Think Fabrazyme® first, think rapid and sustained clearance of GL-3 in the kidney, heart, and skin1

Fabrazyme-treated patients with GL-3 clearance after 6 months in the extension study1,2

A chart showing 6 month Fabrazyme® (agalsidase beta) study data of how patients saw a 96% of GL-3 clearance in the kidneys, 80% GL-3 clearance in the heart, and 96% GL-3 clearance in the skin

Adapted from Germain D et al. 2007.2

In this extension study Fabrazyme cleared GL-3 in as quickly as 6 months in the kidney, heart, and skin capillary endothelium after initiation1

    Study 1: A randomized, 1:1, double-blind, placebo-controlled study of 58 patients with a diagnosis of Fabry disease, aged 16 to 61 years including 56 males, 2 females, naïve to ERT. Patients were randomized 1:1 to receive either 1 mg/kg of Fabrazyme EOW or placebo for 5 months (20 weeks). All 58 patients enrolled in the open-label extension study of 54 months in which they received biweekly 1 mg/kg Fabrazyme infusions for up to an additional 54 months.1

Marie, a female Fabrazyme® (agalsidase beta) patient for 20 plus years

“I’ve been really happy with my results on Fabrazyme. My GL-3 levels have lowered and so have my sons’. This motivates me to stay the course.”

Marie, a real Fabrazyme patient for over 20 years

Think Fabrazyme first, think normalized plasma GL-3 levels that were sustained throughout the 5-year study period1

Fabrazyme rapidly normalized plasma GL-3 and maintained it for up to 5 years1,3,4

A chart showing how Fabrazyme® (agalsidase beta) rapidly normalized plasma GL-3 and maintained it for up to 5 years

Adapted from Eng C et al 2001, Data on File, Fabrazyme Prescribing Information 2023.1,3,4

Fabrazyme® rapidly normalized plasma GL-3 (to normal levels, ≤7.03 µg/ml) within 6 months of treatment and maintained it throughout the 5-year study period

    Study 1: A randomized, 1:1, double-blind, placebo-controlled study of 58 patients with a diagnosis of Fabry disease, aged 16 to 61 years including 56 males, 2 females, naïve to ERT. Patients were randomized 1:1 to receive either 1 mg/kg of Fabrazyme EOW or placebo for 5 months (20 weeks). All 58 patients enrolled in the open-label extension study of 54 months in which they received biweekly 1 mg/kg Fabrazyme infusions for up to an additional 54 months.1

View study results in long-term renal stabilization >

A male wearing a tan jacket, grey jeans, and black and white shoes walking

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.

Initiate FABRAZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g. anaphylaxis) occurs, discontinue FABRAZYME and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur [see Warnings and Precautions (5.1)].

 

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions Including Anaphylaxis

In clinical trials and post-marketing experience, approximately 1% of patients developed anaphylactic or severe hypersensitivity reactions, some life-threatening, during Fabrazyme infusion. Reactions have included localized angioedema (including swelling of the face, mouth, and throat), bronchospasm, hypotension, generalized urticaria, dysphagia, rash, dyspnea, flushing, chest discomfort, pruritus, and nasal congestion. Consider pretreating with antihistamines, antipyretics, and/or corticosteroids; however, reactions may still occur.

In Fabrazyme clinical trials, some patients developed IgE antibodies or skin test reactivity specific to Fabrazyme.

  • Higher incidences of hypersensitivity reactions were observed in adult patients with persistent anti-Fabrazyme antibodies, and in those with high antibody titers compared with antibody negative adult patients.
  • Consider testing for IgE antibodies in patients who experienced suspected hypersensitivity reactions and consider the risks and benefits of continued treatment in patients with anti-Fabrazyme IgE antibodies. Rechallenge of these patients should only occur under the direct supervision of qualified personnel, with appropriate medical support measures readily available.

Infusion-Associated Reactions

In Fabrazyme clinical trials, 59% of patients experienced infusion-associated reactions (IARs), some of which were severe. IARs are defined as those occurring on the same day as the infusion. The incidence of these reactions was higher in patients who were positive for anti-Fabrazyme antibodies than those negative for anti-Fabrazyme antibodies.

  • Consider pretreatment with antipyretics, antihistamines, and/or corticosteroids to reduce the risk of IARs; however, they may still occur.
  • If a mild or moderate IAR occurs, consider holding the infusion temporarily, decreasing the infusion rate, and/or reducing the Fabrazyme dosage. If a severe IAR occurs, discontinue Fabrazyme immediately and initiate appropriate medical treatment as needed. Assess the risks and benefits of readministering Fabrazyme and monitor patients closely if readministering.
  • Patients with advanced Fabry disease may have compromised cardiac function, which may predispose them to a higher risk of severe complications from IARs. Closely monitor patients with compromised cardiac function receiving Fabrazyme.

Common Adverse Reactions

Adverse reactions reported (≥20%) were upper respiratory tract infection, chills, pyrexia, headache, cough, paresthesia, fatigue, peripheral edema, dizziness, and rash.

Please see full Prescribing Information, including Boxed WARNING

IMPORTANT SAFETY INFORMATION

Show more

IMPORTANT SAFETY INFORMATION

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.

Initiate FABRAZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g. anaphylaxis) occurs, discontinue FABRAZYME and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur [see Warnings and Precautions (5.1)].

 

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions Including Anaphylaxis

In clinical trials and post-marketing experience, approximately 1% of patients developed anaphylactic or severe hypersensitivity reactions, some life-threatening, during Fabrazyme infusion. Reactions have included localized angioedema (including swelling of the face, mouth, and throat), bronchospasm, hypotension, generalized urticaria, dysphagia, rash, dyspnea, flushing, chest discomfort, pruritus, and nasal congestion. Consider pretreating with antihistamines, antipyretics, and/or corticosteroids; however, reactions may still occur.

In Fabrazyme clinical trials, some patients developed IgE antibodies or skin test reactivity specific to Fabrazyme.

  • Higher incidences of hypersensitivity reactions were observed in adult patients with persistent anti-Fabrazyme antibodies, and in those with high antibody titers compared with antibody negative adult patients.
  • Consider testing for IgE antibodies in patients who experienced suspected hypersensitivity reactions and consider the risks and benefits of continued treatment in patients with anti-Fabrazyme IgE antibodies. Rechallenge of these patients should only occur under the direct supervision of qualified personnel, with appropriate medical support measures readily available.

Infusion-Associated Reactions

In Fabrazyme clinical trials, 59% of patients experienced infusion-associated reactions (IARs), some of which were severe. IARs are defined as those occurring on the same day as the infusion. The incidence of these reactions was higher in patients who were positive for anti-Fabrazyme antibodies than those negative for anti-Fabrazyme antibodies.

  • Consider pretreatment with antipyretics, antihistamines, and/or corticosteroids to reduce the risk of IARs; however, they may still occur.
  • If a mild or moderate IAR occurs, consider holding the infusion temporarily, decreasing the infusion rate, and/or reducing the Fabrazyme dosage. If a severe IAR occurs, discontinue Fabrazyme immediately and initiate appropriate medical treatment as needed. Assess the risks and benefits of readministering Fabrazyme and monitor patients closely if readministering.
  • Patients with advanced Fabry disease may have compromised cardiac function, which may predispose them to a higher risk of severe complications from IARs. Closely monitor patients with compromised cardiac function receiving Fabrazyme.

Common Adverse Reactions

Adverse reactions reported (≥20%) were upper respiratory tract infection, chills, pyrexia, headache, cough, paresthesia, fatigue, peripheral edema, dizziness, and rash.

Please see full Prescribing Information, including Boxed WARNING

INDICATION AND USAGE

Fabrazyme® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.

References: 1. Fabrazyme® (agalsidase beta). Prescribing Information 2024. 2. Germain D et al. J Am Soc Nephrol 2007;18(5):1547-1557. 3. Data on file. Sanofi. 4. Eng CM et al. N Engl J Med 2001;345(1):9–16.