is supplied separately as package 2 of 2 [see Dosage and Administration (2.2)].
Package 1 of 2
Each Brineura (cerliponase alfa) Injection vial has a green flip‑off cap (plastic), and contains 150 mg cerliponase alfa per 5 mL (30 mg/mL).
Each Intraventricular Electrolytes Injection vial has a yellow flip‑off cap (plastic), and contains 5 mL of solution.
Contents of Package 1
NDC Number
Brineura (cerliponase alfa) Injection (2 vials of 150 mg/5 mL)
Intraventricular Electrolytes Injection (1 vial, 5 mL)
68135-811-02
Package 2 of 2
The Administration Kit for use with Brineura is supplied separately and contains the following single-use, sterile infusion components:
Two 20-mL syringes
Two syringe needles (21 G, 25.4 mm)
One extension line
One infusion set with 0.2 micron inline filter
One port needle (22 G, 16 mm)
Storage
Brineura (cerliponase alfa) Injection and Intraventricular Electrolytes Injection:
Store upright in a freezer (‑25°C to ‑15°C) in original carton to protect from light.
Administration Kit for use with Brineura:
Store in original carton separately from Brineura. Do not freeze.
17 PATIENT COUNSELING INFORMATION
Intraventricular Access Device‑Related Complications
Advise patients and caregivers of the risk of device-related infections. If any signs of infection are present, instruct patients to immediately contact their healthcare provider [see Warnings and Precautions (5.1)].
Cardiovascular Adverse Reactions
Advise patients and caregivers that hypotension and/or bradycardia may occur during and following the infusion of Brineura. Instruct patients immediately to contact their healthcare provider if these reactions occur [see Warnings and Precautions (5.2)]
Hypersensitivity Reactions
Advise patients and caregivers that hypersensitivity reactions related to Brineura treatment, including fever, vomiting, and irritability may occur. Due to the potential for anaphylaxis, inform patients and caregivers of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs and symptoms occur [see Warnings and Precautions (5.3)].
Manufactured by:
BioMarin Pharmaceutical Inc.
Novato, CA 94949
US License Number 1649
1-866-906-6100 (phone)
Codman® and the B Braun Perfusor® are the registered trademarks of their respective owners and are not trademarks of BioMarin® Pharmaceutical Inc.
BRINEURA CARTON
NDC 68135-811-02
BrineuraTM
(cerliponase alfa)
Injection
150 mg/5 mL (30 mg/mL)
For Intraventricular Infusion only
Single-Dose Only
Each vial of Brineura™ contains 150 mg cerliponase alfa in 5 mL of solution (30 mg/mL)
No preservatives
Discard unused portion.
Brineura™ and Intraventricular Electrolytes must be administered with the Administration Kit provided.
Each carton contains:
2 vials, each containing Brineura™ (cerliponase alfa) Injection, 150 mg/5 mL
1 vial of Intraventricular Electrolytes Injection, 5 mL
Package 1 of 2
Administration Kit is supplied and stored separately as package 2 of 2.
Rx Only
BioMarin®
BRI-Carton
CLOSE
BRINEURA VIAL
NDC 68135-500-00
BrineuraTM
(cerliponase alfa)
Injection
150 mg/5 mL (30 mg/mL)
For Intraventricular Infusion Only
Use before Intraventricular Eletrolytes
Brineura V |
