LARONIDASE (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Aldurazyme

? Not commercially available in Canada.

Category

• Enzyme replenisher

Description

Laronidase (liar-OH-ni-days) is usedto treat Hurler and Hurler-Schele syndrome forms of mucopolysaccharidosis(MPS I) disease caused by the lack of a certain enzyme called [alpha ]-L-iduronidasein the body.

Laronidase is available only with your doctor's prescription, in the followingdosage forms:

Parenteral
• Injection (U.S.)

Before Receiving This Medicine

In deciding to use a medicine, the risks of receiving the medicine mustbe weighed against the good it will do. This is a decision you and your doctorwill make. For laronidase the following should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to laronidase. Also tell your doctor and pharmacist ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Laronidase has not been studied in pregnant women.However, laronidase has not been shown to cause birth defects or other problemsin animal studies.

Breast-feeding?It is not known whether laronidase passes intobreast milk. Although most medicines pass into breast milk in small amounts,many of them may be used safely while breast-feeding. Mothers who are takingthis medicine and who wish to breast-feed should discuss this with their doctor.

Children?This medicine has been tested in children 5 yearsof age and older, and has not been shown to cause different side effects orproblems than is does in adults. It is not know if children under 5 responddifferently from older children.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof laronidase in the elderly with use in other age groups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicines.

Proper Use of This Medicine

Dosing?The dose of laronidase will be different for different patients. Follow your doctor's orders The following informationincludes only the average doses of laronidase:

• For Mycopolysaccharidosis I:
  • For injection dosage form:
    • Adults and children?The dose is based on body weight and mustbe 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 avein over three to four hours.

Precautions While Receiving This Medicine

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 of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Check with your doctorimmediately if any of the following side effects occur:

More common

Abdominal or stomach pain; accumulationof 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; lightheadednesswhen getting up from a lying or sitting position suddenly; loss of appetite; nausea or vomiting; pinpoint red spots on skin; shortnessof breath; skin rash; sweating; swollen, red, tender area of infection; unpleasant breath odor; unusual bleedingor bruising; unusual tiredness or weakness; vomiting of blood; yellow eyes or skin

Less common

Cough; difficulty breathing; itching skin; large, hive-like swellingon 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 medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome.

More common

Bleeding, blistering, burning, coldness, discoloration of skin; blindness; body achesor pain; body produces substance that can bind todrug making it less effective or cause side effects; burning, crawling, itching, numbness, prickling, "pins and needles" , or tinglingfeelings; 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 ofvoice; nasal congestion; overactive reflexes; runny nose; sneezing; sore throat; swelling of legs and feet; swelling or puffinessof face; varicose or spider veins

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.