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cerliponase alfa
Overview
What is Brineura?
Cerliponase alfa is a purified human enzyme produced by recombinant DNA technology in a Chinese hamster ovary cell line. The active substance is a recombinant human tripeptidyl peptidase-1 (rhTPP1), a lysosomal exopeptidase. The primary activity of the mature enzyme is the cleavage of N-terminal tripeptides from a broad range of protein substrates.
Cerliponase alfa contains 544 amino acids with an average molecular mass of 59 kDa. The mature enzyme is 368 amino acids in length. There are 5 consensus N-glycosylation sites on rhTPP1 that contain high mannose, phosphorylated high mannose and complex glycosylation structures.
Brineura (cerliponase alfa) Injection and Intraventricular Electrolytes Injection are administered by intraventricular infusion. The solutions are sterile, nonpyrogenic, and free of foreign particulates. Brineura is a clear to slightly opalescent and colorless to pale yellow solution. Intraventricular Electrolytes is a clear to colorless solution.
Brineura and Intraventricular Electrolytes Injection are packaged in 10 mL clear Type 1 single-dose glass vials Each vial of Brineura provides 5 mL of solution containing 150 mg cerliponase alfa. Each vial of Intraventricular Electrolytes Injection provides 5 mL of solution. Both Brineura and Intraventricular Electrolytes Injection are formulated with the following excipients: calcium chloride dihydrate (1.05 mg); magnesium chloride hexahydrate (0.8 mg); potassium chloride (1.1 mg); sodium chloride (43.85 mg); sodium phosphate, dibasic, heptahydrate (0.55 mg); sodium phosphate, monobasic, monohydrate (0.4 mg); and Water for Injection, USP. The pH of the solution is between 6.2 to 6.8 for Brineura, and between 6.0 to 7.0 for Intraventricular Electrolytes Injection.
Each vial contains: sodium: 0.76 mEq, and potassium: 0.015 mEq.
What does Brineura look like?
What are the available doses of Brineura?
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. ()
What should I talk to my health care provider before I take Brineura?
How should I use Brineura?
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.
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 to the cerebrospinal fluid (CSF) by infusion via a surgically implanted reservoir and catheter. ()
Pre-treatment of patients with antihistamines with or without antipyretics or corticosteroids is recommended 30 to 60 minutes prior to the start of infusion. ()
The recommended dosage is 300 mg administered once every other week as an intraventricular infusion followed by infusion of Intraventricular Electrolytes over approximately 4.5 hours. ()
For complete information on preparation, specific intraventricular access device for use, and administration, see the full prescribing information. (, , , )
What interacts with Brineura?
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What are the warnings of Brineura?
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What are the precautions of Brineura?
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What are the side effects of Brineura?
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What should I look out for while using Brineura?
Brineura is contraindicated in patients with:
What might happen if I take too much Brineura?
Sorry No Records found
How should I store and handle Brineura?
Brineura is supplied as a sterile, clear to slightly opalescent and colorless to pale yellow solution for intraventricular infusion and Intraventricular Electrolytes Injection is supplied as a clear to colorless solution for intraventricular infusion; both are included in package 1 of 2. The Administration Kit for use with Brineura is supplied separately as package 2 of 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.Package 2 of 2The Administration Kit for use with Brineura is supplied separately and contains the following single-use, sterile infusion components: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.Brineura is supplied as a sterile, clear to slightly opalescent and colorless to pale yellow solution for intraventricular infusion and Intraventricular Electrolytes Injection is supplied as a clear to colorless solution for intraventricular infusion; both are included in package 1 of 2. The Administration Kit for use with Brineura is supplied separately as package 2 of 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.Package 2 of 2The Administration Kit for use with Brineura is supplied separately and contains the following single-use, sterile infusion components: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.Brineura is supplied as a sterile, clear to slightly opalescent and colorless to pale yellow solution for intraventricular infusion and Intraventricular Electrolytes Injection is supplied as a clear to colorless solution for intraventricular infusion; both are included in package 1 of 2. The Administration Kit for use with Brineura is supplied separately as package 2 of 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.Package 2 of 2The Administration Kit for use with Brineura is supplied separately and contains the following single-use, sterile infusion components: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.Brineura is supplied as a sterile, clear to slightly opalescent and colorless to pale yellow solution for intraventricular infusion and Intraventricular Electrolytes Injection is supplied as a clear to colorless solution for intraventricular infusion; both are included in package 1 of 2. The Administration Kit for use with Brineura is supplied separately as package 2 of 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.Package 2 of 2The Administration Kit for use with Brineura is supplied separately and contains the following single-use, sterile infusion components: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.Brineura is supplied as a sterile, clear to slightly opalescent and colorless to pale yellow solution for intraventricular infusion and Intraventricular Electrolytes Injection is supplied as a clear to colorless solution for intraventricular infusion; both are included in package 1 of 2. The Administration Kit for use with Brineura is supplied separately as package 2 of 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.Package 2 of 2The Administration Kit for use with Brineura is supplied separately and contains the following single-use, sterile infusion components: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.Brineura is supplied as a sterile, clear to slightly opalescent and colorless to pale yellow solution for intraventricular infusion and Intraventricular Electrolytes Injection is supplied as a clear to colorless solution for intraventricular infusion; both are included in package 1 of 2. The Administration Kit for use with Brineura is supplied separately as package 2 of 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.Package 2 of 2The Administration Kit for use with Brineura is supplied separately and contains the following single-use, sterile infusion components: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.Brineura is supplied as a sterile, clear to slightly opalescent and colorless to pale yellow solution for intraventricular infusion and Intraventricular Electrolytes Injection is supplied as a clear to colorless solution for intraventricular infusion; both are included in package 1 of 2. The Administration Kit for use with Brineura is supplied separately as package 2 of 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.Package 2 of 2The Administration Kit for use with Brineura is supplied separately and contains the following single-use, sterile infusion components: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.Brineura is supplied as a sterile, clear to slightly opalescent and colorless to pale yellow solution for intraventricular infusion and Intraventricular Electrolytes Injection is supplied as a clear to colorless solution for intraventricular infusion; both are included in package 1 of 2. The Administration Kit for use with Brineura is supplied separately as package 2 of 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.Package 2 of 2The Administration Kit for use with Brineura is supplied separately and contains the following single-use, sterile infusion components: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.Brineura is supplied as a sterile, clear to slightly opalescent and colorless to pale yellow solution for intraventricular infusion and Intraventricular Electrolytes Injection is supplied as a clear to colorless solution for intraventricular infusion; both are included in package 1 of 2. The Administration Kit for use with Brineura is supplied separately as package 2 of 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.Package 2 of 2The Administration Kit for use with Brineura is supplied separately and contains the following single-use, sterile infusion components: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.Brineura is supplied as a sterile, clear to slightly opalescent and colorless to pale yellow solution for intraventricular infusion and Intraventricular Electrolytes Injection is supplied as a clear to colorless solution for intraventricular infusion; both are included in package 1 of 2. The Administration Kit for use with Brineura is supplied separately as package 2 of 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.Package 2 of 2The Administration Kit for use with Brineura is supplied separately and contains the following single-use, sterile infusion components: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.Brineura is supplied as a sterile, clear to slightly opalescent and colorless to pale yellow solution for intraventricular infusion and Intraventricular Electrolytes Injection is supplied as a clear to colorless solution for intraventricular infusion; both are included in package 1 of 2. The Administration Kit for use with Brineura is supplied separately as package 2 of 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.Package 2 of 2The Administration Kit for use with Brineura is supplied separately and contains the following single-use, sterile infusion components: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.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CLN2 disease is a neurodegenerative disease caused by deficiency of the lysosomal enzyme tripeptidyl peptidase-1 (TPP1), which catabolizes polypeptides in the CNS. TPP1 has no known substrate specificity. Deficiency in TPP1 activity results in the accumulation of lysosomal storage materials normally metabolized by this enzyme in the central nervous system (CNS), leading to progressive decline in motor function.
Cerliponase alfa (rhTTP1), a proenzyme, is taken up by target cells in the CNS and is translocated to the lysosomes through the Cation Independent Mannose-6-Phosphate Receptor (CI-MPR, also known as M6P/IGF2 receptor). Cerliponase alfa is activated in the lysosome and the activated proteolytic form of rhTPP1 cleaves tripeptides from the N-terminus of proteins.
Non-Clinical Toxicology
Brineura is contraindicated in patients with: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 .
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) . 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 .
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.
The following adverse reactions are described below and elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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