Zuellig Pharma
Concise Prescribing Info
Monotherapy or in combination w/ methotrexate for moderate to severe active RA in adult patients who have responded inadequately to or are intolerant to ≥1 disease-modifying anti-rheumatic drugs (DMARDs).
Dosage/Direction for Use
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
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 transaminases elevation; high risk for DVT & pulmonary embolism. 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 (JAK) inhibitors. Not recommended in concomitant use w/ live, attenuated vaccines. Not to be used in severe hepatic impairment (Child-Pugh C). Severe renal impairment, end-stage renal disease. 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. Elderly ≥75 yr.
Adverse Reactions
Upper resp tract infections. Neutropaenia; hypercholesterolaemia; cough; nausea; pyrexia; increased blood CPK, ALT, AST, wt.
Drug Interactions
Increased exposure w/ strong CYP3A4 inhibitors eg, ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin. Decreased exposure w/ strong CYP3A4 inducers eg, rifampin, phenytoin. Decreased midazolam plasma exposure. Decreased rosuvastatin & atorvastatin AUC.
ATC Classification
L04AA44 - upadacitinib ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Rinvoq XR-FC tab 15 mg
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