Baricitinib
Indications
Baricitinib is a Janus kinase (JAK)
inhibitor indicated for the treatment of adult patients with moderately
to severely active rheumatoid arthritis who have had an inadequate
response to one or more TNF antagonist therapies.
Limitation of Use: Use of Baricitinib in combination with other JAK inhibitors, biologic DMARDs or with potent immunosuppressants such as Azathioprine and cyclosporine is not recommended.
Limitation of Use: Use of Baricitinib in combination with other JAK inhibitors, biologic DMARDs or with potent immunosuppressants such as Azathioprine and cyclosporine is not recommended.
Pharmacology
Baricitinib is a Janus kinase (JAK)
inhibitor. JAKs are intracellular enzymes which transmit signals arising
from cytokine or growth factor-receptor interactions on the cellular
membrane to influence cellular processes of hematopoiesis and immune
cell function. Within the signaling pathway, JAKs phosphorylate and
activate Signal Transducers and Activators of Transcription (STATs)
which modulate intracellular activity including gene expression.
Baricitinib modulates the signaling pathway at the point of JAKs,
preventing the phosphorylation and activation of STATs.
Dosage & Administration
The recommended dose of Baricitinib is 2 mg
once daily. Baricitinib may be used as monotherapy or in combination
with Methotrexate or other DMARDs.
Interaction
The recommended dose of Baricitinib in
patients taking strong Organic Anion Transporter 3 (OAT3) inhibitors
(e.g., probenecid) is 1 mg once daily
Contraindications
- Anemia: Avoid initiation or interrupt Baricitinib in patients with hemoglobin less than 8 g/dL.
- Lymphopenia: Avoid initiation or interrupt Baricitinib in patients with an Absolute Lymphocyte Count less than 500 cells/mm3.
- Neutropenia: Avoid initiation or interrupt Baricitinib in patients with an Absolute Neutrophil Count less than 1000 cells/mm3.
Side Effects
It is not known if Baricitinib will harm an
unborn baby. Because of the potential for serious adverse reactions in
nursing infants, advice an Baricitinib treated woman not to breastfeed.
Pregnancy & Lactation
It is not known if Baricitinib will harm an
unborn baby. Because of the potential for serious adverse reactions in
nursing infants, advice an Baricitinib treated woman not to breastfeed.
Precautions & Warnings
- Serious Infections: Avoid use of Baricitinib in patients with active, serious infection, including localized infections. If a serious infection develops, interrupt Baricitinib therapy until the infection is controlled. Do not give Baricitinib to patients with active tuberculosis.
- Thrombosis: Use with caution in patients who may be at increased risk.
- Gastrointestinal Perforations: Use with caution in patients who may be at increased risk.
- Laboratory Assessment: Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids.
- Vaccinations: Avoid use of Baricitinib with live vaccines
Use in Special Populations
Moderate Renal Impairment: Reduce dose to 1 mg once daily.
Overdose Effects
In case of an overdose, it is recommended
that the patient should be monitored for signs and symptoms of adverse
reactions. Patients who develop adverse reactions should receive
appropriate treatment.
Therapeutic Class
Immunosuppressant
Storage Conditions
Store below 30°C. Protect from light & moisture. Keep all medicines out of the reach of children.
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