Elaprase Solution For Injection 6Mg Drug Medication Dosage Information
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Elaprase: Solution for injection (6mg)

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What is this Medicine?

IDURSULFASE (EYE dur SUL fase) is used to replace an enzyme that is missing in patients with Hunter syndrome. It is not a cure.

In-Depth Information

Elaprase 6mg/3mL Solution for Injection

NDC: 540920700
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Mucopolysaccharidosis II (Hunter Syndrome)

Storage Information
Refrigerate (between 36 and 46 degrees F)
Protect from light
Discard product if it contains particulate matter, is cloudy, or discolored
Diluted product if not used immediately can be stored at 36 to 46 degrees F for up to 24 hours
Protect from freezing
Elaprase 6mg/3mL Solution for Injection

Reported Side Effects for Elaprase 6mg/3mL Solution for Injection

Skin Rash Incidence:
13.0%*
Severity: MILD
Onset: EARLY
Swelling Incidence:
13.0%*
Severity: MODERATE
Onset: DELAYED
Upset Stomach Incidence:
13.0%*
Severity: MILD
Onset: EARLY
Irritability Incidence:
13.0%*
Severity: MILD
Onset: DELAYED
Nervousness Incidence:
13.0%*
Severity: MILD
Onset: DELAYED
Infusion-related Reactions Incidence:
15.0%*
Severity: MODERATE
Onset: RAPID
Muscle Pain Incidence:
16.0%*
Severity: MILD
Onset: EARLY
Hives Incidence:
16.0%*
Severity: MILD
Onset: RAPID
Wheezing Incidence:
19.0%*
Severity: MODERATE
Onset: RAPID
Visual Impairment Incidence:
22.0%*
Severity: SEVERE
Onset: EARLY
Feeling Sick Incidence:
22.0%*
Severity: MILD
Onset: EARLY
High Blood Pressure Incidence:
25.0%*
Severity: MODERATE
Onset: EARLY
Itching Incidence:
28.0%*
Severity: MILD
Onset: RAPID
Joint Pain Incidence:
31.0%*
Severity: MILD
Onset: DELAYED
Antibody Formation Incidence:
51.0%*
Severity: MODERATE
Onset: DELAYED
Headache Incidence:
59.0%*
Severity: MILD
Onset: EARLY
Fever Incidence:
63.0%*
Severity: MILD
Onset: EARLY
*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 C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

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


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Patient Experiences with Elaprase

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