Tremfya 100mg Injection

Guselkumab is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. adults with moderately to severely active ulcerative colitis. adults with moderately to severely active Crohn's disease. Plaque Psoriasis Guselkumab is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. Psoriatic Arthritis Guselkumab is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. Ulcerative Colitis Guselkumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis. Crohn's Disease Guselkumab is indicated for the treatment of adult patients with moderately to severely active Crohn's disease.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur. Infections: Guselkumab may increase the risk of infections. Do not initiate treatment with Guselkumab in patients with clinically important active infection until the infection resolves or is adequately treated. If such an infection develops, discontinue Guselkumab until the infection resolves. Tuberculosis (TB): Evaluate for TB prior to initiating treatment with Guselkumab. Monitor patients for signs and symptoms of active TB during and after treatment with Guselkumab. Hepatotoxicity: Drug-induced liver injury has been reported. For the treatment of ulcerative colitis or Crohn's disease, evaluate liver enzymes and bilirubin levels at baseline, for at least 16 weeks of treatment, and periodically thereafter according to routine patient management. For the treatment of plaque psoriasis or psoriatic arthritis, if clinically indicated, evaluate liver enzymes and bilirubin at baseline, and periodically thereafter according to routine patient management. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Immunizations: Avoid use of live vaccines. Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, have been reported with post market use of Guselkumab. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, discontinue Guselkumab and initiate appropriate therapy. Infections Guselkumab may increase the risk of infection. In placebo-controlled clinical trials of up to 48 weeks in subjects with ulcerative colitis and Crohn's disease, serious infections occurred in ≤ 2% of subjects who received Guselkumab. In the 16-week placebo-controlled trials in subjects with plaque psoriasis, the rate of serious infections for the Guselkumab group and the placebo group was ≤ 0.2%. A similar rate of serious infections was seen in placebo-controlled trials in subjects with psoriatic arthritis. The overall rates of infections were similar between subjects in the Guselkumab groups and subjects in the placebo groups in clinical trials for all indicated populations. Treatment with Guselkumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing Guselkumab. Instruct patients to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection or is not responding to standard therapy, monitor the patient closely and discontinue Guselkumab until the infection resolves. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following adverse reactions are discussed in greater detail in other sections of labeling: Hypersensitivity Reactions Infections Tuberculosis Hepatotoxicity Most common adverse reactions associated with Guselkumab are: Plaque Psoriasis and Psoriatic Arthritis (≥1%): upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections. Ulcerative Colitis (≥3%): injection site reactions, arthralgia, upper respiratory tract infections, headache, gastroenteritis, fatigue, pyrexia, and rash. Crohn's Disease (≥3%): respiratory tract infections, abdominal pain, injection site reactions, headache, fatigue, arthralgia, diarrhea, and gastroenteritis. Clinical Trials Experience 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. Adverse Reactions in Adults with Plaque Psoriasis In clinical trials, a total of 1823 adult subjects with moderate-to-severe plaque psoriasis received Guselkumab. Of these, 1393 subjects were exposed to Guselkumab for at least 6 months and 728 subjects were exposed for at least 1 year. 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 Guselkumab (100 mg administered subcutaneously at Weeks 0 and 4, followed by every 8 weeks). Weeks 0 to 16: In the 16-week placebo-controlled period of the pooled clinical trials (PsO1 and PsO2), adverse events occurred in 49% of subjects in the Guselkumab group compared to 47% of subjects in the placebo group and 49% of subjects in the U.S. licensed adalimumab group. Serious adverse events occurred in 1.9% of subjects in the Guselkumab group (6.3 events per 100 patient-years of follow-up) compared to 1.4% of subjects in the placebo group (4.7 events per 100 patient-years of follow-up), and in 2.6% of subjects in U.S. licensed adalimumab group (9.9 events per 100 patient-years of follow-up). Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the Guselkumab group than in the placebo group during the 16-week placebo-controlled period. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.