Formulary
Pegunigalsidase alfa: Indications, Dosing, Side Effects and Interactions
Pegunigalsidase alfa is a pegylated form of recombinant human alpha-galactosidase A used for long-term enzyme replacement therapy in Fabry's disease.
MedNext Academy | 3 min read
Pegunigalsidase alfa: Indications, Dosing, Side Effects and Interactions
Pegunigalsidase alfa is a pegylated form of recombinant human alpha-galactosidase A used for long-term enzyme replacement therapy in Fabry's disease.
Drug action
Pegunigalsidase alfa is a pegylated form of recombinant human alpha-galactosidase A used for long-term enzyme replacement therapy in Fabry's disease.
Indications and dose
**Fabry's disease (under expert supervision)**
- **Adult** (By Intravenous Infusion): 1 mg/kg every 2 weeks.
Cautions
Infusion-related reactions Cautions, further information Infusion-related reactions Infusion-related reactions can occur and pegunigalsidase alfa should only be administered when appropriately trained staff and resuscitation facilities are available; these reactions may be minimised by pre-medication with an antihistamine and corticosteroid. Patients should be closely monitored for signs of infusion-related reactions during and for 2 hours after administration, and managed appropriately-consult product literature. M
Side effects
Common or very common Anxiety; arrhythmias; arthralgia; asthenia; chest discomfort; chills; diarrhoea; dizziness; gastrointestinal discomfort; headache; hypersensitivity; infusion related reaction; malaise; musculoskeletal stiffness; myalgia; nausea; pain; paraesthesia; skin reactions; vertigo; vomiting Uncommon Bronchospasm; chronic kidney disease; dyspnoea; flushing; gastrointestinal disorders; glomerulonephritis membranoproliferative; hypertension; hypohidrosis; hypotension; influenza like illness; insomnia; lymphoedema; nasal complaints; nipple pain; oedema; peripheral neuropathy; proteinuria; restless legs; throat irritation; tremor; ventricular hypertrophy; weight increased
Pregnancy
Use with caution (no information available). M
Breast feeding
Specialist sources indicate use with caution (no information available). Large molecular weight suggests limited excretion into milk and drug molecule likely to be partially destroyed in the infant's gastro-intestinal tract.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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