Serious Infections
Baricitinib modifies immune-system signaling and can increase susceptibility to infection.
Serious infections have been reported, including bacterial, fungal and viral infections.
Patients should contact their healthcare professional if they develop concerning infection symptoms.
Tuberculosis
Tuberculosis is an important consideration before and during treatment.
Patients with tuberculosis risk factors may require screening before therapy.
Appropriate management should be determined by a healthcare professional.
Viral Infections
Certain viral infections can become clinically important in people receiving immunomodulatory treatment.
Patients should promptly report symptoms suggesting significant infection.
Blood Clots
Thrombosis is an important safety concern associated with JAK inhibitors.
Patients should seek urgent medical assessment for symptoms such as:
- Sudden shortness of breath
- Chest pain
- Unexplained leg swelling
- Sudden limb pain
- Other symptoms concerning for a blood clot
Major Cardiovascular Events
JAK inhibitor treatment requires consideration of cardiovascular risk.
This is especially important in patients with:
- Cardiovascular disease
- Previous cardiovascular events
- Smoking history
- Other established risk factors
The overall benefit-risk balance should be assessed individually.
Malignancy
Malignancy is another important safety consideration.
Patients should discuss their cancer history and risk factors with their healthcare professional.
Blood-Cell Abnormalities
Baricitinib can cause laboratory abnormalities involving blood cells.
Healthcare professionals may monitor:
- Absolute lymphocyte count
- Absolute neutrophil count
- Hemoglobin
- Other relevant blood parameters
Treatment may require interruption if clinically significant abnormalities develop.
Liver Abnormalities
Liver enzyme elevations can occur.
Patients with existing liver disease should ensure that their healthcare professional is aware of the condition.
Lipid Abnormalities
Baricitinib may increase cholesterol levels.
Appropriate lipid assessment may therefore form part of routine treatment monitoring.
Kidney Function
Kidney function influences baricitinib dosing.
Patients with impaired renal function may require dose modification or may not be suitable for certain regimens.
Pregnancy
Pregnancy requires special consideration.
Current European product information states that baricitinib should not be used during pregnancy.
Patients should notify their healthcare professional immediately if pregnancy occurs or is being considered.
Breastfeeding
Current U.S. labeling advises against breastfeeding during treatment and for four days after the last dose.
Vaccinations
Patients should discuss vaccination before starting treatment.
Live vaccines require particular consideration because of immune-system effects.
Drug Combinations
Combining baricitinib with other potent immunosuppressive medicines may increase safety concerns.
For rheumatoid arthritis, current U.S. labeling does not recommend combining baricitinib with other JAK inhibitors, biologic DMARDs or potent immunosuppressants.
When to Seek Urgent Care
Urgent medical attention may be appropriate for:
- Severe breathing difficulty
- Chest pain
- Sudden neurological symptoms
- Severe allergic symptoms
- Severe infection symptoms
- Symptoms suggestive of thrombosis
- Other rapidly worsening serious symptoms
Safety Monitoring
Treatment monitoring may include clinical review and laboratory testing.
The exact monitoring plan depends on:
- Indication
- Age
- Kidney function
- Existing conditions
- Concomitant medicines
- Laboratory findings
- Treatment response
Final Safety Principle
Baricitinib can provide important therapeutic benefits for appropriately selected patients, but it is not risk-free.
The safest approach is professional assessment before treatment and ongoing monitoring during therapy.