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Para consultar la información para prescribir completa de Olumiant® (Baricitinib) de clic en el siguiente enlace:
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Baricitinib: Potential Drug-Drug Interactions
An established drug-drug interaction exists between baricitinib and OAT3 inhibitors. The recommended dose of baricitinib in patients taking an OAT3 inhibitor is 2 mg once daily. Other clinically relevant drug-drug interactions have not been identified.
The information contained in this letter may notcompletely match the current local labeling for BARICITINIB.Please see local labeling approved in your country. If you require the local labeling, please request it through your Sales Representative.
Potential Drug-Drug Interaction Evaluations
In Vitro and Clinical Pharmacology Study Descriptions
In vitro studies were conducted to
identify the CYP enzymes and transporters for which BARI is a substrate,
determine if BARI is an inhibitor or inducer of CYP enzymes or hepatic or renal transporters, and
predict transporter-mediated drug-drug interactions for BARI.1,2
Seven clinical pharmacology studies in healthy subjects and 1 clinical pharmacology study in patients with RA were conducted to assess potential drug-drug interactions with BARI. Each study was powered to evaluate statistically significant differences in exposure.1,2 See study details in Baricitinib Drug-Drug Interaction Studies.
A physiologically-based PK model and a covariate analysis in the primary phase 2 and 3 population PK did not find a clinically relevant interaction between BARI and the less potent OAT3 inhibitors, ibuprofen and diclofenac.1,3
Therefore, the recommended dose of BARI in patients taking an OAT3 inhibitor with strong inhibition potential, like probenecid, is 2 mg once daily. No dose adjustment is needed when BARI is coadministered with OAT3 inhibitors with less inhibition potential, such as ibuprofen or diclofenac.3
Clinically meaningful changes in the PK of drugs that are substrates for these transporters due to BARI inhibition are unlikely.3
In healthy subjects, when BARI was coadministered with a Pgp substrate digoxin or simvastatin, for which the active metabolite simvastatin acid is an OATP1B1 substrate, there were no clinically relevant effects on the PK of digoxin or simvastatin acid.2,3 See Effect of Baricitinib on the PK of Other Drugs.
Potential Drug-Drug Interactions from US Claims Data
An observational, retrospective, cross-sectional study of various US drug claims databases was performed. This analysis included 152,853 patients with rheumatoid arthritis.6
Up to10% of these patients had been prescribed a medication that may interact with BARI. Specifically,
<0.1% had concomitant claims for a strong OAT3 inhibitor,
1% had claims for the combination of a strong CYP3A4 and strong CYP2C19 inhibitor,
3% had claims for a strong CYP3A4 inhibitor alone, and
almost 10% had claims for the combination of a moderate CYP3A4 and a strong CYP2C19 inhibitor.6
The authors concluded from the study that DDIs were a risk for RA patients, and that these need to be recognized and managed to avoid therapeutic failures and adverse drug reactions.6
Concomitant Use of Baricitinib with other RA Therapies
The following concomitant medications were allowed during the phase 3 clinical program
6Walton A, Paik J, Quebe A et al. Frequency of Prescription Claims for Drugs that MayInteract with Janus Kinase Inhibitors Among Patientswith Rheumatoid Arthritis in the US. Rheumatol Ther 2021. Published online January 23, 2021; https://doi.org/10.1007/s40744-020-00275-8
AUC = area under the concentration-time curve
BARI = baricitinib
BCRP = breast cancer resistance protein
CI = Confidence Interval
CYP = cytochrome P450
DMARD = disease-modifying antirheumatic drug
IC50 = inhibitory concentration of 50%
JAK = Janus kinase
LSMean = least squares mean
MATE = multidrug and toxin extrusion protein
MRP = multidrug resistance-associated protein
MTX = methotrexate
NSAID = nonsteroidal anti-inflammatory drug
OAT = organic anion transporter
Pgp = P-glycoprotein
PK = pharmacokinetic
RA = rheumatoid arthritis
STAT = signal transducers and activators of transcription
Tmax = time of maximum observed drug concentration
TYK = tyrosine kinase
Fecha de la última revisión:2021 M03 11
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