Fabrazyme® (agalsidase beta) Safety Profile

The safety profile of Fabrazyme has been well established¹

The safety of Fabrazyme has been assessed in 4 clinical trials involving 162 patients with more than 473 patient-years of experience^1,2

In clinical trials and post-marketing safety experience with Fabrazyme, approximately 1% of patients developed anaphylactic or severe hypersensitivity reactions during infusion¹
In clinical trials with Fabrazyme, 59% of patients experienced infusion-associated reactions, some of which were severe. In patients experiencing infusion-associated reactions, pretreatment with an antipyretic and antihistamine is recommended. Infusion-associated reactions occurred in some patients after receiving pretreatment¹
High incidences of hypersensitivity reactions were observed in adult patients with persistent anti-Fabrazyme antibodies and in adult patients with high antibody titer compared with that in antibody negative adult patients¹
Patients with advanced Fabry disease may have compromised cardiac function, which may predispose them to a higher risk of severe complications from infusion-associated reactions. These patients should be monitored closely if Fabrazyme is administered¹

Summary of Common Adverse Reactions in Clinical Trials (Studies 1 and 2)

Reported at a rate of at least 5% of Fabrazyme-treated patients and >2.5% compared with placebo-treated patients¹

Adverse reaction	Fabrazyme (n=80)%	Placebo (n=60)%
Upper respiratory tract infection^a	53	42
Chills^b	49	13
Pyrexia	39	22
Headache	39	28
Cough	33	25
Paresthesia	31	18
Fatigue	24	17
Peripheral edema	21	7
Dizziness	21	8
Rash	20	10
Pain in extremity	19	8
Myalgia^c	18	7
Lower respiratory tract infection	18	7
Pain	16	13
Back pain	16	10
Hypertension	14	5
Pruritus	10	3
Tachycardia	9	3

Adverse reaction	Fabrazyme (n=80)%	Placebo (n=60)%
Excoriation	9	2
Increased blood creatinine	9	5
Tinnitus	8	3
Dyspnea	8	2
Fall	6	3
Burning sensation	6	0
Anxiety	6	3
Depression	6	2
Wheezing	6	0
Hypoacusis	5	0
Chest discomfort	5	2
Fungal infection	5	0
Viral infection	5	0
Hot flash	5	0

^aIncludes reports of upper respiratory infection, nasal congestion, sinusitis, respiratory tract congestion, and pharyngitis.
^bIncludes reports of chills and feeling cold.
^cIncludes reports of myalgia and muscle spasms.

Explore Fabrazyme first for what matters most

View Fabrazyme First →

Indication

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

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

Important Safety Information

References: 1. Fabrazyme (agalsidase beta). Prescribing Information. Sanofi. 2. Data on file. Sanofi.

Fabrazyme® (agalsidase beta) Safety

The safety profile of Fabrazyme has been well established1

The safety of Fabrazyme has been assessed in 4 clinical trials involving 162 patients with more than 473 patient-years of experience1,2

Summary of Common Adverse Reactions in Clinical Trials (Studies 1 and 2)

Explore Fabrazyme first for what matters most

Indication

Important Safety Information

WARNINGS AND PRECAUTIONS

Indication

Important Safety Information

Fabrazyme^® (agalsidase beta) Safety

The safety profile of Fabrazyme has been well established¹

The safety of Fabrazyme has been assessed in 4 clinical trials involving 162 patients with more than 473 patient-years of experience^1,2