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Brineura

  • Brand Name – Brineura
  • Active Ingredient – Cerliponase alfa
  • Strength – 150 mg/5 ml (30 mg/ml)
  • Originator Name/Marketing-authorisation Holder – Biomarin

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What is Brineura?

Briniura medicine contains cerliponase alfa, a purified human enzyme produced by recombinant DNA technology in a Chinese hamster ovary cell line. The active ingredient is a recombinant human tripeptidyl peptidase-1 (rhTPP1), a lysosomal exopeptidase. And the primary activity of the mature enzyme is the breakdown of N-terminal tripeptides from a broad range of protein substrates.

What are the uses of Brineura?

Professionals recommend Brineura to slow the loss of ambulation in symptomatic pediatric patients 3 years old and older with the disease late infantile neuronal ceroid lipofuscinosis type 2, also called tripeptidyl peptidase 1 (TPP1) deficiency.

Side effects

There are numerous side effects of this medicine, and they are as follows:

Common
Pyrexia, ECG abnormalities, Decreased CSF protein, Vomiting

Uncommon
Seizures, Device-related complications, and Hypersensitivity are some uncommon side effects.

Less frequent
Increased CSF protein, Hematoma, Headache, Irritability, and Pleocytosis are less frequent side effects.

Rare
Device-related infections, bradycardia, feeling jittery, and hypotension are known rare side effects.

Note: Every patient does not experience these side effects.

Precautions and Warnings

Bacterial meningitis
There were case studies that bacterial meningitis requires antibiotic treatment and removal of the device during post-marketing use of Brineura. Additionally, there were reports of other device-related clinical infections confirmed by positive CSF cultures, treated with antibiotics, and device removal in clinical trials and post-marketing service. After the replacement of the device, patients resumed treatment with Brineura.

Complications related to Intraventricular Access Device
During the clinical trial and in post-marketing reports, there are reports on intraventricular access device-related complications (e.g., device leakage, device failure, extravasation of CSF fluid, or bulging of the scalp around or above the intraventricular access device). For any such complications with the implanted intraventricular access device, consult a neurosurgeon to confirm the integrity or performance of the device.

Cardiovascular Reactions

One should perform electrocardiogram (ECG) monitoring during infusion in patients with a history of bradycardia, conduction disorder, or structural heart disease, as some patients with CLN2 disease may develop conduction disorders or heart disease. In patients without cardiac abnormalities, one should perform regular 12-lead ECG evaluations every 6 months.

Hypersensitivity reactions including anaphylaxis
There are reports on Hypersensitivity reactions, including anaphylaxis in Brineura-treated patients during clinical studies and post-marketing use. In clinical trials, 46% of patients experienced these reactions during the infusion or within 24 hours of completion of the injection. Patients in clinical trials were routinely medicated early with antihistamines with or without antipyretics or corticosteroids before intake of the medicine. During post-marketing use, anaphylactic reactions occurred during or within several hours of infusion.

Handling and storage

Each Brineura infusion Injection vial has a green flip-off cap and contains 150 mg cerliponase alfa per 5 mL (30 mg/mL).
Each Intraventricular Electrolytes Injection ampoule has a yellow flip-off cap and contains 5 ml of solution.
The administration kit for use with the medicine is supplied separately and contains the below-mentioned single-use, sterile infusion components:

  • Two 20-mL syringes
  • Two syringe needles
  • One extension line
  • One infusion set with 0.2-micron inline filter
  • One port needle

Cerliponase Injection and Intraventricular Electrolytes Injection:
Store it upright in a freezer (-25°C to -15°C) in the original carton to protect it from light.
Administration Kit for use with the medicine:
Store it in the original carton separately from Brineura.
Do not freeze it.

Frequently asked questions (FAQs)

Briniura medicine contains cerliponase alfa, a purified human enzyme produced by recombinant DNA technology in a Chinese hamster ovary cell line. The active ingredient is a recombinant human tripeptidyl peptidase-1 (rhTPP1). 

Brineura contains cerliponase alfa as an active ingredient, whereas calcium chloride dihydrate; magnesium chloride hexahydrate; potassium chloride; sodium chloride; sodium phosphate, dibasic, heptahydrate; sodium phosphate, monobasic, monohydrate; and water for injection are inactive ingredients.

One should administer Brineura and the Intraventricular Electrolytes only by the intraventricular route, using the provided administration kit for use with the medicine. Each ampoule of Brineura and Intraventricular Electrolytes is suggested for a single dose only. Each infusion consists of 10 ml of the medication after the 2 ml of Intraventricular Electrolytes. One must administer the complete infusion using an infusion set with a 0.2-micron inline filter. One should use the Intraventricular Electrolytes for flushing the infusion line, port needle, and intraventricular access device to fully administer Brineura and maintain patency of the intraventricular access device.

For medicine Brineura Biomarin is the innovator. Ikris Pharma Network is an authorized partner of it, who can help access this medicine in India for the patient through legal procedure. To know more, contact Ikris at toll-free no. 18008891064 or write at info@ikrispharmanetwork.com.

In India, you can buy Brineura with the help of Ikris Pharma Network, an authorized partner of “Biomarin” for this medicine.