nistration Kit for use with Brineura components [see How Supplied/Storage and Handling (16)].
2.2 Dosage
The recommended dosage of Brineura in pediatric patients 3 years of age and older is 300 mg administered once every other week by intraventricular infusion. Administer Brineura first followed by infusion of the Intraventricular Electrolytes each at an infusion rate of 2.5 mL/hr. The complete Brineura infusion, including the required infusion of Intraventricular Electrolytes, is approximately 4.5 hours.
Pre-treatment of patients with antihistamines with or without antipyretics or corticosteroids is recommended 30 to 60 minutes prior to the start of infusion.
2.3 Method of Administration
Brineura and the Intraventricular Electrolytes must only be administered by the intraventricular route, using the provided Administration Kit for use with Brineura. Each vial of Brineura and Intraventricular Electrolytes is intended for a single dose only.
Each infusion consists of 10 mL of Brineura followed by 2 mL of Intraventricular Electrolytes. The complete infusion must be administered using an infusion set with a 0.2 micron inline filter. The Intraventricular Electrolytes are used to flush the infusion line, port needle, and intraventricular access device in order to fully administer Brineura and to maintain patency of the intraventricular access device.
2.4 Preparation for Infusion
Gather supplies:
Brineura and Intraventricular Electrolytes Injection vials (package 1 of 2) [see How Supplied/Storage and Handling (16)]
Administration Kit for use with Brineura (package 2 of 2) [see How Supplied/Storage and Handling (16)]
Syringe pump (not supplied)
Inspect the Administration Kit infusion components to ensure the components are in the individual packages and have not been compromised.
Thaw Brineura and Intraventricular Electrolytes Injection vials at room temperature for approximately 60 minutes. Do not thaw or warm vials any other way. Do not shake vials. Condensation will occur during thawing period. Do not re‑freeze vials or freeze syringes containing Brineura or Intraventricular Electrolytes.
Inspect fully thawed Brineura and Intraventricular Electrolytes Injection vials. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Brineura is a clear to slightly opalescent and colorless to pale yellow solution. Intraventricular Electrolytes is a clear to colorless solution. Do not use if the solutions are discolored or if there is other foreign particulate matter in the solutions. Brineura vials may occasionally contain thin translucent fibers or opaque particles. These naturally occurring particles are cerliponase alfa. These particles are removed via the 0.2 micron inline filter without having a detectable effect on the purity or strength of Brineura. Intraventricular Electrolytes may contain particles, which appear during the thaw period; however, these dissolve when the solution reaches room temperature.
2.5 Intraventricular Infusion Procedure
Intraventricular Infusion of Brineura
Figure 1 represents the intraventricular infusion system set up. Use aseptic technique during the infusion. Follow the steps below to proceed with the intraventricular infusion.
Figure 1
Figure 1
1. Use aseptic technique when preparing the Brineura syringe for infusion. Label one steri |
