Narrator:
What is GATTEX?
GATTEX (teduglutide) for subcutaneous injection is a prescription medicine used in adults and children 1 year and age or older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous
(IV) feeding (parenteral support). It is not known if GATTEX is safe and effective in children under 1 year of age.
What is the most important information I should know about GATTEX?
GATTEX may cause serious side effects including making abnormal cells grow faster, polyps in the intestines, blockage of the bowel (intestines), swelling (inflammation) or blockage of your gallbladder or pancreas, and fluid overload.
GATTEX may cause serious side effects including making abnormal cells grow faster, polyps in the intestines, blockage of the bowel (intestines), swelling (inflammation) or blockage of your gallbladder or pancreas, and fluid overload.
Marrika:Hi, I’m Marrika and I have Short Bowel Syndrome and receive parenteral support or PS. I was prescribed GATTEX by my doctor to manage my Short Bowel Syndrome, also known as SBS.
GATTEX is a subcutaneous, or under the skin, injection. There are many steps involved when preparing the medication.
It may seem overwhelming at first, but this video will walk you through the entire process. If you’re anything like me, the more you practice, the more comfortable you’ll become.
Before we get started, there are a few important things you should know.
Narrator:
Read the Instructions for Use before you start using GATTEX and each time you get a refill, as 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. This video provides step-by-step instructions on how to inject GATTEX and can serve as a helpful reminder if you need to review a part of the process.
Marrika:
Once trained by a healthcare professional, adults can self-administer. If you cannot give yourself the injection, ask your healthcare provider, nurse, or someone trained by a healthcare provider or nurse to give your injection. For children, GATTEX should be injected by a healthcare provider or nurse, or a parent or adult caregiver who has been trained by a healthcare provider or nurse to give the injection.
The use of the GATTEX 5 mg kit is not recommended in children weighing less than 22 pounds or (10 kg).
Narrator:Before you start, you need to check the “Use By” date on your GATTEX kit. If the “Use By” date has passed, do not use anything in the kit.
Marrika:
Always give the injection of GATTEX within 3 hours after you mix the powder with the Diluent.
Only use the syringes and needles provided in the GATTEX kit.
Do not reuse a GATTEX vial more than 1 time, even if there is medicine left in the vial.
Safely throw away (dispose of) any unused GATTEX and GATTEX vials after you give your injection.
Do not reuse syringes and needles. We’ll review how to safely dispose of syringes and needles later in Chapter 3.
And finally, to help avoid needle-stick injuries, do not recap needles at any point during the process.
Narrator:
Now, let’s take a look at what’s inside the GATTEX kit. Each kit will contain: Syringes prefilled with Diluent, which is sterile water that’s used to dilute your injection, 23 gauge 1½ inch needles, 5 mg vials of GATTEX, 1 mL plastic dosing syringes with 27 gauge 1/2 inch needles attached, needles to attach to the Diluent syringe, and alcohol swab pads.
If your prescribed dose of GATTEX is more than 3.8 mg/day, two 30 vial kits are recommended.
The following supplies are needed to inject GATTEX: a vial of GATTEX, 2 alcohol swab pads, a 23 gauge, 1 ½ inch needle for reconstitution, a Diluent syringe with a white snap-off cap, and a 1 mL plastic dosing syringe with needle attached.
The dosing syringe has individual dosing lines labeled so that you can match the number to your prescribed dose. Your healthcare provider will tell you how many vials of GATTEX you will need for your dose.
You will also need: A sharps disposal container, which we will talk about in Step 7 when disposing of needles and syringes, and possibly an adhesive bandage.
These are not included in the GATTEX kit.
Marrika:
First, choose a well-lit, clean, and flat work surface to prepare your injection.
Lay out all of your supplies and wash your hands well with soap and water.
Narrator:
Next, place the Diluent syringe and the 23 gauge, 1 ½ inch needle in front of you on your work surface.
It’s important to know that the Diluent syringe consists of a plunger and barrel.
Hold the Diluent syringe by the middle part, or barrel.
Snap the white cap off the top of the syringe by bending it sideways until it comes off. Only the top part of the white cap should snap off. The lower part of the white cap should stay in place. Throw the cap away.
Then you’ll take the 23 gauge 1 ½ inch needle and remove it from its packaging by peeling back the plastic cover. Leave the plastic cap on.
Push the open end of the needle onto the end of the Diluent syringe. Twist it clockwise—to the right—until the cap stops turning.
When the needle is tightly in place, you can put the Diluent syringe and needle on your work surface.
Narrator
You can now grab your GATTEX vial. Remove the green cap from the GATTEX vial and throw it away. You’ll notice a tiny circle in the center of the gray seal.
Use one of your alcohol swab pads to clean the gray rubber seal. Don’t touch it after you clean it.
If you do accidentally touch the seal at any time, make sure to clean it with a new alcohol pad.
Pick up the Diluent syringe with the needle attached. Remove the plastic cap covering the needle and throw the cap away.
With your other hand, hold the GATTEX vial between your thumb and index or pointer finger. Be careful not to touch the gray rubber seal.
Now push the needle down through the tiny circle in the center of the gray rubber seal. Then slowly push down on the plunger of the Diluent syringe until you have emptied all the Diluent into the GATTEX vial.
When that is done, leave the needle and Diluent syringe connected to the vial.
Gently tap the barrel (or middle part) of the Diluent syringe with your finger repeatedly to make sure all the Diluent has gone into the GATTEX vial.
Now, remove the Diluent syringe and needle from the GATTEX vial. Let the vial sit for about 30 seconds.
Do not put the needle cap back on the needle. Throw that out separately. Throw away the Diluent syringe and needle in your sharp’s disposal container.
After 30 seconds, place the GATTEX vial between the palms of your hands and gently roll it for about 15 seconds without touching the gray rubber seal. If you do touch it, clean it with a new alcohol pad. Do not shake the GATTEX vial.
Let the GATTEX vial stand on your work surface for about 2 minutes. Then, move to Step 4.
For Step 4, you’ll check the mixed GATTEX. After two minutes, check the GATTEX mixture. Take a look at your GATTEX vial. The liquid in the vial should be clear and colorless, or even a pale yellow. There should not be any particles in it. If there is any powder in the GATTEX vial that didn’t dissolve, gently roll the vial in your hands for 15 seconds more.
Remember not to shake the GATTEX vial!
Check the GATTEX vial again for anything that did not dissolve. Do not use the GATTEX vial again if there are still particles in it. Start from the beginning of the Instructions for Use to prepare a new GATTEX vial using new supplies.
If your vial is clear, then it’s time to proceed to Step 5.
For Step 5, pick up the plastic dosing syringe and remove it from its packaging.
Remove the needle cap from the plastic dosing syringe and throw it away. Don’t touch the needle or let it touch anything.
Carefully pull back on the plunger until it reaches the line that matches the dose your healthcare provider prescribed.
Use 1 hand to hold the GATTEX vial steady. Use your other hand to insert the needle straight down into the middle of the gray rubber seal on the GATTEX vial.
You may feel some resistance as the needle passes through the rubber seal.
Gently push the plunger down until all the air has gone from the plastic dosing syringe into the GATTEX vial.
Then turn the GATTEX vial and plastic dosing syringe upside down. Hold the GATTEX vial with 1 hand.
Slowly pull back the plunger of the dosing syringe with your other hand until the black tip lines up with the mark that matches your prescribed dose, and the plastic dosing syringe is filled to that line with liquid.
Keep the plastic dosing syringe and needle in the GATTEX vial.
You may see some bubbles inside the GATTEX vial when the syringe is filled. This is normal. If you see bubbles, gently tap the side of the plastic dosing syringe with one of your fingers with the needle still in the vial to make the bubbles rise to the top.
Slowly push the plunger up until all air bubbles are out of the plastic dosing syringe. Make sure the tip of the needle is in the fluid. Slowly pull back the plunger to draw up the right dose of GATTEX into the plastic dosing syringe.
Remove the plastic dosing syringe and needle from the GATTEX vial. Remember, don’t touch the needle, or let it touch anything!
Marrika:
Now that the needle is prepared, you are ready to inject GATTEX. Choose a location on your body to inject GATTEX— it can be the stomach area, thighs, or upper arms. Make sure to choose a different site each day. You don’t want to inject in areas where the skin is tender, bruised, red, or hard.
Narrator:
Clean the part of the skin that you are giving the injection with a new alcohol swab pad.
Don’t touch this area again before your injection. Use 1 hand to gently pinch up a fold of skin. Use your other hand to hold the plastic dosing syringe.
Insert the full length of the needle into your skin at a 45-degree angle, using a quick, dart- like motion. Let go of your skin. Hold the syringe barrel with 1 hand while you slowly push down on the plunger, releasing GATTEX until the plastic dosing syringe is empty.
Once emptied, quickly pull the needle out of your skin. You may have a little bleeding at the injection site. Apply a bandage if you need to.
Marrika:
Now that you’ve injected GATTEX, you can throw away the supplies you used, including all syringes, needles, and the GATTEX vial.
You can safely dispose of the needles in a sharps container. The injection is done, but there are still a few important things to remember.
Do not re-use a syringe or needle. To help avoid needle-stick injuries, do not recap a needle. Put your needles and syringes in an FDA-cleared sharps disposal container right away after use.
Narrator:
Do not throw away (dispose of) loose needles and syringes in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: made of heavy- duty plastic, can be closed with a tight- fitting, puncture-resistant lid, without sharp items being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container.
Marrika:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharp’s disposal container. There may be local or state laws about how to throw away syringes and needles. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal.
Marrika:
There are a few guidelines for storing GATTEX that you should know.
Store GATTEX powder at room temperature— below 77°F, or 25°C Never freeze GATTEX.
Make sure to use the GATTEX powder by the expiration date. Look for the “Use By” sticker on the kit.
And when you do mix it, make sure to use GATTEX within 3 hours.
Throw away any unused GATTEX that’s been mixed, even if there is medicine left in the vial.
Do not store any mixed GATTEX.
And lastly, keep GATTEX and all other medicines out of the reach of children.
Marrika:
Now that we’ve gone through the administration overview, please be sure to follow these instructions in the future. If you need more information, you can revisit any step in this video.
If you have any questions, refer to the GATTEX Instructions for Use or call your healthcare provider.
Narrator:
What is GATTEX?
GATTEX® (teduglutide) for subcutaneous injection is a prescription medicine used in adults and children 1 year of age and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous
(IV) feeding (parenteral support). It is not known if GATTEX is safe and effective in children under 1 year of age.
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 increased risk that
abnormal cells could become cancer. If you get cancer of the bowel (intestines), liver, gallbladder or pancreas while using GATTEX, your healthcare provider should stop GATTEX. If you get other types of cancers, you and your healthcare provider should discuss the risks and benefits of using GATTEX.
Polyps in the intestines
Polyps are growths on the inside of the intestines. For adult patients, your healthcare provider will have your colon and upper intestines checked for polyps within 6 months before starting GATTEX, and have any polyps removed. To keep using GATTEX, your healthcare provider should have your colon and upper intestines checked for polyps at the end of 1 year of using GATTEX.
For pediatric patients, your healthcare provider will check for blood in the stool within 6 months before starting GATTEX. If there is blood in the stool, your healthcare provider will check your colon and upper intestines for polyps, and have any polyps removed. To keep using GATTEX, your healthcare provider will check for blood in the stool every year during treatment of GATTEX. If there is blood in the stool, your healthcare provider will check your colon and upper intestines for polyps. The colon will be checked for polyps at the end of 1 year of using GATTEX.
For adult and pediatric patients, if no polyp is found at the end of 1 year, your healthcare provider should check you for polyps as needed and at least every 5 years. If any new polyps are found, your healthcare provider will have them removed and may recommend additional monitoring. If cancer is found in a polyp, your healthcare provider should stop GATTEX.
Blockage of the bowel (intestines)
A bowel blockage keeps food, fluids, and gas from moving through the bowels in the normal way. Tell your healthcare provider right away if you have any of these symptoms of a bowel or stomal blockage:
- trouble having a bowel movement or passing gas
- stomach area (abdomen) pain or swelling
- nausea
- vomiting
- swelling and blockage of your stoma opening, if you have a stoma
If a blockage is found, your healthcare provider may temporarily stop GATTEX.
Swelling (inflammation) or blockage of your gallbladder or pancreas
Your healthcare provider will do tests to check your gallbladder and pancreas within 6 months before starting GATTEX and at least every 6 months while you are using GATTEX. Tell your healthcare provider right away if you get:
- stomach area (abdomen) pain and tenderness
- chills
- fever
- a change in your stools
- nausea
- vomiting
- dark urine
- yellowing of your skin or the whites of your eyes
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 in adults include:
- stomach area (abdomen) pain or swelling
- nausea
- cold or flu symptoms
- skin reaction where the injection was given
- vomiting
- swelling of the hands or feet
- allergic reactions
The side effects of GATTEX in children and adolescents are similar to those seen in adults.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
What should I tell my healthcare provider before using GATTEX?
Tell your healthcare provider about all your medical conditions, including if you or your child:
- have cancer or a history of cancer
- have or had polyps anywhere in your bowel (intestines) or rectum
- have heart problems
- have high blood pressure
- have problems with your gallbladder, pancreas, kidneys
- are pregnant or planning to become pregnant. It is not known if GATTEX will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while using GATTEX.
- are breastfeeding or plan to breastfeed. It is not known if GATTEX passes into your breast milk. You should not breastfeed during treatment with GATTEX. Talk to your healthcare provider about the best way to feed your baby while using GATTEX.
Tell your healthcare providers about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. Using GATTEX with certain other medicines may affect each other causing side effects. Your other healthcare providers may need to change the dose of any oral medicines (medicines taken by mouth) you take while using GATTEX. Tell the healthcare provider who gives you GATTEX if you will be taking a new oral medicine.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800- FDA-1088.
