Olumiant ® (baricitinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).

Can I give Olumiant® (baricitinib) and oral contraceptives concomitantly in patients with rheumatoid arthritis?

The concomitant use of baricitinib and oral contraceptives is not contraindicated. In rheumatoid arthritis clinical trials, some patients treated with baricitinib were taking concomitant oral contraceptives.


Clinical trial exclusion criteria 

Women of childbearing potential were excluded from the study if they did not agree to use 2 forms of highly effective birth control when having sex during the study and for at least 28 days after the last dose.1

Pharmacokinetics considerations 

Based on clinical pharmacology studies, baricitinib (BARI) had no effect on the pharmacokinetics of the components of the combined oral contraceptive Microgynon® (Bayer, United Kingdom), a cytochrome (CYP) 3A substrate.2

No clinically relevant effects on BARI pharmacokinetics occurred with the co-administration of BARI and

  • a CYP 3A inhibitor
  • a CYP2C19/CYP2C9/CYP 3A inhibitor
  • a CYP 3A inducer, or
  • a P-glycoprotein (Pgp) inhibitor.2

Safety considerations based on the use of oral contraceptives and association of venous thromboembolism

In all BARI-treated patients with RA, risk factors possibly associated with venous thromboembolism (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, 2017.3

Concomitant use of BARI and oral contraceptive pills or selective estrogen receptor modulators was observed in

  • 3 (7.1%) of the 42 patients with VTE, and
  • 214 (6.2%) of the 3450 patients without VTE.1

No association was observed between concomitant use of oral contraceptive pills or selective estrogen receptor modulators and incidence of VTE.1

Safety considerations based on the SmPC

Deep venous thrombosis (DVT) and pulmonary embolism (PE) are listed as uncommon in the table of adverse reactions in the summary of product characteristics. 4

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.4

If clinical features of DVT/PE occur,

  • discontinue baricitinib
  • evaluate your patient promptly, and
  • treat it appropriately.4


1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Payne C, Zhang X, Shahri N, et al. Evaluation of potential drug-drug interactions with baricitinib. Ann Rheum Dis. 2015;74(suppl 2):1063. European League Against Rheumatism abstract AB0492. http://dx.doi.org/10.1136/annrheumdis-2015-eular.1627

3Eli Lilly and Company. Lilly FDA Advisory Committee Meeting NDA 207924 Briefing Document. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM605062.pdf. Accessed July 23, 2018. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM605062.pdf

4Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Date of Last Review: 11 March 2021

Contact Lilly

Call or Email us

If you want to ask a Medical Information question or you want to report an adverse event or product complaint you can call us or email us at ukmedinfo@lilly.com

Available Mon - Fri, 10am - 4pm, excluding Bank Holidays

Or you can

Chat with Us

Click to Chat is Offline

If you have a question, you can chat online with a Lilly Medical Information professional.

Submit a request