usion of Intraventricular Electrolytes at a rate of 2.5 mL per hour.
20. Periodically inspect the infusion system during the infusion for signs of leakage or delivery failure.
21. When the Intraventricular Electrolytes infusion is complete, detach and remove the empty syringe from the pump and disconnect from the infusion line.
22. Remove the port needle. Apply gentle pressure and 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 Brineura and Intraventricular Electrolytes immediately. If not used immediately, store unopened vials in the refrigerator at 2°C to 8°C and use within 24 hours.
Sorage 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°C to 8°C up to 4 hours prior to infusion.
3 DOSAGE FORMS AND STRENGTHS
Injection: Brineura 150 mg/5 mL (30 mg/mL) solution, two single-dose vials per carton co-packaged with Intraventricular Electrolytes Injection 5 mL in a single-dose vial. Brineura is a clear to slightly opalescent and colorless to pale yellow solution. Intraventricular Electrolytes is a clear to colorless solution [see How Supplied/Storage and Handling (16)].
4 CONTRAINDICATIONS
Brineura is contraindicated in patients with:
acute intraventricular access device-related complications (e.g., leakage, device failure, or device-related infection) [see Warnings and Precautions (5.1)].
ventriculoperitoneal shunts.
5 WARNINGS AND PRECAUTIONS
5.1 Intraventricular Access Device‑Related Complications
Brineura must be administered using aseptic technique to reduce the risk of infection. Healthcare professionals should inspect the scalp for skin integrity to ensure the intraventricular access device is not compromised prior to each infusion [see Dosage and Administration (2.5)].
Brineura is contraindicated if there are signs of acute intraventricular access device-related complications (e.g., leakage, device failure or signs of device-related infection such as swelling, erythema of the scalp, extravasation of fluid, or bulging of the scalp around or above the intraventricular access device) [see Contraindications (4)]. In case of intraventricular access device complications, discontinue the Brineura infusion and refer to the device manufacturer’s labeling for further instructions.
The signs and symptoms of device-related infections may not be apparent, therefore, CSF samples should routinely be sent for testing to detect subclinical device infections [see Dosage and Administration (2.5)].
In clinical studies with Brineura, intraventricular access device-related infections were observed in two patients. In each case, antibiotics were administered, the intraventricular access device was replaced, and the patient continued on Brineura treatment.
Material degradation of the intraventricular access device reservoir may occur after approximately 105 perforations of the intraventricular access device. The intraventricular access device may require replacement as soon as, or prior to, 105 administrations of Brineura, equating to approximately 4.3 years of regular administrations.
5.2 Cardiovascular Adverse Reactions
Monitor v |
