16 HOW SUPPLIED/STORAGE AND HANDLING
How supplied information for XELJANZ/XELJANZ XR is shown in Table 19.
(number of tablets)
5 mg tofacitinib tablets
White, round, immediate-release film-coated tablets, debossed with "Pfizer" on one side, and "JKI 5" on the other side
10 mg tofacitinib tablets
Blue, round, immediate-release film-coated tablets, debossed with "Pfizer" on one side, and "JKI 10" on the other side
11 mg tofacitinib 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
22 mg tofacitinib tablets
Beige, oval, extended-release film-coated tablets with a drilled hole at one end of the tablet band and "JKI 22" printed on one side of the tablet
How supplied information for XELJANZ Oral Solution is shown in Table 20.
|XELJANZ Oral Solution|
1 mg/mL tofacitinib oral solution
Clear, colorless solution
|240 mL||NDC 0069-1029-02|
Store XELJANZ/XELJANZ XR at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].
Do not repackage.
XELJANZ Oral Solution
XELJANZ 1 mg/ mL oral solution is a clear, colorless solution that contains 1 mg of tofacitinib. It is packaged in HDPE bottles as follows:
Each bottle is packaged with one press-in bottle adapter and one 5 mL oral dosing syringe with 3.2 mL, 4 mL, and 5 mL gradations. The press-in bottle adapter and oral dosing syringe are not made with natural rubber latex.
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). [See USP Controlled Room Temperature].
Store in the original bottle and carton to protect from light.
Use contents of bottle within 60 days of opening.
Discard remaining oral solution after 60 days.