Cerliponase alfa

Generic name: Cerliponase Alfa
Brand names: Brineura
Dosage form: injectable kit (150 mg/5 mL)
Drug class: Lysosomal enzymes

Usage of Cerliponase alfa

Cerliponase alfa 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). cerliponase alfa is for use in children who are at least 3 years old.

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

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

Cerliponase alfa side effects

Get emergency medical help if your child has signs of an allergic reaction within 24 hours after each infusion. Symptoms may include fever, vomiting, fussiness, hives, difficult breathing, and swelling in the face or throat.

Your child will remain under constant supervision during the cerliponase alfa infusion. Any problems the child has during this time may require further treatment by healthcare professionals.

Call your child's doctor at once if you notice:

swelling, redness, or warmth in the child's scalp;

bulging or puffiness around the catheter;

oozing or discharge around the catheter;

fever with headache, neck stiffness, increased sensitivity to light, vomiting, or drowsiness;

severe weakness; or

any behavior changes, such as a lack of normal responses from your child.

Common side effects of cerliponase alfa may include:

slow heartbeats, low blood pressure;

an allergic reaction;

bruising;

fever;

a seizure;

signs of infection on or around the catheter, such as redness, tenderness, or discharge;

feeling jittery;

fussiness;

vomiting;

headache; or

abnormal blood tests or EKGs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Cerliponase alfa

Your child should not be treated with cerliponase alfa if he or she is allergic to it, or if the child has:

complications with the surgically implanted catheter used to deliver cerliponase alfa;

any sign of infection on the child's scalp in the area around the implanted catheter; or

a shunt in the brain (to help drain fluid build-up around the brain).

Tell your doctor if your child has ever had:

slow heartbeats;

a heart defect; or

heart rhythm problems.

Cerliponase alfa is not approved for use by anyone younger than 3 years old.

Relate drugs

How to use Cerliponase alfa

Usual Pediatric Dose for Neuronal Ceroid Lipofuscinosis:

3 years or older: 300 mg by intraventricular infusion once every other week Comments:-Pretreatment with antihistamines with or without antipyretics or corticosteroids should occur 30 to 60 minutes prior to the start of infusion.-Prior to each infusion, inspect the scalp for signs of intraventricular access device leakage, failure, or potential infection. -Prior to each infusion, and when clinically indicated, obtain a sample of CSF for cell count and culture. -Infusion rate 2.5 mL/hr; administer with the B Braun Perfusor Space Infusion Pump System, follow infusion with Intraventricular Electrolytes provided in the administration kit.Use: To slow the loss of ambulation in symptomatic pediatric patients 3 years or older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency

Warnings

What other drugs will affect Cerliponase alfa

Your child's caregivers will manage and monitor all medications given to the child during treatment with cerliponase alfa. A drug interaction between cerliponase alfa and other medications is not expected to occur.

Do not give any medications to your child that have not been prescribed by your doctor. This includes vitamins, minerals, or herbal products.

Popular FAQ

Brineura is used to slow the loss of ambulation (ability to crawl or walk unaided) in patients with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency. Brineura is used in pediatric patients 3 years of age and over who have symptomatic disease. CLN2 is a neurodegenerative disease and a type of Batten disease. It is caused by a lack of the enzyme TPP1, which leads to the build up of lysosomal storage materials in the central nervous system (CNS) and results in a progressive decline in motor function. Brineura is a proenzyme of TPP1. It is taken up by the CNS and is activated in the lysosomes, which results in their break down. Continue reading

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