Brineura, an enzyme replacement, is the first and only product to treat CLN2 disease.
Brineura is administered to the cerebrospinal fluid via intraventricular infusion.
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Brineura is contraindicated in patients with:
Brineura has not been studied in pregnancy or lactation.
Safety and effectiveness in pediatric patients below 3 years of age have not been established.
What is the most important information I should know about Brineura?
Administration: Brineura is only given by infusion into the fluid of the brain (known as an intraventricular injection) and using sterile technique to reduce the risk of infection. An intraventricular access device or port must be in place at least 5 to 7 days prior to the first infusion.
Meningitis and other device-related infections: Intraventricular access device-related infections, including meningitis, were observed with Brineura treatment. Infections required treatment with antibiotics and removal of the access device. If any signs of infection or meningitis occur, contact your child’s doctor immediately. The signs and symptoms of infections may not be readily apparent in patients with CLN2 disease.
The most common side effects reported during Brineura infusions included: