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ALIMENTARY TRACT AND METABOLISM › OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS › OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS › Enzymes
pegunigalsidase alfa
A16AB20
Forms & Strengths
- Lyophilized powder for reconstitution: 20 mg per vial
Adult Dosing
- 1 mg/kg administered intravenously every 2 weeks
Pediatric Dosing
- Safety and efficacy not established in pediatric patients <18 years of age
Indications
- Treatment of confirmed Fabry disease in adult patients
Mechanism of Action
- Recombinant human alpha-galactosidase A enzyme replacement therapy
- Provides exogenous alpha-galactosidase A to hydrolyze accumulated globotriaosylceramide (GL-3) in affected tissues
Contraindications
- History of life-threatening hypersensitivity reaction to pegunigalsidase alfa or any of its components
Adverse Reactions
- Infusion-associated reactions (chills, pyrexia, nausea, vomiting, dyspnea)
- Nasopharyngitis
- Headache
- Dizziness
- Peripheral edema
- Fatigue
- Development of anti-drug antibodies
Drug Interactions
- No formal clinical drug-drug interaction studies have been conducted
- Not expected to inhibit or induce cytochrome P450 enzymes based on its structure and mechanism
Curated Content: Needs Vetting Before Put to Clinical Use