1. Rheumatoid Arthritis: 2. Psoriatic Arthritis 3. Ankylosing Spondylitis 4. Ulcerative Colitis 5. Polyarticular Course Juvenile Idiopathic Arthritis

Disease-Modifying Antirheumatic Agents

1. Absorption: Oral: IR tablet: Rapid (74%); Cmax is reduced by 32% when administered with high-fat meal, but AUC remains unchanged. Extended release: When administered with high-fat meal, Cmax,following an 11 mg and 22 mg dose, increased by 27% and 19%, respectively, and Tmax was extended by ~1 hour, but AUC remains unchanged. 2. Distribution: Vd: 87 L. 3. Bioavailability: The AUC and Cmax of 11 mg extended release once daily are equivalent to 5 mg IR tablet administered twice daily. 4. Protein binding: ~40% (predominantly to albumin). 5. Metabolism: Hepatic (70%): CYP3A4 and CYP2C19 to inactive metabolites. 6. Half-life elimination: ~3 hours (IR solution, tablet); ~6 to 8 hours (extended release). 7. Time to peak: 0.5 to 1 hour (IR solution, tablet); 4 hours (extended release). 8. Excretion: Primarily urine (30%) as unchanged drug.

There are no contraindications listed in the manufacturer's US labeling.

Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

Advise women not to breastfeed during treatment with Xeljanz

Bone marrow suppression, acute myocardial infarction, GI perforation, Increased liver enzymes, Infection

XELJANZ XR 11 mg once daily.

The safety and efficacy of XELJANZ XR for pediatric patients have not been established.

CLcr >50 and ?80 mL/minute: same as patients with normal renal function. CLcr ?50 mL/minute: XELJANZ tablets 5 mg once daily For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended after dialysis.

Child-Pugh A : 11 mg once daily Child-Pugh B : XELJANZ tablets 5 mg once daily Child-Pugh C: Use of XELJANZ XR is not recommended.

Store at 20°C to 25°C, do not repackage.