tests for these infections should be considered as dictated by clinical circumstances. (5.2)
Tuberculosis (TB): eva luate patients for TB prior to initiating treatment with STELARA®. Initiate treatment of latent TB before administering STELARA®. (5.3)
Malignancies: STELARA® may increase risk of malignancy. The safety of STELARA® in patients with a history of or a known malignancy has not been eva luated. (5.4)
Hypersensitivity Reactions: Anaphylaxis or other clinically significant hypersensitivity reactions may occur. (5.5)
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): One case was reported. If suspected, treat promptly and discontinue STELARA®. (5.6)
ADVERSE REACTIONS
Most common adverse reactions are:
Psoriasis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue. (6.1)
Crohn's Disease, induction (≥3%): vomiting. (6.1)
Crohn's Disease, maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 11/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Psoriasis (Ps)
1.2 Psoriatic Arthritis (PsA)
1.3 Crohn's Disease (CD)
2 DOSAGE AND ADMINISTRATION
2.1 Psoriasis
2.2 Psoriatic Arthritis
2.3 Crohn's Disease
2.4 General Considerations for Administration
2.5 Instructions for Administration of STELARA® Prefilled Syringes Equipped with Needle Safety Guard
2.6 Preparation and Administration of STELARA® 130 mg/26 mL (5 mg/mL) Vial for Intravenous Infusion (Crohn's Disease)
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Infections
5.2 Theoretical Risk for Vulnerability to Particular Infections
5.3 Pre-treatment eva luation for Tuberculosis
5.4 Malignancies
5.5 Hypersensitivity Reactions
5.6 Reversible Posterior Leukoencephalopathy Syndrome
5.7 Immunizations
5.8 Concomitant Therapies
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
6.3 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Live Vaccines
7.2 Concomitant Therapies
7.3 CYP450 Substrates
7.4 Allergen Immunotherapy
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
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
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Psoriasis
14.2 Psoriatic Arthritis
14.3 Crohn's Disease
15 REFERENCES
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 Psoriasis (Ps)
STELARA® is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic |
