Alglucosidase alfa Intravenous

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.

alglucosidase alfa 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 alglucosidase alfa, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to alglucosidase alfa 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of alglucosidase alfa injection in children.

Geriatric

No information is available on the relationship of age to the effects of alglucosidase alfa injection in the geriatric population.

Pregnancy

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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 alglucosidase alfa. Make sure you tell your doctor if you have any other medical problems, especially:

• Breathing problems or
• Cardiac hypertrophy (heart is larger than normal) or
• Heart rhythm problems (eg, arrhythmia) or
• Lung disease—Use with caution. May make these conditions worse.

It is very important that your doctor check the progress of you or your child at regular visits to make sure that alglucosidase alfa is working properly. Blood tests may be needed to check for unwanted effects.

alglucosidase alfa 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.

alglucosidase alfa 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 alglucosidase alfa.

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.