Description
Alglucosidase alfa injection is an enzyme used to treat Pompe disease (glycogen storage disease type II), including infantile-onset Pompe disease. This medicine contains a human enzyme called acid alpha-glucosidase, which helps with the digestion and absorption of glycogen. People with Pompe disease are not able to make enough of this enzyme.
This medicine is to be given only by or under the direct supervision of your 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of alglucosidase alfa injection in children.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alglucosidase alfa injection in the elderly.
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.
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:
- Heart disease or
- Heart rhythm problems (eg, arrhythmia) or
- Lung or breathing problems—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through an IV catheter that is placed in one of your veins.
The medicine must be injected slowly, so the IV will need to stay in place for 4 hours. It is usually given every 2 weeks.
Your doctor will give you other medicines (eg, allergy, fever, or steroid medicine) before you receive this medicine to help prevent unwanted effects.
Missed Dose
Call your doctor or pharmacist for instructions.
Precautions
It is very important that your doctor check your or your child's progress closely at regular visits to make sure this medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child have blurred vision, chest discomfort or tightness, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast heartbeat, flushing, redness of the skin, rash, itching, hoarseness, sweating, trouble breathing, trouble swallowing, unusually warm skin, any swelling of the hands, face, or mouth, or unusual tiredness or weakness after receiving this medicine.
This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have chest discomfort, fever, chills or shaking, confusion, difficulty swallowing, dizziness, fast heartbeat, flushing, redness of the skin, increased or decreased blood pressure, trouble breathing, itching or rash, unusually warm skin, or lightheadedness, or fainting after receiving this medicine.
Immune-mediated reactions (eg, protein in the urine, kidney problems, and skin reactions) may occur while you or your child are receiving this medicine. Check with your doctor away if you or your child have bumps and rash on the skin, cloudy or bloody urine, high blood pressure, or swelling of the face, feet, or lower legs.
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
- Blue lips, fingernails, or skin
- body aches or pain
- bone pain
- chest discomfort, pain, or tightness
- chills
- cough
- difficulty with swallowing
- dizziness
- dry, red, hot, or irritated skin
- ear congestion
- fast, pounding, or irregular heartbeat or pulse
- feeling of warmth
- fever
- headache
- hives, itching, or skin rash
- increased sweating
- irregular, fast, slow, or shallow breathing
- lightheadedness, dizziness, or fainting
- loss of voice
- muscle pain, cramps, spasm, stiffness, tightness, or twitching
- nasal congestion
- pain
- pale skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the face, neck, arms, and occasionally, upper chest
- redness or pain at the catheter site
- runny nose
- shakiness in the legs, arms, hands, or feet
- slow or irregular heartbeat
- sneezing
- sore throat
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- trembling or shaking of the hands or feet
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Less common
- Blood in the urine
- decreased urine
- dry mouth
- increased thirst
- loss of appetite
- mood changes
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- pain in the groin or genitals
- sharp back pain just below the ribs
- seizures
Incidence not known
- Blue-green to black skin discoloration
- blurred vision
- bumps and rash on the skin
- cloudy urine
- confusion
- dilated neck veins
- extreme fatigue
- heart stops
- high blood pressure
- inability to speak
- no breathing
- no pulse or blood pressure
- pain, redness, swelling, or sloughing of the skin at the place of injection
- severe or sudden headache
- severe pain in the chest
- slurred speech
- sudden and severe weakness in the arm or leg on one side of the body
- sudden onset of severe breathing difficulty
- swelling of the face, fingers, feet, or lower legs
- temporary blindness
- unconscious
- weight gain
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
- Acid or sour stomach
- belching
- body aches or pain
- change in hearing
- congestion
- constipation
- dryness or soreness of the throat
- ear discomfort or pain
- ear drainage
- earache
- feeling of constant movement of self or surroundings
- general feeling of discomfort or illness
- heartburn
- hoarseness
- indigestion
- redness of the skin
- redness or swelling in the ear
- sensation of spinning
- sore mouth or tongue
- stomach discomfort, upset, or pain
- tender, swollen glands in the neck
- upper abdominal or stomach pain
- voice changes
- white patches in the mouth or on the tongue
Less common
- Bloody nose
- sleepiness or unusual drowsiness
Incidence not known
- Burning, dry, or itching eyes
- discharge, excessive tearing
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
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.
DRG-20074293
