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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 to treat type 1 Gaucher's 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 the pediatric population. 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 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 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 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.

This medicine may cause a rare but serious type of an allergic reaction called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have cough, chest pain or discomfort, difficulty with swallowing, dizziness, fast heartbeat, headache, trouble with breathing, swelling in your face or hands, fever, chills, itching or hives, or lightheadedness or faintness while you are receiving this medicine or within 24 hours after you receive it.

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 pain or discomfort
dizziness
facial swelling
fever or chills
headache
hives or welts
itching
nausea or vomiting
redness of the skin
shortness of breath
skin rash
weakness
Incidence not known
difficult or labored breathing
difficulty with swallowing
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
tightness in the chest
unusual tiredness or weakness
wheezing

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
Back pain
bladder pain
bloody or cloudy urine
body aches or pain
congestion
difficult, burning, or painful urination
dryness or soreness of the throat
frequent urge to urinate
lack or loss of strength
runny nose
sneezing
voice changes
Less common
Abdominal or stomach pain
bloating or swelling of the face, arms, hands, lower legs, or feet
bone pain
diarrhea
muscle spasms
tingling of the hands or feet
trouble with sleeping
unusual weight gain or loss
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: 4/4/2014

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