atients with severe hepatic impairment is not recommended.
Table 1: Dose Adjustments for Lymphopenia
Low Lymphocyte Count [see WARNINGS AND PRECAUTIONS (5.4)]
Lab Value
(cells/mm3) Recommendation
Lymphocyte count greater than or equal to 500 Maintain dose
Lymphocyte count less than 500 Discontinue XELJANZ/XELJANZ XR
(Confirmed by repeat testing)
Table 2: Dose Adjustments for Neutropenia
Low ANC [see WARNINGS AND PRECAUTIONS (5.4)]
Lab Value
(cells/mm3) Recommendation
ANC greater than 1000 Maintain dose
ANC 500–1000 For persistent decreases in this range, interrupt dosing until ANC is greater than 1000
When ANC is greater than 1000, resume XELJANZ 5 mg twice daily/XELJANZ XR 11 mg once daily
ANC less than 500 Discontinue XELJANZ/XELJANZ XR
(Confirmed by repeat testing)
Table 3: Dose Adjustments for Anemia
Low Hemoglobin Value [see WARNINGS AND PRECAUTIONS (5.4)]
Lab Value
(g/dL) Recommendation
Less than or equal to 2 g/dL decrease and greater than or equal to 9.0 g/dL Maintain dose
Greater than 2 g/dL decrease or less than 8.0 g/dL Interrupt the administration of XELJANZ/XELJANZ XR until hemoglobin values have normalized
(Confirmed by repeat testing) CLOSE
3 DOSAGE FORMS AND STRENGTHS
XELJANZ is provided as 5 mg tofacitinib (equivalent to 8 mg tofacitinib citrate) tablets: White, round, immediate-release film-coated tablets, debossed with "Pfizer" on one side, and "JKI 5" on the other side.
XELJANZ XR is provided as 11 mg tofacitinib (equivalent to 17.77 mg tofacitinib citrate) tablets: Pink, oval, extended release film-coated tablets with a drilled hole at one end of the tablet band and "JKI 11" printed on one side of the tablet.
4 CONTRAINDICATIONS
None
5 WARNINGS AND PRECAUTIONS
5.1 Serious Infections
Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving XELJANZ. The most common serious infections reported with XELJANZ included pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis. Among opportunistic infections, tuberculosis and other mycobacterial infections, cryptococcosis, histoplasmosis, esophageal candidiasis, pneumocystosis, multidermatomal herpes zoster, cytomegalovirus infections, BK virus infection, and listeriosis were reported with XELJANZ. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunomodulating agents such as methotrexate or corticosteroids.
Other serious infections that were not reported in clinical studies may also occur (e.g., coccidioidomycosis).
Avoid use of XELJANZ/XELJANZ XR in patients with an active, serious infection, including localized infections. The risks and benefits of treatment should be considered prior to initiating XELJANZ/XELJANZ XR in patients:
with chronic or recurrent infection
who have been exposed to tuberculosis
with a history of a serious or an opportunistic infection
who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
with underlying conditions that may predispose them to infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with XELJANZ/ |
