Pyzchiva
Authorised
This medicine is authorised for use in the European Union
ustekinumab
MedicineHumanAuthorised
Overview
Pyzchiva is a medicine used to treat:
- 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;
- 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). Pyzchiva may be used alone or in combination with methotrexate (a DMARD);
- moderately to severely active Crohn’s disease (a disease-causing inflammation of the gut) in adults whose condition has not improved enough with other treatments for Crohn’s disease or who cannot receive such treatments;
- moderately to severely active ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding) in adults whose condition has not improved enough with other treatments or who cannot receive such treatments.
Pyzchiva is a ‘biosimilar medicine’. This means that Pyzchiva is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Pyzchiva is Stelara. For more information on biosimilar medicines, see here.
Pyzchiva contains the active substance ustekinumab.
Pyzchiva can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in diagnosing and treating the diseases that Pyzchiva is used for.
In plaque psoriasis and psoriatic arthritis, Pyzchiva is injected under the skin. The first injection is followed by another 4 weeks later, and then one injection every 12 weeks.
In Crohn’s disease and ulcerative colitis, treatment is started with Pyzchiva infusion (drip) into a vein over at least 1 hour. Eight weeks after the infusion, Pyzchiva is injected under the skin. Patients then continue with one injection under the skin every 8 or 12 weeks depending on how well the treatment is working.
Patients or their caregivers may inject Pyzchiva under the skin once they have been trained to do so and if their doctor thinks that this is appropriate.
For more information about using Pyzchiva, see the package leaflet or contact your doctor or pharmacist.
The active substance in Pyzchiva, ustekinumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific target in the body. Ustekinumab attaches to 2 messenger molecules in the immune system called interleukin 12 and interleukin 23. Both are involved in inflammation and other processes that are important in psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. By blocking their activity, ustekinumab reduces the activity of the immune system and the symptoms of the disease.
Laboratory studies comparing Pyzchiva with Stelara have shown that the active substance in Pyzchiva is highly similar to that in Stelara in terms of structure, purity and biological activity. Studies have also shown that giving Pyzchiva produces similar levels of the active substance in the body to giving Stelara.
In addition, a study involving 503 people with moderate to severe chronic plaque psoriasis showed that Pyzchiva was as effective as Stelara in improving symptoms of the disease. After 12 weeks of treatment, PASI scores (a measure of disease severity and area of skin affected) had improved by around 86% in both Pyzchiva and Stelara groups.
Because Pyzchiva is a biosimilar medicine, the studies on effectiveness and safety of ustekinumab carried out with Stelara do not all need to be repeated for Pyzchiva.
The safety of Pyzchiva has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Stelara.
For the complete list of side effects and restrictions of Pyzchiva, see the package leaflet.
The most common side effects with Pyzchiva (which may affect more than 5 in 100 people) include headache and nasopharyngitis (inflammation of the nose and throat).
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pyzchiva has a highly similar structure, purity and biological activity to Stelara and is distributed in the body in the same way. In addition, studies in moderate to severe chronic plaque psoriasis have shown that the safety and effectiveness of Pyzchiva is equivalent to that of Stelara in moderate to severe chronic plaque psoriasis.
All these data were considered sufficient to conclude that Pyzchiva will behave in the same way as Stelara in terms of effectiveness and safety in its authorised uses. Therefore, the Agency’s view was that, as for Stelara, the benefits of Pyzchiva outweigh the identified risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pyzchiva have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Pyzchiva are continuously monitored. Suspected side effects reported with Pyzchiva are carefully evaluated and any necessary action taken to protect patients.
Pyzchiva received a marketing authorisation valid throughout the EU on 19 April 2024.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Pyzchiva
- Active substance
- Ustekinumab
- International non-proprietary name (INN) or common name
- ustekinumab
- Therapeutic area (MeSH)
- Crohn Disease
- Colitis, Ulcerative
- Arthritis, Psoriatic
- Anatomical therapeutic chemical (ATC) code
- L04AC05
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Crohn’s Disease
Pyzchiva 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.
Ulcerative colitis
Pyzchiva is indicated for the treatment of 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 (see section 5.1).
Plaque psoriasis
Pyzchiva 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).
Paediatric plaque psoriasis
Pyzchiva 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).
Psoriatic arthritis (PsA)
Pyzchiva, 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).
Crohn’s Disease
Pyzchiva 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.
Ulcerative colitis
Pyzchiva is indicated for the treatment of 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 (see section 5.1).
News on Pyzchiva
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