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XELJANZ / XELJANZ XR (tofacitinib)
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XELJANZ / XELJANZ XR Quick Finder
Highlights
Boxed Warning
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS...
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Indications and Usage
1 INDICATIONS AND USAGE
1.1 Rheumatoid Arthritis
XELJANZ/XELJANZ XR is indicated for the treatment of adult...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
- XELJANZ XR (tofacitinib extended-release tablets) is not interchangeable or substitutable...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
XELJANZ Tablets:
- 5 mg tofacitinib: White, round, immediate-release film-coated tablets, debossed with "Pfizer" on one...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Serious Infections
Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Serious Infections [see Warnings and Precautions (5.1)...
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Drug Interactions
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.
...
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Use in Specific Populations
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).
...
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Overdosage
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....
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Description
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...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Tofacitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 39-week toxicology study in monkeys, tofacitinib at exposure levels...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Rheumatoid Arthritis
The XELJANZ clinical development program included six confirmatory trials. Although other doses have been studied, the...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
How supplied information for XELJANZ/XELJANZ XR is shown in Table 22.
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Medication Guide
| This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: December 2021 | ||||
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Instructions For Use
INSTRUCTIONS FOR USE
XELJANZ® (ZEL' JANS')
(tofacitinib)
Oral Solution
Read this Instructions for Use before you...
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