Olumiant

Monotherapy or in combination w/ MTX for moderate to severe active RA in adult patients who have responded inadequately to, or who are intolerant to, ≥1 DMARDs. Moderate to severe atopic dermatitis in adult & paed patients ≥2 yr who are candidates for systemic therapy. Severe alopecia areata in adults. Active juvenile idiopathic arthritis in patients ≥2 yr who have had inadequate response or intolerance to ≥1 prior conventional synthetic or biologic DMARDs: polyarticular juvenile idiopathic arthritis (polyarticular RF+ or -, extended oligoarticular), enthesitis-related arthritis, & juvenile psoriatic arthritis.

Recommended dose: 4 mg once daily. May taper dose to 2 mg once daily if control of disease activity is sustained. Patients at higher risk of VTE, major adverse CV events & malignancy; ≥65 yr; w/ history of chronic or recurrent infections; who have achieved sustained control of disease activity w/ 4 mg once daily; adult w/ CrCl 30-60 mL/min 2 mg once daily. Paed patients w/ CrCl 30-60 mL/min Reduce dose by ½. Atopic dermatitis All doses given w/ or w/o topical corticosteroids. Adult 4 mg once daily. Childn & adolescent ≥2 yr weighing ≥30 kg 4 mg once daily, 10 to <30 kg 2 mg once daily. Juvenile idiopathic arthritis Patients 2 to <18 yr weighing ≥30 kg 4 mg once daily, 10 to <30 kg 2 mg once daily.

May be taken with or without food: May disperse tab in water.

Hypersensitivity. Pregnancy.

Discontinue treatment in patients w/ suspected VTE regardless of dose or indication; if any serious allergic or anaphylactic reactions 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. Viral reactivation including herpes virus reactivation eg, herpes zoster & herpes simplex. Dose dependent increases in blood lipid parameters; blood ALT & AST. Patients w/ history of ASCVD or other CV risk factors eg, current or past long-time smoker; malignancy risk factors eg, current or history of malignancy; active, chronic or recurrent infections; diabetes; known risk factors for VTE eg, previous VTE, undergoing surgery & immobilization, use of hormonal contraceptives or HRT, inherited coagulation disorder; diverticular disease & especially those chronically treated w/ concomitant medicinal products associated w/ increased risk of diverticulitis eg, NSAIDs, corticosteroids & opioids. Perform screen for viral hepatitis; TB before starting therapy; skin exam particularly in patients w/ risk factors for skin cancer. Consider anti-TB therapy prior initiation of treatment in patients w/ previously untreated latent TB. Monitor for HBV DNA in patients w/ hepatitis B surface Ab & core Ab w/o hepatitis B antigen. Update all immunisations prior to initiating treatment. Assess lipid parameters approx 12 wk following initiation of therapy & thereafter. Evaluate patients presenting w/ new onset abdominal signs & symptoms for early identification of diverticulitis or GI perforation. Not recommended to use in combination w/ live attenuated vaccines during, or immediately prior to therapy; biological DMARDs & immunomodulators or other Janus kinase inhibitors (risk of additive immunosuppression); ciclosporin or other potent immunosuppressants. 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 breast-feeding. Childn <2 yr; <18 yr w/ alopecia areata. Elderly ≥65 yr; w/ diabetes. 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).

Additive immunosuppression w/ biological DMARDs & immunomodulators or other Janus kinase inhibitors. Increased AUC w/ probenecid (OAT3 inhibitor w/ strong inhibition potential). Increased exposure w/ leflunomide or teriflunomide (weak OAT3 inhibitors).

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

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

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