ncluding 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.
GATTEX® is a registered trademark of NPS Pharmaceuticals
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
550 Hills Drive, 3rd Floor
Bedminster, NJ 07921
USA
For information about GATTEX contact:
NPS Pharmaceuticals
550 Hills Drive, 3rd Floor
Bedminster, NJ 07921
USA
1-855-5GATTEX
www.GATTEX.com
Instructions for Use
GATTEX®(Ga'-tex)
(teduglutide [rDNA origin])
for injection
Read this Instructions for Use before you start using GATTEX and each time you get a refill. There may be new information. Your healthcare provider or nurse should show you how to prepare, measure your dose, and give your injection of GATTEX the right way.
If you cannot give yourself the injection:
ask your healthcare provider or nurse to help you, or
ask someone who has been trained by a healthcare provider or nurse to give your injections
Important information:
Before you start, check the "Use By" date on your GATTEX kit. Make sure that the "Use By" date has not passed. Do not use anything in the GATTEX kit after the "Use By" date on the kit.
Give GATTEX within 3 hours after you mix the powder with the Diluent (Sterile Water for Injection).
Use the syringes and needles provided in the GATTEX kit.
Do not use a GATTEX vial more than one time, even if there is medicine left in the vial. Throw away any unused GATTEX after you give your injection.
Safely throw away GATTEX vials after use.
Do not re-use syringes or needles. See "Step 7: Dispose of syringes and needles" for information about how to safely throw away needles and syringes.
To help avoid needle-stick injuries, do not recap needles.
GATTEX kit
Gather the supplies you will need to prepare GATTEX and to give your injection. (See Figure A)
From your GATTEX kit you will need:
5-mg vial of GATTEX with green cap
Your healthcare provider will tell you how many vials of GATTEX you will need for your injection.
2 alcohol swab pads
Diluent syringe. Your kit has only 1 type of Diluent syringe.
With a white snap-off cap OR
With a gray screw top
22 gauge, 1½ inch needle
Plastic dosing syringe with needle attached
An FDA-cleared sharps disposal container. See "Step 7: Dispose of needles and syringes."
Step 1: Prepare the injection.
Choose a well-lit, clean, flat work surface.
Wash your hands with soap and water.
Step 2: Preparing the Diluent syringe.
Put the Diluent syringe and 22G 1½ inch needle in front of you on your work surface. (See Figure B1)
Hold the Diluent syringe by the barrel.
a.
If you have the Diluent syringe with the white snap-off cap: Snap or twist off the white cap (bend the cap sideways until the cap comes off). Only the top portion of the white cap should be snapped off. The lower portion of the cap will remain in place (See Figure B |
