Bimzelx 160 Mg 2 Prefilled Pen (Refrigerator)

Product Description:

• 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.

How to use:

• 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.

Caution & Warnings:

• 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 peast-feeding, or to discontinue/abstain from Bimzelx therapy, considering the benefit of peastfeeding for the child, and the benefit of therapy for the woman.

Ingredients:

• Bimekizumab 160 Mg