USTEKINUMAB (Stelara): What is used for?

What is Ustekinumab?

Ustekinumab is a active ingredient used to treat Crohn’s Disease, Psoriasis, Psoriatic Arthritis and Plaque Psoriasis.

Ustekinumab’s brand name in United States is Stelara.

Mechanism of action (MOA) of Ustekinumab

Inhibits the activity of human cytokines IL-12 and IL-23 by preventing the binding of these cytokines to their receptor protein IL-12Rß1, expressed on the surface of immune cells.
Ustekinumab is believed to interrupt signalling and cytokine cascades associated with psoriatic pathology.

Therapeutic indications, uses and benefits of Ustekinumab

Moderate to severe plaque psoriasis in adults who do not respond, are contraindicated, or do not tolerate other systemic treatments, including cyclosporine, methotrexate, or PUVA (psoralene and ultraviolet A).

Pediatric psoriasis moderate to severe plaque in adolescents ≥12 years, who have presented an inadequate response, or are intolerant to other systemic therapies, or phototherapies.

Psoriatic arthritis. Alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological treatments with disease-modifying anti-rheumatic drugs (DMARDs) has been inadequate.

Moderate to severe active Crohn’s disease in adults who have had an inadequate response, have a loss of response, are intolerant to conventional treatment or TNFalfa antagonists, or have medical contraindications to those treatments.

Dosage of Ustekinumab

Moderate to severe plaque psoriasis and active psoriatic arthritis. Subcutaneous. Adults: initial 45 mg, followed by another dose of 45 mg 4 weeks later and every 12 weeks thereafter. Patients body weight >100 kg: administer 90 mg instead of 45 mg. Suspend if there is no response after 28 weeks.

Moderate to severe pediatric plaque psoriasis in ≥12 year olds. Subcutaneous. Recommended dose based on body weight. Administered at 0 and 4 weeks, then every 12 weeks. Body weight <60 kg: 0.75 mg/kg to ; body weight ≥60-≤100 kg: 45 mg; body weight>100 kg: 90 mg.
To calculate injection volume (ml) for <60 kg, use the formula: body weight (kg) x 0.0083 (ml/kg). The calculated volume should be rounded to the nearest 0.01 ml and administered using a 1 ml graduated syringe.

Crohn’s disease. Adults: First dose of ustekinumab is administered intravenously. Recommended single dose: 6 mg/kg. The first subcutaneous dose of 90 mg should be administered in the week 8 after the intravenous dose.
After this, administer one dose every 12 weeks. If there is no adequate response 8 weeks after the first subcutaneous dose, a second subcutaneous dose may be given at that time. If there is no response to the 12-week regimen, it may be given every 8 weeks. Continue with the regimen every 8 weeks or every 12 weeks according to clinical criteria.

Suspend treatment if there are no indications of therapeutic benefit in the 16th week or after 16 weeks of changing to the 8-week pattern. The administration of immunomodulators and/or corticosteroids may be maintained during treatment.
If there is a response to treatment with ustekinumab, corticosteroids may be reduced or discontinued in accordance with usual care practices.

Mode of administration of Ustekinumab

– Concentrate for solution for infusion 130 mg: administered exclusively intravenously, must be administered for at least one hour.

– Injectable solution 45 and 95 mg are administered by subcutaneous injection. As far as possible, areas of the skin showing psoriasis should be avoided as injection sites.
After having learned the technique of subcutaneous injection correctly, patients may be able to inject themselves if the physician considers it appropriate.


Hypersensitivity to ustekinumab, clinically important active infections (e.g. active tuberculosis).

Warnings and precautions with Ustekinumab

Liver failure, renal failure, increases the risk of infections and reactivates latent infections, chronic infection or history of recurrent infections; do not administer in active tuberculosis.

Concomitant use with other immunosuppressants, including biological ones, or with phototherapy or during the transition after administration of other immunosuppressants (use extreme caution). History of cancer.

Older patients, higher incidence of infections. Children < 12 years (plaque psoriasis, psoriatic arthritis) and < 18 years (Crohn’s disease), not established safety and efficacy.
Risk of malignant tumors, cutaneous and noncutaneous, severe hypersensitivity reactions.

Do not administer live virus or bacteria vaccines. Use contraceptive measures (during and up to 15 weeks after treatment). Risk of developing erythrodermal psoriasis (patients with plaque psoriasis), pay attention to symptoms of erythrodermal psoriasis or exfoliative dermatitis, if appropriate treatment is instituted.

Liver failure

Caution (lack of studies). Dosage recommendations cannot be made.

Kidney failure

Caution (lack of studies). Dosage recommendations cannot be made.

Interactions with Ustekinumab

Do not administer concomitant with live attenuated vaccines.

Pregnancy and Ustekinumab

There is no data. As a precaution, it is preferable to avoid use in pregnancy.


It is not known whether it is excreted in human breast milk.
Animal studies have shown excretion at low concentrations in breast milk.

It is not known whether ustekinumab is absorbed systemically after ingestion. Given the potential of ustekinumab to produce adverse reactions in infants, the decision to discontinue breastfeeding during treatment and up to 15 weeks after treatment or to discontinue treatment should be made taking into account the beneficial effects of breastfeeding for the child and the benefits of treatment for the woman.

Adverse reactions and side effects of Ustekinumab

Upper respiratory tract infection, nasopharyngitis, dental infections; dizziness, headache; pharyngeal pain; diarrhea, nausea; itching; back pain, myalgias; tiredness, erythema at the injection site.


Source: The content of this active ingredient has been written taking into account the clinical and molecular information of all medicines authorised and marketed in the United States under the Unique Ingredient Identifier (UNII) by the Substance Registration System (SRS) of the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP).

In order to know in detail the information authorized by the FDA for each drug, you should consult the corresponding medication guide authorized by the FDA.


NCI Thesaurus: C84237

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