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 Elaprase (Idursulfase). If you are concerned about side effects, discuss the risks and benefits of Elaprase (Idursulfase) with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. 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.

• Acne
• Diarrhea
• ear problems
• Eczema
• heartburn
• increased tear production
• joint pain
• nausea
• sore throat
• tremor
• upper abdominal pain

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:

• dizziness
• Fever
• infusion reactions (e.g., headache, rash, itching, flushing redness, Hives, high blood pressure)
• increased blood pressure
• skin rash
• swelling at the place of injection
• swelling of the feet, ankles, or hands

Stop taking the medication and seek immediate medical attention if any of the following occur:

• abnormal heart rhythm(skipped or extra heartbeats)
• bluish skin colour (e.g., lips)
• chest pain
• seizures
• signs of a blood clot in the lung (e.g., difficulty breathing, cough, chest pain, increased breathing rate)
• signs of a Anaphylaxis (severe allergic reaction) (e.g., hives; difficulty breathing; wheezing; dizziness; seizure; swelling of the face, lips, tongue, or throat)

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

Each single use vial of sterile, aqueous, clear to slightly opalescent, colourless solution contains a 2 mg per mL of solution of Elaprase (Idursulfase) protein (6 mg in an extractable volume of 3 mL). The concentrate must be further diluted. Nonmedicinal ingredients: polysorbate 20, sodium chloride, sodium phosphate dibasic (heptahydrate), sodium phosphate monobasic (monohydrate), and water for injection.

Elaprase (Idursulfase) should not be used by anyone who is allergic to Elaprase (Idursulfase) or to any of the ingredients of the medication or the container.

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. 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. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.

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 Elaprase (Idursulfase).

Allergic reactions: Elaprase (Idursulfase) can cause serious allergic reactions that can be life-threatening. If you experience hives; difficulty breathing; bluish skin; seizures; severe dizziness; or swelling of the face, tongue, mouth, or lips while receiving Elaprase (Idursulfase), get immediate medical attention. In some cases, people who have had an allergic reaction to Elaprase (Idursulfase) will get more allergy symptoms after the infusion has stopped. If this occurs, get immediate medical attention.

Infusion-related reactions: Infusion-related reaction caused by Elaprase (Idursulfase) can include skin rash, itchy skin, fever, headache, flushing, hives, and high blood pressure. If these occur, you doctor may suggest that the infusion be slowed down or stopped temporarily. Your doctor may also recommend medications such as antihistamines and corticosteroids to reduce or prevent infusion-related reactions.

Lung problems: People with poor lung function or other lung problems may be more likely to experience infusion-related reactions. Infusion-related reactions include headache, rash, itchy skin, red skin, and high blood pressure. Your doctor will monitor you closely if you have lung problems and are receiving Elaprase (Idursulfase).

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

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

Children: The safety and effectiveness of using Elaprase (Idursulfase) have not been established for children under 5 years of age.

Seniors: The safety and effectiveness of using Elaprase (Idursulfase) have not been established for seniors.