Zuellig Pharma
Concise Prescribing Info
Monotherapy or in combination w/ MTX for moderate to severe active RA & active psoriatic arthritis in adult patients who have responded inadequately to or are intolerant to ≥1 DMARDs. Active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. Moderate to severe atopic dermatitis in adults & adolescents ≥12 yr who are systemic therapy candidates.
Dosage/Direction for Use
RA, psoriatic arthritis & ankylosing spondylitis 15 mg once daily. Atopic dermatitis Adult 15-30 mg once daily. Adolescent 12-17 yr, at least 40 kg & elderly ≥65 yr 15 mg once daily.
May be taken with or without food: Swallow whole, do not split/crush/chew.
Hypersensitivity. Active TB or serious infections. Severe hepatic impairment. Pregnancy.
Special Precautions
Hypersensitivity reactions. Not to be initiated in patients w/ ANC <1 x 109 cells/L, ALC <0.5 x 109 cells/L or Hb levels <8 g/dL; active, serious infection including localised infections. Interrupt treatment if patient develops serious or opportunistic infection. Increased risk of malignancy; CV disorders, HTN, hyperlipidaemia; hepatic transaminase elevations; high risk for DVT & pulmonary embolism; GI perforations. Screen patients for TB, viral hepatitis & monitoring for reactivation prior to initiation. Perform periodic skin exam in patients at increased risk of skin cancer. Closely monitor for development of signs & symptoms of infection. Not recommended in combination w/ other potent immunosuppressants eg, azathioprine, ciclosporin, tacrolimus, biologic DMARDs or other Janus kinase inhibitors. Not recommended in concomitant use w/ live, attenuated vaccines. Not to be used in severe hepatic impairment (Child-Pugh C). Severe renal impairment, ESRD. Women of childbearing potential should use effective contraception during & 4 wk after last dose. Not to be used during pregnancy & lactation. Childn & adolescents 0-18 yr w/ RA, psoriatic arthritis & ankylosing spondylitis; childn & adolescents 0-12 yr w/ atopic dermatitis; adolescents <40 kg. Elderly ≥75 yr.
Adverse Reactions
URTI; acne. Bronchitis, herpes zoster & simplex, folliculitis, flu; anaemia, neutropaenia; hypercholesterolaemia; cough; abdominal pain, nausea; urticaria; fatigue, pyrexia; increased blood CPK, ALT, AST & wt; headache.
Drug Interactions
Increased exposure w/ strong CYP3A4 inhibitors eg, ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, grapefruit. Decreased exposure w/ strong CYP3A4 inducers eg, rifampin, phenytoin. Decreased AUC & Cmax of midazolam, rosuvastatin, atorvastatin.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants / Other Dermatologicals
ATC Classification
L04AF03 - upadacitinib ; Belongs to the class of Janus-associated kinase (JAK) inhibitors. Used as immunosuppressants.
Rinvoq XR-FC tab 15 mg
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in