Aldurazyme

What is this drug and what is it used for?

Aldurazyme is used to treat patients with MPS I disease (Mucopolysaccharidosis I). It is given to treat the non-neurological manifestations of the disease.

How is this drug given?

Instruction for use – dilution and administration

The concentrate for solution for infusion has to be diluted before administration and is for intravenous use (see information for health care professionals).

Dosage

The recommended dosage regimen of Aldurazyme is 100 U/kg body weight given once every week as an intravenous infusion. The initial infusion rate of 2 U/kg/h may be gradually increased every fifteen minutes, if tolerated, to a maximum of 43 U/kg/h. The total volume of the administration should be delivered in approximately 3-4 hours.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Possible side effects

Severe systemic allergic reaction (anaphylactic reaction)
Very common symptoms (may affect more than 1 in 10 people) which were not serious include
headache, nausea, abdominal pain, rash, joint disease, joint pain, back pain, pain in arms or legs,
flushing, fever, chills, increased heart rate, increased blood pressure, and reaction at the infusion site.

Other side effects include the following:
Common (may affect up to 1 in 10 people)

• Increased body temperature
• Tingling
• Dizziness
• Cough
• Difficulty in breathing
• Vomiting
• Diarrhoea
• Swelling of the neck
• Hives
• Itching
• Hair loss
• Cold sweat, heavy sweating
• Muscle pain
• Paleness
• Cold hands or feet
• Feeling hot, feeling cold
• Fatigue
• Influenza like illness
• Restlessness