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). This medicine 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.

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 this medicine;
• 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.

Use Cerliponase Alfa (Injectable) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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 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.

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