Elelyso

Elelyso is a prescription medication used to treat Type 1 Gaucher disease. Elelyso belongs to a group of drugs called enzymes. These work by acting like the enzyme glucocerebrosidase. This enzyme does not work well in people with Type 1 Gaucher disease.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional. 

Common side effects of Elelyso include headache, joint pain, and lack of energy.

Elelyso can also cause dizziness. Do not drive or operate heavy machinery until you know how Elelyso affects you.

Elelyso is a prescription medication used to treat Type 1 Gaucher disease in adults and children. Type 1 Gaucher disease is a rare inherited condition, and common symptoms include increased spleen and liver size, and low hemoglobin level (anemia) and low platelet count. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Pfizer Laboratories Div Pfizer Inc.

Serious side effects have been reported with Elelyso. See the "Drug Precautions" section.

Common side effects of Elelyso include the following:

• heachache
• joint pain
• lack of energy
• nausea
• dizziness
• stomach pain
• itching
• flushing
• vomiting
• hives

This is not a complete list of Elelyso side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No drug interactions have been reported by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Elelyso including the following:

Allergic Reactions (Hypersensitivity reactions including anaphylaxis). Serious hypersensitivity or allergic reactions have occurred in some patients treated with Elelyso. Your doctor should monitor you for reactions before, during, and after you receive Elelyso. These reactions can occur up to 3 hours after receiving the infusion. Tell your doctor immediately if you experience any of the following signs or symptoms:

• hives (red itchy welts)
• low blood pressure
• wheezing
• chest tightness
• nausea or vomiting
• dizziness
• rash
• sudden cough
• irritated throat
• flushing (turning red in the face or other areas of the skin)

If you experience any of these symptoms, your doctor may slow your infusion or stop it altogether. Your doctor may give you certain medications before receiving Elelyso to help prevent any infusion reactions. 

Elelyso can cause drowsiness. Do not drive or operate heavy machinery until you know how Elelyso affects you.

Do not receive Elelyso if you are allergic to Elelyso or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Elelyso, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Elelyso, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Elelyso or to any of its ingredients
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The data on Elelyso use in pregnant women is not enough to inform a drug-associated risk.  In animal studies, pregnant animals were given Elelyso and the babies did not show any medical issues related to this medication.

Women with Type 1 Gaucher disease have an increased risk of serious complications with pregnancy if the disease is not adequately controlled before and during pregnancy. Becoming pregnant can also worsen the symptoms of Type 1 Gaucher disease.

You and your doctor should discuss the risks and benefits of receiving Elelyso while pregnant or when you are planning to become pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Elelyso crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Elelyso.

Elelyso comes in an injectable form to be given directly into a vein (IV) by a healthcare professional, once every other week. Elelyso infusions should take 1 to 2 hours to complete.

It is important to keep all of your appointments to receive doses of Elelyso. If you miss an appointment to receive a dose, contact your healthcare provider immediately.

The dose of Elelyso your doctor recommends may be based on the following:

• your weight
• if you are currently being treated with imiglucerase (a different medication for Type 1 Gaucher disease)
• how you respond to this medication

The recommended dose of Elelyso for patients who are not currently receiving any treatment for Type 1 Gaucher disease is 60 units per kg of body weight, given once every other week.

If you are switching from imiglucerase (Cerezyme) to Elelyso, you will receive the same dose of Elelyso that you were receiving of Cerezyme, once every other week.

If Elelyso is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep all appointments with your doctor while you are receiving Elelyso.