Tips for searching:
• You have to select a product and type at least 2 words to activate the search
• Use only words that are specific to the information you are looking for
• Avoid typing questions or sentences
Please do not use this field to report adverse events or product complaints. Adverse events and product complaints should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google play or Apple app store. Adverse events and product complaints should also be reported to Lilly: please call Lilly UK on 01256 315 000.
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).
Olumiant® (baricitinib) and concomitant use of oral contraceptives in patients with rheumatoid arthritis.
The risk of venous thromboembolic events needs further consideration. In rheumatoid arthritis clinical trials, some patients treated with baricitinib were taking concomitant oral contraceptives.
How to manage the risk of venous thromboembolism?
Baricitinib is contraindicated during pregnancy. Women of childbearing potential have to use effective contraception during and for at least 1 week after treatment.1
Deep vein thrombosis (DVT) and pulmonary embolism (PE) are uncommon adverse events of baricitinib, both affects ≥ 1/1 000 to < 1/100 patients (incidences are based on results from clinical trials in rheumatoid arthritis, or rheumatoid arthritis and atopic dermatitis, respectively).1
In a retrospective observational study of baricitinib in rheumatoid arthritis patients, a higher rate of venous thromboembolic events (VTE) was observed compared to patients treated with TNF inhibitors.1
In a large randomized active‑controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a dose dependent higher rate of VTE including deep venous thrombosis (DVT) and pulmonary embolism (PE) was observed with tofacitinib compared to TNF inhibitors.1
In patients with cardiovascular or malignancy risk factors, baricitinib should only be used if no suitable treatment alternatives are available.1
In patients with known VTE risk factors other than cardiovascular or malignancy risk factors, baricitinib should be used with caution.1
VTE risk factors other than cardiovascular or malignancy risk factors include1
- previous VTE,
- patients undergoing major surgery,
- use of combined hormonal contraceptives or hormone replacement therapy, and
- inherited coagulation disorder.
Patients should be re‑evaluated periodically during baricitinib treatment to assess for changes in VTE risk.1
Promptly evaluate patients with signs and symptoms of VTE and discontinue baricitinib in patients with suspected VTE, regardless of dose or indication.1
What is the experience from pivotal clinical trials?
Were patients using oral contraceptives included in the trial?
Patients were excluded from participating in baricitinib 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.2
What was the observed association between oral contraceptives and venous thromboembolism?
In all baricitinib-treated patients with RA, 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, 2017.3
Concomitant use of baricitinib 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.2
Based on the analysis, no association was observed between concomitant use of oral contraceptive pills or selective estrogen receptor modulators and incidence of VTE.2
Is there a potential for drug-drug interactions between baricitinib and oral contraceptives?
Based on clinical pharmacology studies, baricitinib had no effect on the pharmacokinetics of the components of Microgynon®, Bayer, United Kingdom (ethinyl estradiol and levonorgestrel), a cytochrome P450 (CYP) 3A substrate.4
For full information on interactions of baricitinib with other medicinal products please refer to the summary of product characteristics, section 4.5 and 5.2.
1Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
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
4Payne 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
Date of Last Review: 11 March 2021