HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ILUMYA safely and effectively. See full prescribing information for
ILUMYA.
ILUMYA™(tildrakizumab-asmn)injection, for subcutaneous use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
ILUMYA is an interleukin-23 antagonist indicated for the treatment ofadults with moderate-to-severe plaque psoriasis who are candidatesfor systemic therapy or phototherapy. (1)
DOSAGE AND ADMINISTRATION
Administer by subcutaneous injection. (2.1)
Recommended dose is 100 mg at Weeks 0, 4, and every twelveweeks thereafter. (2.1)
DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/mL solution in a single-dose prefilled syringe. (3)
CONTRAINDICATIONS
Serious hypersensitivity reaction to tildrakizumab or to any of theexcipients. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity: If a serious allergic reaction occurs, discontinueILUMYA immediately and initiate appropriate therapy. (5.1)
Infections: ILUMYA may increase the risk of infection. Instructpatients to seek medical advice if signs or symptoms of clinicallyimportant chronic or acute infection occur. If a serious infectiondevelops, consider discontinuing ILUMYA until the infectionresolves. (5.2)
Tuberculosis (TB): eva luate for TB prior to initiating treatment.(5.3)
ADVERSE REACTIONS
Most common (≥1%) adverse reactions associated with ILUMYAtreatment are upper respiratory infections, injection site reactions, anddiarrhea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact MerckSharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Live Vaccines: Avoid use of live vaccines in patients treated withILUMYA. (7.1)
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
2.2 Tuberculosis Assessment Prior to Initiation of ILUMYA
2.3 Important Administration Instructions
2.4 Preparation and Administration of ILUMYA
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
5.2 Infections
5.3 Pretreatment eva luation for Tuberculosis
5.4 Immunizations
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
7 DRUG INTERACTIONS
7.1 Live Vaccinations
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
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information
are not listed.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
ILUMYA™ is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who arecandidates for systemic therapy or phototherapy.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
ILUMYA is administered by subcutaneous injection. The recommended do |
