FABRAZYME

Fabrazyme Generic Name & Formulations

Legal Class

General Description

Agalsidase beta 5mg, 35mg; per vial; lyophilized cake or pwd for IV infusion after reconstitution and dilution; preservative-free.

Pharmacological Class

Recombinant human alpha-galactosidase A enzyme.

How Supplied

Single-use vial—1

Manufacturer

Sanofi Genzyme Company

Generic Availability

Fabrazyme Indications

Indications

Fabry disease.

Fabrazyme Dosage and Administration

Adults and Children

<2yrs: not established. Pretreat with antipyretic and antihistamine. Give by IV infusion. ≥2yrs: 1mg/kg every 2 weeks. Initially infuse at a rate of 0.25mg/min; if tolerated, may increase by increments of 0.05–0.08mg/min with each subsequent infusion. <30kg: max rate 0.25mg/min. ≥30kg: minimum duration is 1.5hrs. Slow rate if infusion reactions occur. Rechallenge: initially give a low dose and infusion rate (eg, 0.5mg/kg at 0.01mg/min); once tolerated, may increase dose to 1mg/kg, titrate rate slowly upwards (doubled every 30mins up to max 0.25mg/min); see full labeling.

Fabrazyme Contraindications

Not Applicable

Fabrazyme Boxed Warnings

Not Applicable

Fabrazyme Warnings/Precautions

Warnings/Precautions

Have appropriate medical support measures readily available; discontinue immediately if anaphylaxis or severe hypersensitivity reactions occur. Consider testing for IgE antibodies in patients who experienced suspected hypersensitivity reactions; if positive, may be rechallenged. Risk of infusion-associated reactions; if reaction occurs, decrease infusion rate, temporarily discontinue, and consider additional antipyretics, antihistamines, and/or steroids; if severe reactions occur, discontinue immediately. Compromised cardiac function; monitor closely. Pregnancy. Nursing mothers.

Fabrazyme Pharmacokinetics

See Literature

Fabrazyme Interactions

Fabrazyme Adverse Reactions

Adverse Reactions

Upper RTI, chills, pyrexia, headache, cough, paresthesia, fatigue, peripheral edema, dizziness, rash.

Fabrazyme

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