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SIMEPREVIR
DIR Classification
Classification:Moderate-DIR concern
Severity Score:3
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- DRUG INTERACTIONS
- Established and Other Potentially Significant Drug Interactions
- Table 8 shows the established and other potentially significant drug interactions based on which alterations in dose or regimen of OLYSIO and/or coadministered drug may be recommended. Drugs that are not recommended for coadministration with OLYSIO are also included in Table 8.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
7
42905
Other ADRs
4033
14113246
Odds Ratio = 0.571
Drug Property Information
ATC Code(s):
- J05AE14 - simeprevir
- J05AE - Protease inhibitors
- J05A - DIRECT ACTING ANTIVIRALS
- J05 - ANTIVIRALS FOR SYSTEMIC USE
- J - ANTIINFECTIVES FOR SYSTEMIC USE
Active Ingredient:simeprevir
Active Ingredient UNII:9WS5RD66HZ
Drugbank ID:DB06290
PubChem Compound:24873435
CAS Number:923604-59-5
Dosage Form(s):capsule
Route(s) Of Administrator:oral
Daily Dose:
- 150.0 mg/day J05AP05
Chemical Structure: 
SMILE Code:
CC1=C(C=CC2=C1N=C(C=C2O[C@@H]3C[C@@H]4[C@@H](C3)C(=O)N(CCCC/C=C\[C@@H]5C[C@]5(NC4=O)C(=O)NS(=O)(=O)C6CC6)C)C7=NC(=CS7)C(C)C)OC
CC1=C(C=CC2=C1N=C(C=C2O[C@@H]3C[C@@H]4[C@@H](C3)C(=O)N(CCCC/C=C\[C@@H]5C[C@]5(NC4=O)C(=O)NS(=O)(=O)C6CC6)C)C7=NC(=CS7)C(C)C)OC
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
1: Evaluation of the Pharmacokinetics and Renal Excretion of Simeprevir in Subjects with Renal Impairment.
[Ouwerkerk-Mahadevan Sivi,Beumont-Mauviel Maria,Mortier Steven,Peeters Monika,Verloes Rene,Truyers Carla,Mannens Geert,Wynant Inneke,Simion Alexandru]Drugs R D.2015 Sep;15(3):261-70. doi: 10.1007/s40268-015-0101-0. PMID: 26248593
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