Special Warning : אזהרת שימוש

4.4       Special warnings and precautions for use
Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Infections

Bimekizumab may increase the risk of infections such as upper respiratory tract infections and oral candidiasis (see section 4.8).

Caution should be exercised when considering the use of bimekizumab in patients with a chronic infection or a history of recurrent infection. Treatment with bimekizumab must not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated (see section 4.3).

Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops an infection, the patient should be carefully monitored. If the infection becomes serious or is not responding to standard therapy, bimekizumab treatment should be discontinued until the infection resolves.

Pre-treatment evaluation for tuberculosis (TB)

Prior to initiating treatment with bimekizumab, patients should be evaluated for TB infection.
Bimekizumab should not be given in patients with active TB (see section 4.3). Patients receiving bimekizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating bimekizumab in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed.


Inflammatory bowel disease

Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab (see section 4.8). Bimekizumab is not recommended in patients with inflammatory bowel disease. 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 and appropriate medical management should be initiated.

Hypersensitivity

Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated.

Vaccinations
Prior to initiating therapy with bimekizumab, completion of all age appropriate immunizations according to current immunization guidelines should be considered.

Live vaccines should not be given in patients treated with bimekizumab.

Patients treated with bimekizumab may receive inactivated or non-live vaccinations. Healthy individuals who received a single 320 mg dose of bimekizumab two weeks prior to vaccination with an inactivated seasonal influenza vaccine had similar antibody responses compared to individuals who did not receive bimekizumab prior to vaccination.

Important information about some of the ingredients:
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially “sodium free”.

Effects on Driving

4.7   Effects on ability to drive and use machines

Bimzelx has no or negligible influence on the ability to drive and use machines.