nd moderate hepatic impairment is XELJANZ 5 mg once daily. (2.5, 8.7, 8.8)
Use of XELJANZ/ XELJANZ XR in patients with severe hepatic impairment is not recommended. (2.5, 8.7)
DOSAGE FORMS AND STRENGTHS
XELJANZ Tablets: 5 mg (3)
XELJANZ XR Tablets: 11 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Avoid use of XELJANZ/XELJANZ XR during an active serious infection, including localized infections. (5.1)
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: Avoid use with XELJANZ/XELJANZ XR. (5.5)
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):
Recommended dose is XELJANZ 5 mg once daily. (2.4, 7.1)
One or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole):
Recommended dose is XELJANZ 5 mg once daily. (2.4, 7.2)
Potent CYP inducers (e.g., rifampin): May result in loss of or reduced clinical response. (2.4, 7.3)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 12/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: SERIOUS INFECTIONS AND MALIGNANCY
1 INDICATIONS AND USAGE
1.1 Rheumatoid Arthritis
1.2 Psoriatic Arthritis
2 DOSAGE AND ADMINISTRATION
2.1 Dosage in Rheumatoid Arthritis
2.2 Dosage in Psoriatic Arthritis
2.3 Dosage Modifications due to Serious Infections and Cytopenias
2.4 Dosage Modifications due to Drug Interactions
2.5 Dosage Modifications in Patients with Renal or Hepatic Impairment
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Serious Infections
5.2 Malignancy and Lymphoproliferative Disorders
5.3 Gastrointestinal Perforations
5.4 Laboratory Abnormalities
5.5 Vaccinations
5.6 General
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
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Use in Diabetics
8.7 Hepatic Impairment
8.8 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Rheumatoid Arthritis
14.2 Psoriatic Arthritis
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
1.1 Rheumatoid Arthritis
XELJANZ/XELJANZ X |
