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DUVALGAGENE OTIPARVOVEC
Generic Name: DUVALGAGENE OTIPARVOVEC
ABSTRACT -
Duvalgagene otiparvovec is an investigational AAV-based gene therapy designed to deliver a codon-optimized human GLA gene for Fabry disease.
DOSAGE -
No approved dosage. Single-dose gene therapy regimens are protocol-defined and expressed as vector genomes per kilogram or fixed vector dose.
SIDE EEFECTS -
- Transient liver enzyme elevations
- Infusion reactions
- Immune responses to AAV capsid or transgene
- Headache or fatigue
- Renal or hematologic laboratory changes
ALLERGIC REACTIONS -
(These symptoms may indicate an allergic reaction and require medical attention.)
- Infusion hypersensitivity
- Rash or urticaria
- Angioedema
- Anaphylaxis (rare)
DRUG INTERACTIONS-
- Immunosuppressive prophylaxis may be protocol-required
- Avoid live vaccines during significant immunosuppression
- Hepatotoxic drugs may increase liver risk
PREAUTONS–
- Assess anti-AAV antibodies and organ function per protocol
- Monitor liver enzymes, complement, renal function, and vector-related immune responses
- Specialist gene therapy setting required
WARNINGS –
- Investigational gene therapy
- Potential serious immune-mediated, hepatic, renal, or thrombotic microangiopathy-like events require close monitoring
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