- Life-threatening anaphylactic reactions have been reported during therapy. Therefore, laronidase should be administered with appropriate medical support [US Black Box Warning]
- Patients with acute respiratory disease or compromised respiratory function may need additional monitoring as there may be a risk of serious acute exacerbation of their respiratory compromise due to infusion reactions [US Black Box Warning]
- In case of anaphylactic or other serious allergic reactions, discontinue the infusion immediately and institute appropriate medical therapy; consider the risks and benefits of re-administration of the drug in such patients. Appropriate resuscitative measures should be available during re-administration
- Patients should receive antipyretics and/or antihistamines prior to infusion
- If an infusion-related reaction occurs, decreasing the infusion rate, temporarily stopping the infusion, and/or administering additional antipyretics and/or antihistamines may ameliorate the symptoms
- Exercise caution while administering epinephrine to patients with MPS I due to the increased prevalence of CAD in these patients
Cautions: Use cautiously in
- Acute illness
- Upper airway obstruction
Pregnancy Category:B
Breastfeeding: Manufacturer advises caution.