Fabrazyme Lyophilisate For Solution For Injection 35Mg Drug Medication Dosage Information
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Fabrazyme: Lyophilisate for solution for injection (35mg)

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What is this Medicine?

AGALSIDASE BETA is used to replace an enzyme that is missing in patients with Fabry disease. It is not a cure.

In-Depth Information

Fabrazyme 35mg Powder for Injection

NDC: 584680040
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Fabry Disease

Storage Information
Refrigerate (between 36 and 46 degrees F)
Reconstituted product should be refrigerated and used within 24 hours if not used immediately
Fabrazyme 35mg Powder for Injection

Reported Side Effects for Fabrazyme 35mg Powder for Injection

Anaphylactoid Reactions Incidence:
<1.0%*
Severity: SEVERE
Onset: RAPID
Infection Incidence:
4.0-44.0%*
Severity: MILD
Onset: DELAYED
Dry Mouth Incidence:
4.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Chest Pain Incidence:
5.0%*
Severity: MODERATE
Onset: EARLY
Flushing Incidence:
5.0%*
Severity: MILD
Onset: RAPID
Deafness Incidence:
5.0%*
Severity: SEVERE
Onset: DELAYED
Vomiting Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Slow Heart Beat Incidence:
>5.0%*
Severity: SEVERE
Onset: RAPID
Stomach Pain Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Hives Incidence:
>5.0%*
Severity: MILD
Onset: RAPID
Pale Skin Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Low Blood Pressure Incidence:
>5.0%*
Severity: MODERATE
Onset: RAPID
Upset Stomach Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Nervousness Incidence:
6.0%*
Severity: MILD
Onset: DELAYED
Sore Throat Incidence:
6.0%*
Severity: MILD
Onset: DELAYED
Wheezing Incidence:
6.0%*
Severity: MODERATE
Onset: RAPID
Depression Incidence:
6.0%*
Severity: MODERATE
Onset: DELAYED
Shortness Of Breath Incidence:
8.0%*
Severity: MODERATE
Onset: EARLY
Ringing In Ears Incidence:
8.0%*
Severity: MILD
Onset: DELAYED
Rapid Heart Rate Incidence:
9.0%*
Severity: MODERATE
Onset: RAPID
Sinus Infection Incidence:
9.0%*
Severity: MILD
Onset: DELAYED
Itching Incidence:
10.0%*
Severity: MILD
Onset: RAPID
High Blood Pressure Incidence:
14.0%*
Severity: MODERATE
Onset: EARLY
Muscle Pain Incidence:
14.0%*
Severity: MILD
Onset: EARLY
Back Pain Incidence:
16.0%*
Severity: MILD
Onset: DELAYED
Stuffy Nose Incidence:
19.0%*
Severity: MILD
Onset: EARLY
Skin Rash Incidence:
20.0%*
Severity: MILD
Onset: EARLY
Lightheadedness Incidence:
21.0%*
Severity: MILD
Onset: EARLY
Swelling Incidence:
21.0%*
Severity: MODERATE
Onset: DELAYED
Tired Incidence:
24.0%*
Severity: MILD
Onset: EARLY
Paresthesias Incidence:
31.0%*
Severity: MILD
Onset: DELAYED
Cough Incidence:
33.0%*
Severity: MILD
Onset: DELAYED
Fever Incidence:
39.0%*
Severity: MILD
Onset: EARLY
Headache Incidence:
39.0%*
Severity: MILD
Onset: EARLY
Chills Incidence:
43.0%*
Severity: MILD
Onset: RAPID
Infusion-related Reactions Incidence:
50.0-55.0%*
Severity: MODERATE
Onset: RAPID
*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

Compatible - This drug is generally safe to take by nursing mothers.


Learning More About
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