– Do not administer XELJANZ during an active infection, including localized infections. If a serious infection develops, interrupt XELJANZ until the infection is controlled. (5.1)
•Lymphomas and other malignancies have been reported in patients treated with XELJANZ. (5.2)
•Gastrointestinal Perforations – Use with caution in patients that may be at increased risk. (5.3)
•Laboratory monitoring –Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids. (5.4)
•Immunizations –Live vaccines should not be given concurrently with XELJANZ. (5. 5)
•Severe hepatic impairment–Not recommended (5.6)
ADVERSE REACTIONS
The most commonly reported adverse reactions during the first 3 months in controlled clinical trials (occurring in greater than or equal to 2% of patients treated with XELJANZ monotherapy or in combination with DMARDs) were upper respiratory tract infections, headache, diarrhea and nasopharyngitis. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
•Potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., ketoconazole): Reduce dose to 5 mg once daily. (2.1)
•One or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole): Reduce dose to 5 mg once daily. (2.1)
•Potent CYP inducers (e.g., rifampin): May result in loss of or reduced clinical response. (2.2)
USE IN SPECIFIC POPULATIONS
Moderate and severe renal impairment and moderate hepatic impairment: Reduce dose to 5 mg once daily. (8.6, 8.7)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide
Revised: 11/2012
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
WARNING: SERIOUS INFECTIONS AND MALIGNANCY
1 INDICATIONS AND USAGE
1.1 Rheumatoid Arthritis
2 DOSAGE AND ADMINISTRATION
2.1 Rheumatoid Arthritis
2.2 General Considerations for Administration
2.3 Dosage Modifications
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Serious Infections
5.2 Malignancy and Lymphoproliferative Disorder
5.3 Gastrointestinal Perforations
5.4 Laboratory Parameters
5.5 Vaccinations
5.6 Hepatic Impairment
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
7 DRUG INTERACTIONS
7.1 Potent CYP3A4 Inhibitors
7.2 Moderate CYP3A4 and Potent CYP2C19 Inhibitors
7.3 Potent CYP3A4 Inducers
7.4 Immunosuppressive Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
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