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BRINEURA
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Drug Name:

BRINEURA Rx

Generic Name and Formulations:
Cerliponase alfa 30mg/mL; soln for intraventricular infusion.

Company:
BioMarin Pharmaceuticals

Therapeutic Use:

Indications for BRINEURA:

To slow the loss of ambulation in late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.

Adult:

Not applicable.

Children:

<3yrs: not established. See full labeling. 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.

Contraindications:

Patients with acute intraventricular access device-related complications (eg, leakage, device failure, infection) or ventriculoperitoneal shunts.

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. Routinely test CSF samples to detect subclinical device infections. 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. Have appropriate medical treatment available. Discontinue immediately if anaphylaxis or severe hypersensitivity reactions occur. Pregnancy. Nursing mothers.

Interactions:

Do not mix with other drugs.

Pharmacological Class:

Hydrolytic lysosomal N-terminal tripeptidyl peptidase.

Adverse Reactions:

Pyrexia, ECG abnormalities, CSF protein increase/decrease, vomiting, seizures, hypersensitivity, hematoma, headache, irritability, pleocytosis, device-related infection, bradycardia, feeling jittery, hypotension; cardiovascular events.

Generic Availability:

NO

How Supplied:

Single-dose vials (5mL)—2 (w. Intraventricular Electrolytes 5mL vial) + Administration Kit—1 (infusion supplies)

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