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Adverse event reporting can be found at the bottom of the page.

Summary of safety information

Please refer to the Summary of Product Characteristics before prescribing.

Dosage and administration1

Treatment with Fabrazyme® should be supervised by a physician experienced in the management of patients with Fabry disease or other inherited metabolic diseases.

The recommended dose of Fabrazyme® is 1mg/kg body weight administered once every 2 weeks as an intravenous infusion.


Intravenous infusion

Initial IV infusion rate: no more than 0.25 mg/min (15 mg/h)

After patient tolerance is well established, the infusion rate may be increased in increments of 0.05 to 0.083 mg/min (3 to 5 mg/hr) with each subsequent infusion. In the event of infusion-associated reactions, the infusion rate may be slowed.


Life threatening hypersensitivity to agalsidase beta or to any of the excipients of this medicine (listed in section 6.1 of the Summary of Product Characteristics).

Fabrazyme® should not be administered with chloroquine, amiodarone, benoquin or gentamycin due to a theoretical risk of inhibition of intra-cellular α-galactosidase A activity.

Precautions and Warnings1


As agalsidase beta is a recombinant protein, the development of IgG antibodies is anticipated in patients with little or no residual enzyme activity. The majority of patients developed IgG antibodies to agalsidase beta, typically within 3 months of the first Fabrazyme® infusion.

Infusion associated reactions

Patients with antibodies to agalsidase beta have a higher risk of experiencing infusion-associated reactions, defined as any adverse event occurring on the infusion day. These patients should be treated with caution when re-administering agalsidase beta to these patients, and their antibody status should be regularly monitored.


A small number of patients have experienced reactions suggestive of immediate (Type I) hypersensitivity. As with any intravenous protein medicinal product, allergic-type hypersensitivity reactions are possible. If severe allergic or anaphylactic-type reactions occur, immediate discontinuation of the administration of Fabrazyme® should be considered and appropriate treatment initiated.

Patients with advanced renal disease

The effect of Fabrazyme® treatment on the kidneys may be limited in patients with advanced renal disease.


This medicinal product contains less than 1 mmol sodium per vial, that is to say essentially 'sodium-free'.


To enhance traceability, it is recommended to clearly record the name and batch number of the administered product

Adverse reactions1

Adverse reactions are listed by system organ class and frequency in the list below. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.1

The list presents adverse reactions reported from clinical trials (168 patients [154 males, 14 females] treated with Fabrazyme® 1 mg/kg EOW for ≥1 infusion up to a maximum of 5 years).1 Frequencies (very common ≥ 1/10; common ≥ 1/100 to < 1/10 and uncommon ≥ 1/1000 to < 1/100). Adverse reactions reported in post-marketing period are indicated as frequency “not known” (cannot be estimated from data).1 Adverse reactions were mostly mild or moderate in severity.1 Adverse reaction terminology is based upon the Medical Dictionary for Regulatory Activities (MedDRA).1

Did you know?

Fabry disease starts early in the kidney and is a silent threat. Progressive accumulation of globotriaocylceramide (GL-3) leads to cellular changes and histological damage.2 Fabry nephropathy shows similarities to other proteinuric nephropathies of metabolic origin.3 Once the mechanisms leading to tissue injury are activated, the progression of Fabry nephropathy becomes irreversible.3,4

Learn more about Fabrazyme®

Fabrazyme® evidence

Explore the results and evidence supporting Fabrazyme® and how it was studied through several clinical trials.

Treatment with Fabrazyme®

Discover more about treatment with Fabrazyme® for patients living with Fabry disease.


Fabrazyme® evidence

Explore the results and evidence supporting Fabrazyme® and how it was studied through several clinical trials.

Treatment with Fabrazyme®

Discover more about treatment with Fabrazyme® for patients living with Fabry disease.


Get in touch with us

Do you have questions or need support? We are here to help you.


Quantifying the effect of Fabrazyme® on the preservation of renal function in Fabry disease

Learning from the Canadian Fabry Disease Initiative

Understanding the impact of Fabrazyme® on long-term renal function



  1. Fabrazyme®. Summary of Product Characteristics 2024.

  2. Waldek S and Ferriozi S. BMC Nephrol. 2014;15:72.

  3. Ortiz A, et al. Mol Genet Metab. 2018;123(4):416–27.

  4. Van der Veen SJ, et al. Mol Genet Metab. 2022;135(2):163–69

MAT-XU-2400637 (v1.0) Date of preparation: March 2024