Brineura

Thaw cerliponase alfa and Intraventricular Electrolytes injection vials at room temperature for approximately 60 minutes; condensation will occur during thawing period. Do NOT thaw or warm vials any other way. Do NOT shake vials. Do NOT re-freeze vials or freeze syringes containing cerliponase alfa or Intraventricular Electrolytes.
Administer the complete infusion (cerliponase alfa and Intraventricular Electrolytes) using an infusion set with a 0.2 micron inline filter.
Intraventricular Infusion of Cerliponase alfa
Administer pre-medication 30 to 60 minutes prior to the start of infusion.
Using aseptic technique, label 1 sterile syringe "Brineura" and attach the syringe needle.
After removing the green flip-off caps from the 2 cerliponase alfa vials, withdraw a total of 10 mL of cerliponase alfa into the "Brineura" labeled syringe. Do not dilute or mix with any other drug.
Label the infusion line "intraventricular infusion only," attach the syringe containing cerliponase alfa to the extension line, and then connect the extension line to the infusion set with a 0.2 micron inline filter. Prime the infusion components with cerliponase alfa.
Inspect scalp for signs of intraventricular access device leakage or failure and for potential infections. Then, prepare the scalp for intraventricular infusion per institution standard of care.
Insert port needle into intraventricular access device and connect a separate empty sterile single-use luer lock syringe (no larger than 3 mL) to the port needle. Withdraw 0.5 to 1 mL of cerebrospinal fluid (CSF) to check patency of intraventricular access device and send specimen for culture. Do NOT return CSF to intraventricular access device. Routinely send CSF samples for infection monitoring.
Attach the infusion set with 0.2 micron inline filter to the port needle and secure the components per institution standard of care.
Place the "Brineura" syringe into the syringe pump, program pump to deliver at an infusion rate of 2.5 mL/hour, and set the occlusion alarm setting to alert at pressure <= 281 mmHg. Do NOT deliver as a bolus or manually.
Monitor vital signs (blood pressure, heart rate) prior to the start of infusion, periodically during infusion, and post-infusion.
During infusion, periodically inspect the infusion system for signs of leakage or delivery failure.
When the infusion is complete, detach and remove the empty syringe from the pump and disconnect from the tubing.
Storage of thawed product: Use thawed cerliponase alfa immediately. If not used immediately, store unopened vials in the refrigerator at 2 to 8 degrees C and use within 24 hours.
Storage of product in syringes: Use product held in labeled syringes immediately. If not used immediately, store product held in labeled syringes in the refrigerator at 2 to 8 degrees C up to 4 hours prior to infusion.
Intraventricular Infusion of Intraventricular Electrolytes
Intraventricular Electrolytes flush the infusion line, port needle, and intraventricular access device ensuring the full cerliponase alfa dose is administered and also maintain patency of the intraventricular access device.
Administer AFTER cerliponase alfa is complete.
Using aseptic technique, label 1 sterile syringe "Intraventricular Electrolytes" and attach the syringe needle.
After removing the yellow flip-off cap from the Intraventricular Electrolytes Injection vial, withdraw 2 mL of Intraventricular Electrolytes into the "Intraventricular Electrolytes" labeled syringe. Discard the remaining unused portion.
Attach syringe to the extension line.
Place the "Intraventricular Electrolytes" syringe into the syringe pump, program pump to deliver at an infusion rate of 2.5 mL/hour, and set the occlusion alarm setting to alert at pressure <= 281 mmHg. Do NOT deliver as a bolus or manually.
During infusion, periodically inspect the infusion system for signs of leakage or delivery failure.
When the infusion is complete, detach and remove the empty syringe from the pump and disconnect from the infusion line.
Remove the port needle and gently apply pressure. Bandage the infusion site per institution standard of care.
Dispose of the infusion components, needles, unused solutions, and other waste materials in accordance with local requirements.
Storage of thawed product: Use thawed Intraventricular Electrolytes immediately. If not used immediately, store unopened vials in the refrigerator at 2 to 8 degrees C and use within 24 hours.
Storage of product in syringes: Use product held in labeled syringes immediately. If not used immediately, store product held in labeled syringes in the refrigerator at 2 to 8 degrees C up to 4 hours prior to infusion.