General Information
Manufacturer: UCB
Medical Name: zilucoplan
Purpose:Zilbrysq is a treatment for adults with gMG who are anti-acetylcholine receptor (AChR) antibody positive.
Myasthenia gravis (MG) is a rare, chronic autoimmune disorder involving your nerves and muscles. Generalized myasthenia gravis (gMG) is a more severe type of MG that can weaken muscles throughout the body.
Common Side Effects
| Side Effect | Percentage Affected | Placebo Affected |
|---|---|---|
| Injection site reactions | 29% | 16% |
| Upper respiratory tract infections | 14% | 7% |
| Diarrhea | 11% | 2% |
| Urinary tract infection | 8% | 5% |
| Nausea or vomiting | 8% | 7% |
| Increased lipase levels (a pancreatic enzyme identified by blood tests) | 7% | 0% |
| Increased amylase levels (another pancreatic enzyme) | 5% | 1% |
Serious Side Effects
| Side Effect | Description |
|---|---|
| Serious Infections | Occurred in approximately 32% of patients in one pooled analysis, with fatal infections reported in 2% of previously untreated CLL patients. |
| Bleeding Problems | Bleeding events of any grade (excluding bruising) occurred in 22-40% of patients, while major hemorrhage occurred in 3.0-4.4% of patients. |
| Heart Rhythm Problems | Atrial fibrillation or flutter of any grade occurred in 4.1-5% of patients, with serious (Grade >= 3 events in about 1.1-1.3%. |
| Second Primary Cancers | Occurred in 12% of patients in clinical trials, with skin cancer being the most frequent. |
Medical Preconditions
| Precondition | Description |
|---|---|
| Active Meningococcal Infection | The initiation of Zilbrysq treatment is strictly contraindicated in patients who have an unresolved, serious infection caused by Neisseria meningitidis bacteria. ZILBRYSQ, as a complement inhibitor, increases a patient's susceptibility to life-threatening or fatal meningococcal infections. |
| Hypersensitivity | Zilbrysq should not be used in patients with a known hypersensitivity to zilucoplan, any non-medicinal ingredient, or component of the container. |
Preconditions for Safe Use (Risk Evaluation and Mitigation Strategy - REMS)
- Patients must be vaccinated against meningococcal disease (serogroups A, C, W, Y, and B) according to current ACIP recommendations, with vaccination completed at least two weeks before the first dose of ZILBRYSQ.
- If urgent treatment is needed before vaccination can be completed, antibacterial prophylaxis should be administered, and vaccinations should follow as soon as possible.
- Patients require close monitoring for signs of infection and should receive a Patient Safety Card.