pharmacopeia
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/api/v1/drug/ustekinumab

Mechanism of action

Sourced from openFDA

Ustekinumab products are human IgG1қ monoclonal antibodies that binds with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation.

Interleukin-12Interleukin-23

Indications

Sourced from openFDA
  • YESINTEK is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) .ICD-10: L40.50, L40.9

Contraindications

Sourced from openFDA
  • YESINTEK is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in YESINTEK [see Warnings and Precautions (5.5) ]. Clinically significant hypersensitivity to ustekinumab products or to any of the excipients in YESINTEK.contraindicated

Dosage & administration

Sourced from openFDA

Adult Patients with Plaque Psoriasis Subcutaneous Recommended Dosage ( 2.1 ) : Weight Range (kilograms) Dosage less than or equal to 100 kg 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks greater than 100 kg 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks Pediatric Patients 6 Years of Age and Older with Plaque Psoriasis Subcutaneous Recommended Dosage ( 2.1 ): Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter. Weight Range (kilograms) Dose less than 60 kg 0.75 mg/kg 60 kg to 100 kg 45 mg greater than 100 kg 90 mg Psoriatic Arthritis Adult Subcutaneous Recommended Dosage ( 2.2 ): The recommended dosage is 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks. For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg, the recommended dosage is 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks. Psoriatic Arthritis Pediatric (6 years of Age and Older Subcutaneous Recommended Dosage ( 2.2 ): Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter.

Warnings & precautions

Sourced from openFDA

Infections: Serious infections have occurred. Avoid starting YESINTEK during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue YESINTEK until the infection resolves. ( 5.1 ) 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. ( 5.2 ) Tuberculosis (TB) : Evaluate patients for TB prior to initiating treatment with YESINTEK. Initiate treatment of latent TB before administering YESINTEK. (5.3) Malignancies: Ustekinumab products may increase risk of malignancy. The safety of ustekinumab products in patients with a history of or a known malignancy has not been evaluated. (5.4) Serious Hypersensitivity Reactions: If a severe or other clinically significant hypersensitivity reaction occurs, discontinue YESINTEK immediately and initiate appropriate medical treatment. (5.5) Posterior Reversible Encephalopathy Syndrome (PRES): If PRES is suspected, treat promptly, and discontinue YESINTEK. (5.6) Immunizations : Avoid use of live vaccines in patients during treatment with YESINTEK. (5.7) Noninfectious Pneumonia: Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. If diagnosis is confirmed, discontinue YESINTEK and institute appropriate treatment.

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are discussed elsewhere in the label: Infections [see Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.4) ] Serious Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.6) ] Noninfectious Pneumonia [see Warnings and Precautions (5.8) ] Most common adverse reactions are: Psoriasis and Psoriatic Arthritis (≥3%) : nasopharyngitis, upper respiratory tract infection, headache, and fatigue. ( 6.1 ) Crohn’s Disease, induction (≥3%) : vomiting. ( 6.1 ) Crohn’s Disease, maintenance (≥3%) : nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. ( 6.1 ) Ulcerative colitis, induction (≥3%) : nasopharyngitis ( 6.1 ) Ulcerative colitis, maintenance (≥3%) : nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. *Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not identified a ustekinumab-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes ( see Data ). There are risks to the mother and the fetus associated with inflammatory bowel disease (IBD) in pregnancy. In animal reproductive and developmental toxicity studies, no adverse developmental effects were observed in offspring after administration of ustekinumab to pregnant monkeys at exposures greater than 100 times the maximum recommended human dose (MRHD). All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and Embryo/Fetal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with IBD is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption In adult subjects with plaque psoriasis, the median time to reach the maximum serum concentration (T max ) was 13.5 days and 7 days, respectively, after a single subcutaneous administration of 45 mg (N=22) and 90 mg (N=24) of ustekinumab. In healthy subjects (N=30), the median T max value (8.5 days) following a single subcutaneous administration of 90 mg of ustekinumab was comparable to that observed in subjects with plaque psoriasis.

Overdosage

Sourced from openFDA

Single doses up to 6 mg/kg intravenously have been administered in clinical trials without dose-limiting toxicity. In case of overdosage, monitor the patient for any signs or symptoms of adverse reactions or effects and institute appropriate symptomatic treatment immediately. Consider contacting the Poison Help line 1-800-222-1222 or a medical toxicologist for additional overdose management recommendations.

Approval history

Sourced from openFDA
  • Sep 25, 2009BLABLA125261Centocor Ortho Biotech Inc
  • Sep 23, 2016BLABLA761044Janssen Biotech
  • Oct 31, 2023BLABLA761285Amgen Inc
  • Oct 31, 2023BLABLA761331Amgen Inc
  • Apr 16, 2024BLABLA761343Alvotech Usa Inc
  • Jun 28, 2024BLABLA761373Samsung Bioepis Co Ltd
  • Jun 28, 2024BLABLA761425Samsung Bioepis Co Ltd
  • Sep 27, 2024BLABLA761379Fresenius Kabi Usa

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
100,571 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective14,60515%
  2. 2Off Label Use12,52612%
  3. 3Product Dose Omission Issue9,9379.9%
  4. 4Fatigue6,7236.7%
  5. 5Psoriasis6,5226.5%
  6. 6Pain6,1356.1%
  7. 7Crohn^s Disease5,7425.7%
  8. 8Arthralgia5,7305.7%
  9. 9Rash5,5455.5%
  10. 10Product Use Issue5,3745.3%
  11. 11Headache5,2145.2%
  12. 12Condition Aggravated5,1565.1%
  13. 13Infusion Related Reaction5,0425.0%
  14. 14Rheumatoid Arthritis4,7304.7%
  15. 15Joint Swelling4,6374.6%

Literature

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Recent PubMed references pinned to Ustekinumab as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 261 ClinicalTrials.gov registrations naming Ustekinumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Ustekinumab work?
Ustekinumab products are human IgG1қ monoclonal antibodies that binds with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation.
What is Ustekinumab used for?
According to FDA labeling, Ustekinumab carries indications including: YESINTEK is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ustekinumab?
Ustekinumab is classified as Interleukin inhibitors, Interleukin-12 Antagonist, Interleukin-23 Antagonist, Interleukin-12 Antagonists, Interleukin-23 Antagonists, Decreased Cytokine Activity.
What are the brand names for Ustekinumab?
Ustekinumab is marketed under brand names including Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Stelara, Steqeyma, Wezlana.
What are the contraindications for Ustekinumab?
Ustekinumab labeling lists contraindications including: YESINTEK is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in YESINTEK [see Warnings and Precautions (5.5) ]. Clinically significant hypersensitivity to ustekinumab products or to any of the excipients in YESINTEK.. Always consult the full prescribing information and a clinician.
Note. Data for ustekinumab is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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