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.

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.

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 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.

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 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).

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.

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

• complications with the surgically implanted catheter used to deliver Brineura;

• 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.

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

Call your doctor for instructions if you miss an appointment for your child's Brineura infusion.

Since Brineura is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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 Brineura 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 Brineura 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.