For US Residents Only | Go to Healthcare Professionals Site | Full Prescribing Information

Sign up for updates

How Elfabrio Works
Designed for you
Built to last
People like you
What to Expect
How Elfabrio was studied
Results & safety: Switching to Elfabrio
Results & safety: New to ERT
If you have side effects
Dosing
Getting Started
Chiesi Total Care℠
Copay programs
Our commitment
Resources
Patient downloads
Fabry glossary
Your healthcare team

We can’t find the page you are looking for.
It is possible that:

• The page has moved
• The page no longer exists

Return to home page

Important Safety
Information

What is the most important information I should know about Elfabrio?

Severe allergic reactions (hypersensitivity reactions), including anaphylaxis, may occur during and after Elfabrio treatment. If severe allergic reactions or anaphylaxis occurs during treatment, your healthcare provider will immediately stop the infusion and provide appropriate medical care. If these reactions should occur after treatment, seek immediate medical care.

What should I know about Elfabrio infusions?

Your healthcare provider may give you other medications prior to your Elfabrio infusions to help manage allergic reactions and infusion-related side effects. They will explain how to recognize the signs and symptoms of these allergic reactions and infusion-related side effects. If these signs and symptoms occur, it’s important for you to seek immediate medical care. If the reaction is mild to moderate, your healthcare provider may choose to slow the infusion rate or withhold the dose.

In clinical trials, 41 patients (29%) experienced an infusion-related side effect. The most common signs and symptoms of an infusion-related reaction with Elfabrio were hypersensitivity, nausea, chills, itchy skin, rash, chest pain, dizziness, vomiting, feelings of weakness, pain, sneezing, shortness of breath, nasal congestion, throat irritation, abdominal pain, skin redness, diarrhea, burning sensation, nerve pain, headache, tingling or numbness, shaking movements, agitation, increased body temperature, flushing, slow heart rate, muscle pain, high blood pressure, and low blood pressure.

Your healthcare provider will do blood and urine tests to check your kidney function during treatment with Elfabrio.

The most common side effects of Elfabrio include infusion-related side effects, common cold, headache, diarrhea, fatigue, nausea, back pain, pain in the limbs, and sinus infection.

Indication

Elfabrio® (pegunigalsidase alfa-iwxj) is a prescription infusion medicine used to treat adults with confirmed Fabry disease.

Please see Full Prescribing Information for Elfabrio.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Chiesi Global Rare Diseases Commitment

References available upon request.

Privacy Policy
Terms of Use
Accessibility
Go to Healthcare Professionals Site

For US residents only

©Chiesi USA, Inc. 2023. All rights reserved.
Elfabrio® is a registered trademark of CHIESI FARMACEUTICI S.p.A.
Chiesi Total Care℠ is a service mark of CHIESI FARMACEUTICI S.p.A.
PP-EF-0012 V2.0

This site is intended for
US residents

I am a:

US healthcare professional

Non-US residents, click here.

You are now leaving the Elfabrio website

This external link is provided to you for your convenience.
Chiesi is not responsible for content on external websites.