Fabrazyme Generic Name & Formulations
Agalsidase beta 5mg, 35mg; per vial; lyophilized cake or pwd for IV infusion after reconstitution and dilution; preservative-free.
Recombinant human alpha-galactosidase A enzyme.
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 Boxed Warnings
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 Adverse Reactions
Upper RTI, chills, pyrexia, headache, cough, paresthesia, fatigue, peripheral edema, dizziness, rash.
Fabrazyme Clinical Trials
Register pregnant patients at www.registrynxt.com or call (800) 745-4447.
Fabrazyme Patient Counseling