Generic Name: alglucosidase alfa (AL-gloo-KOE-si-dase)
Brand Name: Examples include Lumizyme and Myozyme
Severe and sometimes life-threatening allergic reactions have happened with alglucosidase alfa. These reactions have happened while patients received their dose and up to 3 hours after the infusion. Tell your health care provider right away if you experience rash; hives; itching; fast or difficult breathing; chest pain or discomfort; tightness in the chest or throat; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; back pain; bluish skin or nails; burning, numbness, or tingling; dizziness or light-headedness; fainting; fast, slow, or irregular heartbeat; feeling of being cold in the arms or legs; fever or feeling hot; flushing; nervousness; restlessness; seizures; severe headache; severe or unusual nausea; unusual sweating; unusually pale skin; or wheezing. Only use alglucosidase alfa where appropriate measures to treat a severe allergic reaction are available.
Serious reactions (eg, kidney problems, serious skin reactions) have also happened after treatment with alglucosidase alfa. These reactions have happened several weeks to 3 years after treatment started. Tell your health care provider right away if you have a change in how much urine is passed; blood in the urine; red, swollen, blistered, or peeling skin; or any abnormal skin change.
Before using alglucosidase alfa, tell your doctor if you have heart problems or lung or breathing problems. Patients with either of these problems may be at risk for worsening of their condition due to infusion reactions.
Certain brands of alglucosidase alfa are only available through a restricted distribution program. Patients who receive these brands must be enrolled and meet all the conditions of this program.
Alglucosidase alfa is used for:
Treating Pompe disease (alfa-glucosidase deficiency) in certain patients.
Alglucosidase alfa is a glycoprotein. It works by replacing the enzyme alfa-glucosidase in the body.
Do NOT use alglucosidase alfa if:
- you are allergic to any ingredient in alglucosidase alfa, unless your doctor tells you otherwise
Contact your doctor or health care provider right away if any of these apply to you.
Before using alglucosidase alfa:
Some medical conditions may interact with alglucosidase alfa. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have had an allergic reaction (eg, rash, hives, difficulty breathing, dizziness) to this medication in the past
- if you are or have recently been ill, or if you are dehydrated
- if you have heart problems (eg, enlarged heart, Wolff-Parkinson-White syndrome) or lung or breathing problems
Some MEDICINES MAY INTERACT with alglucosidase alfa. However, no specific interactions with alglucosidase alfa are known at this time.
Ask your health care provider if alglucosidase alfa may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use alglucosidase alfa:
Use alglucosidase alfa as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Alglucosidase alfa will be given as an injection at your doctor's office, hospital, or clinic.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- Continue to use alglucosidase alfa even if you feel well. Do not miss any doses.
- If you miss a dose of alglucosidase alfa, contact your doctor right away.
Ask your health care provider any questions you may have about how to use alglucosidase alfa.
Important safety information:
- Tell your doctor or dentist that you use alglucosidase alfa before you receive any medical or dental care, emergency care, or surgery.
- If you will be receiving anesthesia, talk with your doctor. The risk of irregular heartbeat and sudden death due to heart problems may be increased in certain patients.
- Lab tests, including liver function, urine tests, and immune system tests, may be performed while you use alglucosidase alfa. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Certain brands of alglucosidase alfa should only be used for specific types of Pompe disease. Check with you doctor if you have any questions about this information.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using alglucosidase alfa while you are pregnant. It is not known if alglucosidase alfa is found in breast milk. If you are or will be breast-feeding while you use alglucosidase alfa, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of alglucosidase alfa:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; drowsiness; heartburn; runny nose.
Severe allergic reactions (rash; hives; itching; fast or difficult breathing; tightness in the chest or throat; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); agitation, irritability, or restlessness; arm or leg pain; back or neck pain; blood in the urine; blue skin or nails; burning, numbness, or tingling; change in the amount of urine produced; chest pain or discomfort; chills; cough; decreased urination; diarrhea; dizziness or light-headedness; ear pain; fainting; fast, slow, or irregular heartbeat; feeling hot; feeling of being cold in the arms or legs; fever; flushing; hearing changes; increased tear production; muscle pain, stiffness, or twitching; nervousness; nosebleed; pain, swelling, or redness at the injection site; persistent trouble sleeping; purplish skin discoloration; rapid or difficult breathing; seizures; severe or persistent diarrhea, headache, nausea, stomach pain, or vomiting; shortness of breath; sore throat; swelling of the hands, arms, legs, or feet; tremor; unusual skin reactions (eg, redness, swollen, blistered, or peeling skin); unusual sweating; unusual tiredness or weakness; unusually dry mouth or eyes; unusually pale skin; vision changes (eg, blurred vision); vomiting; wheezing; white patches in the mouth.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of alglucosidase alfa:
Alglucosidase alfa is handled and stored by a health care provider. You will not store it at home. Keep all medicines out of the reach of children and away from pets.
- If you have any questions about alglucosidase alfa, please talk with your doctor, pharmacist, or other health care provider.
- Alglucosidase alfa is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take alglucosidase alfa or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about alglucosidase alfa. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to alglucosidase alfa. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using alglucosidase alfa.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.