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XELJANZ / XELJANZ XR (tofacitinib)
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XELJANZ / XELJANZ XR Quick Finder
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS...
1 INDICATIONS AND USAGE
1.1 Rheumatoid Arthritis
XELJANZ/XELJANZ XR is indicated for the treatment of adult...
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
- XELJANZ XR (tofacitinib extended-release tablets) is not interchangeable or substitutable...
3 DOSAGE FORMS AND STRENGTHS
XELJANZ Tablets:
- 5 mg tofacitinib: White, round, immediate-release film-coated tablets, debossed with "Pfizer" on one...
5 WARNINGS AND PRECAUTIONS
5.1 Serious Infections
Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other...
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Serious Infections [see Warnings and Precautions (5.1)...
7 DRUG INTERACTIONS
Table 6 includes drugs with clinically important drug interactions when administered concomitantly with XELJANZ/XELJANZ XR/XELJANZ Oral Solution and instructions for preventing or managing them.
...8 USE IN SPECIFIC POPULATIONS
All information provided in this section is applicable to XELJANZ/XELJANZ XR/XELJANZ Oral Solution as they contain the same active ingredient (tofacitinib).
...10 OVERDOSAGE
There is no specific antidote for overdose with XELJANZ/XELJANZ XR/XELJANZ Oral Solution. In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions....
11 DESCRIPTION
XELJANZ/XELJANZ XR (tofacitinib) tablets and XELJANZ (tofacitinib) Oral Solution are formulated with the citrate salt of tofacitinib, a JAK inhibitor.
Tofacitinib citrate is a white to off-white powder...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Tofacitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 39-week toxicology study in monkeys, tofacitinib at exposure levels...
14 CLINICAL STUDIES
14.1 Rheumatoid Arthritis
The XELJANZ clinical development program included six confirmatory trials. Although other doses have been studied, the...
16 HOW SUPPLIED/STORAGE AND HANDLING
How supplied information for XELJANZ/XELJANZ XR is shown in Table 22.
This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: December 2021 | ||||
INSTRUCTIONS FOR USE
XELJANZ® (ZEL' JANS')
(tofacitinib)
Oral Solution
Read this Instructions for Use before you...
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