Pronunciation:

lair-OH-ni-days

Brand Names:

• Aldurazyme

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Enzyme

Uses of This Medicine:

Laronidase is used to treat Hurler and Hurler-Schele syndrome forms of mucopolysaccharidosis (MPS I) disease caused by the lack of a certain enzyme called a-L-iduronidasein the body.

Laronidase is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For Mycopolysaccharidosis I:
  • 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 While Using 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 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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.