Myozyme Lyophilisate For Solution For Injection 52.5Mg Drug Medication Dosage Information
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Myozyme: Lyophilisate for solution for injection (52.5mg)

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What is this Medicine?

ALGLUCOSIDASE ALFA (al glu KO si das AL fa) is a drug that is used to replace an enzyme that is missing in patients with Pompe disease. It is not a cure.

In-Depth Information

Myozyme 50mg Powder for Injection

NDC: 584680150
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Acid Alpha-glucosidase Deficiency (Pompe Disease)

Storage Information
Store unreconstituted product in refrigerator (36 to 46 degrees F)
Reconstituted product should be refrigerated and used within 24 hours if not used immediately
Protect from light
Protect from freezing
Myozyme 50mg Powder for Injection

Reported Side Effects for Myozyme 50mg Powder for Injection

Loose Stools Incidence:
<62.0%*
Severity: MILD
Onset: EARLY
Severe Allergy Incidence:
1.0-7.0%*
Severity: SEVERE
Onset: RAPID
Suddenly Stopped Heart Incidence:
1.0%*
Severity: SEVERE
Onset: EARLY
Fluid Retention Incidence:
3.0%*
Severity: MODERATE
Onset: DELAYED
Rhinitis Incidence:
6.0%*
Severity: MILD
Onset: EARLY
Feeling Sick Incidence:
6.0%*
Severity: MILD
Onset: EARLY
Chest Pain Incidence:
6.0-7.0%*
Severity: MODERATE
Onset: EARLY
Hives Incidence:
8.0-21.0%*
Severity: MILD
Onset: RAPID
Rapid Heart Rate Incidence:
8.0-23.0%*
Severity: MODERATE
Onset: RAPID
Sore Throat Incidence:
9.0-36.0%*
Severity: MILD
Onset: DELAYED
Stomach Pain Incidence:
15.0%*
Severity: MILD
Onset: EARLY
Slow Heart Beat Incidence:
21.0%*
Severity: SEVERE
Onset: RAPID
Constipation Incidence:
23.0%*
Severity: MODERATE
Onset: DELAYED
Heartburn Incidence:
26.0%*
Severity: MILD
Onset: DELAYED
Runny Nose Incidence:
28.0%*
Severity: MILD
Onset: EARLY
Yeast Infection Incidence:
31.0%*
Severity: MODERATE
Onset: DELAYED
Anemia Incidence:
31.0%*
Severity: MODERATE
Onset: DELAYED
Diaper Rash Incidence:
36.0%*
Severity: MILD
Onset: DELAYED
Antibody Formation Incidence:
89.0-99.0%*
Severity: MODERATE
Onset: DELAYED
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

SECOND Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

THIRD Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


Learning More About
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