Teduglutide

Teduglutide is a prescription medicine used for the treatment of short bowel syndrome in adults who are dependent on parenteral support.

• Teduglutide is available under the following different brand names: Gattex

Common side effects of Teduglutide include:

• stomach pain,
• swelling,
• nausea,
• vomiting,
• cold or flu symptoms,
• swelling, and
• pain, swelling, redness, or other irritation at the injection site

Serious side effects of Teduglutide include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe constipation,
• stomach cramps,
• nausea,
• vomiting,
• swelling in the hands and feet,
• rapid weight gain,
• shortness of breath,
• change in your stools (bowel movements),
• severe pain in the upper stomach spreading to the back,
• fever,
• chills,
• dark urine, and
• yellowing of the skin or eyes (jaundice)

Rare side effects of Teduglutide include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, lyophilized powder for reconstitution

• 5 mg/vial
• 3.8 mg/0.38 mL (after reconstitution)

Short Bowel Syndrome

Adult dosage

• 0.05 mg/kg SC every day

Pediatric dosage

• Age below 1 year: Safety and efficacy not established
• Age above 1 year and weight at least 10 kg: 0.05 mg/kg SC every day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Teduglutide has severe interactions with no other drugs.
• Teduglutide has serious interactions with no other drugs
• Teduglutide has moderate interactions with at least 37 other drugs.
• Teduglutide has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Teduglutide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Teduglutide?”

Cautions

• Cholecystitis, cholangitis, cholelithiasis, and pancreatitis were reported; assess bilirubin, alkaline phosphatase, lipase and amylase within 6 months before starting treatment, and then every 6 months
• Intestinal obstruction reported; discontinue temporarily and restart when obstruction resolves
• Discontinuation of treatment may also result in fluid and electrolyte imbalance; monitor fluid and electrolyte status in patients who discontinue treatment
• Fluid overload and congestive heart failure observed in clinical trials
• Neoplastic growth
  • Based on pharmacologic activity and animal findings, has the potential to cause hyperplastic changes, including neoplasia
• Discontinue with active GI malignancy
  • Small bowel neoplasia observed in rats
• Colorectal polyps
  • Colorectal polyps identified during clinical trials
  • For adults, perform colonoscopy within 6 months before initiating treatment and after 1 year of treatment
  • Colonoscopy/sigmoidoscopy is recommended for all children and adolescents after 1 year of treatment, every 5 years thereafter while on continuous treatment, and if they have new or unexplained gastrointestinal bleeding
  • For children and adolescents, perform fecal occult blood testing before initiating treatment and after 1 year of treatment; colonoscopy/sigmoidoscopy is required if there is unexplained blood in the stool
• See Dosing Considerations for recommendations
• Drug interaction overview
  • Based on the pharmacodynamic effect of teduglutide, absorption of concomitantly administered oral medications may be increased
  • Monitor patients receiving concomitant oral drugs requiring titration or with a narrow therapeutic index for adverse reactions due to potential increased absorption of concomitant drug
  • Concomitant drug may require dosage reduction

Pregnancy and Lactation

Available data from case reports in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; pregnant women with short bowel syndrome are at risk for malnutrition, which is associated with adverse maternal and fetal outcomes; severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations, and perinatal mortality

• Lactation
  • There is no information regarding its presence in human milk, its effects on the breastfed infant, or milk production; the drug is present in the milk of lactating rats; systemic exposure to a breastfed infant is expected to be low; however, because of the potential for serious adverse reactions in a breastfed infant, including tumorigenicity, advise patients that breastfeeding is not recommended during treatment