Stelara Injection

Ustekinumab is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. Moderately to severely active Crohn's disease in adult and pediatric patients 2 years of age and older. Moderately to severely active ulcerative colitis in adult patients. Plaque Psoriasis (PsO) Ustekinumab is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Psoriatic Arthritis (PsA) Ustekinumab is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis. Crohn's Disease (CD) Ustekinumab is indicated for the treatment of adults and pediatric patients 2 years of age and older with moderately to severely active Crohn's disease. Ulcerative Colitis (UC) Ustekinumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

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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.

Infections: Serious infections have occurred. Avoid starting Ustekinumab during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue Ustekinumab until the infection resolves. Theoretical Risk for Particular Infections: Serious infections from mycobacteria, salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances. Tuberculosis (TB): Evaluate patients for TB prior to initiating treatment with Ustekinumab. Initiate treatment of latent TB before administering Ustekinumab. Malignancies: Ustekinumab may increase risk of malignancy. The safety of Ustekinumab in patients with a history of or a known malignancy has not been evaluated. Serious Hypersensitivity Reactions: If a severe or other clinically significant hypersensitivity reaction occurs, discontinue Ustekinumab immediately and initiate appropriate medical treatment. Posterior Reversible Encephalopathy Syndrome (PRES): If PRES is suspected, treat promptly, and discontinue Ustekinumab. Immunizations: Avoid use of live vaccines in patients during treatment with Ustekinumab. Noninfectious Pneumonia: Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of Ustekinumab. If diagnosis is confirmed, discontinue Ustekinumab and institute appropriate treatment. Infections Ustekinumab may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving Ustekinumab. Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: Plaque Psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections. Psoriatic arthritis: cholecystitis. Crohn's disease in adults: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis. Crohn's disease in pediatrics: Aeromonas gastroenteritis Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis. Avoid initiating treatment with Ustekinumab in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of Ustekinumab in patients with a chronic infection or a history of recurrent infection. 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 serious adverse reactions are discussed elsewhere in the label: Infections Malignancies Serious Hypersensitivity Reactions Posterior Reversible Encephalopathy Syndrome (PRES) Noninfectious Pneumonia Most common adverse reactions are: Psoriasis and Psoriatic Arthritis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue. Crohn's Disease in Adults induction (≥3%): vomiting. maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. Ulcerative Colitis in Adults induction (≥3%): nasopharyngitis. maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. 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. Adult Subjects with Plaque Psoriasis The safety data reflect exposure to Ustekinumab in 3117 adult subjects with plaque psoriasis, including 2414 exposed for at least 6 months, 1855 exposed for at least one year, 1653 exposed for at least two years, 1569 exposed for at least three years, 1482 exposed for at least four years and 838 exposed for at least five years. Table 8 summarizes the adverse reactions that occurred at a rate of at least 1% with higher rates in the Ustekinumab groups during the placebo-controlled period of Ps STUDY 1 and Ps STUDY 2. Table 8: Adverse Reactions, Reported by ≥1% of Subjects with Plaque Psoriasis and at Higher Rates in the Ustekinumab Groups through Week 12 in Ps STUDY 1 and Ps STUDY 2 Ustekinumab Placebo 45 mg 90 mg Subjects treated 665 664 666 Nasopharyngitis 51 (8%) 56 (8%) 49 (7%) Upper respiratory tract infection 30 (5%) 36 (5%) 28 (4%) Headache 23 (3%) 33 (5%) 32 (5%) Fatigue 14 (2%) 18 (3%) 17 (3%) Back pain 8 (1%) 9 (1%) 14 (2%) Dizziness 8 (1%) 8 (1%) 14 (2%) Pharyngolaryngeal pain 7 (1%) 9 (1%) 12 (2%) Pruritus 9 (1%) 10 (2%) 9 (1%) Injection site erythema 3 (<1%) 6 (1%) 13 (2%) Myalgia 4 (1%) 7 (1%) 8 (1%) Depression 3 (<1%) 8 (1%) 4 (1%) Adverse reactions that occurred at rates less than 1% in the controlled period of Ps STUDIES 1 and 2 through week 12 included: cellulitis, herpes zoster, diverticulitis, and certain injection site reactions (pain, swelling, pruritus, induration, hemorrhage, bruising, and irritation). 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.