Aldurazyme Solution For Injection 2.9Mg Drug Medication Dosage Information
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Aldurazyme: Solution for injection (2.9mg)

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What is this Medicine?

LARONIDASE (la RON i daz) is a drug that is used to replace an enzyme that is missing in patients with some forms of mucopolysaccharidosis I (MPS I). It is used to treat some of the symptoms of the disease. This medicine is not a cure.

In-Depth Information

Aldurazyme 2.9mg/5ml Solution for Injection

NDC: 584680070
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Mucopolysaccharidosis I (MPS I)

Storage Information
Refrigerate (between 36 and 46 degrees F)
Protect from light
Discard product if it contains particulate matter, is cloudy, or discolored
Discard unused portion. Do not store for later use.
Protect from freezing
Aldurazyme 2.9mg/5ml Solution for Injection

Reported Side Effects for Aldurazyme 2.9mg/5ml Solution for Injection

Anaphylactoid Reactions Incidence:
1.0%*
Severity: SEVERE
Onset: RAPID
Vomiting Incidence:
4.0%*
Severity: MILD
Onset: EARLY
Hives Incidence:
4.0%*
Severity: MILD
Onset: RAPID
Itching Incidence:
>4.0%*
Severity: MILD
Onset: RAPID
Joint Pain Incidence:
4.0%*
Severity: MILD
Onset: DELAYED
Shaking Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Wheezing Incidence:
>5.0%*
Severity: MODERATE
Onset: RAPID
Skin Rash Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Pale Skin Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
7.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
7.0%*
Severity: MILD
Onset: EARLY
Low Platelet Count Incidence:
9.0%*
Severity: MODERATE
Onset: DELAYED
Stomach Pain Incidence:
9.0%*
Severity: MILD
Onset: EARLY
Angioedema Incidence:
9.0%*
Severity: SEVERE
Onset: RAPID
Low Blood Pressure Incidence:
9.0%*
Severity: MODERATE
Onset: RAPID
High Bilirubin Level Incidence:
9.0%*
Severity: MODERATE
Onset: DELAYED
Injection Site Reaction Incidence:
9.0-18.0%*
Severity: MILD
Onset: RAPID
Swelling Incidence:
9.0%*
Severity: MODERATE
Onset: DELAYED
Corneal Opacification Incidence:
9.0%*
Severity: SEVERE
Onset: DELAYED
Chest Pain Incidence:
9.0%*
Severity: MODERATE
Onset: EARLY
Headache Incidence:
9.0%*
Severity: MILD
Onset: EARLY
Rapid Heart Rate Incidence:
10.0%*
Severity: MODERATE
Onset: RAPID
Flushing Incidence:
11.0-23.0%*
Severity: MILD
Onset: RAPID
Fever Incidence:
11.0-30.0%*
Severity: MILD
Onset: EARLY
Overactive Reflexes Incidence:
14.0%*
Severity: MODERATE
Onset: DELAYED
Paresthesias Incidence:
14.0%*
Severity: MILD
Onset: DELAYED
Chills Incidence:
20.0%*
Severity: MILD
Onset: RAPID
Infection Incidence:
20.0-32.0%*
Severity: MILD
Onset: DELAYED
Infusion-related Reactions Incidence:
32.0-49.0%*
Severity: MODERATE
Onset: RAPID
Antibody Formation Incidence:
97.0%*
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.


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