Cerliponase Alfa Injection

What is this medication?

CERLIPONASE ALFA (ser LIP oh nase AL fa) treats neuronal ceroid lipofuscinosis type 2 (CLN2). It works by replacing an enzyme normally made by the body. This helps maintain the ability to crawl or walk.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Brineura

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart disease
• Infection
• Problems with the implanted access device, such as leakage or infection
• Ventriculoperitoneal (VP) shunt, a tube used to help drain excess fluid from the brain
• An unusual or allergic reaction to cerliponase alfa, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is infused into the fluid around the brain. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as newborns, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication can cause serious allergic reactions. To reduce the risk, your care team may give you other medications to take before receiving this one. Follow the directions from your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Fever, neck pain or stiffness, sensitivity to light, headache, nausea, vomiting, confusion, which may be signs of meningitis
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Seizures
• Site infection—skin redness, swelling, warmth, or pain around device site
• Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Headache
• Irritability
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.