Baricitinib
Generic Name: baricitinib
Brand Names:
Olumiant
11 DESCRIPTION OLUMIANT (baricitinib) is a Janus kinase (JAK) inhibitor with the chemical name {1-(ethylsulfonyl)-3-[4-(7 H -pyrrolo[2,3- d ]pyrimidin-4-yl)-1 H -pyrazol-1-yl]azetidin-3-yl}acetonitrile. Baricitinib has an empirical formula of C 16 H 17 N 7 O 2 S and a molecular weight of 371.42. Baricitinib has the following structural formula: OLUMIANT tablets contain a recessed area on each face of the tablet surface and are available for oral administration as debossed, film-coated tablets.
Overview
11 DESCRIPTION OLUMIANT (baricitinib) is a Janus kinase (JAK) inhibitor with the chemical name {1-(ethylsulfonyl)-3-[4-(7 H -pyrrolo[2,3- d ]pyrimidin-4-yl)-1 H -pyrazol-1-yl]azetidin-3-yl}acetonitrile. Baricitinib has an empirical formula of C 16 H 17 N 7 O 2 S and a molecular weight of 371.42. Baricitinib has the following structural formula: OLUMIANT tablets contain a recessed area on each face of the tablet surface and are available for oral administration as debossed, film-coated tablets.
Uses
1 INDICATIONS AND USAGE OLUMIANT ® 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 blockers. ( 1.1 ) Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.1 ) the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. ( 1.2 ) the treatment of adult patients with severe alopecia areata.
Dosage
2 DOSAGE AND ADMINISTRATION Administration Instructions: See the full prescribing information for recommended evaluations and immunizations prior to treatment. ( 2.1 ) Rheumatoid Arthritis and Alopecia Areata: Avoid initiation or interrupt OLUMIANT in patients with anemia (hemoglobin <8 g/dL), lymphopenia (ALC <500 cells/mm 3 ) or neutropenia (ANC <1000 cells/mm 3 ). ( 2.1 , 2.5 , 5.8 ) COVID-19: Avoid initiation or interrupt OLUMIANT in patients with lymphopenia (ALC <200 cells/mm 3 ) or neutropenia (ANC <500 cells/mm 3 ). ( 2.1 , 2.5 , 5.8 ) Recommended Dosage : Rheumatoid Arthritis: 2 mg once daily. ( 2.2 ) OLUMIANT may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. ( 2.2 ) COVID-19: 4 mg once daily for up to 14 days.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 )] Mortality [see Warnings and Precautions ( 5.2 )] Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions ( 5.3 )] Major Adverse Cardiovascular Events [see Warnings and Precautions ( 5.4 )] Thrombosis [see Warnings and Precautions ( 5.5 )] Hypersensitivity [see Warnings and Precautions ( 5.6 )] Gastrointestinal Perforations [see Warnings and Precautions ( 5.7 )] Laboratory Abnormalities [see Warnings and Precautions ( 5.8 )] Adverse reactions reported in clinical trials (≥1%) are: Rheumatoid Arthritis : upper respiratory tract infections (URTIs), nausea, herpes simplex, and herpes zoster.
Interactions
7 DRUG INTERACTIONS In patients taking strong Organic Anion Transporter 3 (OAT3) inhibitors (e.g., probenecid) the recommended dosage should be reduced. ( 2.7 , 7.1 ) 7.1 Strong OAT3 Inhibitors Baricitinib exposure is increased when OLUMIANT is co-administered with strong OAT3 inhibitors (such as probenecid), hence the dosage of baricitinib should be reduced by half the recommended dose [see Dosage and Administration ( 2.2 , 2.3 ) and Clinical Pharmacology ( 12.3 )] . 7.2 Other JAK Inhibitors or Biologic DMARDs OLUMIANT has not been studied in combination with other JAK inhibitors or with biologic DMARDs [see Indications and Usage ( 1.1 , 1.2 )] .
Warnings
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning. Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). 5 WARNINGS AND PRECAUTIONS Hypersensitivity : Serious reactions have been reported. Discontinue OLUMIANT if a serious hypersensitivity reaction occurs. ( 5.6 ) Gastrointestinal Perforations : Monitor patients who may be at increased risk and evaluate promptly new onset of abdominal symptoms. ( 5.7 ) Laboratory Abnormalities : Monitor for changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids. ( 5.8 ) Vaccinations : Avoid use with live vaccines. ( 5.9 ) 5.1 Serious Infections Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients with rheumatoid arthritis receiving OLUMIANT. 4 CONTRAINDICATIONS None. None.
Pregnancy
8.1 Pregnancy Risk Summary Based on the findings from animal reproduction studies, OLUMIANT may cause fetal harm during pregnancy. Available data from clinical trials and postmarketing case reports with OLUMIANT exposure in pregnancy are insufficient to inform a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are no human data on chronic baricitinib exposure throughout pregnancy. There are risks to the mother and the fetus associated with rheumatoid arthritis in pregnancy (see Clinical Considerations) .
Storage
16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Keep out of reach of children.
Frequently Asked Questions
What is Baricitinib used for?▼
1 INDICATIONS AND USAGE OLUMIANT ® 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 blockers. ( 1.1 ) Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.1 ) the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. ( 1.2 ) the treatment of adult patients with severe alopecia areata.
What are the side effects of Baricitinib?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 )] Mortality [see Warnings and Precautions ( 5.2 )] Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions ( 5.3 )] Major Adverse Cardiovascular Events [see Warnings and Precautions ( 5.4 )] Thrombosis [see Warnings and Precautions ( 5.5 )] Hypersensitivity [see Warnings and Precautions ( 5.6 )] Gastrointestinal Perforations [see Warnings and Precautions ( 5.7 )] Laboratory Abnormalities [see Warnings and Precautions ( 5.8 )] Adverse reactions reported in clinical trials (≥1%) are: Rheumatoid Arthritis : upper respiratory tract infections (URTIs), nausea, herpes simplex, and herpes zoster.
Can I take Baricitinib during pregnancy?▼
8.1 Pregnancy Risk Summary Based on the findings from animal reproduction studies, OLUMIANT may cause fetal harm during pregnancy. Available data from clinical trials and postmarketing case reports with OLUMIANT exposure in pregnancy are insufficient to inform a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are no human data on chronic baricitinib exposure throughout pregnancy. There are risks to the mother and the fetus associated with rheumatoid arthritis in pregnancy (see Clinical Considerations) .
What are the important warnings for Baricitinib?▼
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning. Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). 5 WARNINGS AND PRECAUTIONS Hypersensitivity : Serious reactions have been reported. Discontinue OLUMIANT if a serious hypersensitivity reaction occurs. ( 5.6 ) Gastrointestinal Perforations : Monitor patients who may be at increased risk and evaluate promptly new onset of abdominal symptoms. ( 5.7 ) Laboratory Abnormalities : Monitor for changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids. ( 5.8 ) Vaccinations : Avoid use with live vaccines. ( 5.9 ) 5.1 Serious Infections Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients with rheumatoid arthritis receiving OLUMIANT. 4 CONTRAINDICATIONS None. None.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.