Important Notice
This page provides an educational overview of prescribing information. It does not replace the official regulatory label for the specific product or country.
Active Ingredient
The active ingredient is baricitinib.
Baricitinib is a Janus kinase inhibitor with preferential activity against JAK1 and JAK2.
U.S. Indications
Current U.S. labeling identifies baricitinib for:
- Adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers
- Adults with severe alopecia areata
- Hospitalized adults with COVID-19 requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO
European Indications
European authorization includes:
- Moderate to severe rheumatoid arthritis
- Moderate to severe atopic dermatitis
- Severe alopecia areata
- Specified juvenile idiopathic arthritis
The patient age and previous-treatment requirements differ according to indication.
Dosage Principles
Current U.S. labeling includes indication-specific dosing and dose modifications based on renal function.
For rheumatoid arthritis, the labeled adult dose is generally 2 mg once daily.
For severe alopecia areata, the recommended dose may be 2 mg once daily, with an increase to 4 mg once daily in specified circumstances.
For hospitalized adults with COVID-19, treatment duration and dosing follow indication-specific requirements.
Renal Impairment
Renal function is important when prescribing baricitinib.
Dose modification is required in certain degrees of renal impairment, and use may not be recommended in certain patients with severe renal impairment depending on the indication.
Serious Infections
Baricitinib can increase the risk of serious infections.
Before treatment, healthcare professionals may evaluate patients for:
- Active infection
- Tuberculosis
- Other infection risks
During treatment, patients should report symptoms that may indicate infection.
Malignancy
Malignancy is an important safety consideration associated with JAK inhibitor therapy.
The benefit-risk relationship should be assessed individually.
Major Cardiovascular Events
JAK inhibitors carry important cardiovascular safety considerations, especially in patients with cardiovascular risk factors.
Thrombosis
Thrombosis, including deep vein thrombosis and pulmonary embolism, is an important potential risk.
Symptoms such as unexplained leg swelling, sudden chest pain or sudden shortness of breath require prompt medical assessment.
Blood Abnormalities
Baricitinib can affect blood counts.
Treatment may require laboratory monitoring and interruption or adjustment if clinically important abnormalities develop.
Liver Enzymes
Liver-related laboratory abnormalities may occur. Appropriate laboratory monitoring should be determined by the treating professional.
Lipids
Baricitinib can alter lipid levels, including LDL and HDL cholesterol.
Appropriate lipid monitoring may therefore be part of clinical management.
Vaccination
Vaccination history should be considered before therapy. Live vaccines require particular caution during immunomodulatory treatment.
Pregnancy
Pregnancy requires special consideration. European product information states that baricitinib should not be used during pregnancy.
Breastfeeding
Current U.S. information recommends against breastfeeding during baricitinib treatment and for four days following the last dose.
Drug Interactions
The medication list should be reviewed before treatment.
Particular attention may be needed when patients receive other medicines that suppress immune activity.
Combination Therapy
Current U.S. labeling does not recommend combining baricitinib with other JAK inhibitors, biologic DMARDs or potent immunosuppressants for rheumatoid arthritis.
Final Prescribing Principle
The complete official prescribing information should always be consulted before prescribing or administering baricitinib.