After training in the injection technique, patients or caregivers can administer the drug.Vadym Pastukh / iStock / Getty Images Plus / via Getty Images
Résumé
Two new presentations from Wezenla (Utékinumab), 45 mg and 90 mg injectable solution in pre -filled pen, are now available in town and in hospital and indicated only in adults:
- in dermatology in the treatment of psoriasis in moderate to severe plates in the event of failure or intolerance to other systemic treatments;
- in rheumatology, alone or with methotrexate (MTX), in the treatment of active psoriasic rheumatism after failure of a non -biological anti -utomatic basic treatment (DMARD);
- In gastroenterology, in the treatment of moderate to severe Crohn disease after failure to conventional or anti-TNFα treatment.
These pens share the same indications as:
- WHENLA and serial prosecution (hors pédiatry) ;
- Stelara, apart from hemorrhagic rectocolitis (on July 3, 2025).
The bioequivalence between pen and syringe has been demonstrated in a phase I study.
Subcutaneous injection requires training. The pens contain 45 mg/0.5 ml respectively and 90 mg/1 ml.
The instructions specify in particular to leave the pen at room temperature 30 minutes before use, and the recommended injection sites (anterior faces of the thighs or the belly).
LA range Wezenla (Utékinumab), Stelara’s biosimilar, now has two new specialties, available and supported in the city [1] and in the hospital [2] (cf. Framed) :
As a reminder, USTékinumab is a monoclonal antibody that inhibits the activity of the interleukines 12 and 23.
What indications?
Wezenla Injectable solution in pre -filled pen is indicated only in adults:
- and dermatology in the treatment of Psoriasis in moderate to severe plates in the patient who has not responded, or who presents a contraindication, or which is intolerant to other systemic treatments including ciclosporin, methotrexate (MTX) or puvatherapy (psoralene and UVA);
- in rheumatology, alone or in combination with methotrexate (MTX), in the treatment of active psoriatic rheumatism When the patient’s response to a previous non -biological anti -utilumatic background treatment (DMARD) has been inadequate;
- in gastroenterology in the treatment of Crohn’s disease moderately active In the patient with an insufficient response, loss of response or intolerance to conventional treatment or anti-TNFα, or which presents medical contraindication to these treatments.
These new specialties in pre -filled pen at 45 mg and 90 mg have the same indications as:
- Wezenla in pre -filled syringe, already marketed (cf. Our article of November 5, 2024), hors pediatrics ;
- Stelara (reference specialty) 45 mg and 90 mg in pre -filled pen beyond Hemorrhagic rectocolitis (to July 3, 2025).
Bioequivalence between the pen and the pre -filled syringe
In his evaluation notice for the management of Stelara in a pre -filled pen [3]the Transparency Commission (CT) of the High Authority for Health (HAS) cites a phase I study demonstrating bioequivalence between the subcutaneous administration of 90 mg of USTékinumab carried out with the pre-filled pen and that with the pre-filled syringe.
A ready-to-use pre-filled pen for subcutaneous injection
Wezenla 45 mg and 90 mg pre-filled pen are exclusively intended for subcutaneous injection (cf. Illustration). Their use requires prior training by a healthcare professional.
Illust ratio – Le stylo prérempli WHENLA (Extract from the RCP, page 146)
The instructions for using the pre -filled pen are as follows:
- Take it out of the refrigerator and let it return to room temperature for 30 minutes before using it (do not wave it);
- Inspecting the medication that must be clear to opalescent, colorless to light yellow (the presence of air bubbles is not a problem);
- Check the expiration date;
- Remove the cap no more than 5 minutes before injection, as the drug could dry;
- hold the pen to see the window;
- Do not touch and do not push yellow protection;
- Pinch the skin to create a firm surface at the injection site;
- Place the yellow protection at an angle of 90 degrees on the injection site directly against the pinched skin;
- Firmly push the pre -filled pen and keep it pressed (one click is triggered);
- Wait for the window to be completely yellow. The injection can take up to 15 seconds.
The injections are made at the level of the anterior side of a thigh or belly (with the exception of an area 5 cm in diameter around the navel).
If possible, sites should not be used where there are psoriasis lesions and avoid areas with scars, or stretch marks.
Doses and a prescription diagram according to the indications
Each pre -filled down 45 mg pre -filled pen contains 45 mg of USTékinumab in 0.5 ml.
Each pre -filled penmplified pen 90 mg contains 90 mg of USTékinumab in 1 ml.
The color of the label and the size of the pen window differ depending on the doses.
The dose recommendations are defined according to each indication and the weight of the patient (cf. Vidal monographs).
Administrative identity
Wezenla 45 mg et 90 mg:
List in
Prescription reserved for dermatology specialists and services, hepato/gastroenterology, internal medicine and rheumatology
Wezenla 45 mg, 1 0.5 ml pre -filled pen, CIP 3400930310663
Wezenla 90 mg, 1 ml pre -filled pen box, CIP 3400930310670
Refundable at 65 % on exceptional drug prescription [1]
Approval for communities [2]
Public price including tax = 1,128.53 euros (identical price for both specialties) [1]
Registration on the reference list of similar organic groups
Amgen laboratory
