Olumiant

Baricitinib

Moderate to severe active RA in adult patients who have responded inadequately to, or who are intolerant to ≥1 DMARDs as monotherapy or in combination w/ MTX. Moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. Severe alopecia areata in adult patients.

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

May be taken with or without food.

Hypersensitivity. Pregnancy.

Discontinue immediately if serious allergic or anaphylactic reaction occurs. Active, chronic or recurrent infections. Do not give to patients w/ active TB; consider anti-TB therapy prior to initiation of treatment in patients w/ previously untreated latent TB. Do not initiate or temporarily interrupt treatment in patients w/ ANC <1 x 10⁹ cells/L, ALC <0.5 x 10⁹ cells/L or Hb <8 g/dL. Viral reactivation, including herpes virus reactivation (eg, herpes zoster, herpes simplex). Temporarily interrupt treatment if increases in ALT or AST are observed & drug-induced liver injury is suspected. Increased risk of malignancies including lymphoma in patients w/ RA; lymphocytosis in elderly. Discontinue & evaluate promptly if DVT/pulmonary embolism occurs. Patients w/ diverticular disease & those chronically treated w/ concomitant medicinal products associated w/ increased risk of diverticulitis (NSAIDS, corticosteroids, & opioids); evaluate promptly for early identification of diverticulitis or GI perforation in patients presenting w/ new onset abdominal signs & symptoms. Perform screening for viral hepatitis before starting therapy. Assess lipid parameters approx 12 wk following initiation of therapy. Use w/ live, attenuated vaccines during, or prior to therapy is not recommended. Not recommended in combination w/ biological DMARDs, biological immunomodulators, or other Janus kinase inhibitors; ciclosporin or other potent immunosuppressants in atopic dermatitis & alopecia areata. Concomitant use w/ potent immunosuppressive medicinal products (eg, azathioprine, tacrolimus, ciclosporin). Not recommended in patients w/ renal impairment (CrCl <30 mL/min) & severe hepatic impairment. Use effective contraception during & for at least 1 wk after treatment in women of childbearing potential. Not to be used during lactation. Childn & adolescents 0-18 yr.

Upper resp tract infections; hypercholesterolemia. Herpes zoster, herpes simplex, gastroenteritis, UTI, pneumonia, folliculitis; thrombocytosis >600 x 10⁹ cells/L; headache; nausea, abdominal pain; increased ALT ≥3 x ULN; rash, acne; increased creatinine phosphokinase >5 x ULN.

Risk of additive immunosuppression w/ potent immunosuppressive medicinal products eg, azathioprine, tacrolimus, or ciclosporin. Increased AUC_(0-∞) w/ strong OAT3 inhibitor eg, probenecid. Increased exposure w/ leflunomide, teriflunomide, ibuprofen, & diclofenac.

Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

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

Rx