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Gattex

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Gattex

PATIENT INFORMATION

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 for polyps within 6 months before starting GATTEX
  • Have any polyps removed

To keep using GATTEX, your healthcare provider should:

Have your colon checked for new polyps at the end of 1 year of using GATTEX. If no polyp is found, your healthcare provider should check you for polyps as needed and at least every 5 years.

Have any new polyps removed

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 if you have any of these symptoms of a bowel 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 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
  • nausea
  • vomiting
  • chills
  • fever
  • change in your stools
  • dark urine
  • yellowing of your skin or the whites of eyes

These are not all the side effects of GATTEX. For more information, see “What are the possible side effects of GATTEX?”

What is GATTEX?

GATTEX is a prescription medicine used in adults 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 or effective in children.

What should I tell my healthcare provider before using GATTEX?

Before you use GATTEX, tell your healthcare provider if you:

  • 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
  • have any other medical condition
  • 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 and your healthcare provider should decide if you will use GATTEX or breastfeed. You should not do both.

Tell your healthcare providers about all the medicines you take, including prescription and 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 you take while using GATTEX. Tell the healthcare provider who gives you GATTEX if you will be taking a new oral medicine.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use GATTEX?

  • Use GATTEX exactly as your healthcare provider tells you to.
  • GATTEX is given 1 time each day at the same time.
  • Inject your dose of GATTEX under the skin (subcutaneous injection) in your stomach area (abdomen), upper legs (thighs), or upper arms. Do not inject GATTEX into a vein or muscle.
  • Use a different injection site each time you use GATTEX.
  • GATTEX comes as a powder for injection in a vial that is used only 1 time (single-use 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.

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

GATTEX kit - Illustration

Gather the supplies you will need to prepare GATTEX and to give your injection. (See Figure A)

Figure A

Supplies required - Illustration

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 1 ½ inch needle in front of you on your work surface. (see Figure B1)

Figure B1

Diluent syringe - Illustration

  • Hold the Diluent syringe by the barrel.
    • 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 B2). Throw the cap away.

Figure B2

bend the cap sideways - Illustration

    • If you have the Diluent syringe with the gray screw top: Unscrew the top counter clockwise (to the left) (See Figure B3). Throw the top away.

Figure B3

Unscrew the top - Illustration

  •  Remove the 22G 1½ inch needle from the package. Use the fold in the package to peel back the plastic cover (See Figure C). Leave the plastic cap on the needle.

Figure C

Peel back the plastic cover- Illustration

  • Push the open end of the needle onto the end of the Diluent syringe (See Figure D). Twist the needle clockwise (to the right) until it stops turning.

Figure D

Push the open end of the needle onto the end of the Diluent syringe - Illustration

  • When the needle is tightly in place, put the Diluent syringe and needle on your work surface.

Step 3: Mix GATTEX powder with Diluent.

  • Remove the green cap from the GATTEX vial. Throw away the green cap.
  • Find the gray rubber seal on top of the vial (See Figure E).

Figure E

Gray rubber seal - Illustration

  •  Use an alcohol swab pad to clean the gray rubber seal (See Figure F).
  • Do not touch the gray rubber seal after you clean it.

Figure F

Ulean the gray rubber seal - Illustration

  • Pick up the Diluent syringe with the needle attached.
  • Remove the plastic cap that covers the needle (See Figure G). Throw the cap away.

Figure G

Remove the plastic needle cap - Illustration

  • Hold the vial between thumb and index (pointer) finger (See Figure H). Be careful not to touch the gray rubber seal.
  • Push the needle down through the center of the gray rubber seal.
  • Slowly push down on the plunger of the Diluent syringe. Empty all the Diluent into the GATTEX vial.
  • Leave the needle and Diluent syringe in place.

Figure H

Hold the vial between thumb and index (pointer) finger - Illustration

  •  Gently tap the barrel of the Diluent syringe with a finger (See Figure I).
  • Make sure all the Diluent has gone into the GATTEX vial.

Figure I

Gently tap the barrel - Illustration

  • 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.
  • Dispose of the Diluent syringe and needle in your sharps disposal container.
  • After 30 seconds, place the vial between the palms of your hands. Gently roll the vial for about 15 seconds (See Figure J).
  • Do not shake the vial.
  • Do not touch the gray seal. If you do, clean it again with a new alcohol pad.
  • Let the vial stand on your work surface for about 2 minutes.

Figure J

Gently roll the vial - Illustration

 Step 4: Check the mixed GATTEX.

  • After 2 minutes, look at the vial of GATTEX. The liquid in the vial should be clear and colorless to pale yellow, and should not have any particles in it.
  • If there is any powder in the vial that did not dissolve, gently roll the vial between your hands for 15 seconds more.
  • Do not shake the vial.
  • Check the vial again for anything that did not dissolve.
  • Do not use the vial if there is anything in it that did not dissolve. Start from the beginning of this Instructions of Use to prepare a new vial. Use a new GATTEX vial, new Diluent syringe, and a new needle.

Step 5: Draw up your dose of GATTEX.

  • Remove the plastic dosing syringe from the package. Use the fold in the package to peel back the plastic cover (See Figure K).

Figure K

Peel back the plastic cover - Illustration

  • Remove the needle cap from the dosing syringe (See Figure L).
  • Throw the needle cap away. Do not touch the needle or allow it to touch anything.

Figure L

Remove the needle cap - Illustration

  •  Carefully pull back on the plunger to the line that matches the dose prescribed by your healthcare provider.
  • Use one hand to hold the vial steady. Use your other hand to insert the needle straight down into the middle of the gray rubber seal on the GATTEX vial (See Figure M). You may feel some resistance as the needle passes through the rubber seal.
  • Gently push down the plunger until all of the air has gone from the syringe into the vial.
  • Turn the GATTEX vial and syringe upside down (See Figure N).

Figure M

Insert the needle straight down - Illustration

Figure N

Turn the GATTEX vial and syringe upside down - Illustration

  • Hold the GATTEX vial with one hand.
  • Slowly pull back the plunger of the dosing syringe with your other hand.
  • Fill the syringe until the black tip of the plunger lines up with the mark that matches your prescribed dose (See Figure O).
  • Keep the syringe and needle in the vial.

Figure O

Fill the syringe - Illustration

  • You may see some bubbles inside the vial when the syringe is filled. This is normal. With the needle still in the vial, gently tap the side of the syringe with a finger to make any air bubbles rise to the top (See Figure P).

Figure P

Gently tap the side of the syringe - Illustration

  • Slowly push the plunger up until all air bubbles are out of the 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 syringe.
  • Remove the dosing syringe and needle from the vial (See Figure Q). Do not touch the needle or allow it to touch anything.

Figure Q

Remove the dosing syringe - Illustration

 Step 6: Inject GATTEX.

  • Choose an injection site on your stomach area (abdomen), thighs, or upper arms. Choose a different site to give the injection each day. Do not inject into areas where the skin is tender, bruised, red, or hard. (See Figures R, S, and T)

Figure R

Injection sites - Illustration

Figure S

Injection sites - Illustration

  • Clean the skin where you plan to give the injection with a new alcohol swab pad. Do not touch this area again before giving the injection.
  • Use one hand to gently pinch up a fold of skin around the injection site (See Figure T).

Figure T

Pinch up a fold of skin - Illustration

  • Use your other hand to hold the syringe. Insert the full length of the needle into the skin at a 45-degree angle with a quick “dart-like” motion (See Figure U).

Figure U

GATTEX (teduglutide [rDNA origin]) Figure U Illustration

  • Let go of the skin. Hold the syringe barrel with one hand while you slowly push down the plunger until the syringe is empty (See Figure V).

Figure V

Slowly push down the plunger - Illustration

  • When the syringe is empty, quickly pull the needle out of your skin. There may be a little bleeding at the injection site. Apply an adhesive bandage to the injection site if needed.

Step 7: Dispose of syringes and needles.

  • 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. 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.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps 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: http://www.fda.gov/safesharpsdisposal.
  • Do not dispose of your sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your sharps disposal container.
  • Throw away the GATTEX vial into the container where you put the syringes and needles. If you have any questions, talk to your healthcare provider or pharmacist.

How should I store GATTEX?

  • Store GATTEX powder at room temperature up to 77°F (25°C).
  • 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.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 1/7/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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