Gattex Lyophilisate For Solution For Injection 5Mg Drug Medication Dosage Information
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Gattex: Lyophilisate for solution for injection (5mg)

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What is this Medicine?

TEDUGLUTIDE (TE due GLOO tide) is used in patients with short bowel syndrome (SBS) who get nutrition or fluids from an IV.

In-Depth Information
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Gattex 5mg Powder for Injection

NDC: 688750102
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Short Bowel Syndrome

Storage Information
Discard product if it contains particulate matter, is cloudy, or discolored
Do not freeze reconstituted product
Store unreconstituted product at or below 77 degrees F
Discard unused portion. Do not store for later use.
Do not freeze
Reconstituted product should be used within 3 hours
Prior to dispensing, store in refrigerator (36 to 46 degrees F)
Gattex 5mg Powder for Injection

Reported Side Effects for Gattex 5mg Powder for Injection

Antibody Formation Incidence:
<38.0%*
Severity: MODERATE
Onset: DELAYED
Intestinal Blockage Incidence:
1.0-10.0%*
Severity: SEVERE
Onset: DELAYED
Cholecystitis Incidence:
1.0-10.0%*
Severity: SEVERE
Onset: DELAYED
Heart Failure Incidence:
2.6%*
Severity: SEVERE
Onset: DELAYED
Cough Incidence:
5.2%*
Severity: MILD
Onset: DELAYED
Gas Incidence:
9.1%*
Severity: MILD
Onset: EARLY
Swelling Incidence:
11.7%*
Severity: MODERATE
Onset: DELAYED
Vomiting Incidence:
11.7%*
Severity: MILD
Onset: EARLY
Infection Incidence:
11.8%*
Severity: MILD
Onset: DELAYED
Headache Incidence:
15.9%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
18.2%*
Severity: MILD
Onset: EARLY
Injection Site Reaction Incidence:
22.4%*
Severity: MILD
Onset: RAPID
Stomach Pain Incidence:
30.0%*
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 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

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


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