Alglucerase (Intravenous route)
Uses of This Medicine:
Alglucerase is used to treat Gaucher's disease caused by the lack of a certain enzyme, glucocerebrosidase, in the body. This enzyme is necessary for your body to use fats.
Alglucerase is made from human placenta tissue that is collected after a baby is born. Before it is used, the tissue is tested for hepatitis and human immunodeficiency virus (HIV). This is similar to the testing that a blood bank does on donated blood before it is given to anyone else.
Alglucerase is available with your doctor's prescription.
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:
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.
This medicine has been tested in a limited number of children. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of alglucerase in the elderly with use in other age groups.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
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:
This medicine will not cure Gaucher's disease but it does help control it. Therefore, you must continue to receive it if you expect to keep your condition under control. You may have to receive alglucerase for the rest of your life. If Gaucher's disease is not treated, it can cause serious blood, liver, skeletal, or spleen problems.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For Gaucher's disease:
- For injection dosage form:
- Adults and children—The dose is based on body weight. It is injected slowly into a vein over one to two hours. To start, some patients may receive 1.15 Units per kilogram (kg) (0.52 Units per pound) of body weight three times a week. Other patients may receive up to 60 Units per kg (27 Units per pound) of body weight as often as once a week or as seldom as every four weeks. Later, your doctor may raise or lower your dose.
- For injection dosage form:
Precautions While Using This Medicine:
It is important that your doctor check your progress while you are receiving alglucerase to make sure that the dosage is correct for you.
Side Effects of This Medicine:
Since alglucerase is made from human tissue, it is possible that diseases caused by viruses could be passed on. Examples of such diseases are hepatitis and HIV infection. These problems have not been reported to date, however, and are unlikely since the tissue is tested before being used. If you have questions or concerns about this, check with your doctor.
- Less common
- Abdominal discomfort
- nausea and vomiting
- swelling at place of injection
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.
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:
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: 9/4/2017