Safety-Related Labeling Changes

Hypersensitivity reactions, IARs, Immunogenicity, Oedema peripheral, injection site pain, Warn healthcare providers about inappropiate administration leading to gastrointestinal adverse reactions, headache, dizziness, and dyspnea

Trade Name

Aldurazyme

Updated Section

4.4 Special Warnings and Special Precautions for Use, 4.8 Undesirable effects, 4.9 Overdose

Month

Apr,2023