based on pooled data from three Phase 3 trials. These trials included a total of 1178 subjects who received OLYSIO or placebo in combination with 24 or 48 weeks of peginterferon alfa and ribavirin. Of the 1178 subjects, 781 subjects were randomized to receive OLYSIO 150 mg once daily for 12 weeks and 397 subjects were randomized to receive placebo once daily for 12 weeks.
In the pooled Phase 3 safety data, the majority of the adverse reactions reported during 12 weeks treatment with OLYSIO in combination with peginterferon alfa and ribavirin were Grade 1 to 2 in severity. Grade 3 or 4 adverse reactions were reported in 23% of subjects receiving OLYSIO in combination with peginterferon alfa and ribavirin versus 25% of subjects receiving placebo in combination with peginterferon alfa and ribavirin. Serious adverse reactions were reported in 2% of subjects receiving OLYSIO in combination with peginterferon alfa and ribavirin and in 3% of subjects receiving placebo in combination with peginterferon alfa and ribavirin. Discontinuation of OLYSIO or placebo due to adverse reactions occurred in 2% and 1% of subjects receiving OLYSIO with peginterferon alfa and ribavirin and subjects receiving placebo with peginterferon alfa and ribavirin, respectively.
The following table lists adverse reactions (all Grades) that occurred with at least 3% higher frequency among subjects receiving OLYSIO 150 mg once daily in combination with peginterferon alfa and ribavirin compared to subjects receiving placebo in combination with peginterferon alfa and ribavirin during the first 12 weeks of treatment in the pooled Phase 3 trials in subjects who were treatment-na´ve or who had previously relapsed after peginterferon alfa and ribavirin therapy (see Table 3).
Table 3: Adverse Reactions (all Grades) that Occurred
with at Least 3% Higher Frequency Among Subjects Receiving OLYSIO 150 mg Once
Daily in Combination with Peginterferon alfa and Ribavirin Compared to Subjects
Receiving Placebo in Combination with Peginterferon alfa and Ribavirin During
the First 12 Weeks of Treatment (Pooled Phase 3 Trials; Intent-to-Treat
|Preferred Term or Grouped Term||OLYSIO + Peginterferon alfa+ Ribavirin First 12 Weeks
|Placebo + Peginterferon alfa+ Ribavirin First 12 Weeks
|Rash (including photosensitivity)*||28 (218)||20 (79)|
|Pruritus†||22 (168)||15 (58)|
|Nausea||22 (173)||18 (70)|
|Myalgia||16 (126)||13 (53)|
|* Grouped term 'rash'
includes the following preferred terms: rash, erythema, eczema, rash
maculo-papular, rash macular, dermatitis, rash papular, skin exfoliation, rash
pruritic, rash erythematous, urticaria, rash generalized, drug eruption,
dermatitis allergic, dermatosis, vasculitic rash, toxic skin eruption,
exfoliative rash, generalized erythema, dermatitis exfoliative, cutaneous
vasculitis, photosensitivity reaction, polymorphic light eruption, solar
dermatitis, photodermatosis, and sunburn.
† Grouped term 'pruritus' included the preferred terms pruritus and pruritus generalized.
‡ Grouped term 'dyspnea' includes the preferred terms dyspnea and dyspnea exertional.
Rash and Photosensitivity
In the Phase 3 clinical trials, rash (including photosensitivity reactions) was observed in 28% of OLYSIO-treated subjects compared to 20% of placebo-treated subjects during the 12 weeks of treatment with OLYSIO/placebo in combination with peginterferon alfa and ribavirin. Fifty-six percent (56%) of rash events in the OLYSIO group occurred in the first 4 weeks, with 42% of cases occurring in the first 2 weeks. Most of the rash events in OLYSIO-treated subjects were of mild or moderate severity (Grade 1 or Grade 2). Severe (Grade 3) rash occurred in 1% of OLYSIO-treated subjects and in none of the placebo-treated subjects. There were no reports of life-threatening (Grade 4) rash. Discontinuation of OLYSIO/placebo due to rash occurred in 1% of OLYSIO-treated subjects, compared to less than 1% of placebo-treated subjects. The frequencies of rash and photosensitivity reactions were higher in subjects with higher simeprevir exposures.
All subjects enrolled in the Phase 3 trials were directed to use sun protection measures. In these trials, adverse reactions under the specific category of photosensitivity were reported in 5% of OLYSIO-treated subjects compared to 1% of placebo-treated subjects during the 12 weeks of treatment with OLYSIO/placebo in combination with peginterferon alfa and ribavirin. Most photosensitivity reactions in OLYSIO-treated subjects were of mild or moderate severity (Grade 1 or 2). Two OLYSIO-treated subjects experienced photosensitivity reactions which resulted in hospitalization. No life-threatening photosensitivity reactions were reported.
During the 12 weeks of treatment with OLYSIO, dyspnea was reported in 12% of OLYSIO-treated subjects compared to 8% of placebo-treated subjects (all grades; pooled Phase 3). All dyspnea events reported in OLYSIO-treated subjects were of mild or moderate severity (Grade 1 or 2). There were no Grade 3 or 4 dyspnea events reported and no subjects discontinued treatment with OLYSIO due to dyspnea. Sixty-one percent (61%) of dyspnea events occurred in the first 4 weeks of treatment with OLYSIO.
There were no differences between treatment groups for the following laboratory parameters: hemoglobin, neutrophils, platelets, aspartate aminotransferase, alanine aminotransferase, amylase, or serum creatinine. Treatment-emergent laboratory abnormalities that were observed at a higher incidence in OLYSIO-treated subjects than in placebo-treated subjects are listed in Table 4.
Table 4: Treatment-Emergent Laboratory Abnormalities
(WHO Worst Toxicity Grades 1 to 4) Observed at a Higher Incidence in
OLYSIO-Treated Subjects (Pooled Phase 3 Trials; First 12 Weeks of Treatments;
|Laboratory Parameter||WHO Toxicity Range||OLYSIO + Peginterferon alfa + Ribavirin
|Placebo+ Peginterferon alfa + Ribavirin
|Grade 1||> 1.25 to ≤ 2.50 x ULN†||3||1|
|Grade 2||> 2.50 to ≤ 5.00 x ULN||< 1||0|
|Grade 1||> 1.1 to ≤ 1.5 x ULN||27||15|
|Grade 2||> 1.5 to ≤ 2.5 x ULN||18||9|
|Grade 3||> 2.5 to ≤ 5.0 x ULN||4||2|
|Grade 4||> 5.0 x ULN||> 1||0|
|* No Grade 3 or 4 changes in
alkaline phosphatase were observed.
† ULN = Upper Limit of Normal
Elevations in bilirubin were predominately mild to moderate (Grade 1 or 2) in severity, and included elevation of both direct and indirect bilirubin. Elevations in bilirubin occurred early after treatment initiation, peaking by study Week 2, and were rapidly reversible upon cessation of OLYSIO. Bilirubin elevations were generally not associated with elevations in liver transaminases.
Read the entire FDA prescribing information for Olysio (Simeprevir Hard Gelatin Capsules) »
Additional Olysio Information
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