WEZLANA

/ Amgen

Plaque psoriasis
The recommended posology of ustekinumab is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter. Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment. For patients with a body weight > 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy.
Psoriatic arthritis (PsA)
The recommended posology of ustekinumab is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter. Alternatively, 90 mg may be used in patients with a body weight > 100 kg.
Pediatric plaque psoriasis (6 years and older)
The recommended dose of ustekinumab based on body weight
Crohn’s disease and ulcerative colitis
In the treatment regimen, the first dose of ustekinumab is administered intravenously, based on body weight. The first subcutaneous administration of 90 mg ustekinumab should take place at week 8 after the intravenous dose. After this, dosing every 12 weeks is recommended. Patients who lose response on dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks.
See prescribing information for full details.

Plaque psoriasis
Moderate to severe plaque psoriasis in adult patients (18 years or older) who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A).
Pediatric plaque psoriasis
Moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Psoriatic arthritis (PsA)
Ustekinumab is indicated for treating active psoriatic arthritis in adults, either alone or combined with methotrexate, when previous treatment with non-biologic disease-modifying antirheumatic drugs (DMARDs) has not worked adequately.
Crohn’s disease
Adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
Ulcerative colitis
Adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

Hypersensitivity to the active substance or to any of the excipients

Infections
Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections. If a patient develops a serious infection, the patient should be closely monitored and ustekinumab should not be administered until the infection resolves.
Malignancies
Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy. All patients, in particular those greater than 60 years of age, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of skin cancer.
Systemic
Serious hypersensitivity reactions have been reported in the post-marketing setting, in some cases several days after treatment. Anaphylaxis and angioedema have occurred. If an anaphylactic or other serious hypersensitivity reaction occurs, appropriate therapy should be instituted and administration of ustekinumab should be discontinued.
Respiratory
Cases of allergic alveolitis, eosinophilic pneumonia, and non-infectious organizing pneumonia have been reported during post-approval use of ustekinumab. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Improvement has been reported after discontinuation of ustekinumab and also, in some cases, administration of corticosteroids.
Cardiovascular events
Cardiovascular events including myocardial infarction and cerebrovascular accident have been observed in patients with psoriasis exposed to ustekinumab in a post-marketing observational study. Risk factors for cardiovascular disease should be regularly assessed during treatment.
Vaccinations
It is recommended that live viral or live bacterial vaccines should not be given concurrently with ustekinumab. Before live viral or live bacterial vaccination, treatment with WEZLANA should be withheld for at least 15 weeks after the last dose and can be resumed at least 2 weeks after vaccination. Administration of live vaccines to infants exposed in utero to ustekinumab is not recommended for twelve months following birth or until ustekinumab infant serum levels are undetectable.
Long term treatment with ustekinumab does not suppress the humoral immune response to pneumococcal polysaccharide or tetanus vaccines.
Concomitant immunosuppressive therapy
In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab. In Crohn’s disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of ustekinumab. Caution should be exercized when considering concomitant use of other immunosuppressants and ustekinumab or when transitioning from other immunosuppressive biologics. The safety of using ustekinumab together with other immune-suppressing drugs including biologics, or phototherapy hasn’t been fully studied in psoriasis patients.
Serious skin conditions
As part of the monitoring of the patient’s psoriasis, physicians should be alert for symptoms of erythrodermic psoriasis or exfoliative dermatitis. If these symptoms occur, appropriate therapy should be instituted.
Lupus-related conditions
Cases of lupus-related conditions have been reported in patients treated with ustekinumab, including cutaneous lupus erythematosus and lupus-like syndrome. If lesions occur, especially in sun exposed areas of the skin or if accompanied by arthralgia, the patient should seek medical attention promptly. If the diagnosis of a lupus-related condition is confirmed, ustekinumab should be discontinued and appropriate treatment initiated.
See prescribing information for full details.

Common: Upper respiratory tract infection, nasopharyngitis, sinusitis, Dizziness, headache, Oropharyngeal pain, Diarrhea, nausea, vomiting, Pruritus, Back pain, myalgia, arthralgia, Fatigue, injection site erythema, injection site pain.
See prescribing information for full details.

Live vaccines should not be given concurrently with ustekinumab.
No interaction studies have been performed in humans
See prescribing information for full details.

Women of childbearing potential
Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment.
Pregnancy
Data from a moderate number of prospectively collected pregnancies following exposure to ustekinumab with known outcomes, including more than 450 pregnancies exposed during the first trimester, do not indicate an increased risk of major congenital malformations in the newborn.
However, the available clinical experience is limited. As a precautionary measure, it is preferable to avoid the use of ustekinumab in pregnancy.
Ustekinumab crosses the placenta and has been detected in the serum of infants born to female patients treated with ustekinumab during pregnancy. The clinical impact of this is unknown, however, the risk of infection in infants exposed in utero to ustekinumab may be increased after birth.
Administration of live vaccines to infants exposed in utero to ustekinumab is not recommended for twelve months following birth or until ustekinumab infant serum levels are undetectable. If there is a clear clinical benefit for the individual infant, administration of a live vaccine might be considered at an earlier timepoint, if infant ustekinumab serum levels are undetectable.
Lactation:
Limited data from published literature suggests that ustekinumab is excreted in human breast milk in very small amounts. It is not known if ustekinumab is absorbed systemically after ingestion. Because of the potential for adverse reactions in nursing infants from ustekinumab, a decision on whether to discontinue breast-feeding during treatment and up to 15 weeks after treatment or to discontinue therapy with ustekinumab must be made taking into account the benefit of breast-feeding to the child and the benefit of ustekinumab therapy to the woman.

Single doses up to 6 mg/kg have been administered intravenously in clinical studies without dose-limiting toxicity. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.