From the Research
Avalglucosidase alfa (Nexviazyme) can cause vein irritation during intravenous administration, and to minimize this side effect, healthcare providers should administer the medication through a central venous line when possible, rather than a peripheral IV, as supported by the study 1.
Administration Guidelines
To reduce the risk of vein irritation, the following guidelines should be followed:
- Administer the medication through a central venous line when possible
- Give the infusion slowly, following the recommended rate escalation protocol
- Dilute the medication properly in 0.9% sodium chloride solution
- Pre-medicate with antihistamines, antipyretics, and/or corticosteroids 30-60 minutes before infusion to reduce infusion-related reactions
- Monitor the IV site for signs of phlebitis, such as redness, swelling, or pain
- Rotate infusion sites for patients requiring regular treatments to prevent repeated trauma to the same vein
Mechanism of Vein Irritation
Vein irritation occurs because avalglucosidase is a large protein molecule that can trigger inflammatory responses in blood vessel walls, particularly when administered at higher concentrations or faster rates than recommended, as noted in the study 1.
Clinical Evidence
The study 1 evaluated the safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory efficacy of avalglucosidase alfa in patients with late-onset Pompe disease, and found that the medication was well-tolerated, with most treatment-emergent adverse events being non-serious and of mild-to-moderate intensity. However, infusion-associated reactions, including vein irritation, were reported in some patients.
Real-World Experience
A real-world experience study 2 in Italy found that patients with infantile-onset Pompe disease who were switched to avalglucosidase alfa after being treated with alglucosidase alfa for an average of 11.5 years showed improved biomarker levels and clinical outcomes, including improved motor performance and cardiac parameters. However, this study did not specifically address vein irritation.
Recent Approval
Avalglucosidase alfa received its first approval in the USA in 2021 for the treatment of patients 1 year of age and older with late-onset Pompe disease, as reported in the study 3.