Note: This document contains side effect information about pegunigalsidase alfa. Some dosage forms listed on this page may not apply to the brand name Elfabrio.
Applies to pegunigalsidase alfa: intravenous solution.
Warning
Intravenous route (Solution)
Warning: Hypersensitivity Reactions including AnaphylaxisPatients treated with pegunigalsidase alfa-iwxj have experienced hypersensitivity reactions, including anaphylaxis. Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available during pegunigalsidase alfa-iwxj administration. If a severe hypersensitivity reaction (eg, anaphylaxis) occurs, discontinue pegunigalsidase alfa-iwxj immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reaction, a desensitization procedure to pegunigalsidase may be considered.
Serious side effects of Elfabrio
Along with its needed effects, pegunigalsidase alfa (the active ingredient contained in Elfabrio) 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 pegunigalsidase alfa:
More common
- Back pain
- bloody or cloudy urine
- burning, numbness, tingling, or painful sensations
- chest tightness
- chills
- cough
- ear congestion
- fast heartbeat
- fever
- flushing
- headache
- loss of voice
- muscle aches
- nausea and vomiting
- nerve pain
- pain in the arms, legs, lower back, bottom, or hips
- skin itching, rash, or redness
- sneezing
- sore throat
- stuffy or runny nose
- swelling of the face, throat, or tongue
- trouble breathing
- trouble swallowing
- unsteadiness or awkwardness
- unusual tiredness or weakness
- weakness in the arms, hands, legs, or feet
Incidence unknown
- Blurred vision
- chest pain or discomfort
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- nervousness
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- shakiness in the legs, arms, hands, or feet
- slow or irregular heartbeat
- sweating
- swelling of the face, feet, or lower legs
- trembling or shaking of the hands or feet
- vomiting
Other side effects of Elfabrio
Some side effects of pegunigalsidase 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
- Diarrhea
- pain or tenderness around the eyes and cheekbones
- stomach pain
Incidence not known
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- difficulty in moving
- joint pain
- lack or loss of strength
- muscle cramps, pains, or stiffness
- sneezing
- swollen joints
- throat irritation
For Healthcare Professionals
Applies to pegunigalsidase alfa: intravenous solution.
General
The most common adverse reactions reported in 15% of patients or greater included infusion-associated reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, and sinusitis.[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (19%), nausea (17%), abdominal pain (12%)[Ref]
Hypersensitivity
Hypersensitivity and anaphylactic reactions included headache, nausea, vomiting, throat tightness, facial and oral edema, truncal rash, macular rash, tachycardia, hypotension, rigors, urticaria, intense pruritus, moderate upper airway obstructions, macroglossia, and mild lip edema.[Ref]
Very common (10% or more): Hypersensitivity reactions (up to 14%)
Common (1% to 10%): Anaphylaxis (3%)[Ref]
Local
Very common (10% or more): Infusion-associated reactions (up to 32%)
Common (1% to 10%): Infusion-site extravasation[Ref]
Infusion-associated reactions included nausea, chills, pruritus, rash, chest pain, dizziness, vomiting, asthenia, pain, sneezing, dyspnea, nasal congestion, throat irritation, abdominal pain, erythema, diarrhea, burning sensation, neuralgia, headache, paresthesia, tremor, agitation, increased body temperature, flushing, bradycardia, myalgia, hypertension, and hypotension. These events occurred within 24 hours of infusion.[Ref]
Musculoskeletal
Very common (10% or more): Back pain (15%), pain in extremity (15%)[Ref]
Nervous system
Very common (10% or more): Headache (21%)
Common (1% to 10%): Neuralgia, peripheral neuropathy, sciatica[Ref]
Other
Very common (10% or more): Fatigue (17%)[Ref]
Respiratory
Very common (10% or more): Nasopharyngitis (up to 21%), sinusitis (15%)
Common (1% to 10%): Upper respiratory tract congestion[Ref]
Renal
Very common (10% or more): Proteinuria (12%)
Common (1% to 10%): Hematuria
Frequency not reported: Membranoproliferative glomerulonephritis[Ref]
