Trial Criteria Related to Birth Control
were excluded from participating in BARI RA clinical studies if they
were women of childbearing potential who did not agree to use 2 forms
of highly effective birth control when engaging in sexual intercourse
while enrolled in the study and for at least 28 days following the
last dose of study treatment.1
for Drug-Drug Interactions
on clinical pharmacology studies, BARI had no effect on the
pharmacokinetics of the components of Microgynon® (Bayer, United
Kingdom), a CYP 3A substrate.2
addition, no clinically relevant effects on BARI pharmacokinetics
occurred with the co-administration of BARI and
and PE are listed as uncommon in the table of adverse reactions in
the summary of product characteristics. 3
of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been
reported in patients receiving baricitinib. Baricitinib should be
used with caution in patients with risk factors for DVT/PE, such as
older age, obesity, a medical history of DVT/PE, or patients
undergoing surgery and immobilisation. If clinical features of DVT/PE
occur, baricitinib treatment should be discontinued and patients
should be evaluated promptly, followed by appropriate treatment.3
Use of Oral Contraceptives and Association of VTE
all BARI-treated patients with rheumatoid arthritis, risk factors
possibly associated with VTE events were evaluated in a single- and
multi-variable analysis comparing the risks between patients with
(n=42) and without events (n=3450) using data through April 1, 2017.4
use of BARI and oral contraceptive pills or selective estrogen
receptor modulators was observed in
(7.1%) of the 42 patients with VTE, and
(6.2%) of the 3450 patients without VTE.1
on the analysis, no association was observed between concomitant use
of oral contraceptive pills or selective estrogen receptor modulators
and incidence of VTE.1
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Payne C, Zhang X, Shahri N, et al. Evaluation of potential drug-drug
interactions with baricitinib [abstract]. Ann Rheum Dis.
Olumiant [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Eli Lilly and Company. Lilly FDA Advisory Committee Meeting NDA
207924 Briefing Document.
Accessed July 23, 2018.
= cytochrome P450
= deep vein thrombosis
= ethinyl estradiol and levonorgestrel
= venous thromboembolism
medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions.