Elaprase

Elaprase is used to treat Hunter syndrome (Mucopolysaccharidosis II, MPS II). This is a rare condition which occurs in males. It is an inherited disease in which the breakdown of a certain chemical in the body (mucopolysaccharide) is defective due to the absence of an enzyme called iduronate-2-sulfatase.

Idursulfase improves signs and symptoms in patients, especially walking capacity, by replacing the missing enzyme in Hunter syndrome. This medicine is available only with your doctor's prescription.

Before using Elaprase, 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. Inform 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of idursulfase injection in children. However, safety and efficacy have not been established in children younger than 16 months of age.

Geriatric appropriate studies have not been performed on the relationship of age to the effects of idursulfase injection in the geriatric population. Safety and efficacy have not been established. Pregnancy information about this idursulfase-intravenous-in animal studies have shown an adverse effect and there are no adequate studies in pregnant women or no animal studies have been conducted and there are no adequate studies in pregnant women. Moreover, 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 may occur and hence 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 may also occur when certain medicines are 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. 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: Fluid overload (too much fluid in the blood) or Heart disease or Illness with fever or Lung disease or breathing problems and hence, this medicine needs to be used with caution; it may increase the risk of developing life-threatening complications.

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

The medicine is given slowly, so the needle will remain in place for a few hours. You or your child may also receive medicines to help prevent possible allergic reactions to the injection.

In using Elaprase, you must be careful and take some precautions as advised by your doctor.

It is very important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and check you for unwanted effects that may be caused by this medicine. This medicine may cause serious allergic reactions, including anaphylaxis.

Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you or your child have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you or your child get the injection.

As with many medications, there are several potential side effects associated with Elaprase.

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. The most common symptoms of side effects are:

• Bone or muscle pain
• Chest pain
• Chills
• Cough
• Fast, pounding, or irregular heartbeat or pulse feeling of warmth fever
• Headache
• Hives or welts itching
• Rash redness of the face, neck, arms, and occasionally, upper chest
• Redness of the skin
• Sneezing
• Sore throat
• Tightness in the chest
• Unusual tiredness or weakness

Less common side effects may present as:

• Blurred vision
• Confusion
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Sweating

Some of the incidences are not known to occur when using this medicine and they include:

• Difficulty with swallowing
• Dilated neck veins
• Extreme fatigue
• Heart stops
• Irregular breathing
• No breathing
• No pulse or blood pressure
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Unconscious weight gain

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:

• Change in hearing
• Diarrhea
• Ear drainage
• Earache or
• Pain in the ear

The less common side effects include:

• Nausea and
• Vomiting

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.