Elelyso Lyophilisate For Solution For Injection 200iu Drug Medication Dosage Information
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ELELYSO: Lyophilisate for solution for injection (200IU)

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What is this Medicine?

Taliglucerase alfa (tal i GLOO ser ace alfa) is a man-made form of an enzyme that is missing in patients with Gaucher's disease. It is used to treat the symptoms of Gaucher's disease. It is not a cure.

In-Depth Information

Elelyso 200unit Powder for Injection

NDC: 000690106
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Gaucher's Disease

Storage Information
Refrigerate (between 36 and 46 degrees F)
Protect from light
Reconstituted product should be refrigerated and used within 24 hours if not used immediately
Do not freeze
Discard unused portion. Do not store for later use.
Elelyso 200unit Powder for Injection

Reported Side Effects for Elelyso 200unit Powder for Injection

Anaphylactoid Reactions Incidence:
2.0-3.0%*
Severity: SEVERE
Onset: RAPID
Tired Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Back Pain Incidence:
>5.0%*
Severity: MILD
Onset: DELAYED
Skin Rash Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Itching Incidence:
6.0%*
Severity: MILD
Onset: RAPID
Hives Incidence:
6.0%*
Severity: MILD
Onset: RAPID
Stomach Pain Incidence:
6.0%*
Severity: MILD
Onset: EARLY
Vomiting Incidence:
6.0%*
Severity: MILD
Onset: EARLY
Flushing Incidence:
6.0%*
Severity: MILD
Onset: RAPID
Lightheadedness Incidence:
9.0%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
9.0%*
Severity: MILD
Onset: EARLY
Headache Incidence:
13.0-19.0%*
Severity: MILD
Onset: EARLY
Antibody Formation Incidence:
13.0-53.0%*
Severity: MODERATE
Onset: DELAYED
Joint Pain Incidence:
13.0%*
Severity: MILD
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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