Elelyso

Elelyso is used for the long-term treatment of type 1 Gaucher disease. This disease is caused by the lack of a certain enzyme in the body called glucocerebrosidase.

This enzyme is necessary for the body to use fats correctly, and fats will build up in certain areas of the body if the enzyme is not present.

Taliglucerase alfa replaces the missing enzyme to help the body process fats. This medicine is to be given only by or under the direct supervision of a doctor.

Before using Elelyso, it is important that 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. Before this medicine can be used, it is important that you inform your medical doctor whether 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 have not been performed on the relationship of age to the effects of taliglucerase alfa injection in children younger than 4 years of age. Safety and efficacy have not been established. Although appropriate studies on the relationship of age to the effects of taliglucerase alfa injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy Information about this taliglucerase alfa intravenous-route in animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breastfeeding There is 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 when certain medicines are used together with other medicines, 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 Certain medicines should not be 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.

For proper usage Elelyso will be given by a trained nurse or other trained health professional in a hospital or clinic. This medicine is given through a needle placed in one of your veins. This medicine is usually given every other week.

Each treatment usually takes 60 to 120 minutes. You or your child may also receive medicines to help prevent unwanted effects from the injection.

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

It is very important that your doctor check you closely while you or your child is receiving the medicine. This is to make sure that this medicine is working properly and does not cause unwanted effects. This medicine may cause serious allergic reactions, including anaphylaxis.

Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting.

Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

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

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:

More common

• Chest tightness
• Dizziness
• Feeling of warmth hives or welts
• Itching or skin rash
• Irritation in the throat
• Large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Nausea or vomiting
• Redness of the face, neck, arms, and occasionally, upper chest redness of the skin

Less common

• Blurred vision
• Confusion
• Cough
• Difficulty with swallowing dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Fast heartbeat
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue sweating
• Unusual tiredness or weakness

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

• Abdominal or stomach pain
• Difficulty with moving feeling of warmth
• Headache
• Muscle pain or stiffness
• Pain in the joints
• Incidence not known
• Bleeding
• Blistering
• Burning
• Coldness
• Discoloration of the skin
• Feeling of pressure
• Hives
• Infection
• Inflammation
• Itching
• Lumps
• Numbness
• Pain
• Rash
• Redness
• Scarring
• Soreness
• Stinging
• Swelling
• Tenderness
• Tingling
• lceration
• or Warmth at the injection site

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.