Applies to cerliponase alfa: intracerebroventricular solution.
Serious side effects of Cerliponase alfa
Along with its needed effects, cerliponase alfa 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:
More common
- Blurred vision
- chest pain or discomfort
- chills
- fever
- headache
- hives, itching, skin rash
- hoarseness
- itching, pain, redness, or swelling at the insertion site
- joint pain, stiffness, or swelling
- lightheadedness, dizziness, or fainting
- redness of the skin
- seizures
- slow, fast, or irregular heartbeat
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- trouble breathing
- trouble swallowing
- unusual bruising
- unusual tiredness
- vomiting
Incidence not known
- Confusion
- drowsiness
- general feeling of illness
- nausea
- severe headache
- stiff neck or back
Other side effects of Cerliponase alfa
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:
More common
- Collection of blood under the skin
- deep, dark purple bruise
- irritability
- jitteriness
- sweating
For Healthcare Professionals
Applies to cerliponase alfa: injectable kit.
General
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
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.
Very common (10% or more): Hypersensitivity reactions (58%)
Nervous system
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]
Very common (10% or more): Seizure (50%), headache (17%), pleocytosis (17%)
Postmarketing reports: Meningitis[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
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]
Psychiatric
Very common (10% or more): Irritability (17%)[Ref]
Respiratory
Frequency not reported: Hypoxia[Ref]
