Xeljanz Dosage/Direction for Use

Important Administration Instructions: Do not initiate XELJANZ in patients with an absolute lymphocyte count less than 500 cells/mm³, an absolute neutrophil count (ANC) less than 1000 cells/mm³ or who have hemoglobin levels less than 9 g/dL.
Dose interruption is recommended for management of lymphopenia, neutropenia and anemia (see Precautions and Adverse Reactions).
Interrupt use of XELJANZ if a patient develops a serious infection until the infection is controlled (see Precautions).
Take XELJANZ with or without food (see Pharmacology: Pharmacokinetics under Actions).
Recommended Dosage in Rheumatoid Arthritis and Psoriatic Arthritis: Table 13 displays the recommended adult daily dosage of XELJANZ and dosage adjustments for patients receiving CYP2C19 and/or CYP3A4 inhibitors, in patients with moderate or severe renal impairment (including but not limited to those with severe insufficiency who are undergoing hemodialysis) or moderate hepatic impairment, with lymphopenia, neutropenia, or anemia. (See Table 13.)

Click on icon to see table/diagram/image

Recommended Dosage in Ulcerative Colitis: Table 14 displays the recommended adult daily dosage of XELJANZ and dosage adjustments for patients receiving CYP2C19 and/or CYP3A4 inhibitors, with moderate or severe renal impairment (including but not limited to those with severe insufficiency who are undergoing hemodialysis) or moderate hepatic impairment, with lymphopenia, neutropenia or anemia. (See Table 14.)

Click on icon to see table/diagram/image

Hepatic Impairment: Severe Impairment: XELJANZ has not been studied in patients with severe hepatic impairment; therefore, use of XELJANZ in patients with severe hepatic impairment is not recommended.
Moderate Impairment: XELJANZ-treated patients with moderate hepatic impairment had greater tofacitinib blood concentration than XELJANZ-treated patients with normal hepatic function (see Pharmacology: Pharmacokinetics under Actions). Higher blood concentrations may increase the risk of some adverse reactions. Therefore, dosage adjustment of XELJANZ is recommended in patients with moderate hepatic impairment (see previously mentioned).
Mild Impairment: No dosage adjustment of XELJANZ is required in patients with mild hepatic impairment.
Hepatitis B or C Serology: The safety and efficacy of XELJANZ have not been studied in patients with positive hepatitis B virus or hepatitis C virus serology.
Renal Impairment: Moderate and Severe Impairment: XELJANZ-treated patients with moderate or severe renal impairment had greater tofacitinib blood concentrations than XELJANZ-treated patients with normal renal function. Therefore, dosage adjustment of XELJANZ is recommended in patients with moderate or severe renal impairment (including but not limited to those with severe insufficiency who are undergoing hemodialysis).
Mild Impairment: No dosage adjustment is required in patients with mild renal impairment.
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 tofacitinib-treated subjects 65 years of age and older was higher than among those under the age of 65.
Of the 1156 XELJANZ treated patients in the UC program, a total of 77 patients (7%) were 65 years of age or older. The number of patients aged 65 years and older was not sufficient to determine whether they responded differently from younger patients.
As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly (see Precautions).
Pediatric Use: The safety and effectiveness of XELJANZ in pediatric patients have not been established.
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.