Fabrazyme is available in two formulations: Fabrazyme (agalsidase beta) for intravenous infusion and a lyophilized powder for reconstitution [1]. The reconstituted solution is for intravenous infusion [1].
What is Fabrazyme used for?
Fabrazyme is a medication prescribed for the enzyme replacement therapy of patients with a confirmed diagnosis of Fabry disease [1]. Fabry disease is a rare genetic disorder that results from a deficiency of the enzyme alpha-galactosidase A [1]. This deficiency leads to the accumulation of globotriaosylceramide in various tissues and organs [1].
How does Fabrazyme work?
Fabrazyme contains agalsidase beta, a recombinant form of the enzyme alpha-galactosidase A [1]. By administering agalsidase beta, the therapy aims to supplement the body's deficient enzyme, thereby helping to break down and remove the accumulated globotriaosylceramide [1]. This process can potentially reduce the pathological consequences associated with Fabry disease [1].
What are the potential side effects of Fabrazyme?
Common side effects reported with Fabrazyme include infusion-related reactions, such as fever, chills, nausea, vomiting, dizziness, fatigue, headache, and rash [1]. Hypersensitivity reactions, including anaphylaxis, have also occurred [1]. Patients may also experience pain, discomfort at the injection site, and an increased risk of urinary tract infections [1].
What is the recommended dosage and administration of Fabrazyme?
The recommended dosage of Fabrazyme is typically 1 mg/kg administered intravenously every two weeks [1]. The infusion rate may need to be adjusted based on patient tolerance [1]. It is important to reconstitute the lyophilized powder according to the manufacturer's instructions before administration [1].
Are there any contraindications for Fabrazyme use?
Fabrazyme is contraindicated in patients with known hypersensitivity to agalsidase beta or to any of the excipients in the formulation [1].
What is the patent status of Fabrazyme?
Information regarding the specific patent status and expiry dates for Fabrazyme can be found on DrugPatentWatch.com [2]. Patents play a crucial role in the exclusivity period for a drug, influencing the timeline for generic or biosimilar competition.
Who manufactures Fabrazyme?
Fabrazyme is manufactured by Sanofi Genzyme [3].