Brineura Side Effects

Generic name: cerliponase alfa

Medically reviewed by Drugs.com. Last updated on Aug 22, 2024.

Note: This document provides detailed information about Brineura.

Applies to cerliponase alfa: intracerebroventricular solution Side Effects associated with cerliponase alfa. Some dosage forms listed on this page may not apply specifically to the brand name Brineura.

Applies to cerliponase alfa: intracerebroventricular solution.

Precautions

It is very important that your doctor check your or your child's progress closely and at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may increase your risk of infections in your brain or nerves (eg, meningitis) or on or around the device insertion site on your head (eg, cellulitis). If you have fever, headache, nausea, vomiting, and a stiff neck or back, or pain, redness, or swelling at the insertion site while receiving this medicine, check with your doctor right away.

This medicine may worsen the condition of patients with a history of heart disease or heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme tiredness or weakness, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain. You might also feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat.

This medicine may cause serious types of allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Serious side effects of Brineura

Along with its needed effects, cerliponase alfa (the active ingredient contained in Brineura) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking cerliponase alfa:

Other side effects of Brineura

Some side effects of cerliponase alfa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to cerliponase alfa: injectable kit.

General adverse events

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]

Hypersensitivity

• Very common (10% or more): Hypersensitivity reactions (58%)

Hypersensitivity reactions occurred in 14 of 24 patients with severe hypersensitivity reactions occurring in 3 patients. No patients discontinued therapy due to hypersensitivity. The most common manifestations included pyrexia with vomiting, pleocytosis, or irritability, which are inconsistent with classic immune mediated hypersensitivity. These reactions were observed during or within 24 hours after the infusion and did not interfere with treatment. Symptoms resolved over time or with administration of antipyretics, antihistamines and/or glucocorticosteroids.

Nervous system

• Very common (10% or more): Seizure (50%), headache (17%), pleocytosis (17%)
• Postmarketing reports: Meningitis^[Ref]

Seizures occurred in 12 of 24 patients; seizure types included atonic, generalized tonic-clonic, focal, and absence seizure. Seizures were managed per standard of care and did not result in treatment discontinuation.^[Ref]

Cardiovascular

• Very common (10% or more): ECG abnormalities (71%), hematoma (21%)
• Common (1% to 10%): Bradycardia, hypotension^[Ref]

ECG abnormalities included non-specific repolarization abnormality, notched QRS, ST segment elevation, biphasic T wave abnormality, supraventricular asystole, bradycardia, sinus tachycardia, and intraventricular conduction delay.

Hematoma reactions presented as hematoma, post-procedural hematoma, traumatic hematoma, and subdural hematoma, none of which required treatment and did not interfere with infusion.

Hypotension was reported in 2 patients; these patients did not require treatment alterations as reactions resolved spontaneously or after IV fluids.^[Ref]

Local

• 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]

Gastrointestinal

• Very common (10% or more): Vomiting (63%)^[Ref]

Other

• Very common (10% or more): Pyrexia (71%), CSF protein decreased (71%), CSF protein increased (21%)
• Common (1% to 10%): Feeling jittery^[Ref]

Immunologic

• Very common (10% or more): Antidrug antibodies developed (up to 79%), hypersensitivity (46%)^[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]

Psychiatric

• Very common (10% or more): Irritability (17%)^[Ref]

Respiratory

• Frequency not reported: Hypoxia^[Ref]

See also:

Frequently asked questions

• What condition is Brineura used to treat?

Further information

Brineura side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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