Laronidase (Intravenous Route)

Laronidase is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Solution

Before Using

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.

Pediatric

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 .

Geriatric

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

Pregnancy

Breastfeeding

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.

Drug Interactions

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 diseasea€”Use with caution. May make these conditions worse .

Proper Use

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

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

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.