Elfabrio Side Effects

Generic name: pegunigalsidase alfa

Medically reviewed by Drugs.com. Last updated on Oct 16, 2023.

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]