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Teduglutide Dosage

Medically reviewed on March 1, 2018.

Applies to the following strengths: 5 mg

Usual Adult Dose for Short Bowel Syndrome

0.05 mg/kg via subcutaneous injection once a day

Comments:
-Injection sites should be alternated, and may include the thighs, arms, and abdominal quadrants.
-IV and IM administration should be avoided.
-Missed doses should be taken as soon as possible on that day; patients should not take 2 doses on the same day.

Use: Treatment of patients with short bowel syndrome who are dependent on parenteral support

Renal Dose Adjustments

Mild Renal Dysfunction: No adjustment recommended.
Moderate to Severe Renal Dysfunction (CrCl less than 50 mL/min) and End-Stage Renal Disease: Reduce the daily dose by 50%.

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh Grades A and B): No adjustment recommended.
Severe liver dysfunction: Data not available

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for this drug. It includes elements to assure safe use. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Injection sites should be alternated, and may include the thighs, arms, and abdominal quadrants.
-IV and IM administration should be avoided.
-Missed doses should be taken as soon as possible on that day; patients should not take 2 doses on the same day.

Storage requirements:
-Consult the manufacturer product information.

Reconstitution/preparation techniques:
-Consult the manufacturer product information.

General:
-Some experts recommend recording the name and lot number of the product every time this drug is administered to the patient to maintain a link between the patient and lot of the product.
-Discontinuation of treatment should be managed carefully as it may result in fluid and electrolyte imbalance.
-Administration of this drug may trigger the development of antibodies, which is consistent with the potentially immunogenic properties of medicinal products containing peptides. Antibody formation appears to have no impact on short term (up to 2.5 years) efficacy and safety, although the long-term impact is unknown.

Monitoring:
-Cardiovascular: Fluid overload, electrolyte status
-Gastrointestinal: Small bowel and pancreas function
-Hepatic: Gallbladder and biliary tract function; laboratory assessments of bilirubin, alkaline phosphatase, lipase, and amylase (within 6 months prior to treatment initiation, and every 6 months thereafter; further diagnostic workup recommended if clinically meaningful elevation is seen)
-Metabolic: Weight (at each patient visit)
-Oncologic: Entire colon imaging with removal of polyps (within 6 months prior to starting treatment, and at the end of 1 year of treatment)
---If no polyp found: colon imaging at least every 5 years
---If polyp found: adhere to current polyp follow-up guidelines

Patient advice:
-Patients should be told to contact their healthcare provider if they develop sudden weight gain, swollen ankles, and/or dyspnea occur.
-Inform patients that this drug may cause fainting, and they should avoid driving or operating machinery if this side effect occurs.
-Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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