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Taliglucerase alfa (Intravenous route)

Pronunciation:

tal-i-GLOO-ser-ase AL-fa

Brand Names:

  • Elelyso

Dosage Forms:

  • Powder for Solution

Classifications:

Therapeutic—

Enzyme Replacement

Pharmacologic—

Enzyme

Uses of This Medicine:

Taliglucerase alfa injection 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 This Medicine:

In deciding to use a medicine, 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:

Allergies—

Tell 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.

Children—

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.

Older adults—

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—

Pregnancy CategoryExplanation
All TrimestersBAnimal 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.

Breast-feeding—

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.

Other medicines—

Although 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—

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.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine 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.

Precautions While Using This Medicine:

It is very important that your doctor check you closely while you or your child are 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. 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, ulceration, 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.


Last Updated: 11/4/2014

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