The following adverse reactions are discussed in greater detail in other sections of labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Of the subjects who developed antidrug antibodies, approximately 7% had antibodies that were classified as neutralizing antibodies. Adverse reactions that occurred in < 1% but > 0.1% of subjects in the TREMFYA group and at a higher rate than in the placebo group through Week 16 in PsO1 and PsO2 were migraine, candida infections, and urticaria. Tell your doctor all medications and supplements you use and all vaccines you recently received. The following adverse reactions have been reported during post-approval of TREMFYA. In the 24-week placebo-controlled period, combined across the two studies, bronchitis occurred in 1.6% of subjects in the TREMFYA q8w group and 2.9% of subjects in the TREMFYA q4w group compared to 1.1% of subjects in the placebo group. Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the TREMFYA group than in the placebo group during the 16-week placebo-controlled period. Of the 748 subjects who received TREMFYA, 375 subjects received TREMFYA 100 mg at Week 0, Week 4, and every 8 weeks thereafter and 373 subjects received TREMFYA 100 mg every 4 weeks. Our Tremfya (guselkumab) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. See additional information. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locater Tool Including 24 Hour, Pharmacies. Consult your doctor before breastfeeding. The overall safety profile observed in subjects with psoriatic arthritis treated with TREMFYA is generally consistent with the safety profile in subjects with plaque psoriasis with the addition of bronchitis and neutrophil count decreased. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. The dose of Tremfya is 100 mg administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter. In clinical trials, a total of 1823 subjects with moderate-to-severe plaque psoriasis received TREMFYA. This is not a complete list of side effects and others may occur. home Table 1: Adverse Reactions Occurring in ≥1% of Subjects through Week 16 in PsO1 and PsO2. Immune system disorders: Hypersensitivity, including anaphylaxis [see WARNINGS AND PRECAUTIONS], Skin and subcutaneous tissue disorders: Rash [see WARNINGS AND PRECAUTIONS], Read the entire FDA prescribing information for Tremfya (Guselkumab for Injection). Tremfya may interact with "live" vaccines and CYP450 substrates. Up to Week 24, 2% (n=15) of subjects treated with TREMFYA developed antidrug antibodies. Psoriasis causes the top layer of skin cells to become inflamed and grow too quickly and flake off. Tremfya(Guselkumab for Injection) side effects drug center, Medical Editor: John P. Cunha, DO, FACOEP. In the 16-week placebo-controlled period of the pooled clinical trials (PsO1 and PsO2), adverse events occurred in 49% of subjects in the TREMFYA group compared to 47% of subjects in the placebo group and 49% of subjects in the U.S. licensed adalimumab group. You may report side effects to FDA at 1-800-FDA-1088. Of the 21 subjects who were reported to have elevated liver enzymes in the TREMFYA group, all events except one were mild to moderate in severity and none of the events led to discontinuation of TREMFYA. For these reasons, comparison of incidence of antibodies to guselkumab across indications or with the incidences of antibodies to other products may be misleading. The most common (≥ 1%) infections were upper respiratory infections, gastroenteritis, tinea infections, and herpes simplex infections; all cases were mild to moderate in severity and did not lead to discontinuation of TREMFYA. Overall, the small number of subjects who were positive for antibodies to guselkumab limits definitive conclusion of the effect of immunogenicity on the pharmacokinetics, efficacy and safety of guselkumab. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to TREMFYA exposure. Data from two placebo- and active-controlled trials (PsO1 and PsO2) in 1441 subjects (mean age 44 years; 70% males; 82% white) were pooled to evaluate the safety of TREMFYA (100 mg administered subcutaneously at Weeks 0 and 4, followed by every 8 weeks).
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