Olumiant

Olumiant

baricitinib

Manufacturer:

Eli Lilly

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Baricitinib
Indications/Uses
As monotherapy or in combination w/ methotrexate in moderate to severe active RA in adults who have responded inadequately to, or who are intolerant to ≥1 DMARDs.
Dosage/Direction for Use
Initially 4 mg once daily. Patients aged ≥75 yr, w/ history of chronic or recurrent infections, those who have achieved sustained control of disease activity w/ 4 mg once daily & are eligible for dose tapering, renal impairment (CrCl 30-60 mL/min), &/or taking organic anion transporter 3 (OAT3) inhibitors 2 mg once daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Carefully consider patients w/ active, chronic or recurrent infections prior to initiating therapy. Temporarily interrupt treatment & monitor patients if an infection, herpes zoster, DVT or pulmonary embolism (PE) develops. Screen patients for TB prior to starting therapy. Do not administer in patients w/ active TB. Consider anti-TB therapy prior to initiation of therapy in patients w/ previously untreated latent TB. Observe patients w/ absolute neutrophil count <1 x 109 cells/L, absolute lymphocyte count <0.5 x 109 cells/L & Hb <8 g/dL & temporarily interrupt treatment; risk of lymphocytosis may increase in elderly patients w/ RA. Perform screening for viral hepatitis in accordance w/ clinical guidelines prior to initiation of therapy. Monitor for HBV DNA expression in patients w/ hepatitis B surface Ab & hepatitis B core Ab w/o hepatitis B surface antigen. Concomitant use w/ live, attenuated vaccines during or immediately prior to therapy is not recommended. Assess lipid parameters approx 12 wk following initiation of therapy. Temporarily interrupt treatment until drug-induced liver injury is excluded & if alanine transaminase (ALT) or aspartate transaminase (AST) elevations occur. May increase risk of malignancies eg, lymphoma. Patients w/ risk factors for DVT/PE (eg, older age, obesity, medical history of DVT/PE & those undergoing surgery or immobilisation). Concomitant use w/ biologic DMARDs or other Janus kinase (JAK) inhibitors, & potent immunosuppressive drugs (eg, azathioprine, tacrolimus, ciclosporin). May decrease female fertility during treatment. Women of childbearing potential must use effective contraception during & for at least 1 wk after treatment. Lactation.
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.
Drug Interactions
Concomitant use w/ biologic DMARDs or other JAK inhibitors. Risk of additive immunosuppression w/ potent immunosuppressives eg, azathioprine, tacrolimus, or ciclosporin. Increased in AUC(0-∞) w/ probenecid. Increased baricitinib exposure w/ leflunomide.
ATC Classification
L04AA37 - baricitinib ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Olumiant FC tab 4 mg
Packing/Price
28's
Form
Olumiant FC tab 2 mg
Packing/Price
28's
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