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Brineura Generic Name & Formulations
Legal Class
Rx
General Description
Cerliponase alfa 30mg/mL; soln for intraventricular infusion.
Pharmacological Class
Hydrolytic lysosomal N-terminal tripeptidyl peptidase.
How Supplied
Single-dose vials (5mL)—2 (w. Intraventricular Electrolytes 5mL vial) + Administration Kit—1 (infusion supplies)
Manufacturer
Generic Availability
NO
Brineura Indications
Indications
To slow the loss of ambulation in late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.
Brineura Dosage and Administration
Adult
Not applicable.
Children
<3yrs: not established. Give by intraventricular infusion via implanted access device; administer first dose at least 5–7 days post-implantation. Pre-treat with antihistamines ± antipyretics or corticosteroids 30–60mins prior to infusion. Infuse Brineura first, followed by Intraventricular Electrolytes each at a rate of 2.5mL/hr. ≥3yrs: 300mg once every other week. See full labeling.
Brineura Contraindications
Contraindications
Any sign or symptom of acute, unresolved localized infection on or around the device insertion site (eg, cellulitis, abscess). Suspected or confirmed CNS infection (eg, meningitis, cloudy CSF, positive CSF gram stain). Patients with acute intraventricular access device-related complications (eg, leakage, fluid extravasation, device failure) or ventriculoperitoneal shunts.
Brineura Boxed Warnings
Not Applicable
Brineura Warnings/Precautions
Warnings/Precautions
Should be administered by trained healthcare providers. Inspect the scalp to ensure access device is not compromised prior to each infusion. Discontinue if access device-related complications develop. Monitor for meningitis and other device-related infections; obtain CSF sample for cell count and culture prior to each infusion. Have appropriate medical support readily available. Discontinue immediately if anaphylaxis or severe hypersensitivity reactions occur; consider risks/benefits prior to readministration. Monitor BP and HR before starting, during, and post-infusion. History of bradycardia, conduction disorder, structural heart disease: perform ECG during infusion; without cardiac abnormalities: perform ECG every 6 months. Pregnancy. Nursing mothers.
Brineura Pharmacokinetics
See Literature
Brineura Interactions
Interactions
Do not mix with other drugs.
Brineura Adverse Reactions
Adverse Reactions
Pyrexia, ECG abnormalities, CSF protein increase/decrease, vomiting, seizures, hypersensitivity, hematoma, headache, irritability, pleocytosis, device-related infection, bradycardia, feeling jittery, hypotension; meningitis, cardiovascular events.
Brineura Clinical Trials
See Literature
Brineura Note
Not Applicable
Brineura Patient Counseling
See Literature
