Laronidase (Systemic)
   
Laronidase (Systemic)
US Brand Names
• Aldurazyme
Description
Laronidase (liar-OH-ni-days) is used to treat Hurler and Hurler-Schele syndrome forms of mucopolysaccharidosis (MPS I) disease caused by the lack of a certain enzyme called α-L-iduronidase in the body.
Laronidase is available only with your doctor's prescription, in the following dosage forms:
Parenteral
• Injection (U.S.)
Before Receiving This Medicine
In deciding to use a medicine, the risks of receiving the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For laronidase the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to laronidase. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy
Laronidase has not been studied in pregnant women. However, laronidase has not been shown to cause birth defects or other problems in animal studies.
Breast-feeding
It is not known whether laronidase passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.
Children
This medicine has been tested in children 5 years of age and older, and has not been shown to cause different side effects or problems than is does in adults. It is not know if children under 5 respond differently from older children.
Older adults
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of laronidase in the elderly with use in other age groups.
Other medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.
Administration
Dosing
The dose of laronidase will be different for different patients. Follow your doctor's orders The following information includes only the average doses of laronidase:
• For Mycopolysaccharidosis I:
o For injection dosage form:
§ Adults and children-The dose is based on body weight and must be determined by your doctor. The usual dose is 0.58 milligrams (mg) per kilogram (kg), (0.26 mg per pound) given once weekly. It is injected slowly into a vein over three to four hours.
Precautions
Regular visits: If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Abdominal or stomach pain; accumulation of pus; black, tarry stools; bleeding gums; blood in urine or stools; blurred vision; chest pain; chills; clay-colored stools; confusion; dark urine; dizziness; facial swelling; faintness; fever; headache; itching; lightheadedness when getting up from a lying or sitting position suddenly; loss of appetite; nausea or vomiting; pinpoint red spots on skin; shortness of breath; skin rash; sweating; swollen, red, tender area of infection; unpleasant breath odor; unusual bleeding or bruising; unusual tiredness or weakness; vomiting of blood; yellow eyes or skin.
Less common
Cough; difficulty breathing; itching skin; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; noisy breathing; redness of skin; shortness of breath; tightness in chest; wheezing.
Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.
More common
Bleeding, blistering, burning, coldness, discoloration of skin; blindness; body aches or pain; body produces substance that can bind to drug making it less effective or cause side effects; burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings; decreased vision; ear congestion; feeling of pressure; hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at injection site; loss of voice; nasal congestion; overactive reflexes; runny nose; sneezing; sore throat; swelling of legs and feet; swelling or puffiness of face; varicose or spider veins.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
April 09, 2004 
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