In this article, we will discuss about Baricitinib (Dosage). So, let’s get started.
Baricitinib
Indications
Rheumatoid Arthritis
Baricitinib (OLUMIANT®) 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.
Limitation of Use: Use of Baricitinib (OLUMIANT®) in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Dosage
Dosage in Rhoumatoid Arthritis
• The recommended dose of Baricitinib (OLUMIANT®) is 2 mg once daily.
• Baricitinib (OLUMIANT®) may be used as monotherapy or in combination with methotrexate or other DMARDS.
• Baricitinib (OLUMIANT®) is given orally with or without food.
General Considerations for Administration
• Baricitinib (OLUMIANT®) initiation is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm³, absolute neutrophil count (ANC) less than 1000 cells/mm³ or hemoglobin level less than 8 g/dL.
• Avoid use of Baricitinib (OLUMIANT®) in patients with active, serious infection, including localized infections.
Prior to initiating Baricitinib (OLUMIANT®), test patients for latent tuberculosis (TB). If positive, consider treating for T prior to Baricitinib (OLUMIANT®) use.
Dose Modifications Due to Serious infections and Cytopenias
• If a patient develops a senous infection, hold treatment with Baricitinib (OLUMIANT®) until the infection is controlled
• Modify dosage in cases of lymphopenia, neutropenia or anemia (see below). For treatment initiation criteria.
(A) Dose Adjustments for Lymphopenia
Low Absolute Lymphocyte Count (ALC)
Lab Value (cells/mm³) – Recommendation
• ALC greater than or equal to 500 – Maintain dose
• ALC less than 500 – Interrupt Baricitinib (OLUMIANT®) until ALC greater than or equal to 500
(B) Dose Adjustments for Neutropenia
Low Absolute Neutrophil Count (ANC)
Lab Value (cells/mm³) – Recommendation
• ANC greater than or equal to 1000 – Maintain dose
• ANC less than 1000 – Interrupt Baricitinib (OLUMIANT®) until ANC greater than or equal to 1000
(C) Dose Adjustments for Anemia
Low Hemoglobin Value
Lab Value (g/dL) – Recommendation
• Greater than or equal to 8 – Maintain dose
• Less than 8 – Interrupt Baricitinib (OLUMIANT®) until hemoglobin greater than or equal to 8
Dose Modifications in Patients with Renal or Hepatic Impairment
• Baricitinib (OLUMIANT®) is not recommended for use in patients with estimated GFR of less than 60 mL/min/1.73 m².
• Baricitinib (OLUMIANT®) is not recommended for use in patients with severe hepatic impairment.
Dose Modifications Due to Drug Interactions
Baricitinib (OLUMIANT®) is not recommended for use in patients taking strong Organic Anion Transporter 3 (OAT3) inhibitors, such as probenecid.
Warnings and Precautions
• Serious Infections: Avoid use of Baricitinib (OLUMIANT®) in patients with
active, serious infection, including localized infections. If a serious infection develops, interrupt Baricitinib (OLUMIANT®) therapy until the infection is controlled. Do not give Baricitinib (OLUMIANT®) 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 (OLUMIANT®) with live vaccines.
More Information about Baricitinib (Warnings and Precautions)
Serious Infections
Patients treated with Baricitinib (OLUMIANT®) are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
If a serious infection develops, interrupt Baricitinib (OLUMIANT®) until the infection is controlled.
Reported infections include:
• Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before initiating Baricitinib (OLUMIANT®) and during therapy. Treatment for latent infection
should be considered prior to OLUMIANT use.
• Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
• Bacterial, viral, and other infections due to opportunistic pathogens.
The risks and benefits of treatment with Baricitinib (OLUMIANT®) should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Baricitinib (OLUMIANT®) including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Malignancies
Lymphoma and other malignancies have been observed in patients treated with Baricitinib (OLUMIANT®).
Thrombosis
Thrombosis, including deep venous thrombosis and pulmonary embolism, has been observed at an increased incidence in patients treated with Baricitinib (OLUMIANT®) compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.