2 DOSAGE AND ADMINISTRATION
2.1 Important Preparation and Administration Information
2.2 Dosage
2.3 Method of Administration
2.4 Preparation for Infusion
2.5 Intraventricular Infusion Procedure
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Intraventricular Access Device‑Related Complications
5.2 Cardiovascular Adverse Reactions
5.3 Hypersensitivity Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
Brineura is indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.
2 DOSAGE AND ADMINISTRATION
2.1 Important Preparation and Administration Information
Aseptic technique must be strictly observed during preparation and administration.
Brineura should be administered by, or under the direction of a physician knowledgeable in intraventricular administration.
Brineura is administered into the cerebrospinal fluid (CSF) by infusion via a surgically implanted reservoir and catheter (intraventricular access device). Brineura is intended to be administered via the Codman® HOLTER RICKHAM Reservoirs (Part Numbers: 82-1625, 82-1621, 82-1616) with the Codman® Ventricular Catheter (Part Number: 82-1650). The intraventricular access device must be implanted prior to the first infusion. It is recommended that the first dose be administered at least 5 to 7 days after device implantation.
Brineura is intended to be administered with the B Braun Perfusor® Space Infusion Pump System. The essential performance requirements for this syringe pump used to deliver Brineura are as follows:
Delivery rate of 2.5 mL/hr with delivery accuracy of +/- 1 mL/hr
Compatible with 20 mL syringes provided in the Administration Kit for use with Brineura
Occlusion alarm setting to ≤ 281 mm Hg
Administer Brineura and the Intraventricular Electrolytes using the provided Admi |
