Baricitinib requires careful patient selection and monitoring.
Serious infections
Baricitinib can reduce immune-system function and increase the risk of serious infections.
Patients should be evaluated for active infection before treatment.
For RA and alopecia areata, the current U.S. label recommends testing for latent TB before treatment and monitoring for TB during therapy.
Tuberculosis
Baricitinib should not be given to patients with active tuberculosis.
Latent TB should be evaluated and treated appropriately before therapy for the indications where TB screening is required.
Cardiovascular risk
Patients with cardiovascular risk factors require careful consideration.
The EMA advises that baricitinib should only be used in patients aged 65 years or older, patients with cardiovascular disease or cardiovascular risk factors such as current or former long-term smoking, or patients at increased cancer risk when no suitable treatment alternatives are available.
Blood clots
Patients at increased risk of thrombosis require particular attention.
Cancer
Malignancy has been reported with JAK inhibitor therapy. Individual risk assessment is important.
Laboratory monitoring
The current U.S. label recommends monitoring:
- Lymphocytes
- Neutrophils
- Hemoglobin
- Liver enzymes
- Lipids
Pregnancy
The current U.S. prescribing information states that baricitinib may cause fetal harm based on animal data and advises against use during pregnancy unless specifically appropriate.
EMA states that Olumiant should not be used during pregnancy and recommends contraception during treatment and for at least one week after stopping.
Breastfeeding
The current U.S. label advises against breastfeeding during treatment.
Vaccination
Live vaccines should be avoided during baricitinib therapy. Vaccinations should be reviewed before treatment begins.
Drug combinations
The U.S. label does not recommend combining baricitinib with:
- Other JAK inhibitors
- Biologic DMARDs
- Certain potent immunosuppressants