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Alglucosidase alfa (Intravenous route)

Pronunciation:

al-gloo-KOE-si-dase AL-fa

Brand Names:

  • Lumizyme
  • Myozyme

Dosage Forms:

  • Powder for Solution

Warnings:

Intravenous route(Powder for Solution)

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 .

Classifications:

Therapeutic

Enzyme Replacement

Pharmacologic

Enzyme

Uses of This Medicine:

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.

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:

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.

Children

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of alglucosidase alfa injection in children.

Older adults

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

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

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.

Other 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.

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:

  • 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.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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.

Side Effects of 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:

More common
Blue lips, fingernails, or skin
body aches or pain
chest discomfort or pain
chills
cough
difficult or labored breathing
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
nasal congestion
pain
pale skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid shallow breathing
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
tightness in the chest
trembling or shaking of the hands or feet
troubled breathing
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
Less common
Blood in the urine
convulsions
decreased urine
dry mouth
increased thirst
loss of appetite
mood changes
muscle pain or cramps
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
Incidence not known
Blue-green to black skin discoloration
blurred vision
confusion
dilated neck veins
extreme fatigue
heart stops
inability to speak
no breathing
no pulse or blood pressure
pain, redness, swelling, or sloughing of the skin at the place of injection
seizures
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
Abdominal or stomach pain
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
muscle or bone pain, stiffness, or tightness
muscle twitching
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
welts
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
muscle spasm
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.


Last Updated: 9/15/2016
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