Description
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.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
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 an IV catheter that is placed in one of your veins. The medicine must be injected slowly, so your IV will need to stay in place for 60 to 120 minutes. It usually given every other week.
Your doctor may give you other medicines before treatment (eg, allergy medicine, steroid) to help prevent unwanted effects.
Precautions
It is very important that your doctor check your or your child's progress closely while receiving this medicine. This is to make sure the medicine is working properly and does not cause unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis which can be life-threatening and require immediate medical attention. Check with your doctor right away if you or your child have a cough, difficulty swallowing, dizziness, fast heartbeat, rash, itching, trouble breathing, or unusual tiredness or weakness after receiving this medicine.
Side Effects
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
- Difficulty with moving
- feeling of warmth
- headache
- joint pain
- muscle pain or stiffness
- stomach pain
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.
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