Krystexxa Solution For Injection 8Mg Drug Medication Dosage Information
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Krystexxa: Solution for injection (8mg)

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What is this Medicine?

PEGLOTICASE (peg LOE ti kase) is an enzyme used to treat chronic gout.

In-Depth Information
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KRYSTEXXA 8mg/mL Solution for Injection

NDC: 543960801
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Gout

Storage Information
Protect from light
Store unopened containers in refrigerator (36 to 46 degrees F)
Store in carton until time of use
Discard unused portion. Do not store for later use.
Protect from freezing
KRYSTEXXA 8mg/mL Solution for Injection

Reported Side Effects for KRYSTEXXA 8mg/mL Solution for Injection

Heart Failure Incidence:
2.4%*
Severity: SEVERE
Onset: DELAYED
Vomiting Incidence:
5.0%*
Severity: MILD
Onset: EARLY
Anaphylactoid Reactions Incidence:
5.1%*
Severity: SEVERE
Onset: RAPID
Constipation Incidence:
6.0%*
Severity: MODERATE
Onset: DELAYED
Skin Redness Incidence:
7.0-9.5%*
Severity: MODERATE
Onset: EARLY
Tired Incidence:
7.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
>7.0%*
Severity: MILD
Onset: EARLY
Sore Throat Incidence:
7.0%*
Severity: MILD
Onset: DELAYED
Itching Incidence:
7.0-9.5%*
Severity: MILD
Onset: RAPID
Back Pain Incidence:
7.0%*
Severity: MILD
Onset: DELAYED
Infection Incidence:
7.0%*
Severity: MILD
Onset: DELAYED
Skin Rash Incidence:
7.0%*
Severity: MILD
Onset: EARLY
Shortness Of Breath Incidence:
7.1-10.0%*
Severity: MODERATE
Onset: EARLY
Chest Pain Incidence:
9.5%*
Severity: MODERATE
Onset: EARLY
Upset Stomach Incidence:
10.0-12.0%*
Severity: MILD
Onset: EARLY
Headache Incidence:
10.0%*
Severity: MILD
Onset: EARLY
Fever Incidence:
10.0%*
Severity: MILD
Onset: EARLY
Anemia Incidence:
10.0%*
Severity: MODERATE
Onset: DELAYED
Hives Incidence:
10.6%*
Severity: MILD
Onset: RAPID
Bruise Incidence:
11.0%*
Severity: MILD
Onset: DELAYED
Joint Pain Incidence:
12.0%*
Severity: MILD
Onset: DELAYED
Kidney Stones Incidence:
15.0%*
Severity: MODERATE
Onset: DELAYED
Infusion-related Reactions Incidence:
26.0%*
Severity: MODERATE
Onset: RAPID
Antibody Formation Incidence:
76.0-92.0%*
Severity: MODERATE
Onset: DELAYED
Gout Incidence:
77.0-88.0%*
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 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

Avoid - This drug is known to cause harm to infants when taken by nursing mothers.


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