Generic Name

Ustekinumab

Brand Names
Pyzchiva, Imuldosa, Yesintek, Otulfi, Selarsdi, Ustekinumab-aekn, Starjemza, Wezlana, Steqeyma, Ustekinumab-TTWE, Stelara
FDA approval date: September 25, 2009
Classification: Interleukin-12 Antagonist
Form: Injection, Solution

What is Pyzchiva (Ustekinumab)?

Living with chronic autoimmune conditions like psoriasis, Crohn’s disease, or ulcerative colitis can be physically and emotionally exhausting. Frequent flares, visible skin symptoms, and digestive discomfort often affect confidence and daily life. Ustekinumab (brand name Stelara) is a biologic medication that has helped transform care for many people by offering a targeted way to calm inflammation and restore quality of life.

What does Ustekinumab do?

Ustekinumab is used to treat several immune-mediated inflammatory diseases, including:

  • Moderate to severe plaque psoriasis in adults and children aged 6 +.
  • Active psoriatic arthritis in adults.
  • Moderate to severe Crohn’s disease and ulcerative colitis in adults who haven’t responded well to other treatments.

By addressing the overactive immune system that drives these diseases, ustekinumab helps reduce inflammation, control symptoms, and improve daily comfort.

Patients with psoriasis often notice a significant reduction in skin plaques and itching, while those with Crohn’s disease or ulcerative colitis may experience fewer flare-ups, less abdominal pain, and improved bowel habits.

Clinical trials have shown ustekinumab’s strong and sustained effectiveness. For example, in psoriasis studies, many patients achieved clear or almost clear skin within 12 weeks of treatment (Papp et al., 2008). In Crohn’s and ulcerative colitis trials, ustekinumab significantly improved remission rates and endoscopic healing compared to placebo (Feagan et al., 2016).

How does Ustekinumab work?

Ustekinumab is a monoclonal antibody, a type of biologic therapy that precisely targets specific parts of the immune system. It works by blocking two proteins, interleukin-12 (IL-12) and interleukin-23 (IL-23), which play a central role in inflammation and immune cell activation.

By inhibiting IL-12 and IL-23, ustekinumab helps reduce the inflammatory signals that trigger immune cells to attack healthy tissues in the skin, joints, or intestines. This targeted approach helps control disease activity without broadly suppressing the entire immune system.

Clinically, this mechanism matters because it helps maintain long-term disease control while reducing flare frequency and the need for continuous steroids or stronger immunosuppressants.

Ustekinumab side effects

Most people tolerate ustekinumab well, but like all prescription medications, it can cause side effects. Most are mild and improve with time or supportive care.

Common side effects:

  • Upper respiratory infections (such as sinus infections or sore throat)
  • Headache
  • Fatigue
  • Injection site redness or itching

Less common or serious side effects:

  • Increased risk of infections (including tuberculosis and shingles)
  • Allergic reactions (rash, swelling, or breathing difficulty)
  • Rare cases of cancer or reversible posterior leukoencephalopathy syndrome (a rare brain condition)

Because ustekinumab affects immune signaling, doctors screen patients for latent infections such as tuberculosis and hepatitis before starting treatment. Ongoing monitoring helps ensure early detection of any complications.

Patients should avoid live vaccines while taking ustekinumab and report symptoms like fever, persistent cough, or unusual skin changes promptly.

People with active infections, a history of certain cancers, or weakened immune systems should discuss risks carefully with their doctor before using this medication.

Ustekinumab dosage

Ustekinumab is given either as an injection under the skin (subcutaneous) or as an intravenous infusion, depending on the condition being treated.

  • For psoriasis and psoriatic arthritis, treatment usually begins with a subcutaneous injection, followed by maintenance doses every few months.
  • For Crohn’s disease and ulcerative colitis, patients typically start with an intravenous infusion, then switch to subcutaneous injections for ongoing maintenance.

This infrequent dosing schedule is one of ustekinumab’s major benefits, as it allows patients to maintain disease control without frequent injections or daily pills.

Doctors may monitor:

  • Blood counts and liver function, to ensure treatment safety.
  • Infection screening, before and during therapy.
  • Response to treatment, using symptom tracking or imaging (like colonoscopy or skin assessment).

Older adults or those with chronic infections may require closer follow-up to ensure safety.

Does Ustekinumab have a generic version?

As of now, no generic or biosimilar version of ustekinumab is approved in the United States. It is marketed exclusively under the brand name Stelara by Janssen Biotech.

Because ustekinumab is a biologic (made from living cells rather than chemicals), any future alternatives will be biosimilars, not traditional generics. Biosimilars are required to demonstrate equivalent safety, purity, and effectiveness to the original product before FDA approval.

In some countries, biosimilar versions are under development, but they are not yet widely available for clinical use.

Conclusion

Ustekinumab represents a major advancement in the treatment of chronic autoimmune conditions such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. By precisely targeting key inflammatory proteins (IL-12 and IL-23), it helps restore balance to the immune system and reduce symptoms that affect skin, joints, and digestion.

While monitoring and infection precautions are essential, most patients find ustekinumab well-tolerated and life-changing in terms of comfort, mobility, and confidence.

As with any biologic therapy, ongoing communication with your healthcare provider is vital. When prescribed and monitored appropriately, ustekinumab is a safe and effective option that empowers patients to take control of their autoimmune condition and focus on living a fuller, healthier life.

References

  1. U.S. Food and Drug Administration (FDA). (2019). Stelara (ustekinumab) prescribing information. https://www.fda.gov/
  2. Mayo Clinic. (2023). Ustekinumab (injection route) description and precautions. https://medlineplus.gov/
  3. Papp, K. A., et al. (2008). Ustekinumab, a human interleukin-12/23 monoclonal antibody, for moderate-to-severe psoriasis. New England Journal of Medicine, 358(6), 580–592. https://www.nejm.org/
  4. Feagan, B. G., et al. (2016). Ustekinumab as induction and maintenance therapy for Crohn’s disease. New England Journal of Medicine, 375(20), 1946–1960. https://www.nejm.org/

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Brand Information

    1DOSAGE FORMS AND STRENGTHS
    PYZCHIVA (ustekinumab-ttwe) is a clear, colorless to light yellow, sterile and preservative-free solution.
    Subcutaneous Injection
    • Injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe
    • Injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled autoinjector (PYZCHIVA AUTOINJECTOR)
    • Injection: 45 mg/0.5 mL solution in a single-dose vial
    Intravenous Infusion
    • Injection: 130 mg/26 mL (5 mg/mL) solution in a single-dose vial
    2CONTRAINDICATIONS
    PYZCHIVA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in PYZCHIVA
    3ADVERSE REACTIONS
    The following serious adverse reactions are discussed elsewhere in the label:
    • Infections
    • Malignancies
    • Serious Hypersensitivity Reactions
    • Posterior Reversible Encephalopathy Syndrome (PRES)
    • Noninfectious Pneumonia
    3.1Clinical 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 5 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
    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).
    One case of PRES occurred during clinical trials in adult subjects with plaque psoriasis
    Infections
    In the placebo-controlled period of clinical trials of subjects with plaque psoriasis (average follow-up of 12.6 weeks for subjects receiving placebo and 13.4 weeks for ustekinumab-treated subjects), 27% of ustekinumab-treated subjects reported infections (1.39 per patient-years of follow-up) compared with 24% of subjects receiving placebo (1.21 per patient-years of follow-up). Serious infections occurred in 0.3% of ustekinumab-treated subjects (0.01 per patient-years of follow-up) and in 0.4% of subjects receiving placebo (0.02 per patient-year of follow-up)
    In the controlled and non-controlled portions of clinical trials in subjects with plaque psoriasis (median follow-up of 3.2 years), representing 8998 patient-years of exposure, 72.3% of ustekinumab-treated subjects reported infections (0.87 per patient-years of follow-up). Serious infections were reported in 2.8% of subjects (0.01 per patient-years of follow-up).
    Malignancies
    In the controlled and non-controlled portions of clinical trials in subjects with plaque psoriasis (median follow-up of 3.2 years, representing 8998 patient-years of exposure), 1.7% of ustekinumab-treated subjects reported malignancies excluding non-melanoma skin cancers (0.60 per hundred patient-years of follow-up). Non-melanoma skin cancer was reported in 1.5% of ustekinumab-treated subjects (0.52 per hundred patient-years of follow-up)
    Pediatric Subjects with Plaque Psoriasis
    The safety of ustekinumab was assessed in two trials of pediatric subjects with moderate to severe plaque psoriasis. Ps STUDY 3 evaluated safety for up to 60 weeks in 110 pediatric subjects 12 to 17 years old. Ps STUDY 4 evaluated safety for up to 56 weeks in 44 pediatric subjects 6 to 11 years old. The safety profile in pediatric subjects was similar to the safety profile from trials in adults with plaque psoriasis.
    Psoriatic Arthritis
    The safety of ustekinumab was assessed in 927 subjects in two randomized, double-blind, placebo-controlled trials in adults with active psoriatic arthritis (PsA). The overall safety profile of ustekinumab in subjects with PsA was consistent with the safety profile seen in clinical trials in adult subjects with plaque psoriasis. A higher incidence of arthralgia, nausea, and dental infections was observed in ustekinumab-treated subjects when compared with placebo- treated subjects (3% vs. 1% for arthralgia and 3% vs. 1% for nausea; 1% vs. 0.6% for dental infections) in the placebo-controlled portions of the PsA clinical trials.
    Crohn's Disease
    The safety of ustekinumab was assessed in 1407 subjects with moderately to severely active Crohn's disease (Crohn's Disease Activity Index [CDAI] greater than or equal to 220 and less than or equal to 450) in three randomized, double-blind, placebo-controlled, parallel-group, multicenter trials. These 1407 subjects included 40 subjects who received a prior investigational intravenous ustekinumab formulation but were not included in the efficacy analyses. In trials CD-1 and CD-2 there were 470 subjects who received ustekinumab 6 mg/kg as a weight-based single intravenous induction dose and 466 who received placebo
    The overall safety profile of ustekinumab was consistent with the safety profile seen in the clinical trials in adult subjects with plaque psoriasis and psoriatic arthritis. Common adverse reactions in trials CD-1 and CD-2 and in trial CD-3 are listed in Table 6 and Table 7, respectively.
    Other less common adverse reactions reported in subjects in trials CD-1 and CD-2 included asthenia (1% vs 0.4%), acne (1% vs 0.4%), and pruritus (2% vs 0.4%).
    Infections
    In subjects with Crohn's disease, serious or other clinically significant infections included anal abscess, gastroenteritis, and pneumonia. In addition, listeria meningitis and ophthalmic herpes zoster were reported in one subject each
    Malignancies
    With up to one year of treatment in the Crohn's disease clinical trials, 0.2% of ustekinumab-treated subjects (0.36 events per hundred patient-years) and 0.2% of placebo-treated subjects (0.58 events per hundred patient-years) developed non- melanoma skin cancer. Malignancies other than non-melanoma skin cancers occurred in 0.2% of ustekinumab-treated subjects (0.27 events per hundred patient-years) and in none of the placebo-treated subjects.
    Hypersensitivity Reactions Including Anaphylaxis
    In CD trials, two subjects reported hypersensitivity reactions following ustekinumab administration. One subject experienced signs and symptoms consistent with anaphylaxis (tightness of the throat, shortness of breath, and flushing) after a single subcutaneous administration (0.1% of subjects receiving subcutaneous ustekinumab). In addition, one subject experienced signs and symptoms consistent with or related to a hypersensitivity reaction (chest discomfort, flushing, urticaria, and increased body temperature) after the initial intravenous ustekinumab dose (0.08% of subjects receiving intravenous ustekinumab). These subjects were treated with oral antihistamines or corticosteroids and in both cases symptoms resolved within an hour
    Ulcerative Colitis
    The safety of ustekinumab was evaluated in two randomized, double-blind, placebo- controlled clinical trials (UC-1 [IV induction] and UC-2 [SC maintenance]) in 960 adult subjects with moderately to severely active ulcerative colitis
    • Induction (UC-1): nasopharyngitis (7% vs 4%).
    • Maintenance (UC-2): nasopharyngitis (24% vs 20%), headache (10% vs 4%), abdominal pain (7% vs 3%), influenza (6% vs 5%), fever (5% vs. 4%), diarrhea (4% vs 1%), sinusitis (4% vs 1%), fatigue (4% vs 2%), and nausea (3% vs 2%).
    Infections
    In subjects with ulcerative colitis, serious or other clinically significant infections included gastroenteritis and pneumonia. In addition, listeriosis and ophthalmic herpes zoster were reported in one subject each
    Malignancies
    With up to one year of treatment in the ulcerative colitis clinical trials, 0.4% of ustekinumab-treated subjects (0.48 events per hundred patient-years) and 0.0% of subjects receiving placebo (0.00 events per hundred patient-years) developed non- melanoma skin cancer. Malignancies other than non-melanoma skin cancers occurred in 0.5% of ustekinumab-treated subjects (0.64 events per hundred patient-years) and 0.2% of subjects receiving placebo (0.40 events per hundred patient-years).
    3.2Immunogenicity
    The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of ustekinumab or of other ustekinumab products. Approximately 6 to 12.4% of subjects treated with ustekinumab in clinical trials in subjects with plaque psoriasis and psoriatic arthritis developed antibodies to ustekinumab, which were generally low-titer. In clinical trials in subjects with plaque psoriasis, antibodies to ustekinumab were associated with reduced or undetectable serum ustekinumab concentrations and reduced efficacy. In trials in subjects with plaque psoriasis, the majority of subjects who were positive for antibodies to ustekinumab had neutralizing antibodies.
    In clinical trials in subjects with Crohn's disease and ulcerative colitis, 2.9% and 4.6% of subjects, respectively, developed antibodies to ustekinumab when treated with ustekinumab for approximately one year. No apparent association between the development of antibodies to ustekinumab and the development of injection site reactions was seen.
    3.3Postmarketing Experience
    The following adverse reactions have been reported during post-approval use of ustekinumab products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to ustekinumab product exposure.
    Immune system disorders: Hypersensitivity reactions (e.g., anaphylaxis, angioedema, dyspnea, rash, urticaria), including a fatal case that presented with chest tightness and dyspnea during infusion of the first dose.
    Infections and infestations: Lower respiratory tract infection (including opportunistic fungal infections and tuberculosis).
    Neurological disorders: Posterior Reversible Encephalopathy Syndrome (PRES).
    Respiratory, thoracic and mediastinal disorders: Interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia.
    Skin reactions: Pustular psoriasis, erythrodermic psoriasis, hypersensitivity vasculitis.
    4OVERDOSAGE
    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.
    5DESCRIPTION
    Ustekinumab-ttwe, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons.
    PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3.
    PYZCHIVA for Subcutaneous Use
    Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover.
    Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled autoinjector.
    Each 0.5 mL prefilled syringe, prefilled PYZCHIVA AUTOINJECTOR or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg).
    Each 1 mL prefilled syringe or prefilled PYZCHIVA AUTOINJECTOR delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg).
    PYZCHIVA for Intravenous Infusion
    Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper.
    Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).
    6REFERENCES
    1 Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence - SEER 6.6.2 Regs Research Data, Nov 2009 Sub (1973–2007) - Linked To County Attributes - Total U.S., 1969– 2007 Counties, National Cancer Institute, DCCPS, Surveillance Research Program, Surveillance Systems Branch, released April 2010, based on the November 2009 submission.
    7HOW SUPPLIED/STORAGE AND HANDLING
    PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution. It is supplied as individually packaged, single-dose prefilled syringe, single-dose prefilled PYZCHIVA AUTOINJECTOR or single-dose vial.
    For Subcutaneous Use
    Prefilled Syringes
    • 45 mg/0.5 mL (NDC 61314-651-01)
    • 90 mg/mL (NDC 61314-652-01)
    Each prefilled syringe is equipped with a 29 gauge fixed ½ inch needle, a needle safety guard, and a needle cover that is not made with natural rubber latex.
    Prefilled Autoinjector (PYZCHIVA AUTOINJECTOR)
    • 45 mg/0.5 mL (NDC 61314-651-96)
    • 90 mg/mL (NDC 61314-652-96)
    Single-dose Vial
    •   45 mg/0.5 mL (NDC 61314-651-94)
    For Intravenous Infusion
    Single-dose Vial
    • 130 mg/26 mL (5 mg/mL) (NDC 61314-654-94)
    Storage and Stability
    Store PYZCHIVA vials, prefilled syringes, and prefilled PYZCHIVA AUTOINJECTORs refrigerated between 2°C to 8°C (36°F to 46°F). Store PYZCHIVA vials upright. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.
    If needed, individual prefilled syringes, and prefilled PYZCHIVA AUTOINJECTORs may be stored at room temperature up to 30°C (86°F) for a maximum single period of up to 35 days in the original carton to protect from light. If not used within 35 days of room temperature storage, discard the prefilled syringe and prefilled PYZCHIVA AUTOINJECTOR. The prefilled syringe, and prefilled PYZCHIVA AUTOINJECTOR may be returned to the refrigerator one time only for a maximum of 60 days. If not used within 60 days, discard the prefilled syringe and prefilled PYZCHIVA AUTOINJECTOR. Record the date when the prefilled syringe, and prefilled PYZCHIVA AUTOINJECTOR are removed from and returned to the refrigerator on the carton in the space provided.
    Do not use PYZCHIVA after the expiration date on the carton or on the prefilled syringe.
    8PATIENT COUNSELING INFORMATION
    Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
    Infections
    Inform patients that PYZCHIVA may lower the ability of their immune system to fight infections and to contact their healthcare provider immediately if they develop any signs or symptoms of infection
    Malignancies
    Inform patients of the risk of developing malignancies while receiving PYZCHIVA
    Serious Hypersensitivity and Reactions
    • Inform patients that serious hypersensitivity reactions have been reported with intravenous and subcutaneous administration of ustekinumab products. Instruct patients to discontinue Pyzchiva and seek immediate medical attention if they experience any signs or symptoms of hypersensitivity reactions
    Posterior Reversible Encephalopathy Syndrome (PRES)
    Inform patients to immediately contact their healthcare provider if they experience signs and symptoms of PRES (which may include headache, seizures, confusion, or visual disturbances)
    Immunizations
    Inform patients that PYZCHIVA can interfere with the usual response to immunizations and that they should avoid live vaccines
    Administration
    Instruct patients to follow sharps disposal recommendations, as described in the Instructions for Use.
    Manufactured by:
    Samsung Bioepis Co., Ltd.,
    76, Songdogyoyuk-ro, Yeonsu-gu, Incheon, 21987, Republic of Korea
    U.S. License No. 2046
    Manufactured for:
    Sandoz Inc.
    Princeton, NJ 08540
    9mg Carton Label 
    NDC 61314-651-01
    Pyzchiva® 45 mg/0.5 mL
    (ustekinumab-ttwe)
    Injection
    For subcutaneous use
    Contains one 45 mg/0.5 mL syringe
    Recommended Dosage: See Prescribing Information
    ATTENTION: Dispense the enclosed
    Medication Guide to each patient.
    SAMSUNG BIOEPIS
    10mg Carton Label
    NDC 61314-652-01
    90mg-carton
    11mg Carton Label
    NDC 61314-654-94
    SAMSUNG BIOEPIS
    image description
    12mg Carton Label
    NDC 61314-651-94
    SAMSUNG BIOEPIS
    Pyzchiva has been selected.