Zuellig Pharma
Concise Prescribing Info
Moderate to severe active RA & active psoriatic arthritis in adults who have responded inadequately to or who are intolerant to ≥1 DMARDs; may be used as monotherapy or in combination w/ MTX. Active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Moderate to severe atopic dermatitis in adults & adolescents ≥12 yr who are candidates for systemic therapy, & inadequately controlled or medically inadvisable to be treated w/ topical medications.
Dosage/Direction for Use
RA, psoriatic arthritis & ankylosing spondylitis Adult 15 mg once daily. Atopic dermatitis Concomitant topical therapies: May be used w/ or w/o topical corticosteroids or topical calcineurin inhibitors for sensitive areas (eg, face, neck, & intertriginous & genital areas). Consider discontinuation if no evidence of therapeutic benefit is observed after 12 wk of treatment. Adult 15 mg once daily. Consider 30 mg once daily for patients w/ high disease burden or w/ inadequate response to previous dose. Adolescent 12-17 yr (≥30 kg) & elderly ≥65 yr 15 mg once daily. Severe renal impairment May administer 15 mg once daily w/ caution.
May be taken with or without food: Swallow whole, do not split/crush/chew.
Hypersensitivity. Active TB or active serious infections. Severe hepatic impairment. Pregnancy.
Special Precautions
Discontinue use & institute appropriate therapy if clinically significant hypersensitivity reaction (eg, anaphylaxis & angioedema) occurs. Not recommended to be used in combination w/ other potent immunosuppressants (eg, azathioprine, ciclosporin, tacrolimus & biologic DMARDs or other Janus kinase inhibitors) due to risk of additive immunosuppression. Potential serious & fatal infections. Should not be initiated in patients w/ active, serious infection, including localised infections. Patients w/ chronic or recurrent infection, who have been exposed to TB, w/ serious or opportunistic infection history, who have resided or traveled in areas of endemic TB or mycoses, w/ underlying conditions that may predispose them to infection. Interrupt therapy if patient develops a serious or opportunistic infection. Closely monitor for the development of signs & symptoms of infection during & after treatment. Screen patient for TB before starting therapy. Consider anti-TB therapy prior to initiation in patients w/ previously untreated latent TB or in patients w/ TB-infection risk factors. Monitor for the development of signs & symptoms of TB, including patients who tested -ve for latent TB infection prior to therapy. Potential herpes virus reactivation. Interrupt therapy if patient develops herpes zoster. Perform screening for viral hepatitis & monitoring for reactivation before starting & during therapy. Not recommended to use live, attenuated vaccines during or immediately prior to therapy. Increased risk of malignancies (including lymphoma) in patients w/ RA. Malignancy risk (including lymphoma) may be increased by immunomodulatory medicinals. Possible NMSC; periodic skin exam is recommended for patients at increased risk for skin cancer. Consider the risk & benefits prior to initiating therapy in patients w/ CV risk factors or when considering continuing treatment in patients who develop major adverse CV events. Not to be initiated or should be temporarily interrupted in patients w/ ANC <1 x 109 cells/L, ALC <0.5 x 109 cells/L or Hb <8 g/dL. RA patients have increased risk for CV disorders. Manage patient risk factors (eg, HTN, hyperlipidaemia) as part of usual standard of care. Increased lipid parameters, including total cholesterol, LDL-C & HDL-C. Increased incidence of liver enzyme elevation. Interrupt therapy if ALT or AST increased & drug-induced liver injury is suspected. Patients w/ high risk of DVT/pulmonary embolism (PE). Discontinue & evaluate promptly, followed by appropriate treatment if clinical features of DVT/PE occur. Patients who may be at increased risk for GI perforation (eg, patients w/ history of diverticulitis or taking NSAIDs). Patients w/ new-onset abdominal symptoms should be evaluated promptly for early identification of GI perforation. Patients receiving chronic treatment w/ strong CYP3A4 inhibitors. Monitor for changes in disease activity during co-administration w/ strong CYP3A4 inducers. Severe renal impairment (not recommended to use 30 mg once daily dose). Women of childbearing potential should use effective contraception during treatment & for 4 wk following the final upadacitinib dose. Lactation. Female ped patients who experience menarche during treatment. Childn <12 yr w/ atopic dermatitis; ≤18 yr w/ RA, psoriatic arthritis & ankylosing spondylitis. Elderly ≥65 yr.
Adverse Reactions
URTI. Neutropenia; cough; nausea; pyrexia; increased blood creatinine phosphokinase & wt. RA, psoriatic arthritis & ankylosing spondylitis: Hypercholesterolaemia; increased ALT & AST. Atopic dermatitis: Acne. Herpes simplex & zoster; folliculitis, flu; anaemia; abdominal pain; fatigue; urticaria; 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).
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants / Other Dermatologicals
ATC Classification
L04AA44 - upadacitinib ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Rinvoq XR tab 15 mg
1 × 28's
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