Bimzelx 160mg pre-filled syringe and pre-filled pen

Bimzelx 160mg pre-filled syringe and pre-filled pen are now available on the High-Tech Medicine Scheme for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Each pre-filled device contains 160mg of bimekizumab in 1ml. Bimekizumab, a new active substance, is a humanised IgG1 monoclonal antibody produced in a genetically engineered Chinese hamster ovary (CHO) cell line by recombinant DNA technology. Bimzelx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis.

Mode of action

Bimekizumab is a humanised IgG1/κ monoclonal antibody that selectively binds with high affinity to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex. Elevated concentrations of IL-17A and IL-17F have been implicated in the pathogenesis of several immune-mediated inflammatory diseases including plaque psoriasis. Bimekizumab inhibits these proinflammatory cytokines, resulting in the normalization of skin inflammation and therefore improvement in clinical symptoms associated with psoriasis.

Posology

The recommended dose for adult patients with plaque psoriasis is 320mg (given as two subcutaneous injections of 160mg each), at week 0, 4, 8, 12, 16 and every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who have shown no improvement after 16 weeks. Suitable areas for injection include the thigh, abdomen, and upper arm. Injection sites should be rotated, and injections should not be given into psoriasis plaques or areas where the skin is tender, bruised, erythematous, or indurated. The pre-filled syringe or pre-filled pen must not be shaken. After proper training in subcutaneous injection technique, patients may self-inject Bimzelx if their consultant determines that it is appropriate, and with medical follow-up, as necessary. Patients should be instructed to inject the full amount of Bimzelx according to the instructions for use provided in the package leaflet.

Special warnings and precautions for use

• To improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded;
• Bimekizumab may increase the risk of infections such as upper respiratory tract infections and oral candidiasis. Treatment with Bimekizumab must not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated;
• Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur;
• Bimekizumab should not be given to patients with active TB, and all patients should be monitored for signs and symptoms of active TB;
• Cases of new or exacerbations of pre-existing inflammatory bowel disease have been reported with Bimekizumab. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, Bimekizumab should be discontinued;
• If a serious hypersensitivity reaction occurs, administration of Bimekizumab should be discontinued immediately and appropriate therapy initiated;
• Prior to initiating therapy, completion of all immunisations according to current guidelines should be considered. Live vaccines should not be given to patients being treated with Bimekizumab;
• Women of childbearing potential should use an effective method of contraception during treatment, and for at least 17 weeks after treatment;
• As a precautionary measure, it is preferable to avoid the use of Bimzelx during pregnancy; and
• A decision must be made whether to discontinue breast-feeding, or to discontinue/abstain from Bimzelx therapy, considering the benefit of breastfeeding for the child, and the benefit of therapy for the woman.

Adverse reactions

The most commonly reported adverse reactions were infections, neutropenia, hypersensitivity, headache, inflammatory bowel disease, dermatitis, eczema, acne, injection site reactions, and fatigue.

EU authorisation and pack size details

• The pre-filled syringes and pre-filled pens must be stored in the refrigerator (2°-8°C);
• They should be kept in the outer carton to protect from light;
• They may be stored at room temperature (up to 25°C) for a maximum of25 days. Once removed from the refrigerator and stored under theseconditions, the injections must be discarded after 25 days or by the expiry date printed on the container, whichever occurs first.A field for the date is provided on the carton to record the date removed from the refrigerator; and
• Bimzelx was first authorised in the EU in August 2021 and was added to the IPU Product File with the June 2023 update, following addition to the High-Tech Scheme by the HSE.

High Tech Numbers:

Bimzelx 160mg solution for injection pre-filled pen           2 pens                   89277

Bimzelx 160mg solution for injection pre-filled syringe   2 syringes            89278