Olumiant

Baricitinib

Monotherapy or in combination w/ MTX for 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.

Recommended dose: 4 mg once daily w/ or w/o topical corticosteroids. Patients ≥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, w/ renal impairment (CrCl 30-60 mL/min), &/or taking organic anion transporter 3 (OAT3) inhibitors 2 mg once daily. Elderly ≥75 yr Starting dose of 2 mg.

May be taken with or without food.

Hypersensitivity. Pregnancy.

Discontinue treatment if DVT or pulmonary embolism; any serious allergic or anaphylactic reaction occur. Temporarily interrupt treatment if patient is not responding to standard therapy for infection; in patients w/ ANC <1 x 10⁹ cells/L, absolute lymphocyte count <0.5 x 10⁹ cells/L or Hb <8 g/dL; if herpes zoster develops; increased ALT or AST & drug-induced liver injury is suspected. Not to be given in patients w/ active TB. Increased rate of infections (eg, URTI); risk of malignancies including lymphoma in patients w/ RA. Viral reactivation including herpes virus reactivation (eg, herpes zoster & herpes simplex). Dose dependent increases in blood lipid parameters; blood ALT & AST. Patients w/ active, chronic or recurrent infections; risk factors for DVT/pulmonary embolism eg, older age, obesity, history, or patients undergoing surgery & immobilization; diverticular disease & especially those chronically treated w/ concomitant medicinal products associated w/ increased risk of diverticulitis eg, NSAIDs, corticosteroids & opioids. Screen patients for TB; viral hepatitis before starting therapy. Update all immunisations prior initiating treatment. Consider anti-TB therapy prior initiation of treatment in patients w/ previously untreated latent TB. Evaluate patients presenting w/ new onset abdominal signs & symptoms for early identification of diverticulitis or GI perforation. Assess lipid parameters approx 12 wk following initiation of therapy & thereafter. Not recommended in combination w/ biological DMARDs & immunomodulators or other Janus kinase inhibitors (risk of additive immunosuppression); ciclosporin or other potent immunosuppressants; live attenuated vaccines during, or immediately prior to therapy. Concomitant use w/ MTX; potent immunosuppressive medicinal products eg, azathioprine, tacrolimus, ciclosporin. 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. Not to be used during lactation. Childn & adolescents 0-18 yr. Elderly ≥75 yr. Increased risk of lymphocytosis in elderly w/ RA.

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.

Increased AUC_(0-∞) w/ probenecid. Increased exposure w/ leflunomide or teriflunomide. RA: Risk of additive immunosuppression w/ potent immunosuppressive medicinal products eg, azathioprine, tacrolimus or ciclosporin. Atopic dermatitis & alopecia areata: Not recommended in combination w/ ciclosporin or other potent immunosuppressants.

Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants

L04AA37 - baricitinib ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.

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