RISK OF SERIOUS ALLERGIC REACTIONS
Some patients have experienced serious allergic reactions (including life-threatening anaphylactic reactions) during and up to 24 hours after treatment, regardless of how long they were taking ELAPRASE. Anaphylactic reactions are immediate and include breathing problems, low oxygen levels, low blood pressure, hives and/or swelling of the throat or tongue. If a patient (you or your child) has experienced an anaphylactic reaction, the patient may require an extended period of observation by the patient’s healthcare team. If you or your child has breathing problems, a fever, or a respiratory illness, you or your child may be at risk of life threatening worsening of those conditions due to allergic reactions from ELAPRASE. Your healthcare team should be advised of those conditions before treatment with ELAPRASE because the information may affect the timing of ELAPRASE treatment.
Please see full Prescribing Information and additional Important Safety Information below.
ELAPRASE is a prescription medicine for patients with Hunter syndrome. ELAPRASE has been shown to improve walking ability in patients 5 years and older.
In patients 16 months to 5 years old, ELAPRASE did not show improvement in disease-related symptoms or long term clinical result; however, treatment with ELAPRASE has reduced spleen size similarly to patients 5 years and older. It is not known if ELAPRASE is safe and effective in children under 16 months old.