What are the precautions for Bimekizumab?

In clinical studies of Bimekizumab, warnings and precautions such as suicidal ideation and behavior, infection, tuberculosis, liver biochemical abnormalities, and inflammatory bowel disease have emerged. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity. Complete all age-appropriate vaccinations according to current immunization guidelines before initiating bimeclizumab treatment. Avoid use of live vaccines in patients receiving bimeclizumab.

1. Suicidal ideation and behavior: During the 16-week placebo-controlled Ps-1 and Ps-2 trials, the incidence of suicidal ideation was reported to be higher in subjects treated with bimezumab than in subjects treated with placebo. In psoriasis clinical trials, suicidal ideation and behavior are prospectively monitored using the Columbia Suicide Severity Rating Scale (C-SSRS), an interview-based tool that monitors the presence and severity of suicidal ideation (ranging from"none" to "active suicidal ideation with specific plan and intent") and behavior (assessing the harm and potential lethality of self-injury, if present).

Before using bimelizumab in patients with a history of severe depression or suicidal ideation or behavior, prescribers should weigh the potential risks and benefits. Advise patients, their caregivers, and families to monitor for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, they are advised to seek medical attention promptly. Patients receiving bimeclizumab should be referred to a mental health professional as appropriate if they develop new or worsening depressive symptoms or suicidal ideation and/or behavior. If such an event occurs, prescribers should also reassess the risks and benefits of continued treatment with bimezumab.

2. Infection: Bimezumab may increase the risk of infection. In clinical trials, after 16 weeks of treatment, 36% of the mezizumab group developed infections, including upper respiratory tract infections, candida infections, ringworm infections, gastroenteritis and herpes simplex infections more frequently. Do not treat patients with any clinically important active infection with bimelizumab until the infection has resolved or been adequately treated. For patients with chronic infections or a history of recurrent infections, the risks and benefits should be considered before prescribing bimelizumab. Instruct patients to seek medical advice if clinically important signs or symptoms of infection occur. If a patient develops such an infection or does not respond to standard treatment, the patient should be monitored closely and bimeclizumab should be discontinued until the infection resolves.

3. Tuberculosis: Before starting treatment with bimezumab, assess the patient for tuberculosis (TB) infection. Avoid the use of bimeclizumab in patients with active tuberculosis infection. Before starting bimeclizumab, initiate treatment for latent tuberculosis. Consider antituberculous therapy before initiating bimeclizumab in patients with a past history of latent or active tuberculosis and for whom an adequate course of treatment cannot be determined. Monitor patients receiving bimezumab closely for signs and symptoms of active tuberculosis during and following treatment.

4. Liver biochemical abnormalities: In randomized clinical trials, bimezumab treatment was associated with an increased incidence of elevated liver enzymes compared with placebo treatment. Hepatic serum aminotransferase elevations more than 3 times the upper limit of normal have been reported in subjects treated with bimetizumab. The elevated hepatic serum aminotransferases resolved after discontinuation of bimeclizumab. The onset of these adverse reactions varied between 28 and 198 days after initiating bimeclizumabtreatment.

During bimeclizumab treatment, measure liver enzymes, alkaline phosphatase, and bilirubin at baseline periodically according to routine patient management. If treatment-related elevations in liver enzymes occur and drug-induced liver injury is suspected, interrupt bimelizumab until the diagnosis of liver injury is ruled out. Bimezumab should be permanently discontinued in patients with combined elevations causally related to transaminases and bilirubin. Patients with acute liver disease or cirrhosis may be at increased risk of severe liver injury; avoid use of bimezumab in these patients.

5. Inflammatory bowel disease: Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors (including bimeclizumab). Patients with active IBD should avoid the use of bimezumab . During treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if there is a new onset or worsening of signs and symptoms.

The generic drug Bimeizumab has not yet been launched in the country, so it cannot be included in medical insurance. The European version of bimezumab original drug sold overseas, specifications160mg*2 per box may cost more than 40,000 yuan (the price may fluctuate due to the exchange rate). The price is still relatively high. There is currently no generic version of bimezumab produced and launched. For the specific price and drug information of this drug, please consult a medical consultant.