Cerliponase alfa
Generic name: cerliponase alfa [ ser-LIP-oh-nase-AL-fa ]
Brand name: Brineura
Dosage form: injectable kit (150 mg/5 mL)
Drug class:Lysosomal enzymes
What is 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.
Warnings
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.
Before taking this medicine
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.
How is cerliponase alfa given?
Cerliponase alfa 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.
Cerliponase alfa is given using an infusion pump. The medicine enters the body through a catheter placed through the skull and into the brain.
Cerliponase alfa is given only by a certain type of healthcare professional. To prevent infection, cerliponase alfa is given in a sterile medical setting.
This 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 cerliponase alfa 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 i...
