Rinvoq

Rinvoq

upadacitinib

Manufacturer:

AbbVie

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Upadacitinib
Indications/Uses
Moderate to severe active RA & 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. Adults w/ active non-radiographic axial spondyloarthritis w/ objective signs of inflammation as indicated by elevated C-reactive protein &/or MRI who have responded inadequately to NSAIDs. 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. Adults w/ moderately to severely active ulcerative colitis who have had inadequate or lost response or were intolerant to either conventional therapy or biologic agent.
Dosage/Direction for Use
RA, psoriatic arthritis, non-radiographic axial spondyloarthritis & ankylosing spondylitis Adult 15 mg once daily. Atopic dermatitis Concomitant topical therapies: May be used w/ or w/o topical corticosteroids; topical calcineurin inhibitors for sensitive areas (eg, face, neck, intertriginous & genital areas). Consider discontinuation if no evidence of therapeutic benefit 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 15 mg once daily, if clinically warranted & based on benefit-risk assessment. Adolescent 12-17 yr (weighing ≥30 kg) & elderly ≥65 yr 15 mg once daily. Ulcerative colitis Induction: 45 mg once daily for 8 wk. May continue for additional 8 wk in patients w/ inadequate therapeutic benefit by wk 8. Discontinue use if no evidence of therapeutic benefit by wk 16. Maintenance: 15 or 30 mg once daily based on individual patient presentation. Consider 30 mg once daily for patients w/ high disease burden (eg, severe disease, pancolitis) or requiring 16-wk induction treatment; w/ inadequate therapeutic benefit to 15 mg once daily. Use the lowest effective dose for maintenance. May reduce or discontinue corticosteroids in patients who responded to treatment w/ upadacitinib. Patient receiving strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin) Recommended induction dose: 30 mg once daily. Recommended maintenance dose: 15 mg once daily. Elderly ≥65 yr Recommended maintenance dose: 15 mg once daily.
Administration
May be taken with or without food: Swallow whole, do not split/crush/chew.
Contraindications
Hypersensitivity. Active TB or 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. Not to be initiated in patients w/ active, serious infection, including localised infections. Consider the risks & benefits prior to initiating treatment in patients w/ chronic or recurrent infection, who have been exposed to TB, w/ serious or opportunistic infection history, who have resided or travelled in areas of endemic TB or mycoses or w/ underlying conditions that may predispose them to infection. Higher rate of serious infections was observed w/ upadacitinib 30 mg compared to 15 mg. Closely monitor for the development of signs & symptoms of infection during & after treatment. Interrupt therapy if patient develops serious or opportunistic infection. 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 & monitor for reactivation before starting & during therapy. Not recommended to use live, attenuated vaccines during or immediately prior to therapy. Recommended that patients be brought up to date w/ all immunisations including prophylactic zoster vaccinations prior to & during treatment. Consider the benefits & risks prior to initiating or continuing therapy particularly in patients w/ known malignancy (other than successfully treated NMSC), those who develop malignancy when on treatment & those who are current or past smokers. Possible NMSC; periodic skin exam is recommended for patients at increased risk for skin cancer. Consider benefits & risks for individual patient prior to initiating or continuing therapy particularly in those who are current or past smokers & w/ other CV risk factors. Inform patients about symptoms of serious CV events & steps to take if they occur. 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. 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 at high risk of DVT/pulmonary embolism (PE). Discontinue use & promptly evaluate, followed by appropriate treatment if symptoms of thrombosis occur. Patients who may be at risk for GI perforation (eg, patients w/ diverticular disease, history of diverticulitis or who are taking NSAIDs, corticosteroids or opioids). Patients w/ new onset abdominal signs & symptoms should be evaluated promptly for early identification of GI perforation. 15 mg once daily should be used w/ caution in patients receiving chronic treatment w/ strong CYP3A4 inhibitors. 30 mg once daily dose is not recommended for patients w/ atopic dermatitis receiving chronic treatment w/ strong CYP3A4 inhibitors. Avoid food or drinks containing grapefruit during treatment. Monitor for changes in disease activity during co-administration w/ strong CYP3A4 inducers. Severe renal impairment [RA, psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, atopic dermatitis & ulcerative colitis (maintenance): may administer 15 mg once daily w/ caution; ulcerative colitis (induction): may administer 30 mg once daily w/ caution]. Advise women of childbearing potential to use effective contraception during treatment & for 4 wk following the final upadacitinib dose. Female paed patients who experience menarche during treatment should inform the treating physician. Not to be used during breast-feeding. No safety & efficacy data in childn <12 yr w/ atopic dermatitis; <18 yr w/ RA, psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis & ulcerative colitis. Elderly ≥75 yr; >15 mg once daily is not recommended in elderly ≥65 yr w/ atopic dermatitis & for ulcerative colitis maintenance therapy.
Adverse Reactions
RA, psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis & ulcerative colitis: URTI, nausea, increased creatine phosphokinase (CPK), cough; serious infections. Atopic dermatitis: URTI, acne, herpes simplex, increased CPK, headache; serious infections.
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.
Presentation/Packing
Form
Rinvoq XR tab 15 mg
Packing/Price
1 × 28's
Form
Rinvoq XR tab 30 mg
Packing/Price
1 × 28's
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