Baricinix is the first once-daily oral selective JAK1 and JAK2 inhibitor for the treatment of moderate to severe active rheumatoid arthritis (RA) who have not responded well enough to or could not tolerate at least one medicine called a tumor necrosis factor (TNF) antagonist.
COMPOSITION
Baricitinix 2 mg Tablet : Each film-coated tablet contains Baricitinib INN 2 mg.
THERAPEUTIC CLASS: Anti-Rheumatic
THERAPEUTIC INDICATIONS
Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Baricitinib may be used as monotherapy or in combination with Methotrexate.
DOSAGE AND ADMINISTRATION
The recommended dose of Baricitinib is 4 mg once daily. A dose of 2 mg once daily is appropriate for patients such as those aged ≥ 75 years and may be appropriate for patients with a history of chronic or recurrent infections. A dose of 2 mg once daily may also be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering.
Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) less than 0.5 x 109 cells/L, an absolute neutrophil count (ANC) less than 1 x 109 cells/L, or who have a haemoglobin value less than 8 g/dL. Treatment may be initiated once values have improved above these limits.
Renal impairment
The recommended dose is 2 mg once daily in patients with creatinine clearance between 30 and 60 mL/min. Baricitinib is not recommended for use in patients with creatinine clearance < 30 mL/min.
Hepatic impairment
No dose adjustment is required in patients with mild or moderate hepatic impairment. Baricitinib is not recommended for use in patients with severe hepatic impairment.
Co-administration with OAT3 inhibitors:
The recommended dose is 2 mg once daily in patients taking Organic Anion Transporter 3 (OAT3) inhibitors with a strong inhibition potential, such as probenecid.
Paediatric population
The safety and efficacy of Baricitinib in children and adolescents aged 0 to 18 years have not yet been established. No data are available.
Method of administration
Baricitinib is to be taken once daily with or without food and may be taken at any time of the day.
IMPORTANT SAFETY INFORMATION
Serious infections. Baricinix is a medicine that affects your immune system. Baricinix can lower your immune system’s ability to fight infections, which can make you more likely to get infections or make infections worse. Some people have had serious infections while using Baricinix, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Your healthcare provider (HCP) should test you for TB before starting Baricinix and watch closely for signs and symptoms of TB during treatment. You should not start Baricinix if you have any kind of infection unless your HCP tells you it is okay. You may be at higher risk of developing shingles. While taking Baricinix, tell your Doctors right away if you have symptoms of an infection, including:
ADDITIONAL INFORMATION
Baricinix is available by prescription only.
