Brineura cost | 100% Good Quality

$147,806.00

Brineura® (cerliponase alfa) is a prescription medication used to slow loss of ability to walk or crawl (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. Brineura cost.

Description

What is Brineura? | Brineura cost | 100% Good Quality

Brineura cost/Brineura is used to slow the loss of ability to crawl or walk in children with symptoms of a rare genetic condition called ceroid lipofuscinosis type 2 disease (CLN2). Brineura is for use in children who are at least 3 years old.

Brineura may help slow the loss of certain physical abilities in children with ceroid lipofuscinosis type 2 disease (CLN2). However, this medicine is not a cure for this condition.

Brineura may also be used for purposes not listed in this medication guide.

DESCRIPTION

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. Brineura cost.

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 cost.

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 cost.

Brineura and Intraventricular Electrolytes Injection are packaged in 10 mL clear Type 1 single-dose glass vials [see HOW SUPPLIED]. 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. Brineura cost.

Each vial contains: sodium: 0.76 mEq, and potassium: 0.015 mEq.

How is Brineura given?

Brineura is infused directly in the cerebrospinal fluid through a catheter device that is surgically implanted in the child’s head. This device must be in place at least 5 to 7 days before your child gets his or her first dose of cerliponase alfa.Brineura cost.

Brineura is given using an infusion pump. The medicine enters the body through a catheter placed through the skull and into the brain.

Brineura is given only by a certain type of healthcare professional. To prevent infection, this medicine is given in a sterile medical setting.

his medicine is usually given once every other week. Your child will also receive an infusion of electrolytes after each infusion of cerliponase alfa. The entire procedure will take about 4.5 hours to complete.

About 30 to 60 minutes before each Brineura infusion, your child will be given medication to prevent certain side effects of this medicine.

Your child’s breathing, blood pressure, oxygen levels, and other vital signs will be watched closely during each infusion. The child’s heart function may also need to be monitored using an electrocardiograph or ECG (sometimes called an EKG). Brineura cost.

In some cases, the child’s heart function should be checked every 6 months. Be sure to keep all appointments with your child’s doctor.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Meningitis And Other Intraventricular Access Device-Related Infections

Bacterial meningitis requiring antibiotic treatment and removal of the device was reported during postmarketing use of Brineura. Additionally, in clinical trials and during postmarketing use there were reports of other device-related clinical infections which were confirmed by positive CSF cultures, treated with antibiotics and removal of the device, and in which patients resumed treatment with Brineura after the device was replaced [see ADVERSE REACTIONS].

In all cases, antibiotics were administered, the intraventricular access devices were removed and replaced, and patients resumed treatment with Brineura.Brineura cost.

The signs and symptoms of infections may not be readily apparent in patients with CLN2 disease. To reduce the risk of infectious complications, Brineura should be administered by, or under the direction of, a physician experienced in intraventricular administration [see DOSAGE AND ADMINISTRATION]. Prior to each infusion of Brineura, and when clinically indicated, obtain a sample of CSF for cell count and culture.

Do not administer Brineura if there are localized signs of infection on or around the device insertion site, such as erythema, tenderness, or discharge or suspected or confirmed CNS infection (e.g. cloudy CSF or positive CSF gram stain, or meningitis) [see CONTRAINDICATIONS].Brineura cost.

Healthcare providers should be vigilant for the development of signs and symptoms of infection, including meningitis, during treatment with Brineura and monitor the device insertion site for signs of infection.Brineura cost.

Intraventricular Access Device-Related Complications

During the clinical trial and in postmarketing reports, intraventricular access device-related complications were reported (e.g., device leakage, device failure extravasation of CSF fluid, or bulging of the scalp around or above the intraventricular access device) [see ADVERSE REACTIONS].

For any complications with the implanted intraventricular access device, consult with a neurosurgeon to confirm the integrity or performance of the device. In case of intraventricular access device-related complications, discontinue the Brineura infusion and refer to the device manufacturer’s labeling for further instructions [see CONTRAINDICATIONS].Brineura cost.

Material degradation of the intraventricular access device reservoir was reported after approximately 4 years of administration, which may impact the effective and safe use of the device. During benchtop testing such material degradation was recognized after approximately 105 perforations of the intraventricular access device. The intraventricular access device should be replaced prior to 4 years of single-puncture administrations, which equates to approximately 105 administrations of Brineura.Brineura cost.

Cardiovascular Adverse Reactions

Monitor vital signs (blood pressure, heart rate) before infusion starts, periodically during infusion, and post-infusion in a healthcare setting [see DOSAGE AND ADMINISTRATION]. Upon completion of the infusion, clinically assess the patient status. Continued observation may be necessary if clinically indicated.Brineura cost.

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

In the clinical studies, hypotension was reported in 2 (8%) patients, which occurred during or up to eight hours after Brineura infusion. Patients did not require alteration in treatment, and reactions resolved spontaneously or after intravenous fluid administration [see ADVERSE REACTIONS].Brineura cost.

Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions including anaphylaxis have been reported in Brineura-treated patients during clinical studies and postmarketing use [see ADVERSE REACTIONS]. In clinical trials, a total of 11 (46%) patients experienced hypersensitivity reactions during the infusion or within 24 hours of completion of the infusion. Patients in clinical trials were routinely pre-medicated with antihistamines with or without antipyretics or corticosteroids, prior to infusion of Brineura.

During postmarketing use, anaphylactic reactions occurred during or within several hours of Brineura infusion. Epinephrine was administered in one case. Patients received subsequent Brineura infusions without recurrence of anaphylaxis.Brineura cost.

Due to the potential for anaphylaxis, appropriate medical support should be readily available when Brineura is administered. Observe patients closely during and after the infusion. If a severe hypersensitivity reaction or anaphylaxis occurs, immediately discontinue the infusion and initiate appropriate medical treatment.

Inform patients/caregivers of the signs and symptoms of hypersensitivity reactions and anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.

The management of hypersensitivity reactions should be based on the severity of the reaction and may include temporarily interrupting the infusion, and/or treatment with antihistamines, antipyretics, and/or corticosteroids. Consider the risks and benefits of readministration of Brineura following an anaphylactic reaction.

If the decision is made to readminister Brineura after the occurrence of anaphylaxis, ensure appropriately trained personnel and equipment for emergency resuscitation (including epinephrine and other emergency medicines) are readily available during infusion. Initiate subsequent infusion at approximately one-half the initial infusion rate at which the anaphylactic reaction occurred.

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