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.

Therapeutic Class

Immunosuppressant

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.

Storage Conditions

Store below 30°C. Protect from light & moisture. Keep all medicines out of the reach of children.