What is Cerliponase alfa?
Cerliponase is used to treat children who have symptoms of ceroid lipofuscinosis, type 2 (CLN2), a rare genetic disorder. Cerliponase is only for children older than 3 years. Cerliponase beta may slow the decline of certain physical abilities among children who have ceroid lipofuscinosis 2 (CLN2). Cerliponase is not a treatment for this condition. This medication guide does not list all possible uses of Cerliponase Alfa.
Side effects of Cerliponase alfa
Seek emergency medical attention if you notice any signs of an allergy reaction in your child within 24 hours following each infusion. You will be able to monitor your child at all times during the infusion. If your child experiences any problems during this period, they may need to be treated by healthcare professionals.
If you notice any of the following:
- The child may have swelling or redness on their scalp.
- Bulging or puffiness around the catheter
- Oozing or discharge from the catheter
- Fever with drowsiness, nausea, increased sensitivity to light, neck stiffness, or headache
- A severe weakness
- Any changes in behaviour, for example, a child who does not respond as usual,
Some of the common side effects associated with cerliponase Alfa include:
- Low blood pressure, slow heartbeat
- An allergic reaction
- Bruising;
- Fever;
- A seizure;
- Signs of infection around or on the catheter, such as tenderness, redness, or discharge
- Feeling jittery;
- Fussiness;
- Vomiting;
- Headache
- Ekgs, or abnormal blood tests.
There may be other side effects.Call your physician if experiencing side effects; for reporting purposes contact the FDA at 1-800-FDA-1088.
Warnings
Seek emergency medical attention if you notice symptoms of an allergic reaction in your child within 24 hours following each infusion. These include fever, vomiting, and fussiness. Other symptoms may include hives or difficulty breathing.
Before you take this drug
If your child is allergic to cerliponase or has any of the following:
- Cerliponase Alfa delivery catheter
- Any sign of infection around the catheter on the child's head;
- A shunt is placed in the brain to drain the fluid that has accumulated around the brain.
If your child has experienced any of the following:
- Slow heartbeats
- A heart defect;
- Heart rhythm disorders
Cerliponase alfa should not be used by children under 3 years of age.
How to take Cerliponase alfa?
The catheter is implanted surgically in the child's skull. Cerliponase alfa will be infused into the cerebrospinal liquid. This device should be implanted at least five to seven days before the first dose of Cerliponase Alpha is given. Cerliponase alfa can be administered using an infusion device. The medication is injected into the body via a catheter inserted through the skull into the brain.
Cerliponase alfa can only be administered by certain types of healthcare professionals. Cerliponase is only given by a certain type of healthcare professional. This medication is typically given every other week. After each infusion, your child will receive an electrolyte infusion. The whole procedure should take about 4.5 to 5 hours. Your child will receive medication 30–60 minutes prior to each infusion of cerliponase. This medicine is designed to reduce the risk of certain side effects.
During each infusion, your child's vital signs, such as breathing, blood pressure, and oxygen levels, will be closely monitored. It may be necessary to monitor the child's heart using an ECG or electrocardiograph (also called an EKG). In certain cases, it is recommended that the heart function of a child be tested every six months. Keep all doctor's appointments for your child.
Details on dosage
The usual paediatric dose for neuronal ceroid lipofuscinosis is:
For 3-year-olds and older, 300 mg intraventricular infusion every 2 weeks
Comments:
Pretreatment with antihistamines, with or without antipyretics Or corticosteroids 30–60 minutes before the infusion should be performed.
Before each infusion, check the scalp for any signs of leakage or failure of an intraventricular access device, as well as potential infections.
Before each infusion and when clinically indicated, obtain a CSF sample for cell counting and culture.
Infusion rate: 2.5 ml/hr. Administer the Braun Perfusor Space Infusion Pump System. Follow infusion with the intraventricular electrolytes included in the administration kit.
Use: To reduce the loss of ambulation among symptomatic children aged 3 or older who have late infantile lipofuscinosis type 2 (CLN2), also known as tripeptidyl-peptidase deficiency (TPP1).
What happens if I miss the dose?
If you are unable to attend the appointment set for your child’s cerliponase-alfa infusion, call your doctor.
What happens if I overdose?
Overdoses are unlikely because cerliponase is administered by a healthcare provider in a medical environment.
What should be avoided?
If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.
Interaction with other drug
The carers of your child will monitor and manage all medication given to them during the treatment with cerliponase. There is no expectation of drug interactions occurring between cerliponase and other medications. This includes vitamins, minerals, or herbal products. Do not give your child vitamins or minerals.
