Aldurazyme

Aldurazyme is used to treat Hurler and Hurler-Scheie Syndrome forms of Mucopolysaccharidoses (MPS I) disease caused by the lack of the enzyme called a-L-iduronidase in the body.

This medication is only available with your doctor’s prescription.

This product is available in the following forms:

• Solution

As with all medicines, the risks of using Aldurazyme must be compared to how much this medication will help you. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

• Allergies - Inform your doctor if you have ever had an allergic reaction to Doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.
• Pediatric - No appropriate studies have been performed on the relationship of age to the effects of this medication in children younger than 5 years of age. Safety and efficacy have not been established.
• Geriatric - No appropriate studies have been performed on the relationship of age to the effects of this medication in elderly patients. Safety and efficacy have not been established.
• Pregnancy - This medication is listed as Pregnancy Category B. This means that animal studies have revealed no evidence of harm to the unborn baby, however there are are no studies in pregnant women OR animal studies have showed an adverse affect to the unborn baby, but studies in pregnant women have not shown a risk to the unborn baby.
• Breastfeeding - There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.
• Drug Interactions - Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any prescription or over the counter medications.
• Other Interactions - Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.
• Other Medical Problems - Pre-existing medical problems may affect the use of this medication. Be sure to tell your doctor if you have any other medical problems, especially:
  • Breathing problems
  • Lung disease - Use with caution. May make these conditions worse.

A nurse or other trained health professional will give you Aldurazyme. This medication is given through a needle placed in one of your veins (intravenously).

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

It is very important that your doctor checks in with you often while you are receiving Aldurazyme to make sure that it is working properly.

This medication may cause anaphylaxis. This is a life-threatening condition and requires immediate medical attention.

Call your doctor immediately if you have

• A rash
• Itching
• Swelling of the face, tongue and throat
• Lightheadedness
• Slow or irregular heartbeat (bradycardia)
• Shortness of breath
• Difficulty breathing
• Chest pain
• Tightness after receiving this injection

Aldurazyme may produce unwanted affects along with the intended 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 you experience any of the following side-effects:

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 (tachycardia, palpitations, arrhythmias)
• 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
• Red spots on skin
• Shortness of breath
• Sweating
• Swollen, red, or tender area of infection
• Trouble breathing
• Unpleasant breath odor
• Unusual bleeding or bruising
• Unusual fatigue or weakness
• Vomiting of blood
• Yellow eyes or skin (jaundice)

Less Common

• Blindness
• Cough
• Itching skin
• Large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Noisy breathing
• Redness of skin
• Wheezing

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

More Common

• Bleeding, blistering, burning, coldness, or discoloration of skin
• Body aches or pain
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Decreased vision
• Diarrhea
• Difficulty 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

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

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