se vial). The powder must be mixed with Sterile Water for Injection (a diluent) provided in a pre-filled syringe before you inject it.
GATTEX must be injected within 3 hours after you mix it with the diluent.
If you miss a dose, take it as soon as you remember that day. Take your next dose the next day at the same time you take it every day.
Do not take 2 doses on the same day.
If you use more than 1 dose, call your healthcare provider right away.
Read the Instructions for Use for detailed instructions for preparing and injecting a dose of GATTEX.
What are the possible side effects of GATTEX?
GATTEX may cause serious side effects, including:
See "What is the most important information I should know about GATTEX?"
Fluid overload. Your healthcare provider will check you for too much fluid in your body. Too much fluid in your body may lead to heart failure, especially if you have heart problems. Tell your healthcare provider if you get swelling in your feet and ankles, you gain weight very quickly (water weight), or you have trouble breathing.
The most common side effects of GATTEX include:
stomach area (abdomen) pain or swelling
skin reaction where the injection was given
nausea
headache
cold or flu like symptoms
vomiting
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of GATTEX.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store GATTEX?
Store GATTEX powder at room temperature up to 25°C (77°F).
Do not freeze GATTEX.
Use the GATTEX powder by the expiration date on the "Use By" sticker on the kit. Use GATTEX within 3 hours after mixing it.
Throw away any unused GATTEX that has been mixed, even if there is medicine left in the vial.
Do not store any GATTEX you have mixed.
Keep GATTEX and all medicines out of the reach of children.
General information about the safe and effective use of GATTEX
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GATTEX for a condition for which it was not prescribed. Do not give GATTEX to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information about GATTEX talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about GATTEX that is written for health professionals.
For more information go to www.GATTEX.com or call 1-855-542-8839.
What are the ingredients in GATTEX?
Active ingredient: teduglutide
Inactive ingredients: L-histidine, mannitol, monobasic sodium phosphate monohydrate, and dibasic sodium phosphate heptahydrate.
Sterile Water for Injection is provided as a diluent.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Hospira, Inc.
1776 N. Centennial Drive
McPherson, KS 67460
U.S.A.
Distributed by:
NPS Pharmaceuticals, Inc.
550 Hills Drive
Bedminster, NJ 07921
U.S.A.
Revised: June 2014
U.S. License No.203441
©2014 NPS Pharmaceuticals, Inc.
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 o |
