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About MPS I
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Full Prescribing Information (PDF)

What is it like to receive enzyme replacement therapy? Aldurazyme® (laronidase) is given once weekly by intravenous (IV) infusion, meaning that the medication is delivered directly into your bloodstream, and from there to your body’s cells and organs to break down the GAG buildup. Treatments with Aldurazyme are usually given in a hospital and last about three to four hours. Here's a description of the typical process during a treatment session: This may not reflect your individual experience.

The check-up
You will receive an Aldurazyme infusion as prescribed by your doctor once a week. After arriving at the hospital, you may meet with a physician for a routine exam to check on your symptoms and gauge the progress of your therapy.

Preparing for the therapy
A health care professional will review and discuss the infusion process with you. He or she will likely prescribe pretreatment medications, such as antihistamines or antifever therapies, to reduce the occurrence of reactions that may occur during an infusion. If prescribed, these medications are taken approximately 60 minutes before the start of the infusion.

Next, the health care professional typically checks your vital signs (pulse, blood pressure, respiration, temperature, and weight). He or she then customarily uses alcohol to clean a spot on your arm or hand, and inserts a small needle into the vein. The needle is then usually secured with a piece of tape. A bag of liquid containing Aldurazyme is connected to the needle with intravenous (IV) tubing.

The infusion
The health care professional will typically prescribe for Aldurazyme to drip slowly into the vein for about three to four hours. While receiving the infusion, you may usually lie down or sit comfortably doing activities such as reading a book, doing homework, or watching television. The health care professional will generally recheck your vital signs approximately every 15 minutes for the first hour of infusion. When the bag is empty, a clear solution may be injected to ensure that all the medication has been given. Then the IV needle is removed, and vital signs are checked one more time and then it is usually time to go home.

Sometimes when people are receiving their medication through an IV, they may develop reactions, occurring during or following the infusion. The most common infusion-related side effects include flushing, fever, headache, and rash. Many of these reactions are natural responses to medication and usually resolve over time.

Infusion-related reactions were not significantly different between Aldurazyme and placebo infusions during clinical trials.

For more information about infusion related reactions, ask your doctor and see the
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This site is intended for use in the United States. Please visit the Genzyme site for your country or region.
By reducing GAG (glycosaminoglycan) levels, Aldurazyme may help slow the underlying disease process of MPS I, and may thereby help reduce damage to several of the body’s organs and improve some physical capabilities.
If you, your child, or someone you care about has been newly diagnosed with MPS I, you may feel confused or anxious, but knowledge may help you overcome certain fears.

ALDURAZYME® (laronidase) is indicated for patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms.  The risks and benefits of treating mildly affected patients with the Scheie form have not been established.

 

ALDURAZYME has been shown to improve pulmonary function and walking capacity.  ALDURAZYME has not been evaluated for effects on the central nervous system manifestations of the disorder.

 

Important Safety Information

 

WARNING

Risk of anaphylaxis.

Life-threatening anaphylactic reactions have been observed in some patients during ALDURAZYME infusions.  Therefore, appropriate medical support should be readily available when ALDURAZYME is administered.  Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to infusion reactions, and require additional monitoring.

 

Life-threatening anaphylactic reactions have been observed in some patients during or up to 3 hours after ALDURAZYME infusions. Reactions have included: respiratory failure, respiratory distress, stridor, tachypnea, bronchospasm, airway obstruction, hypoxia, hypotension, bradycardia, and urticaria. Interventions have included: resuscitation, mechanical ventilatory support, emergency tracheotomy, hospitalization, and treatment with inhaled beta-adrenergic agonists, epinephrine, and intravenous corticosteroids.

 

In clinical trials and postmarketing safety experience with ALDURAZYME, approximately 1% of patients experienced severe or serious allergic reactions. In patients with MPS I, pre-existing upper airway obstruction may have contributed to the severity of some reactions. Due to the potential for severe allergic reactions, appropriate medical support should be readily available when ALDURAZYME is administered. Because of the potential for recurrent reactions, some patients who experience initial severe reactions may require prolonged observation. The risks and benefits of re-administering ALDURAZYME following an anaphylactic or severe allergic reaction should be considered.

 

Patients with an acute illness at the time of ALDURAZYME infusion may be at greater risk for infusion-related reactions. Careful consideration should be given to the patient’s clinical status prior to administration of ALDURAZYME.

 

Patients should receive antipyretics and/or antihistamines prior to infusion. If an infusion reaction occurs, regardless of pretreatment, decreasing the infusion rate, temporarily stopping the infusion, and/or administration of additional antipyretics and/or antihistamines may ameliorate the symptoms.

 

The most common adverse reactions associated with ALDURAZYME treatment in the clinical studies were upper respiratory tract infection, rash, and injection site reaction  The most common adverse reactions requiring intervention were infusion-related reactions involving flushing, fever, headache, and rash. 

 

In postmarketing experience with ALDURAZYME, severe and serious infusion-related reactions have been reported, some of which were life-threatening.  The most frequently reported adverse reactions included: chills, vomiting, nausea, arthralgia, diarrhea, tachycardia, abdominal pain, blood pressure increased, and oxygen saturation decreased. 

 

Approximately 91% of patients treated with ALDURAZYME in clinical studies were positive for antibodies to laronidase. The clinical significance of antibodies to ALDURAZYME is not known, including the potential for product neutralization. Adverse events should be reported promptly to Genzyme Medical Information at 800-745-4447, option 2. ALDURAZYME is available by prescription only. To learn more, please see the full prescribing information (PDF) including boxed warning, visit www.ALDURAZYME.com or contact Genzyme at 1-800-745-4447.
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