NAGLAZYME® (galsulfase) safety and tolerability
Safety and tolerability data were collected from 55 patients in 3 clinical trials over a total period of 144 weeks. The safety and tolerability data reported are for 144 weeks of follow up for the Phase 1/2 trial, 96 weeks for the phase 2 trial, and 48 weeks for the phase 3 trial.
The most frequent adverse events related to the use of NAGLAZYME occurred during administration of the drug through IV infusion.
Infusion-associated reactions, most commonly fever, chills/rigors, headache, rash, and mild to moderate urticaria, occurred in 30 of 55 patients across all 3 studies. Other commonly reported symptoms included nausea, vomiting, elevated blood pressure, retrosternal pain, abdominal pain, malaise, and joint pain.1
- Initial reactions occurred as late as week 55
- The most frequent serious adverse events related to NAGLAZYME occurring during infusions included urticaria of the face and neck, bronchospasm, respiratory distress, and apnea.1
Safety profile
The most common adverse events observed across all clinical studies included headache, fever, arthralgia, vomiting, upper respiratory infections, abdominal pain, diarrhea, ear pain, cough, and otitis media.1
The most common adverse reactions requiring interventions were infusion-related ARs (IARs). No study patients discontinued due to IARs.1
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