e
Treatment effect on inhibition of radiographic progression in psoriatic arthritis could not be established from the results of Study PsA-I.
16 HOW SUPPLIED/STORAGE AND HANDLING
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, and available in:
XELJANZ
Bottles of 28: NDC 0069-1001-03
Bottles of 60: NDC 0069-1001-01
Bottles of 180: NDC 0069-1001-02
XELJANZ XR is provided as 11 mg tofacitinib (equivalent to 17.77 mg tofacitinib citrate) tablets: Pink, oval, extended release tablet with a drilled hole at one end of the tablet band and "JKI 11" printed on one side of the tablet:
XELJANZ XR
Bottles of 14: NDC 0069-0501-14
Bottles of 30: NDC 0069-0501-30
Storage and Handling
Store XELJANZ/XELJANZ XR at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].
XELJANZ/XELJANZ XR
Do not repackage.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Patient Counseling
Advise patients of the potential benefits and risks of XELJANZ/XELJANZ XR.
Serious Infection
Inform patients that XELJANZ/XELJANZ XR may lower the ability of their immune system to fight infections. Advise patients not to start taking XELJANZ/XELJANZ XR if they have an active infection. Instruct patients to contact their healthcare provider immediately during treatment if symptoms suggesting infection appear in order to ensure rapid eva luation and appropriate treatment [see WARNINGS AND PRECAUTIONS (5.1)].
Advise patients that the risk of herpes zoster, some cases of which can be serious, is increased in patients treated with XELJANZ [see WARNINGS AND PRECAUTIONS (5.1)].
Malignancies and Lymphoproliferative Disorders
Inform patients that XELJANZ/XELJANZ XR may increase their risk of certain cancers, and that lymphoma and other cancers have been observed in patients taking XELJANZ. Instruct patients to inform their healthcare provider if they have ever had any type of cancer [see WARNINGS AND PRECAUTIONS (5.2)].
Important Information on Laboratory Abnormalities
Inform patients that XELJANZ/XELJANZ XR may affect certain lab test results, and that blood tests are required before and during XELJANZ/XELJANZ XR treatment [see WARNINGS AND PRECAUTIONS (5.4)].
Pregnancy
Inform patients that XELJANZ/XELJANZ XR should not be used during pregnancy unless clearly necessary, and advise patients to inform their doctors right away if they become pregnant while taking XELJANZ/XELJANZ XR. Inform patients that Pfizer has a registry for pregnant women who have taken XELJANZ/XELJANZ XR during pregnancy. Advise patients to contact the registry at 1-877-311-8972 to enroll [see USE IN SPECIFIC POPULATIONS (8.1)]. Women of reproductive potential should be advised to use effective contraception during treatment with XELJANZ/XELJANZ XR and for at least 4 weeks after the last dose [see USE IN SPECIFIC POPULATIONS (8.3)]. Inform patients that they should not breastfeed while taking XELJANZ/XELJANZ XR [see USE IN SPECIFIC POPULATIONS (8.2)].
Residual Tablet Shell
Patients receiving XELJANZ XR may notice an inert tablet shell passing in the stool or via colostomy. Patients should be informed that the active medication has already been absorbed b |
