premiere [30:<8 years of age; a however, experts recommend initiation of enzyme replacement therapy in children with clinical manifestations of Fabry s disease. 3 5 IgG seroconversion in pediatric patients associated with increased half-life and plasma agalsidase beta concentrations; this phenomenon is rarely observed in adult patients. a (See Immunologic Reactions and Antibody Formation under Cautions.) Geriatric Use Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults. 1 Females Response in females does not appear to differ from that in males. a Common Adverse Effects Infusion reactions (e.g., vomiting, chills, fever, fatigue, feeling cold, hypertension), anemia, peripheral edema, pain, respiratory tract infection, nasopharyngitis, procedural pain. a Interactions for Fabrazyme Specific Drugs Drug Interaction Comments Amiodarone Potential inhibition of intracellular α-galactosidase activity 5 Concomitant use not recommended by some clinicians 5 Chloroquine Potential inhibition of intracellular α-galactosidase activity 5 Concomitant use not recommended by some clinicians 5 Gentamicin Potential inhibition of intracellular α-galactosidase activity 5 Concomitant use not recommended by some clinicians 5 Monobenzone Potential inhibition of intracellular α-galactosidase activity 5 Concomitant use not recommended by some clinicians 5 Fabrazyme Pharmacokinetics Absorption AUC does not increase proportionately with increased dose. a Elimination Half-life 82 199 minutes. 1 Special Populations Half-life is increased in pediatric patients who develop IgG antibodies. a Stability Storage Parenteral Powder for Injection 2 8°C. 1 Following reconstitution and dilution, 2 8°C up to 24 hours; however, immediate use following reconstituion and dilution preferred since product contains no preservatives. a Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. Parenteral Solution Compatibility Compatible Sodium chloride 0.9% 1 Actions Provides exogenous source of α-galactosidase that catalyzes the hydrolysis of glycosphingolipids, including GL-3, in patients with Fabry s disease. 1 2 3 5 May reverse histologic abnormalities and decrease clinical manifestations of Fabry s disease. 2 5 Reduces GL-3 inclusions in the capillary endothelium of the kidney, heart, and skin. a Advice to Patients Importance of notifying clinician immediately if manifestations of infusion reaction (fever, rigors, chest tightness, hypertension, hypotension, pruritus, myalgia, dyspnea, urticaria, abdominal pain, headache) occur. 1 Importance of informing patients that a registry has been established to monitor the variability and progression of Fabry s disease and to evaluate long-term treatment effects of agalsidase beta. 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses. a Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. a Importance of informing patients of other important precautionary information. (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Agalsidase Beta Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral For injection, for IV infusion 5 mg Fabrazyme (preservative-free) Genzyme 37 mg Fabrazyme (preservative-free) Genzyme AHFS DI Essentials. Copyright 2017, Selected Revisions October 1, 2012. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Genzyme Corporation. Fabrazyme (agalsidase beta) for intravenous infusion prescribing information. Cambridge, MA. 2003 Apr. 2. Eng CM, Guffon N, Wilcox WR et al. Safety and efficacy of recombinant human α-galactosidase A replacement therapy in Fabry's disease. N Engl J Med . 2001; 345:9-16. [PubMed 11439963] 3. Desnick RJ, Banikazemi M, Wasserstein M. Enzyme replacement therapy for Fabry disease, an inherited nephropathy. Clin Nephrol . 2002; 57:1-8. [PubMed 11837797] 4. Mehta A. New developments in the management of Anderson-Fabry disease. QJM . 2002; 95:647-53. [PubMed 12324636] 5. Desnick RJ, Brady R, Barranger J et al. Fabry disease, an under-recognized multisystemic disorder: expert recommendations for diagnosis, management, and enzyme replacement therapy. Ann Intern Med . 2003; 138:338-46. [PubMed 12585833] 6. US Food and Drug Administration. FDA approves first treatment for Fabry disease. Rockville, MD; 2003 Apr 24. Press release No. P03-32. 7. Gahl WA. New therapies for Fabry's disease. N Engl J Med . 2001; 345:55-7. [PubMed 11439950] 8. Barngrover D. Fabrazyme recombinant protein treatment for Fabry's disease. J Biotechnol . 2002; 95:280-2. [PubMed 12080957] 9. Lee K, Jin X, Zhang K et al. A biochemical and pharmacological comparison of enzyme replacement therapies for the glycolipid storage disorder Fabry disease. Glycobiology . 2003; 13:305-13. [PubMed 12626384] 10. Fabry Registry. 11. Genzyme Corporation, Cambridge, MA: Personal communication. a. Genzyme Corporation. Fabrazyme (agalsidase beta) for intravenous infusion prescribing information. Cambridge, MA. 2006 Sep. Next Interactions Print this page Add to My Med List More about Fabrazyme (agalsidase beta) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: lysosomal enzymes Consumer resources Fabrazyme Fabrazyme (Advanced Reading) Professional resources Fabrazyme (FDA) Agalsidase Beta (AHFS Monograph) Related treatment guides Fabry Disease> ] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturers Genzyme Corporation Sanofi-Aventis U.S. LLC Drug Class Lysosomal enzymes Related Drugs Fabry Disease agalsidase beta , More... Fabrazyme Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! the actuality
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