Brineura Side Effects
Generic Name: cerliponase alfa
Note: This document contains side effect information about cerliponase alfa. Some of the dosage forms listed on this page may not apply to the brand name Brineura.
For the Consumer
Applies to cerliponase alfa: intraventricular solution
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- A heartbeat that does not feel normal.
- Fast or slow heartbeat.
- Very bad dizziness or passing out.
- Feeling irritable.
- Feeling jittery.
- Throwing up.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to cerliponase alfa: injectable kit
The most frequently reported side effects were pyrexia, ECG abnormalities, decreased cerebrospinal fluid (CSF) protein, vomiting, seizures, hypersensitivity, increased CSF protein, hematoma, headache, irritability, pleocytosis, device-related infection, bradycardia, feeling jittery, and hypotension.[Ref]
Very common (10% or more): ECG abnormalities (71%), hematoma (21%)
Common (1% to 10%): Bradycardia, hypotension[Ref]
ECG abnormalities occurred in 71% of symptomatic pediatric patients during clinical studies and included non-specific repolarization abnormality, notched QRS, ST segment elevation, biphasic T wave abnormality, supraventricular asystole, bradycardia, sinus tachycardia, and intraventricular conduction delay.
Hematoma occurred in 21% of symptomatic pediatric patients during clinical trials and included hematoma, post-procedural hematoma, traumatic hematoma, and subdural hematoma, none of which required treatment and did not interfere with infusion.[Ref]
Very common (10% or more): Seizure (50%), headache (17%), pleocytosis (17%)[Ref]
Seizures occurred in 50% of symptomatic pediatric patients during clinical studies and included atonic, generalized tonic-clonic, focal, and absence seizure.[Ref]
Very common (10% or more): Device-related complication (50%)
Common (1% to 10%): Device-related infection[Ref]
Device-related adverse reactions occurred in 50% of symptomatic pediatric patients during clinical studies and included infection (e.g., Propionibacterium acnes, Staphylococcus epidermidis), deliver system-related complications, and pleocytosis. Complications of the non-implanted delivery system components occurred in 9 of these patients (38%). Four patients (16%) had device-related adverse reactions that required medical intervention including 2 patients (8%) with intraventricular access device-related central nervous system infections and 1 patient (4%) each with leakage of the intraventricular access device and pleocytosis.[Ref]
Very common (10% or more): Vomiting (63%)[Ref]
Very common (10% or more): Pyrexia (71%), CSF protein decreased (71%), CSF protein increased (21%)
Common (1% to 10%): Feeling jittery[Ref]
Antidrug antibodies (ADAs) were detected in both serum and CSF in 79% and 33%, respectively, of patients treated with this drug for up to 161 weeks. Patients who experienced hypersensitivity reactions were tested for drug-specific IgE and were found to be negative, including 3 patients who reported grade 3 (severe) hypersensitivity reactions. No association has been found between serum CSF ADA titers and incidence/severity of hypersensitivity.[Ref]
Very common (10% or more): Antidrug antibodies developed (up to 79%), hypersensitivity (46%)[Ref]
Very common (10% or more): Irritability (17%)[Ref]
Frequency not reported: Hypoxia[Ref]
1. "Product Information. Brineura (cerliponase alfa)." BioMarin Pharmaceutical Inc, Novato, CA.
Some side effects of Brineura may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
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- Drug class: lysosomal enzymes
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