Fabrazyme® Dosing and Administration

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Think Fabrazyme first and count on options

Fabrazyme can be administered in multiple treatment settings

Physician offices

Infusion centers

Home

Choice of treatment setting is at the discretion of the healthcare provider, and Fabrazyme should be administered under the supervision of a healthcare provider in a setting with appropriate medical monitoring and support measures.

Think Fabrazyme first, think adapting to your patient’s life by optimizing their infusion time

The initial intravenous infusion rate is 0.25 mg/min (15 mg/hour). After patient tolerance is well established, increase the infusion rate in increments of 3 to 5 mg/hour with each subsequent infusion. Prior to Fabrazyme administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids.¹

Fabrazyme infusion protocol examples for classic patients

Note: This protocol is not mandated and is an example for classic patients.¹^,a

Examples
Patient Weight		50kg		70kg		70kg
Rate increase		5 mg/hr		5 mg/hr		3 mg/hr
Infusion number		Rate (mg/hr)	Total infusion Rate	Rate (mg/hr)	Total infusion Rate	Rate (mg/hr)	Total infusion Rate
	1-8	15	3h 20m	15	4h 40m	15	4h 40m
	9	20	2h 30m	20	3h 30m	18	3h 53m
	10	25	2h	25	2h 48m	21	3h 20m
	11	30	1h 40m	30	2h 20m	24	2h 55m
	12	33	1h 30m	35	2h	27	2h 35m
	13			40	1h 45m	30	2h 20m
	14			45	1h 33m	33	2h 07m
	15					36	1h 57m
	16					39	1h 48m
	17					42	1h 40m
	18					45	1h 33m

After patient tolerance is established, the infusion time may be reduced to as low as 90 minutes gradually with subsequent infusions after evaluation and recommendation by the treating physician¹

You can also offer your Fabry disease patients home infusion therapy. Dose and infusion rate should remain constant while at home, and not be changed without supervision of a healthcare professional

^aFor patients weighing <30 kg: maximum infusion rate should remain at 0.25 mg/min (15/hr).

The recommended dosage of Fabrazyme is 1 mg/kg body weight infused every 2 weeks as an intravenous (IV) infusion.

For step-by-step instructions on how to calculate dose, preparation for use, storage and handling, and administering Fabrazyme, download the Fabrazyme Preparation & Administration Info Sheet.

Download these resources

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

Reference: 1. Fabrazyme (agalsidase beta). Prescribing Information. Sanofi.

Fabrazyme® (agalsidase beta) Dosing and Administration

Think Fabrazyme first and count on options

Fabrazyme can be administered in multiple treatment settings

Physician offices

Infusion centers

Home

Think Fabrazyme first, think adapting to your patient’s life by optimizing their infusion time

Download these resources

Preparation and Administration Sheet

Infusion Supply List

Schedule an in-person in-service presentation

Indication

Important Safety Information

WARNINGS AND PRECAUTIONS

Indication

Important Safety Information

Fabrazyme^® (agalsidase beta) Dosing and Administration