Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
Nov. 25, 2009
Health Canada has issued new restrictions concerning the use of Aldurazyme® (laronidase). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Kidney or liver function: The safety and effectiveness of this medication are not known in people with reduced kidney or liver function. People with reduced kidney or liver function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Premedication: Most people who receive laronidase will also be given medications (e.g., acetaminophen, diphenhydramine) to reduce infusion-related side effects such as fever, chills, headache, and flushing. These medications are usually given about 60 minutes before laronidase is given.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while receiving this medication, contact your doctor immediately.
Breast-feeding: It is not known if laronidase passes into breast milk. If you are a breast-feeding mother and are receiving this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children less than 6 months old.