Aldurazyme

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Aldurazyme (Laronidase). If you are concerned about side effects, discuss the risks and benefits of Aldurazyme (Laronidase) with your doctor.

The following side effects have been reported by at least 1% of people taking Aldurazyme (Laronidase). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• back pain
• infusion reactions (e.g., chills, flushing, Fever, headache, rash)
• injection site reaction (e.g., irritation, redness, or itching at the place where the medication was injected)
• joint pain
• rash
• upper respiratory tract infection

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• chest pain
• dizziness
• fast heart rate
• increased blood pressure
• overactive reflexes
• swelling of the feet or ankles
• unusual prickling, tingling, or burning sensations

Seek immediate medical attention if any of the following occur:

• symptoms of a Anaphylaxis (severe allergic reaction) (e.g., Hives, swelling of face or throat, or difficulty breathing, wheezing)

Some people may experience side effects other than those listed. Check with your doctor or pharmacist if you notice any symptom that worries you while you are taking Aldurazyme (Laronidase).

Each mL of sterile, colourless-to-pale-yellow, clear-to-slightly-opalescent solution contains 0.58 mg of Aldurazyme (Laronidase). The vial does not contain preservatives. Nonmedicinal ingredients: polysorbate 80, sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, and water for injection.

Aldurazyme (Laronidase) should not be used by anyone who is allergic to Aldurazyme (Laronidase) or to any of the ingredients of the medication.

There may be an interaction between Aldurazyme (Laronidase) and any of the following:

• chloroquine
• procaine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Aldurazyme (Laronidase). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Aldurazyme (Laronidase).

Kidney or liver function: The safety and effectiveness of Aldurazyme (Laronidase) are not known in people with reduced kidney or liver function. People with reduced kidney or liver function should discuss with their doctor how Aldurazyme (Laronidase) may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Aldurazyme (Laronidase), and whether any special monitoring is needed.

Premedication: Most people who receive Aldurazyme (Laronidase) will also be given medications (e.g., Acetaminophen, Diphenhydramine) to reduce infusion-related side effects such as fever, chills, headache, and flushing. These medications are usually given about 60 minutes before Aldurazyme (Laronidase) is given.

Pregnancy: Aldurazyme (Laronidase) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while receiving Aldurazyme (Laronidase), contact your doctor immediately.

Breast-feeding: It is not known if Aldurazyme (Laronidase) passes into breast milk. If you are a breast-feeding mother and are receiving Aldurazyme (Laronidase), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Aldurazyme (Laronidase) have not been established for children less than 6 months old.