Dosing and uses of Gattex (teduglutide)
Adult dosage forms and strengths
subcutaneous injection
- 5mg/vial (as lyophilized powder)
- 3.8mg/0.38mL (after reconstitution) is available for the dose
Short Bowel Syndrome
Indicated for adults with short bowel syndrome who are dependent on parenteral support
0.05 mg/kg SC qDay
Dosage modifications
Moderate-to-severe renal impairment (CrCl <50 mL/min) and ESRD: Decrease dose by 50%
Mild-to-moderate hepatic impairment: No dose adjustment required
Severe hepatic impairment: Not studied
Administration
For SC injection only; do not administer IV or Im
Alternate injection sites between thighs, arms, and quadrants of the abdomen
If a dose is missed, take as soon as possible on that day; do not take 2 doses on the same day
Discontinuation
- If discontinued, may result in fluid and electrolyte imbalance
- Carefully monitor electrolyte status
SC injection preparation
- Reconstitute each vial by slowly injecting the 0.5 mL of preservative-free sterile water for injection provided in the prefilled syringe; allow vial to stand for ~30 seconds and then gently roll the vial between your palms for about 15 seconds; DO NOT SHAKE
- Allow mixed contents to stand for ~2 minutes, then inspect for any undissolved powder
- If undissolved powder observed, gently roll the vial again until all material is dissolved; if the product remains undissolved after the second attempt, do not use
- Sterile, clear, colorless to light straw-colored 5 mg/0.5 mL solution after reconstitution
- Following reconstitution, a maximum of 0.38 mL of the reconstituted solution which contains 3.8 mg of teduglutide can be withdrawn from the vial for dosing
- For single-use only; does not preservatives; discard unused portion
- Use within 3 hr after reconstitution
Storage
- Store unreconstituted vial at room temperature up to 77°F (25°C)
- Do not freeze
Pediatric dosage forms and strengths
Safety and efficacy not established
Gattex (teduglutide) adverse (side) effects
>10%
GI stoma complication (41.9%)
Abdominal pain (30%)
Injection site reactions (22.4%)
Abdominal distension (19.5%)
Nausea (18.2%)
Headaches (15.9%)
Abdominal distension (13.8%)
Upper respiratory tract infection (11.8%)
Fluid overload (11.7%)
Vomiting (11.7%)
1-10%
Flatulence (9.1%)
Hypersensitivity (7.8%)
Appetite disorders (6.5%)
Sleep disturbances (5.2%)
Cough (5.2%)
Skin hemorrhage (5.2%)
Postmarketing Reports
Cardiac disorders: Cardiac arrest, cardiac failure
Nervous system disorders: Cerebral hemorrhage
Warnings
Contraindications
None
Cautions
Teduglutide has potential to increase absorption of concomitant oral medications; monitor and adjust dose as necessary of oral medications that require titration or have a narrow therapeutic index; altered mental status reported in patients taking benzodiazepines or phenothiazines
Cholecystitis, cholangitis, cholelithiasis, and pancreatitis reported; assess bilirubin, alkaline phosphatase, lipase and amylase within 6 months prior to starting treatment, and then every 6 months
Intestinal obstruction reported; discontinue until temporarily and restart when obstruction resolves
Fluid overload and congestive heart failure observed in clinical trials
Neoplastic growth
- Based on pharmacologic activity and animal findings, has potential to cause hyperplastic changes including neoplasia
- Discontinue with active GI malignancy
- Colorectal polyps identified during clinical trials
- Colonoscopy (or alternate imaging) of the entire colon with removal of polyps should be done within 6 months prior to starting treatment; follow-up colonoscopy (or alternate imaging) is recommended at the end of 1 yr of teduglutide; if no polyp is found, subsequent colonoscopies should be done no less frequently than every 5 yr
- Small bowel neoplasia observed in rats
Pregnancy and lactation
Pregnancy category: B
Lactation: Unknown whether distributed in human breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Gattex (teduglutide)
Mechanism of action
Analog of naturally occurring glucagon-like peptide-2 (GLP-2); binds to the GLP-2R receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts, and enteric neurons of the submucosal and myenteric plexus
Activation of these receptors results in the local release of intestinal mediators that increases intestinal absorptive capacity, resulting in increased fluid and nutrient absorption
Absorption
Bioavailability: 88%
Peak Plasma Time: 3-5 hr
Peak Plasma Concentration: 36 ng/mL
AUC: 0.15 mcg•hr/mL
Distribution
Vd: 103 mL/kg
Metabolism
Expected to be metabolized by hydrolytic degradation (like native BLP-2)
Elimination
Half-life: 1.3 hr (SBS); ~ 2 hr (healthy volunteers)
Renal clearance: 123 mL/hr/kg
Excretion: Primarily in urine
