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XELJANZ / XELJANZ XR Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY AND THROMBOSIS

SERIOUS INFECTIONS

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1 INDICATIONS AND USAGE

Rheumatoid Arthritis

XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to...

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2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

  • XELJANZ XR (tofacitinib extended-...
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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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4 CONTRAINDICATIONS

None.

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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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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Serious Infections [see

    6.1 Clinical Trials Experience...

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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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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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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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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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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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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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14 CLINICAL STUDIES

14.1 Rheumatoid Arthritis

The XELJANZ clinical development program included two dose-ranging trials and five confirmatory trials. Although other...

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16 HOW SUPPLIED/STORAGE AND HANDLING

How supplied information for XELJANZ/XELJANZ XR is shown in Table 19.

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Table 19: How Supplied Information for XELJANZ/XELJANZ XR
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...
This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: September 2020
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INSTRUCTIONS FOR USE

XELJANZ® (ZEL' JANS')
(tofacitinib)
Oral Solution

Read this Instructions for Use before you...

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This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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