Olumiant

Olumiant

baricitinib

Manufacturer:

Eli Lilly

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Baricitinib
Indications/Uses
Monotherapy or in combination w/ methotrexate for the treatment of moderate to severe active RA in adult patients who have responded inadequately to, or who are intolerant to ≥1 disease-modifying anti-rheumatic drugs (DMARDs).
Dosage/Direction for Use
4 mg once daily. Once sustained control of disease activity is achieved, dose may be tapered to 2 mg once daily. Elderly ≥75 yr 2 mg once daily. Patients w/ history of chronic or recurrent infections 2 mg once daily. Renal impairment w/ CrCl 30-60 mL/min 2 mg once daily. Co-administration w/ OAT3 inhibitors 2 mg once daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue immediately if any serious allergic or anaphylactic reaction occurs. Caution in patients w/ active, chronic or recurrent infections. Do not initiate treatment in patients w/ active TB. Treatment should not be initiated or should be temporarily interrupted in patients w/ haematological abnormalities (ANC <1 x 109 cells/L, ALC <0.5 x 109 cells/L or Hb <8 g/dL). Increased risk of lymphocytosis in elderly patients w/ RA. Reports of viral reactivation including cases of herpes zoster & herpes simplex reactivation; dose-dependent increases in blood lipid parameters; hepatic transaminase elevations; DVT & pulmonary embolism. Increased risk of malignancies, including lymphoma in patients w/ RA. Not recommended when used concomitantly w/ live, attenuated vaccines; biologic DMARDs or other Janus kinase (JAK) inhibitors. Not recommended in patients w/ CrCl <30 mL/min & severe hepatic impairment. Women of childbearing potential should use effective contraception during & for at least 1 wk after treatment. Should not be used during breast-feeding. Childn ≤18 yr.
Adverse Reactions
Upper resp tract infections; hypercholesterolaemia. Herpes zoster, herpes simplex, gastroenteritis, UTI, pneumonia; thrombocytosis >600 x 109 cells/L; nausea; increased ALT ≥3 x ULN; rash.
Drug Interactions
Risk of additive immunosuppression cannot be excluded w/ potent immunosuppressive medicinal products eg, azathioprine, tacrolimus, or ciclosporin. Increased AUC w/ strong OAT3 inhibitor eg, probenecid. Possible increase in exposure w/ leflunomide or teriflunomide.
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
Form
Olumiant FC tab 4 mg
Packing/Price
28's
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