Olumiant Tablets / Film-coated
Baricitinib
4mg
ELI LILLY NEDERLAND B.V.
| Pack size | 28 Tablets |
|---|---|
| Dispensing mode | POM |
| Source | NETHERLANDS |
| Agent | PHARMATRADE |
| Retail Price | 4753.50 AED |
Available as:
Indications
Olumiant Tablets / Film-coated is used for:
Rheumatoid Arthritis
Adult Dose
Rheumatoid Arthritis
Indicated for adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies
May be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs)
2 mg PO qDay
COVID-19 (EUA)
Emergency use authorization (EUA) issued by the FDA for use, in combination with Remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized patients aged >2 years who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)
Adults: 4 mg PO qDay
Recommended treatment duration is 14 days or until hospital discharge, whichever comes first; optimal treatment duration unknown
Hepatic impairment
Rheumatoid arthritis
Mild or moderate: No dose adjustment required
Severe: Not recommended
COVID-19
Increased ALT/AST: Consider interruption until the diagnosis of drug-induced liver injury is excluded
Severe: Not studied; use only if benefits outweigh the risks
Child Dose
COVID-19 (EUA)
Emergency use authorization (EUA) issued by the FDA for use, in combination with Remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized patients aged >2 years who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)
2 to <9 years: 2 mg PO qDay
>9 years: 4 mg PO qDay
Recommended treatment duration is 14 days or until hospital discharge, whichever comes first; optimal treatment duration unknown
Renal Dose
Renal impairment
Rheumatoid arthritis
Moderate (eGFR 30-60 mL/min/1.73 m2): Decrease to 1 mg/day
Severe (eGFR <30 mL/min/1.73 m2): Not recommended (not studied)
COVID-19
eGFR ?60 mL/min/1.73 m2: No dose adjustment
eGFR 30 to <60 mL/min/1.73 m2: Decrease to 2 mg/day
eGFR 15 to <30 mL/min/1.73 m2: Decrease to 1 mg/day
eGFR <15 mL/min/1.73 m2, patients on dialysis, have end-stage renal disease, or have acute kidney injury: Not recommended
Administration
May take with or without food
Contra Indications
Precautions
Serious and sometimes fatal infections may develop owing to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens reported; may cause reactivation of latent TB or viral infections
Consider risks and benefits before initiating in patients with chronic or recurrent infection, history of serious or opportunistic infection, underlying conditions predisposing them to infection, or patients who have been exposed to tuberculosis or have resided or traveled in areas of endemic tuberculosis or mycoses
Consider TB therapy for patients with a negative test for latent TB but who have risk factors for TB infection; consultation with a physician with expertise in TB recommended to aid in decision about whether initiating anti-TB therapy is appropriate
If a new infection develops during treatment, promptly initiate diagnostic tests appropriate for an immunocompromised patient; if necessary, initiate appropriate antimicrobial therapy and closely monitor; interrupt baricitinib therapy if patient unresponsive to treatment
If herpes zoster occurs, interrupt treatment until episode resolves
Malignancies were observed in clinical studies; non-melanoma skin cancers (NMSCs) reported; periodic skin examination is recommended for patients who are at increased risk for skin cancer
Perform screening for viral hepatitis in accordance with clinical guidelines before starting therapy; unknown impact on chronic viral hepatitis reactivation
Increased incidence of thrombosis, including DVT and PE, observed compared with placebo; caution in patients at increased risk of thrombosis
Gastrointestinal perforation reported in clinical studies, although the role of JAK inhibition in these events is unknown
May increase incidence of neutropenia, lymphopenia, anemia, or elevated LFTs or lipids; monitor laboratory values at baseline and periodically during treatment
Pregnancy-Lactation
Pregnancy
Data in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage
Animal studies
In animal embryo-fetal development studies, oral baricitinib administration to pregnant rats and rabbits at exposures equal to and greater than ~20 and 84 times the maximum recommended human dose (MRHD), respectively, resulted in reduced fetal body weights, increased embryo lethality (rabbits only), and dose-related increases in skeletal malformations
Lactation
Unknown if distributed in human breast milk
Baricitinib is present in the milk of lactating rats
Owing to species-specific differences in lactation physiology, the clinical relevance of these data are not clear
Because of the potential for serious adverse reactions in nursing infants, advise women not to breastfeed while taking baricitinib
Interactions
Avoid use of live vaccines; update immunizations in agreement with current immunization guidelines before initiating
Coadministration with strong OAT3 inhibitors may increase baricitinib systemic exposure
Adverse Effects
Side effects of Baricitinib :
>10%
Upper respiratory tract infections (16.3%)
1-10%
Nausea (2.7%)
Increased LFTs (1-2%)
Platelet elevations (1-2%)
Herpes zoster infection (1%)
<1%
Acne (<1%)
Herpes simplex infection (0.8%)
Neutropenia (0.3%)
Mechanism of Action
Janus kinases (JAKs) pathways inhibitor; JAK consists of a group of intracellular tyrosine kinases that transmit signals from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoieses and immune cell function
Within the signaling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which modulate intracellular activity including gene expression; baricitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs
Note
Olumiant 4mg Tablets / Film-coated manufactured by ELI LILLY NEDERLAND B.V.. Its generic name is Baricitinib. Olumiant is availble in United Arab Emirates.
Farmaco UAE drug index information on Olumiant Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.