General Information
Manufacturer: UCB
Medical Name: Bimekizumab-bkzx
Purpose: Bimzelix is indicated for the treatment of adult patients with active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation, active ankylosing spondylitis, moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and moderate-to-severe hidradenitis suppurativa.
Side Effects
| Side-Effect | Percent Affected |
|---|---|
| Headache | 22% |
| Upper respiratory tract infections | 10% |
| Oral candidiasis (thrush) | 10% |
| Injection site reactions: Pain, redness, or swelling at the injection site. | NA% |
| Tinea infections: Fungal infections on the skin (e.g., athlete's foot), affecting about of people. | 3% |
| Gastroenteritis: Stomach flu | 2% |
| Herpes simplex infections: Cold sores | 1% |
| Acne | 1% |
| Folliculitis: Small red bumps on the skin | 1% |
| Fatigue | 1% |
Serious but Less Common Side Effects
| Side Effect | Description |
|---|---|
| Gastrointestinal issues | Diarrhea, abdominal pain, and sometimes symptoms of inflammatory bowel disease, such as blood in the stool. |
| Liver problems | Symptoms can include nausea, vomiting, or jaundice (yellowing of the skin and eyes). |
| Suicidal thoughts and behavior | These have been reported in some patients, so it's important to monitor for any changes in mood or behavior and seek medical attention if they occur. |
| Serious infections | Though rare, more serious infections can occur. Bimzelx should not be taken with an active, significant infection. |
Preconditions
| Precondition | Description |
|---|---|
| Active Infection | Do not start treatment in a patient with any clinically important active infection until it is resolved or adequately treated. Patients with a history of chronic or recurrent infections should be prescribed Bimzelx with caution. |
| Tuberculosis (TB) | Patients must be evaluated for TB infection prior to beginning treatment. Bimzelx should not be used in patients with active TB infection. Latent TB must be treated before starting Bimzelx. |
| Hypersensitivity | The medicine is contraindicated in patients who have a known allergy or severe sensitivity to the active substance (bimekizumab) or any of the other ingredients. |
| Inflammatory Bowel Disease (IBD) | Cases of new onset or worsening IBD (e.g., Crohn's disease or ulcerative colitis) have been reported with IL-17 inhibitors. Use of Bimzelx should be avoided in patients with active IBD, and patients should be monitored for signs and symptoms during treatment. |
| Liver Disease | Bimzelx should be avoided in patients with acute liver disease or cirrhosis due to an increased risk for severe hepatic injury. Liver enzymes should be tested at baseline and periodically during treatment. |
| Suicidal Ideation/Behavior | A causal association has not been definitively established, but prescribers should weigh the potential risks and benefits in patients with a history of severe depression or suicidal ideation/behavior. Patients, their caregivers, and families should be advised to monitor for mood changes and seek medical attention if any occur. |
| Vaccinations | Live vaccines should not be given concurrently with Bimzelx treatment. Patients should complete all age-appropriate vaccinations according to current guidelines prior to initiating therapy. |