Life-threatening anaphylactic, severe allergic, and immune-mediated reactions have been observed in patients during and after alglucosidase alfa infusion. Observe patients closely and appropriate treatment and supportive measures should be readily available. Infantile onset Pompe disease patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation due to fluid overload, and require additional monitoring .
Alglucosidase alfa injection is an enzyme that treats infantile-onset Pompe disease, which is also called glycogen storage disease type II. Alglucosidase alfa contains a human enzyme called acid alpha-glucosidase. This enzyme helps with the digestion and absorption of glycogen. People with Pompe disease are not able to make enough of this enzyme.
This medicine is available only with your doctor's prescription.
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of alglucosidase alfa injection in children.
No information is available on the relationship of age to the effects of alglucosidase alfa injection in the geriatric population.
|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.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in one of your veins.
This medicine must be given slowly, so the needle will remain in place for a few hours. You or your child may also receive medicines to help prevent possible allergic reactions to the injection.
It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause chest pain, fever, chills, itching, hives or a rash, a fast heartbeat, flushing of the face, dizziness, fainting, or lightheadedness, trouble breathing, or swelling of the face, tongue, and throat within a few hours after it is given. Check with your doctor or nurse right away if you or your child have any of these symptoms.
This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, lightheadedness, dizziness, or fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving 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:
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.