eption during treatment with XELJANZ/XELJANZ XR and for at least 4 weeks after the last dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with XELJANZ/XELJANZ XR.
Infertility
Females
Based on findings in rats, treatment with XELJANZ/XELJANZ XR may result in reduced fertility in females of reproductive potential [see NONCLINICAL TOXICOLOGY (13.1)].
8.4 Pediatric Use
The safety and effectiveness of XELJANZ/XELJANZ XR in pediatric patients have not been established.
8.5 Geriatric Use
Of the 3315 patients who enrolled in rheumatoid arthritis Studies I to V, a total of 505 rheumatoid arthritis patients were 65 years of age and older, including 71 patients 75 years and older. The frequency of serious infection among XELJANZ-treated subjects 65 years of age and older was higher than among those under the age of 65.
As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.
8.6 Use in Diabetics
As there is a higher incidence of infection in diabetic population in general, caution should be used when treating patients with diabetes.
8.7 Hepatic Impairment
XELJANZ-treated patients with moderate hepatic impairment had greater tofacitinib levels than XELJANZ-treated patients with normal hepatic function [see CLINICAL PHARMACOLOGY (12.3)]. Higher blood levels may increase the risk of some adverse reactions, therefore, the recommended dose is XELJANZ 5 mg once daily in patients with moderate hepatic impairment [see DOSAGE AND ADMINISTRATION (2.5)]. XELJANZ/XELJANZ XR has not been studied in patients with severe hepatic impairment; therefore, use of XELJANZ/XELJANZ XR in patients with severe hepatic impairment is not recommended. No dose adjustment is required in patients with mild hepatic impairment. The safety and efficacy of XELJANZ/XELJANZ XR have not been studied in patients with positive hepatitis B virus or hepatitis C virus serology.
8.8 Renal Impairment
XELJANZ-treated patients with moderate and severe renal impairment had greater tofacitinib blood levels than XELJANZ-treated patients with normal renal function; therefore, the recommended dose is XELJANZ 5 mg once daily in patients with moderate and severe renal impairment [see DOSAGE AND ADMINISTRATION (2.5)]. In clinical trials, XELJANZ/XELJANZ XR was not eva luated in rheumatoid arthritis patients with baseline creatinine clearance values (estimated by the Cockroft-Gault equation) less than 40 mL/ min (or in patients with active psoriatic arthritis with creatinine clearance values less than 50 mL/min). No dose adjustment is required in patients with mild renal impairment.
10 OVERDOSAGE
Signs, Symptoms, and Laboratory Findings of Acute Overdosage in Humans
There is no experience with overdose of XELJANZ/XELJANZ XR.
Treatment or Management of Overdose
Pharmacokinetic data up to and including a single dose of 100 mg in healthy volunteers indicate that more than 95% of the administered dose is expected to be eliminated within 24 hours.
There is no specific antidote for overdose with XELJANZ/XELJANZ XR. In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate treatment.
11 DESCRIPTION
XELJANZ/XELJANZ XR are formulated with the citrate salt of tofacitinib, a JAK inhibitor.
Tofacitinib citrate |
