(tofacitinib)

Prescribing Information
Download Prescribing Information

Health Professional Information

How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

How supplied information for XELJANZ/XELJANZ XR is shown in Table 22.

Table 22: How Supplied Information for XELJANZ/XELJANZ XR
Bottle Size
(number of tablets)
NDC Number

XELJANZ
5 mg tofacitinib tablets
White, round, immediate-release film-coated tablets, debossed with "Pfizer" on one side, and "JKI 5" on the other side

60

NDC 0069-1001-01

XELJANZ
10 mg tofacitinib tablets
Blue, round, immediate-release film-coated tablets, debossed with "Pfizer" on one side, and "JKI 10" on the other side

60

NDC 0069-1002-01

XELJANZ XR
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

30

NDC 0069-0501-30

XELJANZ XR
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

30

NDC 0069-0502-30

How supplied information for XELJANZ Oral Solution is shown in Table 23.

Table 23: How Supplied Information for XELJANZ Oral Solution
Bottle Fill
(volume mL)
NDC Number

XELJANZ Oral Solution
1 mg/mL tofacitinib oral solution
Clear, colorless solution

240 mL

NDC 0069-1029-02

XELJANZ/XELJANZ XR

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.

Medication Guide
Download Consumer Medicine Information

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Additional Resources

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.

Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.

Available 9AM-5PM ET Monday to Friday; excluding holidays.

 

Submit a medical question for a Pfizer medicine or a vaccine. 

The submission will be reviewed during our standard business hours.

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information: 
Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.