Þ Tinea infections include tinea pedis, tinea cruris, tinea infection, and tinea manuum infections. # Gastroenteritis includes gastroenteritis and viral gastroenteritis. ¶ Injection site reactions include injection site erythema, bruising, hematoma, hemorrhage, swelling, edema, pruritus, pain, discoloration, induration, inflammation, and urticaria. § Headache includes headache and tension headache. licensed adalimumab ‡ Upper respiratory infections include nasopharyngitis, upper respiratory tract infection (URTI), pharyngitis, and viral URTI. * Subjects receiving 100 mg of TREMFYA at Week 0, Week 4, and every 8 weeks thereafter † U.S. Table 1: Adverse Reactions Occurring in ≥1% of Subjects through Week 16 in PsO1 and PsO2 If a patient develops a clinically important or serious infection or is not responding to standard therapy, monitor the patient closely and discontinue TREMFYA until the infection resolves. Instruct patients to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing TREMFYA. ![]() Treatment with TREMFYA should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. A similar risk of infection was seen in placebo-controlled trials in subjects with psoriatic arthritis. The rate of serious infections for the TREMFYA group and the placebo group was ≤ 0.2%. Upper respiratory tract infections, gastroenteritis, tinea infections, and herpes simplex infections occurred more frequently in the TREMFYA group than in the placebo group In clinical trials in subjects with plaque psoriasis, infections occurred in 23% of subjects in the TREMFYA group versus 21% of subjects in the placebo group through 16 weeks of treatment. ![]() TREMFYA may increase the risk of infection. FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 1.1 Plaque Psoriasis 1.2 Psoriatic Arthritis 2 DOSAGE AND ADMINISTRATION 2.1 Plaque Psoriasis 2.2 Psoriatic Arthritis 2.3 Important Administration Instructions 2.4 Preparation for Use of TREMFYA Prefilled Syringe or One-Press Injector 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions 5.2 Infections 5.3 Pre-treatment Evaluation for Tuberculosis 5.4 Immunizations 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Immunogenicity 6.3 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 CYP450 Substrates 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 14.1 Plaque Psoriasis 14.2 Psoriatic Arthritis 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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