Generic

Baricitinib

Indications

Baricitinib is indicated for the treatment of adult patients with moderately to severely active Rheumatoid Arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

Pharmacology

Baricitinib is a selective and reversible inhibitor of Janus kinase (JAK)1 and JAK2. Janus kinases (JAKs) are enzymes that transduce intracellular signals from cell surface receptors for a number of cytokines and growth factors involved in haematopoiesis, inflammation and immune function. Within the intracellular signalling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which activate gene expression within the cell. Baricitinib modulates these signalling pathways by partially inhibiting JAK1 and JAK2 enzymatic activity, thereby reducing 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

Strong OAT3 Inhibitors: Baricitinib exposure is increased when it is co-administered with strong OAT3 inhibitors (such as probenecid). Other JAK Inhibitors or Biologic DMARDs: Baricitinib has not been studied in combination with other JAK inhibitors or with biologic DMARDs.

Contraindications

Anemia: Patients with hemoglobin levels less than 8 g/dL should not start or stop taking Baricitinib.

Lympopenia: Patients with an Absolute Lymphocyte Count of fewer than 500 cells/mm3 should not start or stop taking Baricitinib.

Neutropenia: Patients with an Absolute Neutrophil Count less than 1000 cells/mm3 should not start or stop taking Baricitinib.

Side Effects

It's unclear whether Baricitinib will harm an unborn child. Advice a Baricitinib-treated mother not to breastfeed because of the risk of major adverse effects in nursing infants.

Pregnancy & Lactation

It's unclear whether Baricitinib will cause harm to an unborn child. Advice a woman who is taking Baricitinib not to nurse her baby because of the risk of major side effects in nursing infants.

Precautions & Warnings

• Baricitinib should not be used in patients who have an active, serious infection, including localized infections. If a significant infection occurs, stop taking Baricitinib until the infection is under control.
• Patients with active tuberculosis should not be given Baricitinib.
• Thrombosis: Use with caution in patients who are at a higher risk of thrombosis.
• Use with caution in patients who may be at risk for gastrointestinal perforations.
• Due to possible alterations in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids, a
• laboratory evaluation is recommended.
• Baricitinib should not be used with live vaccinations.

Therapeutic Class

Immunosuppressant

Storage Conditions

Keep it below 30°C. Light and dampness should be avoided. All drugs should be kept out of the reach of youngsters.

Phamaceutical Name

Incepta Pharmaceuticals Ltd.