The Glory Medicina
Concise Prescribing Info
As monotherapy or in combination w/ methotrexate for the treatment of moderate to severe active RA in adults w/ inadequate response to, or w/ intolerance 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
Risk of serious infections; viral reactivation, including herpes virus reactivation. Not recommended to use live, attenuated vaccines during or immediately prior to therapy. Bring patients up to date w/ all immunisations, including prophylactic zoster vaccinations, prior to treatment initiation. Increased risk of malignancies, including lymphoma. Periodic skin examination is recommended for patients at increased risk for skin cancer (eg, non-melanoma skin cancer). Do not initiate or temporarily interrupt treatment in patients w/ absolute neutrophil count <1 x 109 cells/L, absolute lymphocyte count <0.5 x 109 cells/L or Hb <8 g/dL. Increased risk for CV disorders. Increased lipid parameters, including total, LDL & HDL cholesterol. Increased incidence of liver enzyme elevation. Patients at high risk for DVT/pulmonary embolism. Not recommended to combine w/ other potent immunosuppressants (eg, azathioprine, ciclosporin, tacrolimus, & biologic DMARDs or other Janus kinase inhibitors). Patients w/ severe renal impairment; end stage renal disease. Women of childbearing potential should use effective contraception during treatment & for 4 wk following final dose. Should not be used during breast-feeding. Elderly ≥75 yr. Childn & adolescent <18 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). Risk of additive immunosuppression w/ other potent immunosuppressants eg, azathioprine, ciclosporin, tacrolimus & biologic DMARDs or other Janus kinase inhibitors.
ATC Classification
L04AA44 - upadacitinib ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Rinvoq PR tab 15 mg
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