• How to manage the risk of venous thromboembolism?
• Clinical Trial Criteria Related to Birth Control  
• Efficacy and Safety of Baricitinib in Patients with Concomitant Oral Contraceptives
• Is there a potential for drug-drug interactions between baricitinib and oral contraceptives?
• Clinical Use of Oral Contraceptive Therapy and Baricitinib

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,
• immobilisation,
• 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

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

For full information on baricitinib clinical trials in rheumatoid arthritis, please refer to the section 5.1 of the summary of product characteristics (SmPC).1

Thorough subgroup analyses of the efficacy and safety of concomitant use of baricitinib and oral contraceptives have not been conducted.

Summary of Concomitant Hormone Modulators Used in Each Baricitinib Rheumatoid Arthritis Clinical Trials presents the percentages of patients with concomitant use of hormone modulators including contraceptives in the 4 pivotal phase 3 clinical trials in adults with RA.

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.5

In addition, no clinically relevant effects on baricitinib pharmacokinetics occurred with the co-administration of baricitinib and

• a CYP 3A inhibitor
• a CYP2C19/CYP2C9/CYP 3A inhibitor
• a CYP 3A inducer, or
• a P-glycoprotein (Pgp) inhibitor.5

In clinical pharmacology studies, coadministration of baricitinib with the CYP3A substrates simvastatin, ethinyl oestradiol, or levonorgestrel resulted in no clinically meaningful changes in the PK of these medicinal products.1

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.

The treating physician may use the information provided, the patient’s prior medical history and other concomitant medications, and other individual factors, in formulating an assessment and approach. The treating physician should consider potential risks and benefits of treatment options and monitor appropriately.