Cerliponase Alfa (ser-LIP-oh-nase AL-fa)

Treats neuronal ceroid lipofuscinosis type 2 (CLN2) or tripeptidyl peptidase 1 (TPP1) deficiency.

Brand Name(s):

Brineura

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable, Kit

• Your doctor will prescribe your dose and schedule. This medicine is injected into the cerebrospinal fluid using an infusion pump system through a tube placed inside your head.
• A nurse or other health provider will give you this medicine.
• Your doctor may also give you other medicines (including allergy medicine, fever medicine, steroid) 30 to 60 minutes before you receive this medicine to help prevent unwanted effects.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have a history of heart disease, heart rhythm problems, low blood pressure, or a slow heartbeat. Tell your doctor if you have had surgery on your head.
• This medicine may cause the following problems:
  • Increased risk of infections, including meningitis
  • Increased risk of heart disease, heart rhythm problems, or low blood pressure
  • Infusion-related reactions
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, chills, cough, sore throat, body aches
• Lightheadedness, dizziness, fainting
• Pain, redness, tenderness, swelling, or discharge on or around the device insertion site
• Seizures
• Severe headache, drowsiness, confusion, stiff neck or back
• Slow heartbeat, chest pain or discomfort, trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Feeling anxious or restless
• Irritability
• Vomiting

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088