Elfabrio

Generic name: Pegunigalsidase Alfa-iwxj
Dosage form: injection for infusion
Drug class: Lysosomal enzymes

Usage of Elfabrio

Elfabrio is a pegylated enzyme replacement therapy (Pegunigalsidase alfa-iwxj) that may be used to treat adults with cOnfirmed Fabry disease. The correct technical term for Elfabrio is a hydrolytic lysosomal Neutral glycosphingolipid-specific enzyme.

Fabry disease is a rare, inherited, X–linked, disorder caused by a deficiency of the alpha-galactosidase-A enzyme. People with Fabry’s disease do not have enough alpha-galactosidase-A to break down a fatty substance called globotriaosylceramide (Gb3) into smaller components that the body can use for energy. As a result, Gb3 accumulates in blood vessels and tissue, increasing the risk of a heart attack, stroke, or kidney failure. Symptoms may include numbness or tingling in the hands or feet, extreme pain during physical activity, heat or cold intolerance, dizziness, or flu-like symptoms. Males tend to have more severe symptoms. Fabry disease is also known as alpha-galactosidase-A enzyme deficiency or Anderson-Fabry disease.

Elfabrio replaces the missing alpha-galactosidase A enzyme, allowing the body to break down Gb3 and prevent its accumulation.

Elfabrio was approved on May 9, 2023.

Elfabrio side effects

Common adverse reactions include infusion-associated reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in the hands and feet, and sinusitis.

Before taking Elfabrio

The Elfabrio product label carries a Boxed Warning for hypersensitivity reactions, including anaphylaxis.

Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available. If a severe hypersensitivity reaction occurs, Elfabrio should be discontinued immediately and appropriate medical treatment initiated.

Relate drugs

How to use Elfabrio

Elfabrio is administered as an intravenous infusion by a healthcare provider every two weeks.

The recommended dosage is 1 mg/kg every 2 weeks.

Pretreatment with antiHistamines, antipyretics, and/or corticosteroids may be considered to reduce the risk of infusion-related reactions and you will be monitored for one to two hours after the infusion.

Warnings

Warnings and precautions include infusion-associated reactions (IARs) and membranoproliferative glomerulonephritis.

If severe IARs occur, discontinue Elfabrio and initiate appropriate medical treatment.

Monitor serum creatinine and urinary protein to creatinine ratio should be monitored and Elfabrio discontinued if glomerulonephritis is suspected until a diagnostic evaluation can be conducted.

What other drugs will affect Elfabrio

Interaction studies have not been conducted with Elfabrio.

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