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Olumiant

Olumiant

baricitinib

Manufacturer:

Eli Lilly

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Baricitinib
Indications/Uses
Monotherapy or in combination w/ methotrexate for moderate to severe active RA in adult patients w/ inadequate response or intolerance to ≥1 disease modifying antirheumatic drugs (DMARDs). Moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.
Dosage/Direction for Use
4 mg once daily, may be tapered to 2 mg once daily if sustained control of disease activity is achieved. Patient w/ history of chronic or recurrent infection, patient taking OAT3 inhibitors, w/ CrCl between 30 & 60 mL/min 2 mg once daily. Elderly ≥75 yr Initially 2 mg once daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue use if serious allergic or anaphylactic reactions occur. Not to be initiated in patients w/ ANC <1 x 109 cells/L, ALC <0.5 x 109 cells/L or Hb <8 g/dL. Not to be given in patients w/ active TB. Increased risk of malignancies including lymphoma. Active, chronic or recurrent infections; previously untreated latent TB; viral reactivation; DVT/pulmonary embolism, patients undergoing surgery & immobilisation. Assess lipid parameters approx 12 wk following initiation of therapy & thereafter. Not recommended w/ live, attenuated vaccines during or prior to treatment; biologic DMARDs, immunomodulators or other Janus kinase inhibitors; potent immunosuppressives eg, azathioprine, tacrolimus, ciclosporin. Increased ALT or AST during treatment; drug-induced hepatic injury. Not recommended in severe hepatic & renal impairment. May decrease female fertility. Women of childbearing potential should use effective contraception during & at least 1 wk after last dose. Not to be used during lactation. Childn & adolescents 0-18 yr. Increased risk of lymphocytosis in elderly w/ RA.
Adverse Reactions
Upper resp tract infection; hypercholesterolaemia. Herpes zoster & simplex, gastroenteritis, UTI, pneumonia; thrombocytosis; headache; nausea, abdominal pain; increased ALT; rash, acne; increased creatine phosphokinase.
Drug Interactions
Risk of additive immunosuppression w/ azathioprine, tacrolimus or ciclosporin. Increased AUC w/ probenecid. Increased exposure w/ leflunomide, teriflunomide, ibuprofen, diclofenac.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
ATC Classification
L04AA37 - baricitinib ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Olumiant FC tab 2 mg
Packing/Price
28's;7's
Form
Olumiant FC tab 4 mg
Packing/Price
28's
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