Rinvoq (Upadacitinib) 15mg ER Tablet

– Take orally with or without food

– Swallow tablet whole; do not split, crush, or chew

– Store at 2-25ºC (36-77ºF)

– Store in original bottle to protect from moisture

– Evaluate neutrophil counts at baseline and thereafter according to routine patient management.

– Avoid initiation of or interrupt treatment in patients with a low neutrophil count (ANC less than 1000 cells/mm3

– Evaluate lymphocyte counts at baseline and thereafter according to routine patient management.

– Avoid initiation of or interrupt treatment in patients with a low lymphocyte count (less than 500 cells/mm3)

– Decreases in hemoglobin levels to less than 8 g/dL were reported in clinical studies.

– Evaluate hemoglobin at baseline and thereafter according to routine patient management.

– Avoid initiation of or interrupt treatment in patients with a low hemoglobin level (less than 8 g/dL)

– Treatment was associated with increases in lipid parameters, including total

cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol.

– Elevations in LDL cholesterol decreased to pretreatment levels in response to statin therapy

– The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.

– Patients should be monitored 12 weeks after initiation of treatment, and thereafter according to the clinical guidelines for hyperlipidemia

– Manage patients according to clinical guidelines for the management of hyperlipidemia.

– Treatment was associated with increased incidence of liver enzyme elevation

compared to placebo.

– Evaluate at baseline and thereafter according to routine patient management.

– Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury.

– If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.

– Based on findings in animal studies, it may cause fetal harm when administered to a pregnant woman.

– Administration of upadacitinib to rats and rabbits during organogenesis caused

increases in fetal malformations

– Advise women of reproductive potential of the potential risk to

a fetus and to use effective contraception during treatment with RINVOQ and for 4 weeks following completion of therapy

– Use of live, attenuated vaccines during, or immediately prior to, therapy is not recommended

– Prior to initiating of therapy, it is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, in agreement with current immunization guidelines