Pronunciation:

lar-ON-i-dase

Brand Names:

• Aldurazyme

Dosage Forms:

• Solution

Warnings:

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

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 α-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—

Appropriate studies have not been performed on the relationship of age to the effects of laronidase in children younger than 5 years of age. Safety and efficacy have not been established .

Older adults—

Appropriate studies on the relationship of age to the effects of laronidase have not been performed in the geriatric population .

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Breathing problems or
• Lung disease—Use with caution. May make these conditions worse .

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins .

You may also be given other medicines to keep you from having a fever or to prevent allergic reactions before you receive the injection .

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it .

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; lightheadedness; slow or irregular heartbeat; shortness of breath; trouble breathing; or chest pain or tightness after you get the injection .

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 or nurse immediately if any of the following side effects occur:

More common

Abdominal or stomach pain

accumulation of pus

back pain

black, tarry stools

bleeding gums

blood in urine or stools

blurred vision

chest pain

chest tightness

chills

clay-colored stools

confusion

dark urine

dizziness

drowsiness

facial swelling

faintness

fast, pounding, or irregular heartbeat or pulse

fever

flushing

headache

hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at injection site

itching

lightheadedness when getting up from a lying or sitting position suddenly

loss of appetite

nausea or vomiting

pale skin

pinpoint red spots on skin

shortness of breath

skin rash

sweating

swollen, red, or tender area of infection

trouble breathing

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, or sex organs

noisy breathing

redness of skin

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, or discoloration of skin

blindness

body aches or pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

decreased vision

diarrhea

difficulty in moving

ear congestion

feeling of pressure

loss of voice

muscle pain or stiffness

nasal congestion

overactive reflexes

pain in joints

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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.