Lumizyme

1 What is Lumizyme?

Brand: Lumizyme, Myozyme

Generic: Alglucosidase Alfa (Intravenous Route)

Lumizyme 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 medication is only available with your doctor’s prescription.

This medication is available in the following forms:

  • Powder for Solution

2 What to Know Before Using

Before using Lumizyme, you must know all about the risks and complications associated with it.

As with all medicines, the risks must be compared to how much a medication will help you. This is a decision that you and your doctor will make together. For this medication, there are many things that need to be considered:

Allergies

Inform your doctor if you have ever had an allergic reaction to doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.

Pediatric

Up-to-date Pediatric Appropriate studies have not indicated any problems that would limit the use of this medication.

Geriatric

No appropriate studies have been performed on the relationship of age to the effects of this medication in the elderly. Safety and efficacy have not been established.

Pregnancy

This medication is listed as Pregnancy Category C. This means that animal studies have shown an adverse effect and no studies have been performed on pregnant women OR there are no adequate studies on pregnant animals and pregnant women.

Breastfeeding

There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.

Drug Interactions

Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any prescription or over the counter medications.

Other Interactions

Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain mediations may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.

Other Medical Problems

Pre-existing medical problems may affect the use of this medication. Be sure to tell your doctor if you have any other medical problems, especially:

  • Breathing problems
  • Cardiac hypertrophy (heart is larger than normal)
  • Hearth rhythm problems
  • Lung disease - Use with caution. May make these conditions worse.

3 Proper Usage

To use Lumizyme properly, you must follow all instructions given by your doctor.

A nurse or other trained health professional will give you this medication in a hospital. This medication is given through a needle placed in one of your veins (intravenously)

This medication must be given slowly, so the catheter will remain in place for a few hours. You may also receive other medications to help prevent possible allergic reactions to the injection.

4 Precautions to Take

Before using Lumizyme, there are some precautions you must take.

Only take this medication as directed by your doctor. Do not take more, less or for a longer or shorter period of time than your doctor tells you. Blood tests may be needed to check for unwanted effects.

This medication may cause

within a few hours after it is given.

Tell your doctor or nurse immediately if you have any of these symptoms.

This medication may cause serious types of allergic reactions such as anaphylaxis, which is a life-threatening condition and requires immediate medical attention.

Call your doctor immediately if you have

  • a rash, itching,
  • hoarseness,
  • lightheadedness,
  • dizziness or fainting (syncope),
  • difficulty breathing,
  • trouble swallowing
  • any swelling of your hands, face or mouth

after receiving this medication.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Lumizyme.

A medication may produce unwanted affects along with the intended effects. Although not all of these side-effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if you experience any of the following side-effects:

More common:

  • Blue lips, fingernails, or skin (cyanosis)
  • Body aches or pain
  • Chest discomfort or pain (angina)
  • Chills
  • Cough
  • Difficult or labored breathing
  • Difficulty swallowing
  • Dizziness
  • Dry, red, hot, or irritated skin
  • Ear congestion
  • Fast, pounding, or irregular heartbeat or pulse (tachycardia, palpitations, arrhythmias)
  • Feeling of warmth
  • Fever
  • Headache
  • Hives, itching, or skin rash
  • Increased sweating
  • Irregular, fast, slow, or shallow breathing
  • Lightheadedness, dizziness, or fainting (syncope)
  • 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 (bradycardia, arrhythmias)
  • 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 with exertion
  • Unusual bleeding or bruising
  • Unusual fatigue or weakness

Less common:

  • Blood in the urine
  • Convulsions
  • Decreased urine
  • Dry mouth
  • Increased thirst (polydipsia)
  • 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

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

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 (vertigo)
  • General feeling of discomfort or illness (malaise)
  • 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

Some patients may experience other side effects that are not listed.

Check with your doctor if you notice any other side effects.

Ask your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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