STELARA®
(ustekinumab)
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STELARA® (ustekinumab)
Medical Information
STELARA - Management of Hypersensitivity or Infusion Reactions in Adult Patients with Crohn's Disease or Ulcerative Colitis
Last Updated: 08/12/2025
SUMMARY
- Please refer to your local labeling for information regarding the management of hypersensitivity or infusion reactions in adult patients with Crohn’s disease (CD) or ulcerative colitis (UC).
- STELARA is contraindicated in patients with severe hypersensitivity to ustekinumab or any of the excipients.1
- Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported after marketing. If an anaphylactic or other serious hypersensitivity reaction occurs, institute appropriate therapy and discontinue the administration of STELARA.1
- The management of hypersensitivity and infusion reactions is described below from the clinical protocols for STELARA in adult patients with moderately to severely active CD or UC.2
- 5 - In a pooled safety analysis including data from 2 phase 2 CD studies (C0379T07 [T07] and CERTIFI), 3 phase 3 CD studies (UNITI-1, UNITI-2, and IM-UNITI), and 1 phase 3 UC protocol (UNIFI), no serious anaphylactic reactions or serum sickness-like reactions to STELARA were observed. Two patients with CD displayed signs/symptoms of hypersensitivity, one after the first intravenous (IV) dose (chest discomfort, flushing, urticaria, and fever) and one after the first and only subcutaneous (SC) dose (throat tightness, shortness of breath [SOB], and flushing). Both the patients’ symptoms resolved within 1 hour after oral corticosteroid/antihistamine treatment.6
- Additional data are available through a retrospective study and several case reports.7
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CLINICAL DATA
Phase 3 Controlled Trials - CD and UC
Infusion Reactions
- In the clinical trial programs for CD and UC, an infusion reaction was defined as an adverse event (AE) that occurs during or within 1 hour following the infusion of a study agent, with the exception of laboratory abnormalities.2-5
- Minor infusion reactions could be managed by slowing the rate of the IV infusion and/or treating with antihistamines and/or acetaminophen as clinically indicated.
- If an IV infusion of a study agent was stopped because of an infusion reaction and the reaction, in the opinion of the investigator, was not severe or did not result in a serious AE, the infusion could be restarted with caution.
Injection Site Reactions
Hypersensitivity Reactions
- In the clinical trial programs for CD and UC, before an SC injection or IV infusion, appropriately trained personnel and medications to treat allergic reactions, including anaphylaxis, were required to be available. Appropriate medical personnel were required to be in attendance at the time of the infusion and for at least 30 minutes after the SC injection or for at least 1 hour after the start of the infusion.2-5
- Appropriate medical personnel were required to be in close proximity to the infusion center for the remaining duration of the infusion and for 1 hour after the end of the infusion in the event that emergency resuscitation was required. All patients were required to be observed carefully for symptoms of an allergic reaction (eg, urticaria, itching, hives).
- If a mild or moderate allergic reaction was observed, acetaminophen, nonsteroidal anti-inflammatory drugs, and/or diphenhydramine could have been administered.
- In the case of a severe allergic reaction (eg, anaphylaxis), SC aqueous epinephrine, corticosteroids, respiratory assistance, and other proper resuscitative measures were required to be available at the study site where the infusions were being given.
- Subjects who experienced serious adverse reactions related to either an injection or infusion were discontinued from further study injections. For severe reactions related to the injection or infusion, the subject could have been permanently discontinued from further study injections at the discretion of the investigator.
Sandborn et al (2021)6 conducted a pooled safety analysis including data from 2 phase 2 CD studies (C0379T07 [T07] and CERTIFI), 3 phase 3 CD studies (UNITI-1, UNITI-2, and IM-UNITI), and 1 phase 3 UC protocol (UNIFI).
- A total of 2574 patients were treated with STELARA through 1 year of follow-up.
- No serious anaphylactic reactions or serum sickness-like reactions to STELARA were reported. However, 2 patients with CD displayed signs and symptoms of hypersensitivity temporally associated with treatment.
- One patient reported chest discomfort, flushing, urticaria, and fever after the initial IV dose of STELARA. Symptoms resolved within 1 hour after oral corticosteroid/antihistamine treatment.
- Another patient reported throat tightness, SOB, and flushing after the first and only SC dose of STELARA. Symptoms resolved within 1 hour after oral corticosteroid/antihistamine treatment.
Retrospective Study and Case Reports
Additional data are available through a retrospective study and case reports. See Table: Summary of the Management of Hypersensitivity or Infusion Reactions to STELARA in Adult Patients.
| Author and Year | Patient Characteristics and UST Dose | Description of Initial Reaction | Medications Administered and Outcome | Rechallenge Information |
|---|---|---|---|---|
| Retrospective Study | ||||
| Spencer et al (2020)7 | 16 patients experienced infusion reactions over an ~2-year period: 14 patients at infusion center 1, (3% rate of infusion reactions) and 2 patients at infusion center 2 (0.8% rate of infusion reactions) 3/16 patients had a history of infusion reactions to infliximab and/or adalimumab UST weight-based infusion No pretreatment was administered | Median time to infusion reaction: 2 (IQR, 2-4.5) minutes Majority were classified as moderate (50%) or severe (38%) Reactions reported in ≥10% of patients: dyspnea 62.5%, flushing 56%, bronchospasm (acute onset of cough) 12.5%, angioedema (“throat closing”) 25%, stomach pain/nausea 31.3% | Diphenhydramine (87.5%), IV hydrocortisone (75%), famotidine (63%), ondansetron (12.5%), loratadine (12.5%), acetaminophen (12.5%), albuterol/atrovent (12.5%) | 15 patients (94%) restarted UST IV after treatment for infusion reactions (1 patient did not due to personal preference). All 15 patients completed infusions with no further issues 13/14 patients who received UST SC tolerated the injection without issues Pretreatment used in 3 patients: Patient 1: Received prednisone 40 mg 2 days prior and diphenhydramine/ acetaminophen right before the injection Patient 2: Received fexofenadine 30 minutes prior to the injection and continues to receive prior to each injection per allergist recommendations Patient 3: Received acetaminophen and diphenhydramine prior to the injection. The patient experienced chest discomfort and was given IV hydrocortisone, which resolved symptoms. Reactions also occurred during the second and third injections; hence, the patient elected to discontinue UST |
| Case Reports | ||||
| Alves et al (2025)8 | 32-year-old female with CD and a history of local reaction to adalimumab UST 390 mg IV followed by 90 mg SC q8w | Initial maintenance doses were well tolerated during 2021-2023; in 2023, onset of local pruritus, erythema, and edema after 10 minutes of administration was observed, and increased swelling of injection site, which progressed over 3 subsequent cycles to local pain, increase in the edema’s extension, aggravation of previous symptoms, and generalized pruritus immediately after administration | Clemastine 2 mg and/or hydrocortisone 100 mg was administered during the treatment cycle, with symptom resolution after 3 days No systemic symptoms were reported. Intradermal skin testing at 1:10 concentration (0.5 mg/mL) confirmed type I hypersensitivity to UST A medically-supervised administration of UST was preformed along with premedication of montelukast 10 mg, cetirizine 10 mg, and methylprednisolone 60 mg, which did not prevent further allergic reaction (quicker onset of papular exanthema and more intense generalized pruritis) | A 11-step and 3-bag desensitization protocol was conducted to prevent systemic reactions for UST 390 mg IV The first cycle was successful; however, during the final step of the second cycle after 8 weeks of following the protocol (5 mg/mL concentration at infusion rate of 40 mL/h), generalized pruritus, urticaria, and bilateral palpebral angioedema were observed No other systemic symptoms were reported. Clemastine 2 mg IV and hydrocortisone 100 mg were administered; infusion was resumed at 20 mL/h after 30 minutes with no further issues |
| Velasquez et al (2025)9 | 47-year-old female with CD UST 90 mg SC q8w followed by q5w, six months before the current presentation | 3 weeks after a UST dose, the patient developed a nonpruritic, burning rash which spread to the torso and upper and lower extremities, the back and chest | Lab findings were notable for positive antinuclear antibody titer 1:160; skin biopsy revealed IgA vasculitis. UST was discontinued; patient was treated with prednisone and methotrexate, with gradual symptom improvement | A rechallenge with UST was not performed |
| Gonzalez et al (2024)10 | 44-year-old female with perianal CD Patient was treated with UST, with disease remission; UST was restarted years later due to anal fissures and luminal activity | 10 minutes after a UST infusion, the patient developed severe HSR with generalized urticaria, nausea, vomiting, oxygen desaturation, and hypotension | Epinephrine, hydrocortisone, diphenhydramine, and supplemental oxygen were administered with remission of symptoms | A desensitization protocol (3-bag, 12-step) and premedication with dexamethasone, diphenhydramine, aspirin, and montelukast were performed successfully without HSR and a total of 3 subsequent desensitization were performed |
| Thomas et al (2021)11 | Case 1: 41-year-old female with CD and a history of an infusion reaction to infliximab UST 390 mg IV | 10 minutes into UST IV infusion, the patient developed SOB, difficulty breathing, chest discomfort, flushing, and dizziness | UST IV infusion stopped, and the IV line was flushed; symptoms resolved within 10 minutes No treatment was given | 2 weeks later, the patient received UST 90 mg SC injection; 4 hours after, the patient reported erythema, warm sensation, and pruritus at the injection site; desloratadine was administered with subsequent symptom resolution Days 2-4 after the SC dose, the patient reported progressing symptoms, including dyspnea and edema at the injection site. Oral prednisone 20 mg was given for 3 days with resolution in symptoms UST was discontinued |
| Thomas et al (2021)11 | Case 2: 23-year-old female with CD and a history of an infusion reaction to infliximab UST 390 mg IV | 15 minutes into UST IV infusion, the patient developed dyspnea, tingling of the lips, and trouble swallowing | UST IV infusion was stopped, and prednisone 25 mg IV was administered; symptoms resolved | Restarted UST IV at a lower infusion rate and after 5 minutes, similar symptoms occurred; UST was discontinued 2 hours after UST IV infusion, UST 90 mg SC was administered. The patient developed SOB and flushing and was treated with an antihistamine and prednisone 25 mg IV Oral prednisone and antihistamine were continued for 7 days, with complete resolution of symptoms UST was discontinued |
| Thomas et al (2021)11 | Case 3: 54-year-old female with CD and a history of infusion reactions to vedolizumab UST 390 mg IV | 40 minutes into UST IV infusion, the patient developed swollen throat, cough, headache, and fatigue | UST IV infusion was stopped, and an antihistamine was administered; symptoms resolved | UST IV infusion was reinitiated at a lower infusion rate; similar symptoms occurred within 5 minutes UST was discontinued |
| Crosby et al (2021)12 | 61-year-old female with CD UST 520 mg IV | 17 minutes into UST IV infusion, the patient developed skin redness, itchiness, and urticaria; vital signs were stable with no respiratory compromise | Diphenhydramine was administered, and urticaria resolved | 1 month after UST IV infusion, the patient was pretreated with prednisone 40 mg BID the day before and 40 mg 1x on the day of UST 90 mg SC injection The patient received diphenhydramine 25 mg and acetaminophen 650 mg 30 minutes prior to UST SC injection The patient was monitored for 60 minutes and discharged with no reaction After the third UST SC injection, the patient developed transient erythema and redness at the injection site |
| Yabumoto et al (2020)13 | 42-year-old male with CD UST dose was not stated in the publication | 2 days after the administration of UST, the patient developed a pruritic erythematous blistering skin rash on the neck, arms, and trunk without mucous membrane involvement or fever; skin biopsy revealed hypersensitivity skin reaction | No medications were administered; skin reaction resolved in 10 days | The patient received 4 days of premedication with acetaminophen, famotidine, prednisone, and diphenhydramine prior to UST 90 mg SC No reaction to UST SC was reported |
| Cleveland et al (2018)14 | 26-year-old female with CD and a history of anaphylaxis to infliximab UST 260 mg IV | At the time of UST IV infusion, the patient developed tachycardia, flushing, throat tightness, and difficulty breathing | Diphenhydramine 50 mg IV and methylprednisolone 100 mg IV were administered; symptoms resolved | No reaction was observed to UST SC |
| Abbreviations: BID, twice a day; CD, Crohn’s disease; HSR, hypersensitivity reaction; IgA, immunoglobulin A; IQR, interquartile range; IV, intravenous; q5w, every 5 weeks; q8w, every 8 weeks; SC, subcutaneous; SOB, shortness of breath; UST, ustekinumab. | ||||
Literature Search
A literature search of MEDLINE®
References
| 1 | Data on File. Ustekinumab. Company Core Data Sheet v53. Janssen Research & Development, LLC. EDMS-ERI-22004273; 2025. |
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