Version July 2025
Dosage guidance:
Safety: Prior to initiation, certain assessments (clinical and laboratory) are required with documentation and ensure age-appropriate vaccinations are up to date. In general, live vaccines should not be administered within 4 weeks prior to starting therapy (Ref). Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy.
Dosage form information: In the United States, Imuldosa (ustekinumab-srlf), Otulfi (ustekinumab-aauz), Pyzchiva (ustekinumab-ttwe), Selarsdi (ustekinumab-aekn), Steqeyma (ustekinumab-stba), Wezlana (ustekinumab-auub), and Yesintek (ustekinumab-kfce) are approved as biosimilars to Stelara (ustekinumab). In Canada, Finlius, Jamteki, Steqeyma, and Wezlana are approved as biosimilars to Stelara (ustekinumab); refer to Canadian product monograph(s) for biosimilar-specific indication details.
Crohn disease, moderate to severe (Stelara and ustekinumab biosimilars):
Note: May be used as an initial biologic agent for patients with nonfistulizing disease or as second-line therapy for patients who have not responded to other biologic agents (with or without fistulizing disease) (Ref). Data are limited for use in postoperative maintenance (Ref).
Induction of remission:
≤55 kg: IV: 260 mg as single dose (Ref).
>55 kg to 85 kg: IV: 390 mg as single dose (Ref).
>85 kg: IV: 520 mg as single dose (Ref).
Maintenance of remission: SUBQ: 90 mg every 8 weeks starting 8 weeks after the IV induction dose (Ref).
Incomplete response or nonresponse to induction therapy (off-label dosing): If limited or no improvement in clinical symptoms and biomarkers of disease activity (eg, C-reactive protein [CRP] and fecal calprotectin) 12 weeks after induction (4 weeks after first maintenance dose), decrease maintenance dosing interval to every 4 weeks. If inadequate response after an additional 8 to 12 weeks of every 4-week therapy, switch to alternative therapy. May switch to an alternative agent sooner than 8 to 12 weeks if disease activity is severe and symptom control is needed (Ref).
Relapse while on maintenance therapy (off-label dosing): For patients with initial response who have symptomatic relapse while on maintenance therapy, consider decreasing dosing interval to every 4 weeks (Ref).
Plaque psoriasis (Stelara and ustekinumab biosimilars):
Initial and maintenance:
≤100 kg: SUBQ: 45 mg at 0 and 4 weeks, and then 45 mg every 12 weeks thereafter. Note: Some patients may require doses of 90 mg or maintenance dosing every 8 weeks (Ref).
>100 kg: SUBQ: 90 mg at 0 and 4 weeks, and then 90 mg every 12 weeks thereafter. Note: Some patients may require maintenance dosing every 8 weeks (Ref).
Tapering schedule (off-label): Tapering approach may vary, and should be based on patient-specific factors; an example tapering schedule is provided below (Ref):
|
Current dosing schedule |
New dosing scheduleb |
|---|---|
|
a van der Schoot 2022 b If disease activity increases, return to previously effective dosing schedule. c Optional dosing schedules. | |
|
Every 12 weeks |
Every 15 weeksc or every 18 weeks |
|
Every 15 weeks |
Every 18 weeks |
|
Every 18 weeks |
Every 21 weeksc or every 24 weeks |
|
Every 21 weeks |
Every 24 weeks |
Psoriatic arthritis (Stelara and ustekinumab biosimilars): Note: May be administered alone or in combination with methotrexate.
Initial and maintenance: SUBQ: 45 mg at 0 and 4 weeks, and then 45 mg every 12 weeks thereafter.
Coexistent psoriatic arthritis and moderate to severe plaque psoriasis in patients >100 kg: Initial and maintenance: SUBQ: 90 mg at 0 and 4 weeks, and then 90 mg every 12 weeks thereafter. Note: Some patients may require maintenance dosing every 8 weeks (Ref).
Ulcerative colitis, moderate to severe (Stelara and ustekinumab biosimilars):
Induction of remission:
≤55 kg: IV: 260 mg as single dose.
>55 kg to 85 kg: IV: 390 mg as single dose.
>85 kg: IV: 520 mg as single dose.
Maintenance of remission: SUBQ: 90 mg every 8 weeks starting 8 weeks after the IV induction dose (Ref).
Inadequate primary response (off-label dosing):If limited or no improvement in clinical symptoms and biomarkers of disease activity (eg, C-reactive protein [CRP] and fecal calprotectin) 12 weeks after induction (~4 weeks after first maintenance dose), decrease maintenance dosing interval to every 4 to 6 weeks. If inadequate response after an additional 8 to 12 weeks of every 4- to 6-week dosing, switch to alternative therapy. May switch to an alternative agent sooner than 8 to 12 weeks if disease activity is severe and symptom control is needed (Ref).
Relapse while on maintenance therapy (off-label dosing): For patients with symptomatic relapse while on maintenance therapy, consider decreasing dosing interval to every 4 to 6 weeks (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Ustekinumab (including biosimilars): Pediatric drug information")
Dosage guidance:
Safety: Screen for tuberculosis (TB) infection (latent TB) prior to initiating treatment. Avoid use in patients with TB disease (active TB). Consider pretreatment with antituberculosis therapy in patients with TB infection. Discontinue use or avoid use in patients with clinically important active infections. Patients should be current with all age-appropriate immunizations prior to therapy; avoid administering live vaccines during therapy. Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy.
Dosing: Dosing presented in mg/kg and fixed mg; use extra caution to ensure correct dosing units.
Dosage form information: In the United States, Imuldosa (ustekinumab-srlf), Otulfi (ustekinumab-aauz), Pyzchiva (ustekinumab-ttwe), Selarsdi (ustekinumab-aekn), Steqeyma (ustekinumab-stba), Wezlana (ustekinumab-auub), and Yesintek (ustekinumab-kfce) are approved as biosimilars to Stelara (ustekinumab). In Canada, Finlius, Jamteki, Steqeyma, and Wezlana are approved as biosimilars to Stelara (ustekinumab); refer to Canadian product monograph(s) for biosimilar-specific indication details.
Inflammatory bowel disease, moderate to severe; refractory: Limited data available (Ref): Note: Dosing varies by route of administration (IV or SUBQ); use extra caution.
Children ≥12 years and Adolescents:
Induction:
<55 kg: IV: 260 mg as single dose.
≥55 to 85 kg: IV: 390 mg as single dose.
>85 kg: IV: 520 mg as single dose.
Maintenance: SUBQ: 90 mg every 8 weeks; begin maintenance dosing 8 weeks after the IV induction dose.
Dosing based on retrospective studies and case reports. A retrospective study of 52 adolescent and young adult (<21 years) patients (median: 16.8 years; 38 patients <18 years of age) diagnosed with inflammatory bowel disease (n=42 Crohn disease; n=10 ulcerative colitis or unspecified) with a majority (81%) having failed previous tumor necrosis factor (TNF)-modulator therapy, utilized a single-dose weight-based IV induction protocol of ustekinumab in most patients (47/52, 90%); the other subjects (5) received SUBQ induction prior to availability of IV product. Following induction, all patients received fixed dose (regardless of weight) SUBQ maintenance therapy (90 mg every 8 weeks). Results showed at the end of 52 weeks, 58% of patients had achieved steroid-free remission and 65% had achieved clinical remission. At week 52, of the 39 patients who continued on ustekinumab, 62% of patients required dosing every 4 to 7 weeks to maintain remission (Ref). In a retrospective case series, 4 patients (ages 12 to 17 years) who had failed or unable to tolerate previous TNF modifiers received SUBQ induction doses of 90 mg every 4 weeks for 2 doses, followed by 90 mg every 8 weeks. Two patients were able to wean off steroid regimens and had clinical improvement and 2 patients were unresponsive to therapy (Ref).
Plaque psoriasis, moderate to severe:
Children ≥6 years and Adolescents <18 years:
<60 kg: SUBQ: Initial: 0.75 mg/kg at 0 and 4 weeks, followed by maintenance dose of 0.75 mg/kg every 12 weeks.
≥60 to ≤100 kg: SUBQ: Initial: 45 mg at 0 and 4 weeks, followed by maintenance dose of 45 mg every 12 weeks.
>100 kg: SUBQ: Initial: 90 mg at 0 and 4 weeks, followed by maintenance dose of 90 mg every 12 weeks.
Adolescents ≥18 years:
≤100 kg: SUBQ: Initial: 45 mg at 0 and 4 weeks, followed by maintenance dose of 45 mg every 12 weeks.
>100 kg: SUBQ: Initial: 90 mg at 0 and 4 weeks, followed by maintenance dose of 90 mg every 12 weeks.
Psoriatic arthritis, active:
Children ≥6 years and Adolescents <18 years:
<60 kg: SUBQ: Initial: 0.75 mg/kg at 0 and 4 weeks, followed by maintenance dose of 0.75 mg/kg every 12 weeks.
≥60 kg: SUBQ: Initial: 45 mg at 0 and 4 weeks, followed by maintenance dose of 45 mg every 12 weeks.
>100 kg and moderate to severe plaque psoriasis comorbidity: SUBQ: Initial: 90 mg at 0 and 4 weeks, followed by maintenance dose of 90 mg every 12 weeks.
Adolescents ≥18 years: SUBQ: Initial: 45 mg at 0 and 4 weeks, followed by maintenance dose of 45 mg every 12 weeks.
Moderate to severe plaque psoriasis comorbidity and weight >100 kg: SUBQ: Initial: 90 mg at 0 and 4 weeks, followed by maintenance dose of 90 mg every 12 weeks.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Immediate hypersensitivity reactions have been reported, including anaphylaxis and infusion-related reaction (Ref). Delayed reactions have also been reported, including bullous pemphigoid, hypersensitivity angiitis, eczematous rash, morphea, and psoriasiform eruption (Ref).
Mechanism:
Anaphylaxis: Non–dose-related; immunologic (ie, IgE mediated, with specific antibodies formed against a drug allergen following initial exposure) (Ref).
Infusion-related reactions: Unknown; possibly related to release of cytokines, complement activation, degranulation of mast cells and basophils (Ref).
Delayed hypersensitivity reactions: Non–dose-related; immunologic (ie, involving a T-cell–mediated drug-specific immune response) (Ref).
Psoriasiform eruptions: Non–dose-related; possibly related to cytokine imbalance (Ref).
Onset:
Infusion-related reactions: Rapid; during the infusion (Ref). Infusion reactions occur most commonly during the first infusion (Ref).
Psoriasiform eruptions: Delayed; usually within 3 months of initiation but have been reported after 15 months of therapy (Ref).
Risk factors:
• IV route of administration: Some patients have developed immediate reactions following IV ustekinumab but subsequently have tolerated SUBQ ustekinumab (Ref). It has been hypothesized that EDTA, contained in the IV formulation but not the SUBQ formulation, may be responsible for reactions (Ref).
Ustekinumab may increase the risk for infection, including serious infection requiring hospitalization, or reactivation of latent infection. Serious bacterial, mycobacterial, fungal, and viral infections have been observed with use.
Mechanism: Dose-related; due to the role of the interleukin (IL)-12/IL-23 pathway in protecting the host from pathogens, ustekinumab may result in unintended downstream consequences, such as the development of infections (Ref).
Risk factors:
• History of chronic, latent, or recurrent infection
• Concurrent glucocorticoid or immunosuppressive therapy (Ref)
• Genetic deficiency in IL-12/IL-23; in patients with IL-12/IL-23 genetic deficiencies, there is a theoretical increased risk of disseminated infection from mycobacteria, Salmonella, and BCG vaccinations (Ref)
Ustekinumab may increase the risk for malignancy; although, data are conflicting. Cases of rapidly appearing cutaneous squamous cell carcinoma in situ have been reported in patients receiving ustekinumab with preexisting risk factors for developing nonmelanoma skin cancer. However, multiple studies have shown no association between ustekinumab and malignancy (Ref).
Mechanism: Unknown; interleukin (IL)-12 and IL-23 have been suggested to play a role in tumor immunity, but increased risk of malignancy has not been reported in IL-12 or IL-23 genetically deficient patients (Ref).
Risk factors:
• Patients >60 years of age
• History of prolonged immunosuppressant therapy
• Patients with a history of psoralen plus ultraviolet-A radiation treatment
Ustekinumab use has been associated with the development of clinically serious noninfectious pneumonia, including cases of cryptogenic organizing pneumonia, eosinophilic pneumonitis, and interstitial lung disease, some leading to respiratory failure and prolonged hospitalization (Ref).
Mechanism: Unknown; may represent hypersensitivity (Ref). One report speculates that the inhibitory effect on interleukin (IL)-12 and IL-23 may impede T-helper cells Th1 and Th17 activity to initiate a Th2-dominant response and trigger the onset of eosinophilic pneumonitis (Ref).
Onset: Varied; most cases occur after 1 to 3 doses (Ref); but may also occur later (Ref).
Ustekinumab has been associated with reversible posterior leukoencephalopathy syndrome; signs and symptoms may include altered mental status, confusion, headaches, seizures, visual disturbances, and imaging changes (Ref). Cases were reversible with discontinuation.
Mechanism: Unknown; possible genetic predisposition (Ref).
Onset: Varied; most cases occur within a few days to several months after initiation but may also occur after a year or more (Ref).
Risk factors:
• Autoimmune diseases (Ref)
• Immunosuppressive medications (Ref)
Adult and pediatric patients treated with ustekinumab may be at risk for tuberculosis (TB), including active and reactivated TB. Overall, a low rate of TB has been reported with ustekinumab (Ref).
Mechanism: Dose-related; due to the role of the interleukin (IL)-12/IL-23 pathway in protecting the host from pathogens, ustekinumab may result in unintended downstream consequences, such as the development of infections (Ref).
Risk factors:
• Patients with inborn errors of IL-12/IL-23 (disseminated infection) (Ref)
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
Plaque psoriasis/psoriatic arthritis:
>10%:
Immunologic: Antibody development (6% to 12%; associated with reduced efficacy in psoriasis patients)
Infection: Infection (27%; serious infection: 0.3%) (table 1)
|
Drug (Ustekinumab) |
Placebo |
Population |
Indication |
|---|---|---|---|
|
27% |
24% |
Adults |
Plaque psoriasis |
|
Serious: 0.3% |
Serious: 0.4% |
Adults |
Plaque psoriasis |
1% to 10%:
Dermatologic: Pruritus (2%), skin carcinoma (nonmelanoma: 2%, including cutaneous squamous cell carcinoma in situ)
Gastrointestinal: Nausea (3%)
Hematologic & oncologic: Malignant neoplasm (excluding nonmelanoma: 2%)
Local: Erythema at injection site (1% to 2%)
Nervous system: Depression (1%), dizziness (2%), fatigue (3%), headache (5%)
Neuromuscular & skeletal: Arthralgia (3%), back pain (2%)
Respiratory: Pharyngolaryngeal pain (2%)
<1%:
Dermatologic: Cellulitis
Gastrointestinal: Diverticulitis of the gastrointestinal tract
Infection: Herpes zoster infection
Local: Bleeding at injection site, bruising at injection site, induration at injection site, injection-site pruritus, irritation at injection site, pain at injection site, swelling at injection site
Nervous system: Reversible posterior leukoencephalopathy syndrome
Crohn disease/ulcerative colitis:
>10%: Respiratory: Nasopharyngitis (7% to 24%)
1% to 10%:
Dermatologic: Acne vulgaris (1%), pruritus (2% to 4%)
Gastrointestinal: Abdominal pain (7%), diarrhea (4%), nausea (3%), vomiting (4%)
Genitourinary: Urinary tract infection (4%), vaginal mycosis (≤5%), vulvovaginal candidiasis (≤5%)
Immunologic: Antibody development (3% to 5%)
Infection: Influenza (6%)
Local: Erythema at injection site (5%)
Nervous system: Asthenia (1%), fatigue (4%), headache (10%)
Respiratory: Bronchitis (5%), sinusitis (3% to 4%)
Miscellaneous: Fever (5%)
<1%:
Dermatologic: Skin carcinoma (nonmelanoma, including cutaneous squamous cell carcinoma in situ)
Hematologic & oncologic: Malignant neoplasm (excluding nonmelanoma)
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis)
Nervous system: Meningitis due to Listeria monocytogenes
Ophthalmic: Ocular herpes simplex
Frequency not defined (any indication):
Gastrointestinal: Abscess of rectum and/or perirectal area, appendicitis, cholecystitis, gastroenteritis
Infection: Sepsis, viral infection
Neuromuscular & skeletal: Osteomyelitis
Respiratory: Pneumonia
Postmarketing (any indication):
Dermatologic: Bullous pemphigoid (Ref), eczematous rash (Ref), erythrodermic psoriasis (Ref), fixed drug eruption (Ref), psoriasiform eruption (Ref), pustular psoriasis (Ref)
Hypersensitivity: Angioedema, hypersensitivity angiitis (Ref), infusion-related reaction (Ref)
Infection: Atypical mycobacterial infection, bacterial infection, fungal infection (including opportunistic)
Nervous system: Intracranial hypertension (Ref)
Respiratory: Cryptogenic organizing pneumonia (Ref), eosinophilic pneumonitis (Ref), interstitial lung disease (Ref), lower respiratory tract infection, tuberculosis (Ref)
Clinically significant hypersensitivity to ustekinumab or any component of the formulation
Canadian labeling: Additional contraindications (not in the US labeling): Severe infections such as sepsis, tuberculosis, and opportunistic infections
Concerns related to adverse effects:
• Antibody formation: Formation of neutralizing anti-drug antibodies may occur with ustekinumab and may be associated with loss of efficacy (AAD/NPF [Menter 2019]; Loeff 2020).
• Hypersensitivity reactions: Hypersensitivity, including anaphylaxis and angioedema, has been reported. Discontinue immediately with signs/symptoms of hypersensitivity reaction and treat appropriately as indicated.
• Infections: May increase the risk for infections or reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections have been observed with use. Avoid use in patients with clinically important active infection until the infection resolves or is successfully treated. Exercise caution when considering use in patients with a history of new/recurrent infections, with conditions that predispose them to infections (eg, diabetes or residence/travel from areas of endemic mycoses), with chronic, latent, or localized infections, or who are genetically deficient in IL-12/IL-23 (IL-12/IL-23 genetic deficiency may predispose patients to disseminated infection). Patients who develop a new infection while undergoing treatment should consult their health care provider and be monitored closely. If a patient develops a serious infection, therapy should be discontinued until successful resolution of infection.
• Malignancy: May increase the risk for malignancy although the impact on the development and course of malignancies is not fully defined. Rapidly appearing cutaneous squamous cell carcinomas (multiple) have been reported in patients receiving ustekinumab who were at risk for developing nonmelanoma skin cancer. Monitor all patients closely for the development of nonmelanoma skin cancer; closely follow patients >60 years of age, with a history of prolonged immunosuppression, and in patients with a history of PUVA treatment. Use with caution in patients with prior malignancy (use not studied in this population).
• Noninfectious pneumonia: Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia, some leading to respiratory failure and prolonged hospitalization, have been reported; most commonly has occurred within the first few doses. Symptoms may include cough, dyspnea, and interstitial infiltrates. Discontinue therapy and institute appropriate treatment if noninfectious pneumonia is suspected or confirmed.
• Posterior reversible encephalopathy syndrome: Posterior reversible encephalopathy syndrome (PRES) has been reported. Symptoms of PRES include confusion, headache, imaging changes, seizure, and visual disturbances; most cases occur within a few days to several months after initiation of therapy but may occur ≥1 year. Monitor patients closely; discontinue therapy immediately if symptoms occur and administer appropriate therapy.
• Tuberculosis: Do not use in patients with tuberculosis (TB) disease (active TB). Patients should be evaluated for tuberculosis infection (latent TB) with a tuberculin skin test prior to starting therapy. Treatment of TB infection should be initiated before ustekinumab therapy is used. Consider antituberculosis treatment in patients with a history of tuberculosis infection or disease if an adequate prior treatment course cannot be confirmed.
Concurrent drug therapy issues:
• Allergen immunotherapy: Use caution in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis; ustekinumab may decrease the protective effect of allergen immunotherapy, which may increase the risk of an allergic reaction to allergen immunotherapy.
Special populations:
• Patients with rheumatic musculoskeletal disease undergoing hip or knee replacement surgery: Hold biologic disease-modifying antirheumatic drugs (DMARDs) prior to surgery and plan surgery after the next dose is due. Surgery can occur after holding medication for 1 full dosing cycle (eg, for medications administered every 4 weeks, schedule surgery 5 weeks from last administered dose); therapy can be restarted once surgical wound shows evidence of healing (eg, no swelling, erythema, or drainage), sutures/staples are removed, and no ongoing nonsurgical site infections (typically ~14 days to reduce infection risk). Decisions to withhold therapy should be based on shared decision making; ensure the patient and their provider weigh risks of interrupting therapy and disease control versus risks of continuing therapy and surgical complications (ACR/AAHKS [Goodman 2022]).
Dosage form specific issues:
• Latex: Packaging may contain natural latex rubber.
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Caballero 2021; Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Other warnings/precautions:
• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Although the manufacturer suggests that live vaccines should not be given concurrently, expert consensus recommends that ustekinumab be held for one dosing interval (the longest described in labeling) prior to administration of a live vaccine and then ustekinumab be held 4 weeks after administration of a live vaccine in general; individualized consideration should be given to patient risk for vaccine preventable illness and for disease flares if immunosuppressant therapy held (ACR 2022). Inactivated or nonlive vaccines may be given concurrently, but may not elicit a proper immune response. BCG vaccines should not be given 1 year prior to, during, or 1 year following treatment.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Otulfi: Ustekinumab-aauz 130 mg/26 mL (26 mL) [contains edetate (edta) disodium, polysorbate 80]
Pyzchiva: Ustekinumab-ttwe 130 mg/26 mL (26 mL) [contains edetate (edta) disodium, polysorbate 80]
Selarsdi: Ustekinumab-aekn 130 mg/26 mL (26 mL) [contains edetate (edta) disodium, polysorbate 80]
Stelara: 130 mg/26 mL (26 mL) [contains edetate (edta) disodium dihydrate, polysorbate 80]
Steqeyma: Ustekinumab-stba 130 mg per 26 mL (26 mL) [contains edetate (edta) disodium, polysorbate 80]
Wezlana: Ustekinumab-auub 130 mg/26 mL (5 mg/mL) (26 mL) [contains edetate (edta) disodium, polysorbate 80]
Yesintek: Ustekinumab-kfce 130 mg/26 mL (5 mg/mL) (26 mL) [contains edetate (edta) disodium, polysorbate 80]
Generic: 130 mg/26 mL (26 mL)
Solution, Subcutaneous [preservative free]:
Stelara: 45 mg/0.5 mL (0.5 mL) [contains polysorbate 80]
Wezlana: Ustekinumab-auub 45 mg/0.5 mL (0.5 mL) [contains polysorbate 80]
Yesintek: Ustekinumab-kfce 45 mg/0.5 mL (0.5 mL) [contains polysorbate 80]
Generic: 45 mg/0.5 mL (0.5 mL)
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Otulfi: Ustekinumab-aauz 90 mg/mL (1 mL); Ustekinumab-aauz 45 mg/0.5 mL (0.5 mL) [contains polysorbate 80]
Pyzchiva: Ustekinumab-ttwe 90 mg/mL (1 mL); Ustekinumab-ttwe 45 mg/0.5 mL (0.5 mL) [contains polysorbate 80]
Selarsdi: Ustekinumab-aekn 90 mg/mL (1 mL); Ustekinumab-aekn 45 mg/0.5 mL (0.5 mL) [contains polysorbate 80]
Stelara: 45 mg/0.5 mL (0.5 mL); 90 mg/mL (1 mL) [contains polysorbate 80]
Steqeyma: Ustekinumab-stba 90 mg/mL (1 mL); Ustekinumab-stba 45 mg per 0.5 mL (0.5 mL) [contains polysorbate 80]
Wezlana: Ustekinumab-auub 90 mg/mL (1 mL); Ustekinumab-auub 45 mg/0.5 mL (0.5 mL) [contains polysorbate 80]
Yesintek: Ustekinumab-kfce 90 mg/mL (1 mL); Ustekinumab-kfce 45 mg/0.5 mL (0.5 mL) [contains polysorbate 80]
Generic: 45 mg/0.5 mL (0.5 mL); 90 mg/mL (1 mL); Ustekinumab-aekn 45 mg/0.5 mL (0.5 mL); Ustekinumab-aekn 90 mg/mL (1 mL)
Yes
Solution (Otulfi Intravenous)
130MG/26ML (per mL): $77.80
Solution (Pyzchiva Intravenous)
130MG/26ML (per mL): $50.77
Solution (Selarsdi Intravenous)
130MG/26ML (per mL): $64.62
Solution (Stelara Intravenous)
130MG/26ML (per mL): $97.83
Solution (Stelara Subcutaneous)
45 mg/0.5 mL (per 0.5 mL): $17,490.89
Solution (Steqeyma Intravenous)
130MG/26ML (per mL): $14.02
Solution (Ustekinumab Intravenous)
130MG/26ML (per mL): $83.08
Solution (Ustekinumab Subcutaneous)
45 mg/0.5 mL (per 0.5 mL): $13,118.40
Solution (Wezlana Intravenous)
130MG/26ML (per mL): $65.41
Solution (Wezlana Subcutaneous)
45 mg/0.5 mL (per 0.5 mL): $3,341.15
Solution (Yesintek Intravenous)
130MG/26ML (per mL): $18.46
Solution (Yesintek Subcutaneous)
45 mg/0.5 mL (per 0.5 mL): $1,799.99
Solution Prefilled Syringe (Otulfi Subcutaneous)
45 mg/0.5 mL (per 0.5 mL): $2,171.75
90 mg/mL (per mL): $4,343.48
Solution Prefilled Syringe (Pyzchiva Subcutaneous)
45 mg/0.5 mL (per 0.5 mL): $2,505.85
90 mg/mL (per mL): $5,011.72
Solution Prefilled Syringe (Selarsdi Subcutaneous)
45 mg/0.5 mL (per 0.5 mL): $2,505.85
90 mg/mL (per mL): $5,011.72
Solution Prefilled Syringe (Stelara Subcutaneous)
45 mg/0.5 mL (per 0.5 mL): $17,490.89
90 mg/mL (per mL): $34,981.75
Solution Prefilled Syringe (Steqeyma Subcutaneous)
45 mg/0.5 mL (per 0.5 mL): $2,505.85
90 mg/mL (per mL): $5,011.72
Solution Prefilled Syringe (Ustekinumab Subcutaneous)
45 mg/0.5 mL (per 0.5 mL): $4,372.80
90 mg/mL (per mL): $8,745.60
Solution Prefilled Syringe (Ustekinumab-aekn Subcutaneous)
45 mg/0.5 mL (per 0.5 mL): $2,505.85
90 mg/mL (per mL): $5,011.72
Solution Prefilled Syringe (Wezlana Subcutaneous)
45 mg/0.5 mL (per 0.5 mL): $3,341.15
90 mg/mL (per mL): $6,682.28
Solution Prefilled Syringe (Yesintek Subcutaneous)
45 mg/0.5 mL (per 0.5 mL): $1,799.99
90 mg/mL (per mL): $3,599.98
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Finlius: 130 mg/26 mL (26 mL) [contains edetate (edta) disodium dihydrate, polysorbate 80]
Stelara: 130 mg/26 mL (26 mL) [contains edetate (edta) disodium dihydrate, polysorbate 80]
Steqeyma: Ustekinumab-stba 130 mg per 26 mL (26 mL) [contains edetate (edta) disodium dihydrate, polysorbate 80]
Wezlana: Ustekinumab-auub 130 mg/26 mL (5 mg/mL) (26 mL) [contains edetate (edta) disodium dihydrate, polysorbate 80]
Solution, Subcutaneous:
Finlius: 45 mg/0.5 mL (0.5 mL) [contains polysorbate 80]
Jamteki: 45 mg/0.5 mL (0.5 mL) [contains polysorbate 80]
Stelara: 45 mg/0.5 mL (0.5 mL) [contains polysorbate 80]
Wezlana: Ustekinumab-auub 45 mg/0.5 mL (0.5 mL) [contains polysorbate 80]
Solution Auto-injector, Subcutaneous:
Wezlana: Ustekinumab-auub 90 mg/mL (1 mL); Ustekinumab-auub 45 mg/0.5 mL (0.5 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous:
Finlius: 90 mg/mL (1 mL) [contains polysorbate 80]
Jamteki: Ustekinumab-aekn 90 mg/mL (1 mL) [contains polysorbate 80]
Stelara: 90 mg/mL (1 mL) [contains polysorbate 80]
Steqeyma: Ustekinumab-stba 90 mg/mL (1 mL); Ustekinumab-stba 45 mg per 0.5 mL (1 mL) [contains polysorbate 80]
Wezlana: Ustekinumab-auub 90 mg/mL (90 mL); Ustekinumab-auub 45 mg/0.5 mL (0.5 mL) [contains polysorbate 80]
IV: Vials (5 mg/mL) must be diluted prior to administration. Infuse over at least 1 hour; use of IV set with an in-line, low-protein binding filter (0.2 micrometer) required. Do not infuse concomitantly in the same IV line with other agents. Note: Otulfi labeling states to use only polypropylene or polyvinylchloride infusion sets.
SUBQ: Administer by SUBQ injection into the top of the thigh, abdomen, upper arms, or buttocks; insert needle into pinched skin at approximately a 45-degree angle. Rotate sites. Do not inject into tender, bruised, erythematous, or indurated skin. Avoid areas of skin where psoriasis is present. Discard any unused portion. Intended for use under supervision of a health care provider; self-injection or administration by a caregiver may occur after proper training. If using the 45 mg/0.5 mL single-dose vial, a 1 mL syringe with a 27-gauge 1/2-inch needle is recommended. Allowing the prefilled syringe to sit at room temperature for 30 minutes may reduce injection site pain or discomfort. Refer to the manufacturer's labeling and/or instructions for use for additional administration information.
Parenteral:
IV: Vials (5 mg/mL) must be diluted prior to administration. Infuse over at least 1 hour; use an IV set with an in-line, low-protein binding filter (0.2 micrometer). Do not infuse concomitantly in the same IV line with other agents; based on adult recommendations and pediatric (age ≥12 years) trial experience which utilized adult dose (Ref). Note: Otulfi US labeling states to use only polypropylene or PVC infusion sets.
SUBQ: Administer by SUBQ injection into the top of the thigh, abdomen, upper arms, or buttocks; insert needle into pinched skin at approximately a 45-degree angle. Rotate sites. Do not inject into tender, bruised, erythematous, or indurated skin. Avoid areas of skin where psoriasis is present. Discard any unused portion. Pediatric patients should have doses administered by a health care professional; if deemed appropriate, self-injection or administration by a caregiver may occur after proper training. If using the 45 mg/0.5 mL single-dose vial, a 1 mL syringe with a 27-gauge 1/2-inch needle is recommended. Allowing the prefilled syringe to sit at room temperature for 30 minutes may reduce injection-site pain or discomfort. Refer to the manufacturer's labeling and/or instructions for use for additional administration information.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Otulfi: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379s003lbl.pdf#page=36
Stelara: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761044s009lbl.pdf
Wezlana: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761285s001,761331s001lbl.pdf#page=35
Crohn disease (Stelara and ustekinumab biosimilars): Treatment of moderately to severely active Crohn disease in adults.
Plaque psoriasis (Stelara and ustekinumab biosimilars): Treatment of moderate to severe plaque psoriasis in adult and pediatric patients ≥6 years of age who are candidates for phototherapy or systemic therapy.
Psoriatic arthritis (Stelara and ustekinumab biosimilars): Treatment of active psoriatic arthritis in adult and pediatric patients ≥6 years of age.
Ulcerative colitis (Stelara and ustekinumab biosimilars): Treatment of moderately to severely active ulcerative colitis in adults.
Note: In the United States, Imuldosa (ustekinumab-srlf), Otulfi (ustekinumab-aauz), Pyzchiva (ustekinumab-ttwe), Selarsdi (ustekinumab-aekn), Steqeyma (ustekinumab-stba), Wezlana (ustekinumab-auub), and Yesintek (ustekinumab-kfce) are approved as biosimilars to Stelara (ustekinumab). In Canada, Finlius, Jamteki, Steqeyma, and Wezlana are approved as biosimilars to Stelara (ustekinumab); refer to Canadian product monograph(s) for biosimilar-specific indication details.
Hidradenitis suppurativa, moderate to severe
Stelara may be confused with Aldara
Ustekinumab may be confused with infliximab, rituximab
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Allergen Immunotherapy: Ustekinumab may decrease therapeutic effects of Allergen Immunotherapy. Risk C: Monitor
Anifrolumab: Biologic Anti-Psoriasis Agents may increase immunosuppressive effects of Anifrolumab. Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Ustekinumab may decrease therapeutic effects of BCG Products. Ustekinumab may increase adverse/toxic effects of BCG Products. Specifically, the risk of infection may be increased. Risk X: Avoid
Belimumab: May increase immunosuppressive effects of Biologic Anti-Psoriasis Agents. Management: Consider alternatives to the use of belimumab with other biologic therapies. Monitor closely for increased toxicities related to additive immunosuppression (ie, infection, malignancy) if combined. Risk D: Consider Therapy Modification
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers): Ustekinumab may decrease serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
InFLIXimab: May increase immunosuppressive effects of Biologic Anti-Psoriasis Agents. Risk X: Avoid
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Patients treated for plaque psoriasis are encouraged to use contraception during therapy. Based on available data, agents other than ustekinumab may be preferred for use in patients planning to conceive (Yeung 2020). The American Academy of Dermatology considers ustekinumab for the treatment of psoriasis to be acceptable for use in patients planning to father a child (AAD/NPF [Menter 2019]). Females and males with well-controlled psoriasis who are planning a pregnancy and wish to avoid fetal exposure can consider discontinuing ustekinumab 15 weeks prior to attempting pregnancy (Rademaker 2018).
Inflammatory bowel disease is associated with adverse pregnancy outcomes; maternal disease and serum levels of biologic therapy should be optimized prior to conception. Biologics, such as ustekinumab, may be continued in patients with inflammatory bowel disease planning to become pregnant (Mahadevan 2019). Treatment algorithms are available for use of biologics in patients with Crohn disease who are planning to become pregnant (Weizman 2019).
Based on limited data, use of ustekinumab may be continued through conception in patients with rheumatic and musculoskeletal diseases who are planning a pregnancy and not able to use alternative therapies; use should be discontinued once pregnancy is confirmed. Conception should be planned during a period of quiescent/low disease activity. Recommendations for use of ustekinumab to treat rheumatic and musculoskeletal diseases in patients who are planning to father a child are not available due to limited data (ACR [Sammaritano 2020]).
Ustekinumab crosses the placenta (Klenske 2019; Mitrova 2021; Mitrova 2022; Rowan 2018; Saito 2022; Sako 2021).
Ustekinumab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
In pregnant patients with inflammatory bowel disease (IBD), cord blood concentrations of ustekinumab are higher than maternal trough levels at delivery. In most cases, ustekinumab was continued into the third trimester. Cord blood concentrations were lower in some cases when maternal treatment was stopped during the second trimester but may correlate better with maternal blood concentrations than the time of the last dose (Klenske 2019; Mitrova 2021; Mitrova 2022; Rowan 2018; Saito 2022; Sako 2021). The clearance of ustekinumab from the newborn circulation was evaluated in 9 infants of mothers treated for IBD; the time to clearance was 6 to 19 weeks (complete data not available for 7 additional infants) (Flanagan 2022). In 1 case report, ustekinumab was detected in cord blood at delivery (38 weeks' gestation; last maternal dose 23 weeks' gestation) but not in neonatal blood when sampled 6 months postpartum (Sako 2021). In utero exposure to ustekinumab may cause immunosuppression in the newborn.
Based on maternal trough concentrations, pregnancy-induced physiologic changes do not alter the pharmacokinetic properties of ustekinumab in a clinically significant way (Flanagan 2022; Rowan 2018).
Outcome data following maternal use of ustekinumab during pregnancy are becoming available from registries and prospective studies (Abraham 2022; Dernoncourt 2022; Echeverría-García 2017; Ghalandari 2022; Mahadevan 2022; Mitrova 2022); however, current guidance considers the available data related to the use of ustekinumab in pregnancy to be limited (ECCO [Torres 2023]; Lamb 2019; Mahadevan 2019; Yeung 2020).
The American Academy of Dermatology considers the safety of ustekinumab for the treatment of psoriasis in pregnancy to be uncertain (AAD/NPF [Menter 2019]).
Until additional data are available, ustekinumab is not currently recommended for the treatment of rheumatic and musculoskeletal diseases during pregnancy. Ustekinumab should be discontinued once pregnancy is confirmed (ACR [Sammaritano 2020]).
IBD is associated with adverse pregnancy outcomes including an increased risk of miscarriage, premature delivery, delivery of a low-birth-weight infant, and poor maternal weight gain. Management of maternal disease should be optimized prior to pregnancy. Treatment decreases disease flares, disease activity, and the incidence of adverse pregnancy outcomes. When treatment for inflammatory bowel disease is needed in pregnant patients, appropriate biologic therapy can be continued without interruption. Serum levels should be evaluated prior to conception and optimized to avoid subtherapeutic concentrations or high levels which may increase placental transfer. Dosing can be adjusted so delivery occurs at the lowest serum concentration. For ustekinumab, the final injection can be given 6 to 10 weeks prior to the estimated date of delivery (4 to 5 weeks before delivery if every-4-week dosing), then continued 48 hours' postpartum (Mahadevan 2019).
Ustekinumab is present in breast milk (Bar-Gil Shitrit 2021; Klenske 2019; Matro 2018; Saito 2022).
Ustekinumab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021). Data related to the presence of ustekinumab in breast milk are available from several studies that included breastfeeding patients treated for inflammatory bowel disease:
• The presence of ustekinumab in breast milk was evaluated in 6 breastfeeding patients. Detectable concentrations of ustekinumab were present in 4 patients who provided samples over 7 days after their dose. Three of the 4 patients had detectable concentrations for >48 hours. Peak breast milk concentrations occurred between 12 and 72 hours after the maternal dose (Matro 2018).
• Data are also available from 3 patients, 2 who were taking ustekinumab prior to delivery and 1 who started postpartum. Breast milk was sampled 1 hour after the infusion and additional samples were provided for up to 2 weeks. Concentrations of ustekinumab in breast milk were variable but remained lower than the maternal serum concentration. Breastfed infants were followed until 3 to 6 months of age; adverse events were not observed, and developmental milestones were obtained (Bar-Gil Shitrit 2021).
• Ustekinumab was reinitiated in a patient 7 weeks postpartum for Crohn disease (loading dose 390 mg followed by 90 mg every 8 weeks). Maternal trough serum and breast milk concentrations of ustekinumab were 4.6 mcg/mL and 3.2 mcg/mL, respectively, when sampled after 2 doses. Breast milk concentrations were lower within 1 day after the third maintenance dose (0.82 mcg/mL) and continued to decrease (0.16 mcg/mL 4 weeks later). Adverse events were not observed in the breastfed infant, followed until 12 months of age (Klenske 2019).
• Breast milk concentrations of ustekinumab were provided for 30 days from a patient treated for ulcerative colitis. Ustekinumab 90 mg SUBQ was reinitiated on postpartum day 48. Breast milk concentrations peaked 9 days after the dose (0.0136 mcg/mL) on postpartum day 57, then decreased to 0.0034 mcg/mL on postpartum day 78 (Saito 2022).
Systemic exposure to a breastfed infant is expected to be low secondary to the large size of the molecule and the degradation of ustekinumab within the GI tract.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Treatment with ustekinumab may be continued or initiated in breastfeeding patients with rheumatic and musculoskeletal diseases (ACR [Sammaritano 2020]). In general, the decision to breastfeed during treatment for plaque psoriasis should not be influenced by use of a biologic agent (Yeung 2020).
Prior to therapy start:
• Evaluate for malignancy (especially skin cancer), current or latent infection, lymphadenopathy, ensure age-appropriate vaccinations are up to date, and, in general, no live vaccines are administered within 4 weeks of starting therapy (AAD [Menter 2019]; EuroGuiDerm [Nast 2024]). Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy.
• Labs: CBC with differential; complete metabolic panel; testing for tuberculosis (TB) infection (eg, Quantiferon Gold) or interferon gamma release assay for TB in patients who have had Bacillus Calmette-Guérin (BCG) vaccine; chest radiograph if testing for TB infection is positive; serologic testing for hepatitis B virus (hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core antibody), hepatitis C virus antibody, HIV; pregnancy test, C-reactive protein (AAD [Menter 2019]; EuroGuiDerm [Nast 2024]).
During therapy:
• Evaluate for infection, malignancy (specifically skin cancer screening, especially for patients who have a history of skin cancer or UV phototherapy), infusion/injection-site reactions, and symptoms consistent with posterior reversible encephalopathy syndrome or axial polyneuropathy (AAD [Menter 2019]; EuroGuiDerm [Nast 2024]).
• Labs: CBC and LFTs every 3 to 6 months or as clinically indicated, pregnancy test as needed; yearly testing/chest radiograph for TB in high-risk patients (eg, contact with individuals with TB disease [active TB]) (AAD [Menter 2019]; EuroGuiDerm [Nast 2024]); hepatitis B carriers should be periodically evaluated for signs/symptoms of active hepatitis B infection (AAD [Menter 2019]). Consider anti-drug antibody and/or therapeutic drug monitoring in the setting of nonresponse or loss of response to ustekinumab.
After therapy:
• Periodically evaluate patients who are hepatitis B carriers for signs/symptoms of active hepatitis B infection (AAD [Menter 2019]).
Ustekinumab is a human monoclonal antibody that binds to and interferes with the proinflammatory cytokines, interleukin (IL)-12 and IL-23. Biological effects of IL-12 and IL-23 include natural killer (NK) cell activation, CD4+ T-cell differentiation and activation. Ustekinumab also interferes with the expression of monocyte chemotactic protein-1 (MCP-1), tumor necrosis factor-alpha (TNF-α), interferon-inducible protein-10 (IP-10), and interleukin-8 (IL-8). Significant clinical improvement in psoriasis and psoriatic arthritis patients is seen in association with reduction of these proinflammatory signalers.
Onset of action: Psoriasis: Response best determined after 12 weeks (AAD/NPF [Menter 2019]).
Distribution:
Crohn disease: Vd (central compartment): 2.7 L; Vdss: 4.6 L.
Ulcerative colitis: Vd (central compartment): 3 L; Vdss: 4.4 L.
Half-life elimination: SubQ:
Crohn disease, ulcerative colitis: Terminal: ~19 days.
Psoriasis: 14.9 ± 4.6 to 45.6 ± 80.2 days.
Time to peak, plasma: Psoriasis: SubQ: 45 mg: 13.5 days; 90 mg: 7 days.
Body weight: When given the same dose, subjects weighing >100 kg had lower median serum concentrations compared with those subjects weighing ≤100 kg. The median trough serum concentrations of ustekinumab in subjects >100 kg in the 90 mg group were comparable with those in subjects ≤100 kg in the 45 mg group.
