Version May 2024
Short bowel syndrome, parenteral support dependent: SUBQ: 0.05 mg/kg once daily.
Missed doses: If a dose is missed, take as soon as possible on that day; do NOT take 2 doses on the same day.
eGFR ≥60 mL/minute/1.73 m2: No dosage adjustment necessary.
eGFR <60 mL/minute/1.73 m2: SUBQ: Reduce dose to 0.025 mg/kg once daily.
ESRD: SUBQ: Reduce dose to 0.025 mg/kg once daily.
Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Teduglutide: Pediatric drug information")
Short bowel syndrome, requiring parenteral support: Children and Adolescents weighing ≥10 kg: SubQ: 0.05 mg/kg/dose once daily; reductions in parenteral nutrition requirements (including calorie and volume) and advancement of enteral nutrition were observed as early as week 4 of teduglutide therapy in an open-label trial (Ref).
Children and Adolescents: SubQ:
eGFR ≥60 mL/minute/1.73 m2: No dosage adjustment necessary.
eGFR <60 mL/minute/1.73 m2: Reduce dose to 0.025 mg/kg/dose once daily.
End-stage renal disease: Reduce dose to 0.025 mg/kg/dose once daily.
Children and Adolescents:
Mild to moderate impairment: No dosage adjustment necessary.
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Endocrine & metabolic: Fluid retention (1% to 12%)
Gastrointestinal: Abdominal pain (30%), nausea (23%), abdominal distension (20%), vomiting (12%)
Immunologic: Antibody development (3% to 54%; incidence increased with prolonged use)
Local: Injection site reaction (13%)
Respiratory: Upper respiratory tract infection (21%)
Miscellaneous: Intestinal stoma complication (42%)
1% to 10%:
Cardiovascular: Peripheral edema (10%), cardiac failure (3%)
Central nervous system: Sleep disturbance (5%)
Dermatologic: Dermal hemorrhage (5%)
Gastrointestinal: Flatulence (9%), decreased appetite (7%), intestinal stenosis (<5%; including colonic), pancreatic disease (<5%; duct stenosis), cholecystitis (4%), intestinal obstruction (≤4%), gallbladder perforation (1%)
Hypersensitivity: Hypersensitivity reaction (10%)
Infection: Influenza (7%)
Respiratory: Cough (5%), dyspnea (<5%)
Frequency not defined:
Cardiovascular: Edema, flushing, jugular vein distention
Dermatologic: Erythema of skin, pruritus, skin rash
Gastrointestinal: Cholelithiasis, cholestasis, colonic polyp, pancreatic pseudocyst, pancreatitis, rectal polyp
Hematologic & oncologic: Hematoma
Ophthalmic: Eyelid edema
<1%, postmarketing, and/or case reports: Cholangitis, malignant neoplasm
There are no contraindications listed in the US manufacturer's labeling.
Canadian labeling: Hypersensitivity to teduglutide or any component of the formulation; active gastrointestinal (GI) malignancy (GI tract, hepatobiliary, pancreatic); history of GI tract malignancies (including the hepatobiliary system and pancreas) within the last 5 years.
Concerns related to adverse effects:
• Colorectal polyps: Short bowel syndrome: Development of colorectal polyps has occurred. In adults, perform a baseline colonoscopy of the entire colon with polyp removal ≤6 months prior to initiation of therapy. Follow-up colonoscopy (or alternative imaging) should be performed at 1 year and at least every 5 years thereafter, or more frequent if clinically indicated. In children and adolescents, perform fecal occult blood testing at baseline (prior to therapy) and annually; if unexplained blood detected, perform colonoscopy/sigmoidoscopy. Additionally, perform colonoscopy/sigmoidoscopy after 1 year, every 5 years thereafter during therapy, or for new or unexplained GI bleeding. Discontinue teduglutide in patients who develop colorectal cancer.
• Fluid overload: Increased fluid absorption and subsequent fluid overload/congestive heart failure has been reported; consider modification of parenteral support in patients who develop fluid overload, especially in patients with underlying cardiovascular disease. If significant cardiac deterioration develops, reassess the need for continued teduglutide treatment.
• Gallbladder/biliary tract disease: Cholecystitis, cholangitis, and cholelithiasis have been reported; monitor serum bilirubin and alkaline phosphatase ≤6 month prior to initiation of therapy and at least every 6 months for duration of therapy. If clinically meaningful changes are detected, perform further evaluation including gallbladder/biliary tract imaging and reassess the need for continued teduglutide treatment.
• Intestinal obstruction: Temporarily discontinue treatment in patients that develop intestinal or stomal obstruction; teduglutide may be resumed (if clinically indicated) once the obstruction is resolved.
• Malignancy: Teduglutide may increase the risk of hyperplastic changes, including neoplasia. In patients at increased risk for malignancy, consider treatment only if benefits outweigh the risks. Discontinue treatment in patients with active gastrointestinal malignancy (GI tract, hepatobiliary, pancreatic); evaluate risk versus benefit in patients with active non-GI malignancy. Monitor for small bowel neoplasia; remove any benign neoplasm. Discontinue in patients who develop small bowel cancer.
• Pancreatitis: Pancreatitis has been reported; monitor serum lipase and amylase ≤6 months prior to initiation of therapy and at least every 6 months for duration of therapy. If clinically meaningful changes are detected, evaluate for pancreatitis and reassess the need for continued teduglutide treatment.
Concurrent drug therapy issues:
• Oral medications: Teduglutide may increase absorption of oral medications; monitor for adverse effects of concomitant oral medications, particularly those with a narrow therapeutic index.
Special populations:
• Renal function impairment: Use with caution; reduced doses required in moderate to severe renal impairment and end-stage renal disease (ESRD).
Other warnings/precautions:
• Discontinuation: Treatment discontinuation may result in fluid and electrolyte imbalance. Carefully monitor fluid/electrolyte status.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit, Subcutaneous [preservative free]:
Gattex: 5 mg
No
Kit (Gattex Subcutaneous)
5 mg (per each): $2,094.67
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Subcutaneous:
Revestive: 5 mg (1 ea)
SUBQ: For SUBQ use only; do not administer IM or IV. Rotate injection site between thighs, upper arms, and 4 quadrants of the abdomen. Do not inject into areas where skin is bruised, red, hard, or tender. Following patient training and instructions on self-administration, adult patients may self-administer treatment.
SubQ: For subcutaneous administration only; do not administer IM or IV. Rotate injection site between thighs, upper arms, and quadrants of the abdomen.
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203441s018lbl.pdf#page=17, must be dispensed with this medication.
Short bowel syndrome, parenteral support dependent: Treatment of short bowel syndrome in adults and pediatric patients ≥1 year of age who are dependent on parenteral support.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Benzodiazepines: Teduglutide may increase the serum concentration of Benzodiazepines. Risk C: Monitor therapy
Information related to use of teduglutide in pregnancy is limited.
Short bowel syndrome may cause maternal malnutrition, which is associated with adverse fetal effects, including congenital malformations, intrauterine growth restriction, low birth weight, perinatal mortality and preterm birth.
It is not known if teduglutide is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, including tumorigenicity, breastfeeding is not recommended by the manufacturer.
In all patients, serum bilirubin, alkaline phosphatase, lipase, and amylase (baseline [within 6 months prior to initiation] and every 6 months thereafter); monitor fluid status, especially in patients with cardiovascular disease; signs/symptoms of intestinal obstruction; signs/symptoms suggestive of gallbladder disease or pancreatitis; monitor fluid and electrolyte balance following therapy discontinuation. In adults, perform colonoscopy of entire colon with removal of polyps at baseline (within 6 months prior to initiation), 1 year, and ≤5 years thereafter if no polyps found, or more frequent if clinically necessary; follow current guidelines if polyps are found. In children/adolescents, test fecal occult blood at baseline (within 6 months prior to initiation) and yearly during treatment; perform colonoscopy/sigmoidoscopy if unexplained blood in stool at baseline and after 1 year of treatment, every 5 years thereafter during treatment, or if new or unexplained GI bleeding occurs.
Teduglutide is an analog of glucagon-like peptide-2 (GLP-2), which is secreted in the distal intestine. Endogenous GLP-2 increases intestinal and portal blood flow while inhibiting gastric acid secretion, thereby reducing intestinal losses and improving intestinal absorption. Teduglutide binds and activates GLP-2 receptors, resulting in release of mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF).
Distribution: 0.1 L/kg
Metabolism: Similar to endogenous catabolism of GLP-2 but slower due to a single amino acid substitution (Ferrone 2006)
Bioavailability: SubQ: 88%
Half-life elimination:
Children 1 to 11 years: 0.7 ± 0.2 hours
Children 12 to 17 years: 1 ± 0.01 hours
Adults: 1.3 hours
Time to peak, plasma: SubQ: 3 to 5 hours
Excretion: Urine
Altered kidney function: Teduglutide exposure is increased in patients with moderate or severe renal impairment or ESRD.
Hepatic function impairment: Teduglutide exposure is decreased in patients with moderate hepatic impairment.
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