GATTEX® Website for HCPs

Web Name: GATTEX® Website for HCPs

WebSite: http://www.gattexhcp.com

ID:278948

Keywords:

GATTEX,Website,HCPs,for

Description:


Jump to main content
Information for Patients | Important Safety Information | Full Prescribing Information | Medication Guide | REMS | Start Form Short Bowel Syndrome About GATTEX GATTEX in Adults GATTEX in Pediatrics ≥ 1 Year Resources Request A Rep Getting Started

For patients ≥1 year of age with SHORT BOWEL SYNDROME (SBS) who are dependent on parenteral support (PS)*

LESS PARENTERAL SUPPORT.
MORE TIME DOING WHAT THEY LOVE.

*In a 6-month clinical study (N=86), 63% of adult patients treated with GATTEX reduced their weekly PS volume by ≥20% (vs 30% with placebo) and 54% achieved a reduction of ≥1 day off PS per week (vs 23% withplacebo).1

Gattex Results in adults Gattex Results in pediatrics≥1year KAT,
GATTEX PATIENT

GATTEX is the first and only FDA-approved glucagon-like peptide-2 (GLP-2) analog for patients ≥1 year of age with short bowel syndrome (SBS) who are dependent on parenteralsupport(PS)1

In clinical studies of patients with short bowel syndrome (SBS), GATTEX was provento1:

Significantly reduce weekly parenteral support (PS) VOLUME requirements

Help patients achieve more TIME off of parenteral support (PS)

Help some patients achieve complete FREEDOM from parenteral support (PS)

In a 6-month study, adult patients treated with GATTEX (teduglutide) reduced weekly PS volume by ≥20% (27/43) vs placebo (13/43) and achieved a reduction of ≥1 day off PS per week (21/39) vs placebo (9/39). In a 24-month open-label extension, adult patients treated with GATTEX weaned off PS completely after 30 months of treatment (10/30). In a 6-month study, pediatric patients treated with GATTEX reduced weekly PS volume by ≥20% (18/26), achieved a reduction of ≥1 day off PS per week (10/26), and weaned off PS completely (3/26).

Gattex Results In Adults Gattex Results In Pediatrics≥1YEAR

INDICATION
GATTEX® (teduglutide) for injection is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Acceleration of neoplastic growth
Colorectal polyps were identified during clinical trials. There is a risk for acceleration of neoplastic growth. In adults, within 6 months prior to starting treatment with GATTEX, colonoscopy of the entire colon with removal of polyps should be performed and follow-up colonoscopy (or alternate imaging) is recommended at the end of 1 year of GATTEX. Subsequent colonoscopies should be performed every 5 years or more often as needed.

In children and adolescents, perform fecal occult blood testing prior to initiating treatment with GATTEX. Colonoscopy/sigmoidoscopy is required if there is unexplained blood in the stool. Perform subsequent fecal occult blood testing annually in children and adolescents while they are receiving GATTEX. Colonoscopy/sigmoidoscopy is recommended for all children and adolescents after 1 year of treatment, every 5 years thereafter while on continuous treatment with GATTEX, and if they have new or unexplained gastrointestinal bleeding.

In case of intestinal malignancy (GI tract, hepatobiliary, pancreatic), discontinue GATTEX. The clinical decision to continue GATTEX in patients with non-gastrointestinal malignancy should be made based on benefit-risk considerations.

Intestinal obstruction
Intestinal obstruction has been reported in clinical trials and postmarketing. In patients who develop intestinal or stomal obstruction, GATTEX should be temporarily discontinued pending further clinical evaluation and management.

Biliary and pancreatic disease
Cholecystitis, cholangitis, cholelithiasis, and pancreatitis have been reported in clinical trials and postmarketing. Laboratory assessment (bilirubin, alkaline phosphatase, lipase, amylase) should be obtained within 6 months prior to starting GATTEX. Subsequent laboratory tests should be done every 6 months or more often as needed. If clinically meaningful changes are seen, further evaluation is recommended including imaging, and continued treatment with GATTEX should be reassessed.

Fluid imbalance and fluid overload
Fluid overload and congestive heart failure have been observed in clinical trials. If fluid overload occurs, especially in patients with underlying cardiovascular disease, parenteral support should be adjusted and GATTEX treatment reassessed. If significant cardiac deterioration develops while on GATTEX, continued GATTEX treatment should be reassessed.

Discontinuation of treatment with GATTEX may also result in fluid and electrolyte imbalance. Fluid and electrolyte status should be monitored in patients who discontinue treatment with GATTEX.

Increased absorption of concomitant oral medication
In clinical trials, one patient receiving prazepam concomitantly with GATTEX experienced dramatic deterioration in mental status progressing to coma during first week of GATTEX therapy. Patients receiving concomitant oral drugs requiring titration or with a narrow therapeutic index should be monitored for adverse reactions due to potential increased absorption of the concomitant drug. The concomitant drug may require a reduction in dosage.

Adverse Reactions
The most common adverse reactions (≥ 10%) with GATTEX are abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity.

Use in Specific Populations
Breastfeeding is not recommended during treatment with GATTEX.

Please click here for full Prescribing Information or Información de prescripción en español .

GATTEX (teduglutide) for injection [package insert]. Lexington, MA: Shire-NPS Pharmaceuticals, Inc.
Site Map Privacy Notice Terms of Use Contact Us

The information on this site is intended for US healthcare professionals only.

GATTEX and the GATTEX logo are registered trademarks of Shire-NPS Pharmaceuticals, Inc., a Takeda company. ONEPATH and the ONEPATH logo are registered trademarks of Shire Human Genetic Therapies, Inc., a Takeda company. TAKEDA and the TAKEDA logo are registered trademarks of Takeda Pharmaceutical Company Limited.

©2022 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved.

All content of this website including text, images, graphics, sound files, and their arrangement, belongs to Takeda and is protected by international copyright laws. All other intellectual property rights are reserved.

Takeda is not responsible for the terms and conditions, privacy policy, or content of any website not owned by Takeda.

The site is intended solely for US residents and is governed solely by US laws and government regulations. Please see our Privacy Notice for more information. While Takeda Inc. makes reasonable efforts to include accurate, up-to-date information on the site, Takeda Inc. makes no warranties or representations as to its accuracy. Takeda Inc. assumes no liability for any errors or omissions in the content of the site.

US-TED-1065v1.0 06/22

INDICATION

GATTEX® (teduglutide) for injection is indicated for the treatment of adults and pediatric patients 1 year of age and older with short bowel syndrome (SBS) who are dependent on parenteral support.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions
GATTEX has been associated with acceleration of neoplastic growth, intestinal obstruction, biliary and pancreatic disease, fluid imbalance and fluid overload, and increased absorption of concomitant oral medication. Click here for additional Safety Information.

INDICATION
GATTEX® (teduglutide) for injection is indicated for the treatment of adults and pediatric patients 1 year of age and older with short bowel syndrome (SBS) who are dependent on parenteral support.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Acceleration of neoplastic growth
Colorectal polyps were identified during clinical trials. There is a risk for acceleration of neoplastic growth. In adults, within 6 months prior to starting treatment with GATTEX, colonoscopy of the entire colon with removal of polyps should be performed and follow-up colonoscopy (or alternate imaging) is recommended at the end of 1 year of GATTEX. Subsequent colonoscopies should be performed every 5 years or more often as needed.

In children and adolescents, perform fecal occult blood testing prior to initiating treatment with GATTEX. Colonoscopy/sigmoidoscopy is required if there is unexplained blood in the stool. Perform subsequent fecal occult blood testing annually in children and adolescents while they are receiving GATTEX. Colonoscopy/sigmoidoscopy is recommended for all children and adolescents after 1 year of treatment, every 5 years thereafter while on continuous treatment with GATTEX, and if they have new or unexplained gastrointestinal bleeding.

In case of intestinal malignancy (GI tract, hepatobiliary, pancreatic), discontinue GATTEX. The clinical decision to continue GATTEX in patients with non-gastrointestinal malignancy should be made based on benefit-risk considerations.

Intestinal obstruction
Intestinal obstruction has been reported in clinical trials and postmarketing. In patients who develop intestinal or stomal obstruction, GATTEX should be temporarily discontinued pending further clinical evaluation and management.

Biliary and pancreatic disease
Cholecystitis, cholangitis, cholelithiasis, and pancreatitis have been reported in clinical trials and postmarketing. Laboratory assessment (bilirubin, alkaline phosphatase, lipase, amylase) should be obtained within 6 months prior to starting GATTEX. Subsequent laboratory tests should be done every 6 months or more often as needed. If clinically meaningful changes are seen, further evaluation is recommended including imaging, and continued treatment with GATTEX should be reassessed.

Fluid imbalance and fluid overload
Fluid overload and congestive heart failure have been observed in clinical trials. If fluid overload occurs, especially in patients with underlying cardiovascular disease, parenteral support should be adjusted and GATTEX treatment reassessed. If significant cardiac deterioration develops while on GATTEX, continued GATTEX treatment should be reassessed.

Discontinuation of treatment with GATTEX may also result in fluid and electrolyte imbalance. Fluid and electrolyte status should be monitored in patients who discontinue treatment with GATTEX.

Increased absorption of concomitant oral medication
In clinical trials, one patient receiving prazepam concomitantly with GATTEX experienced dramatic deterioration in mental status progressing to coma during first week of GATTEX therapy. Patients receiving concomitant oral drugs requiring titration or with a narrow therapeutic index should be monitored for adverse reactions due to potential increased absorption of the concomitant drug. The concomitant drug may require a reduction in dosage.

Adverse Reactions
The most common adverse reactions (≥ 10%) with GATTEX are abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity.

Use in Specific Populations
Breastfeeding is not recommended during treatment with GATTEX.

Please click here for full Prescribing Information or Información de prescripción en español.

TAGS:GATTEX Website HCPs for

<<< Thank you for your visit >>>

Websites to related :
Biuletyn Informacji Publicznej -

   Przejdź do menu głównego Przejdź do treści Przejdź do wyszukiwarki Załóż własny biuletyn on-lineZleć nam zało

be SPORTS PERFORMANCE at be FITN

   :root{--color_0:255,255,255;--color_27:254,186,158;--color_1:255,255,255;--color_2:0,0,0;--color_3:237,28,36;--color_4:0,136,203;--col

Zachodnie Mazowsze - Informacje

   Menu Strona głównaOgłoszeniaReklamaO nas RegionPowiat GrodziskiPowiat PruszkowskiPowiat ŻyrardowskiPowiat Wars

paradigmendo.com | A new paradig

  HomeFeedbackHomeHomeHome NEWUncategorizedSelect Page ORDER NOW The world&#x2019;s only endodontic file treated with the patented LaserFlex technology

Neocate | ​Hypoallergenic Formu

  For Healthcare ProfessionalsShopSign InCreate AccountMy AccountLogoutCartSearchCountry SelectorHelping Your Child Live their Best LifeNeocate offers c

GiuseArt.com - Thiết kế đồ h

  Skip to content Trang chủThiết kế đồ họaThiết kế websiteGóc chia sẻHọc đồ họaHọc HTMLHọc CSSHọc WordPressCuộc sốngLiên hệ #row

Accueil - Formations.Guru

  AccueilNos formationsWordExcelPowerPointOutils GooglePhotoshopIllustratorHTML 5CSS 3WordPressGmail, G Suite &#038; Google My BusinessContactAgence.gur

FORUM PROFIT HOTEL®

   :root{--color_0:255,255,255;--color_27:252,222,165;--color_1:255,255,255;--color_2:0,0,0;--color_3:237,28,36;--color_4:0,136,203;--col

ASME Community Platform to Be Su

   Menu Close

Amanogawa.com Interactive Softwa

  

ads

Hot Websites