Indications

OLUMIANT (baricitinib tablets) in combination with methotrexate (MTX) is indicated for, for reducing the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs).

Contraindications

Baricitinib is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Warnings and Precautions

Active tuberculosis
Invasive fungal infections
Malignancies
Major adverse cardiovascular events
Thrombosis

Dosage and administration

OLUMIANT should not be used alongside potent immunosuppressants, other JAK inhibitors, or biologic immunomodulators in rheumatoid arthritis patients as it has not been studied and is not recommended.
Avoid starting OLUMIANT in patients with an absolute lymphocyte count (ALC) below 0.5 x 10^9 cells/L, absolute neutrophil count (ANC) below 1 x 10^9 cells/L, or hemoglobin levels below 80 g/L.
Do not initiate OLUMIANT in patients with active serious infections, including localized infections. If a serious infection, opportunistic infection, or sepsis develops, discontinue OLUMIANT.
Avoid using OLUMIANT with live vaccines.
Treat latent tuberculosis infection before starting OLUMIANT.
Screen for viral hepatitis before starting OLUMIANT.
Weigh the risks and benefits of OLUMIANT for geriatric patients, current or past smokers, those with cardiovascular risk factors, known malignancy, or thrombosis risk, and reconsider its use if patients develop malignancy, major cardiovascular events, or thrombosis.
Discontinue OLUMIANT and evaluate immediately if symptoms of thrombosis occur.
OLUMIANT should not be used during pregnancy and is not recommended for breastfeeding women.
Exercise caution and consider monitoring renal function in patients 65 years or older.
OLUMIANT is not recommended for patients with severe hepatic impairment.
Evaluate liver enzymes before starting OLUMIANT; if liver injury is suspected during treatment, interrupt OLUMIANT until liver injury is ruled out.
OLUMIANT is not recommended for patients with moderate to severe renal impairment, including end-stage renal disease (ESRD).
Avoid using OLUMIANT in patients taking strong OAT3 inhibitors like probenecid.

Storage

Store at room temperature between 15°C and 30°C.
Keep out of reach and sight of children.
Medicines should not be disposed of via wastewater or household waste. Return all unused medications to a pharmacy for proper disposal.