<p>Wezenla is a medicine used to treat:</p><p> • moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin). It is used in adults and children above the age of 6 years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A). PUVA is a type of treatment where the patient receives a medicine called psoralen, before being exposed to ultraviolet light;</p><p> • active psoriatic arthritis (inflammation of the joints associated with psoriasis) in adults, when the condition has not improved enough with other treatments called disease-modifying anti-rheumatic drugs (DMARDs). Wezenla may be used alone or combined with methotrexate (a DMARD);</p><p> • moderately to severely active Crohn’s disease (a disease-causing inflammation of the gut) in adults and children weighing at least 40 kg whose condition has not improved enough with other treatments or who cannot receive such treatments. Wezenla contains the active substance ustekinumab and is a biological medicine. It is a ‘biosimilar medicine’; this means that Wezenla is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Wezenla is Stelara.</p><p>For more information on biosimilar medicines, see here. </p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p><strong>Crohn’s disease</strong><br><br>Wezenla is indicated for the treatment of 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.</p><p><strong>Pediatric Crohn's disease</strong><br><br>Wezenla is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.<br><br><strong>Plaque psoriasis</strong><br><br>Wezenla is indicated for the treatment of moderate to severe plaque psoriasis in adults 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) (see section 5.1).<br><br><strong>Paediatric plaque psoriasis</strong><br><br>Wezenla is indicated for the treatment of 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 (see section 5.1).<br><br><strong>Psoriatic arthritis (PsA)</strong><br><br>Wezenla, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).</p></div>
Therapeutic Area (MeSH)
ATC Code
L04AC05
ATC Item
N/A
Pharmacotherapeutic Group
Immunosuppressants
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| ustekinumab | N/A | ustekinumab |
EMA Name
Wezenla
Medicine Name
Wezenla
Aliases
N/ANo risk management plan link.
