d symptoms suggestive of cholecystitis, cholangitis, or cholelithiasis while on GATTEX. [see Warnings and Precautions (5.3)]
17.4 Pancreatic DiseaseAdvise patients that laboratory assessments should be done before and then every 6 months while on GATTEX. If clinically significant change occurs, further eva luation (i.e., imaging studies or other) may be necessary. Advise patients to report to their physician all signs and symptoms suggestive of pancreatic disease while on GATTEX. [see Warnings and Precautions (5.3)]
17.5 Cardiovascular DiseaseAdvise patients with cardiovascular disease to report to their physician any signs of fluid overload or cardiac decompensation while on GATTEX. [see Warnings and Precautions (5.4)]
17.6 Risks Resulting from Increased Absorption of Concomitant Oral MedicationInstruct patients to report to all of their physicians any concomitant oral medications that they are taking in order to assess any potential for increased absorption during GATTEX treatment of those oral medications requiring titration or with a narrow therapeutic index. [see Warnings and Precautions (5.5)]
17.7 InstructionsInform patients that GATTEX should not be administered intravenously or intramuscularly. The drug should be used for subcutaneous injection within 3 hours after reconstitution. Advise patients that subcutaneous administration has been associated with injection site reactions, but if they experience a severe reaction including severe rash, they should contact their physician.
Advise patients that while they may experience abdominal pain and swelling of their stoma especially when starting therapy with GATTEX, if they experience symptoms of intestinal obstruction, they should contact their physician.
Instruct patients to read the Medication Guide as they are starting GATTEX therapy and to re-read it each time their prescription is renewed.
SPL UNCLASSIFIED SECTION
GATTEX® is a registered trademark of NPS Pharmaceuticals, Inc.
GATTEX is covered by US Patent Nos. 5,789,379, 7,056,886 and 7,847,061
Manufactured by:
Hospira, Inc.
1776 N. Centennial Drive
McPherson, KS 67460
USA
Distributed by:
NPS Pharmaceuticals, Inc.
550 Hills Drive
Bedminster, NJ 07921
USA
For information about GATTEX contact:
NPS Pharmaceuticals, Inc.
550 Hills Drive, Bedminster, NJ 07921
USA
1-855-5GATTEX
www.GATTEX.com
MEDICATION GUIDE
GATTEX® (Ga'-tex)
(teduglutide [rDNA origin])
for injection
Read this Medication Guide carefully before you start taking GATTEX® and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical problems or treatment.
What is the most important information I should know about GATTEX?
GATTEX may cause serious side effects, including:
Making abnormal cells grow faster. GATTEX can make abnormal cells that are already in your body grow faster. There is an increase risk that abnormal cells could become cancer. If you get cancer of the bowel (intestines), liver, gall bladder, or pancreas while using GATTEX, your healthcare provider should stop GATTEX.
If you get other types of cancers, you and your healthcare provide should discuss the risks and benefits of using GATTEX.
Polyps in the colon (large intestine). Polyps are growths on the inside of the colon.
Before you start using GATTEX, your healthcare provider will:
Have your colon checked f |
