Olumiant

Baricitinib

Monotherapy or in combination w/ MTX for the treatment of moderate to severe active RA in adults who have responded inadequately to, or who are intolerant to ≥1 DMARDs. Moderate to severe atopic dermatitis in adults who are candidates for systemic therapy. Severe alopecia areata in adults.

4 mg once daily, may be tapered to 2 mg once daily if sustained control of disease activity is achieved. Elderly ≥75 yr 2 mg once daily. Patient w/ renal impairment (CrCl 30-60 mL/min) 2 mg once daily. Patient w/ history of chronic or recurrent infections 2 mg once daily. Co-administration w/ OAT3 inhibitors 2 mg once daily.

May be taken with or without food.

Hypersensitivity. Pregnancy.

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; consider anti-TB therapy prior to treatment initiation in patients w/ previously untreated latent 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; diverticulitis & GI perforation. Increased risk of malignancies including lymphoma in patients w/ RA. Use w/ live attenuated vaccines during, or immediately prior to, Olumiant therapy is not recommended. Combination w/ biological DMARDs, biological immunomodulators, or other Janus kinase (JAK) inhibitors is not recommended. Combination w/ ciclosporin or other potent immunosuppressants is not recommended in atopic dermatitis & alopecia areata. Caution in RA patients when concomitantly used w/ potent immunosuppressives (eg, azathioprine, tacrolimus, ciclosporin). Not recommended in patients w/ renal impairment (CrCl <30 mL/min) & severe hepatic impairment. Women of childbearing potential have to use effective contraception during & for at least 1 wk after treatment. Should not be used during breast-feeding. Safety & efficacy in childn & adolescents 0-18 yr have not yet been established.

URTI; hypercholesterolaemia. Herpes zoster, herpes simplex, gastroenteritis, UTI, pneumonia, folliculitis; thrombocytosis >600 x 10⁹ cells/L; headache; nausea, abdominal pain; increased ALT ≥3x ULN; rash, acne; increased creatine phosphokinase >5x ULN.

Risk of additive immunosuppression w/ potent immunosuppressive medicinal products eg, azathioprine, tacrolimus, or ciclosporin. Increased AUC w/ strong OAT3 inhibitor eg, probenecid. Possible increased exposure w/ leflunomide or teriflunomide.

Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

L04AF02 - baricitinib ; Belongs to the class of Janus-associated kinase (JAK) inhibitors. Used as immunosuppressants.

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