Overview
Indications
® FABRAZYMEis indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.
Boxed Warning
FDA Black Box Warning
Warnings and Precautions (5.1) [see] 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
Contraindications
When this intervention should not be used
None.
Indications & Related Conditions
Conditions associated via SNOMED clinical relationships
Administration & Protocol
Dosing, route, and treatment protocol
Detailed dosage and administration information is available in the full FDA drug label.
View full prescribing information on DailyMedMonitoring & Follow-Up
Biomarkers relevant to this intervention via related conditions
No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.
Clinical Trials
7 trials linked to this intervention
Recent Trials
A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme
China Post-marketing Surveillance (PMS) Study of Fabrazyme®
A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac Fabry Disease
A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease
Ophthalmic Findings During 10-year Enzyme Substitution of Danish Fabry Patients.
Research Evidence
Published studies and systematic reviews
Research data from MEDLINE/PubMed
Benefits & Expected Outcomes
Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.
Risks & Side Effects
Adverse reaction and safety data for this drug is sourced from the FDA-approved label.
View adverse reactions & drug interactions on DailyMedRelated Symptoms
Symptoms associated with conditions this intervention addresses
No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.
Alternatives & Comparisons
Alternative treatments, comparison data, and clinical decision support are pending physician authorship.
This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.
Do not start, stop, or change any treatment without consulting your healthcare provider.
Quick Facts
- Type
- Substance / Medication
- Fully Specified Name
- Agalsidase beta (substance)
- SNOMED CT
- 424725004
- UMLS CUI
- C1137427
- RxNorm CUI
- 338817
- Labeler
- Genzyme Corporation
Clinical Data
This intervention maps to 1 entities in the Ltrl knowledge graph.
Data is sourced from SNOMED CT, UMLS, and the Ltrl clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.