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BYETTA- exenatide injection


  1. Patient Information
  2. Before Taking Byetta, Tell Your Healthcare Provider If You Have Had:
  3. While Taking Byetta:
  4. What Is Byetta?
  5. Do Not Use Byetta If:
  6. Before Taking Byetta, Tell Your Healthcare Provider If You:
  7. Pregnancy Registry:
  8. Especially Tell Your Healthcare Provider If You Take:
  9. How Should I Use Byetta?
  10. Active Ingredient:
  11. Inactive Ingredients:
  12. What Kinds Of Needles Can Be Used With My Byetta Pen?
  13. Do I Use A New Needle For Each Injection?
  14. How Do I Throw Away My Needles?
  15. How Do I Store My Byetta Pen?
  16. How Long Can I Use A Byetta Pen?
  17. Mark The Date When You First Used Your Pen And The Date 30 Days Later In The Spaces Below:
  18. How Do I Clean My Byetta Pen?
  19. 2. Why Are There Air Bubbles In The Cartridge?
  20. 3. What Should I Do If Byetta Does Not Come Out Of The Needle Tip After Four Tries During One-time-only New Pen Setup?
  21. The Injection Is Complete When:
  22. 6. Where Should I Inject Byetta?
  23. 7. What If I Cannot Pull, Turn, Or Push The Dose Knob?
  24. Ifis In The Dose Window:
  25. Ifis In The Dose Window And The Dose Knob Will Not Turn:
  26. Ifand Part Ofare In The Dose Window And The Dose Knob Cannot Be Pushed In:
  27. If Part Ofand Part Ofare In The Dose Window And The Dose Knob Cannot Be Pushed In:
  28. Follow These Steps To Reset Your Pen For Your Next Injection:
  29. Revised: 3/2012document Id:

Patient Information 

Patients should be advised that BYETTA pens are never to be shared with another patient.

Patients should be informed of the potential risks and benefits of BYETTA and of alternative modes of therapy. Patients should also be fully informed about self-management practices, including the importance of proper storage of BYETTA, injection technique, timing of dosage of BYETTA and concomitant oral drugs, adherence to meal planning, regular physical activity, periodic blood glucose monitoring and HbA1ctesting, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications.

17.1 Risk of Pancreatitis

Patients should be informed that persistent severe abdominal pain that may radiate to the back and which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Patients should be instructed to promptly discontinue BYETTA and contact their physician if persistent severe abdominal pain occurs[

Serious side effects can happen in people who take BYETTA, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death.

Before Taking Byetta, Tell Your Healthcare Provider If You Have Had: 

  • pancreatitis.
  • stones in your gallbladder (gallstones).
  • a history of alcoholism.
  • high blood triglyceride levels.

These medical conditions can make you more likely to get pancreatitis in general. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while taking BYETTA.

While Taking Byetta: 

Call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away. The pain may happen with or without vomiting. The pain may be felt going from your abdomen through to your back. These may be symptoms of pancreatitis.

What Is Byetta? 

  • BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program.
  • BYETTA is not insulin.
  • You should not take BYETTA instead of insulin.
  • The use of BYETTA with short acting insulin is not recommended.
  • The use of BYETTA with rapid acting insulin is not recommended.
  • BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis.
  • It is not known if BYETTA is safe and effective in children.
  • BYETTA has not been studied in people who have pancreatitis.
  • BYETTA should not be used in people who have severe kidney problems.

Do Not Use Byetta If: 

  • you have had an allergic reaction to exenatide or any of the other ingredients in BYETTA.

Before Taking Byetta, Tell Your Healthcare Provider If You: 

  • have or have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels.
  • have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food.
  • have or have had kidney problems, or have had a kidney transplant.
  • have any other medical conditions.
  • are pregnant or plan to become pregnant. It is not known if BYETTA will harm your unborn baby.

Pregnancy Registry: 

Amylin Pharmaceuticals, Inc. has a registry for women who take BYETTA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you take BYETTA at any time during pregnancy you may enroll in this registry by calling (800) 633-9081.
  • are breastfeeding or plan to breast-feed. It is not known if BYETTA passes into your breast milk. You and your healthcare provider should decide if you will take BYETTA or breast-feed. You should not do both without talking with your healthcare provider first.
  • Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. BYETTA slows stomach emptying and can affect medicines that need to pass through the stomach quickly. BYETTA may affect the way some medicines work and some other medicines may affect the way BYETTA works.

    Especially Tell Your Healthcare Provider If You Take: 

    • Other anti-diabetes medicines, especially sulfonylurea medicines or insulin.
    • birth control pills that are taken by mouth (oral contraceptives). BYETTA may lower the amount of the medicine in your blood from your birth control pills and they may not work as well to prevent pregnancy. Take your birth control pills at least one hour before your injection of BYETTA. If you must take your birth control pills with food, take it with a meal or snack where you do not also take BYETTA.
    • an antibiotic. Take antibiotic medicines at least one hour before taking BYETTA. If you must take your antibiotic with food, take it with a meal or snack where you do not also take BYETTA.
    • warfarin sodium (Coumadin, Jantoven).
    • a blood pressure medicine.
    • a water pill (diuretic).
    • a pain medicine.
    • lovastatin (Altoprev, Mevacor, Advicor).

    Ask your healthcare provider if you are not sure if your medicine is listed above.

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

    How Should I Use Byetta? 

    BYETTA can cause serious side effects.

    • Store your new, unused BYETTA Pen in the original carton in a refrigerator at 36 F to 46 F (2 C to 8 C).
    • After first use, keep your BYETTA Pen at a temperature cooler than 77 F (25 C).
    • Do not freeze your BYETTA Pen. Do not use BYETTA if it has been frozen.
    • Protect BYETTA from light.
    • Use a BYETTA Pen for only 30 days. Throw away a used BYETTA Pen after 30 days, even if there is some medicine left in the pen.
    • Do not use BYETTA after the expiration date printed on the label.
    • Do not store the BYETTA Pen with the needle attached. If the needle is left on, medicine may leak from the BYETTA Pen or air bubbles may form in the cartridge.

    Active Ingredient: 

    exenatide

    Inactive Ingredients: 

    metacresol, mannitol, glacial acetic acid, and sodium acetate trihydrate in water for injection.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Revised December 2011

    Manufactured for Amylin Pharmaceuticals, Inc., San Diego, CA 92121

    BYETTA is a registered trademark of Amylin Pharmaceuticals, Inc.
    All other marks are the marks of their respective owners.

    2005, 2011 Amylin Pharmaceuticals, Inc. All rights reserved. 823015-AA

    5 mcg PEN USER MANUAL

    Section 1

    Read this section completely before you begin. Then, move on to Section 2 Getting Started.

    WHAT YOU NEED TO KNOW ABOUT YOUR BYETTA PEN

    Byetta
    exenatide injection


    250 mcg/mL, 1.2 mL

    5mcg

    Figure


    PEN USER MANUAL

    PEN USER MANUAL

    Read these instructions carefully BEFORE using your BYETTA Pen.For complete dosing and safety information, also read the BYETTAMedication Guidethat comes with the BYETTA Pen carton.

    It is important that you use your pen correctly. Failure to follow these instructions completely may result in a wrong dose, a broken pen or an infection.

    These instructions do not take the place of talking with your healthcare provider about your medical condition or your treatment. If you are having problems using your BYETTA Pen, call toll free 800-868-1190.

    IMPORTANT INFORMATION ABOUT YOUR BYETTA PEN

    • Each BYETTA Pen contains enough medicine for injection two times each day for 30 days. You do not have to measure any doses, the pen measures each dose for you.
    • Do not transfer the medicine in the BYETTA Pen to a syringe or vial.
    • Do notmix BYETTA and insulin in the same syringe or vial even if you take them at the same time.
    • If any part of your pen appears broken or damaged, do not use the pen.
    • This BYETTA Pen is not recommended for use by people who are blind or have vision problems without the help of a person trained in the proper use of the pen.
    • Follow the injection method explained to you by your healthcare provider.
    • Follow Section 2 only to set up a new pen before first use.
    • Section 3 of this manual should be used for every injection.

    ABOUT PEN NEEDLES

    What Kinds Of Needles Can Be Used With My Byetta Pen? 

    • Pen needles are not included with your pen.You may need a prescription to get them from your pharmacist.
    • Use 29 (thin), 30, or 31 (thinner) gauge disposable pen needles with your BYETTA Pen. Ask your healthcare provider which needle gauge and length is best for you.

    Do I Use A New Needle For Each Injection? 

    • Yes. Do not reuse needles.
    • Remove the needle from the pen immediately after you complete each injection. This will help prevent leakage of BYETTA, keep out air bubbles, reduce needle clogs, and decrease the risk of infection.
    • Do not push the injection button on your pen unless a needle is attached to the pen.

    How Do I Throw Away My Needles? 

    • Do not throw away the pen with a needle attached.
    • Place used needles in a closeable, puncture-resistant container. You may use a sharps container (such as a red biohazard container), a hard plastic container (such as a detergent bottle), or a metal container (such as an empty coffee can). Ask your healthcare provider for instructions on the right way to throw away (dispose of) your used pens and the container. There may be state and local laws about how you should throw away used pens and needles.
    • Do not throw the disposal container in the household trash. Do not recycle.
    • Always keep the puncture-proof container out of reach of children.

    Never share your BYETTA pen or needles with another person. You may give an infection to them, or get an infection from them, and BYETTA may harm them.

    STORING YOUR BYETTA PEN

    How Do I Store My Byetta Pen? 

    • Prior to first use, store your unused BYETTA Pen in the original carton in a refrigerator at 36 F to 46 F (2 C to 8 C).
    • After first use, your BYETTA Pen can be kept at a temperature not to exceed 77 F (25 C).
    • Do not freeze. Do not use BYETTA if it has been frozen. BYETTA should be protected from light.
    • When carrying the pen away from home, store the pen at a temperature between 36 F to 77 F (2 C to 25 C) and keep dry.
    • Do not store the pen with the needle attached. If the needle is left on the pen, BYETTA may leak from the pen and air bubbles may form in the cartridge.

    Keep your pen and needles out of the reach of children.

    How Long Can I Use A Byetta Pen? 

    • You can use your BYETTA Pen for up to 30 days after setting up a new pen for first use.After 30 days, throw away the BYETTA Pen, even if it is not completely empty.

    Mark The Date When You First Used Your Pen And The Date 30 Days Later In The Spaces Below: 

    Date of First UseDate to Throw Away Pen

    • BYETTA should not be used after the expiration date printed on the pen label.

    How Do I Clean My Byetta Pen? 

    • Wipe the outside of the pen with a clean, damp cloth.
    • White particles may appear on the outside tip of the cartridge during normal use. You may remove them with an alcohol wipe or alcohol swab.

    • No.The One-Time-Only New Pen Setup is done only once, just before each new pen is used for the first time.
    • The purpose of the setup is to make sure that your BYETTA Pen is ready to use for the next 30 days.
    • If you repeat the One-Time-Only New Pen Setup before each routine dose, you will not have enough BYETTA for 30 days.The small amount of BYETTA used in the new pen setup will not affect the 30-day supply of BYETTA.

    2. Why Are There Air Bubbles In The Cartridge? 

    • A small air bubble is normal. It will not harm you or affect your dose.
    • If the pen is stored with a needle attached, air bubbles may form in the cartridge.Do notstore the pen with the needle attached.

    3. What Should I Do If Byetta Does Not Come Out Of The Needle Tip After Four Tries During One-time-only New Pen Setup? 

    • Carefully put the outer needle shield back over the needle. Remove the needle by unscrewing it. Throw away the needle properly.
    • Attach a new needle and repeatOne-Time-Only New Pen Setup, Steps B E,in Section 2 of this user manual. Once you

      It is normal for a single drop to remain on the tip of your needle after your injection is complete. If you

    The Injection Is Complete When: 

    • You have firmly pushed the injection button in all the wayuntil it stops
      and
    • You have slowly counted to 5while you are still holding the injection button in and the needle is still in your skin
      and
    • TheFigureis in the center of the dose window.

    If you hear a click sound from your BYETTA Pen, ignore it. You must follow all the steps listed above to make sure your injection is complete.

    6. Where Should I Inject Byetta? 

    Inject BYETTA into your abdomen, thigh, or upper arm using the injection method explained to you by your healthcare provider.

    Figure

    7. What If I Cannot Pull, Turn, Or Push The Dose Knob? 

    Check the symbol in the dose window. Follow the steps next to the matching symbol.

    Ifis In The Dose Window: 

    • Pull the dose knob out untilFigureappears.

    Ifis In The Dose Window And The Dose Knob Will Not Turn: 

    • The cartridge in your BYETTA Pen may not have enough medicine to deliver a full dose. A small amount of BYETTA will always stay in the cartridge. If the cartridge contains a small amount and the dose knob will not turn, your pen does not have enough BYETTA and will not deliver any more doses. Obtain a new BYETTA Pen.

    Ifand Part Ofare In The Dose Window And The Dose Knob Cannot Be Pushed In: 

    • The dose knob was not turned all the way. Continue turning the dose knob away from you untilFigureis in the center of the dose window.

    If Part Ofand Part Ofare In The Dose Window And The Dose Knob Cannot Be Pushed In: 

    • The needle may be clogged, bent, or incorrectly attached.
    • Attach a new needle. Make sure needle is on straight and screwed on all the way.
    • Firmly push the injection button in all the way. BYETTA should come from needle tip.

    Follow These Steps To Reset Your Pen For Your Next Injection: 

    Firmly push the injection button in all the wayuntil it stops.Keep holding the injection button in andslowly count to 5.Then release the injection button and turn the dose knob away from you untilFigureappears in the dose window.

    If you cannot turn the dose knob, the needle may be clogged. Replace the needle and repeat the step above.
  • For your next dose, be sure tofirmly push and holdthe injection button in andslowly count to 5before removing needle from skin.
  • See the complete BYETTAMedication Guide
    that comes with BYETTA. For more information,
    call toll free 800-868-1190 or visit www.BYETTA.com
    Byetta
    exenatide injection

    Manufactured for Amylin Pharmaceuticals, Inc., San Diego, CA 92121. All rights reserved. BYETTA is a registered trademark of Amylin Pharmaceuticals, Inc.
    2007, 2011 Amylin Pharmaceuticals, Inc.
    Literature revised December 2011
    925001-08
    PV 5027 UCP

    PRINCIPAL DISPLAY PANEL - 5 mcg

    5
    mcg

    NDC 54868-5384-0

    Byetta
    exenatide injection
    250 mcg/mL, 1.2 mL

    Dispense the enclosed Medication Guide to each patient

    Each prefilled pen will deliver 60 subcutaneous doses, 5 mcg per dose
    Rx Only

    SUBCUTANEOUS USE ONLY REFRIGERATE DO NOT FREEZE
    DO NOT TRANSFER THIS MEDICATION TO A SYRINGE

    Pen needles not included

    Ask your healthcare provider which pen needle length and gauge is best for you
    Use 29 (thin), 30, or 31 (thinner) gauge disposable pen needles

    PRINCIPAL DISPLAY PANEL - 5 mcg package label
    BYETTA
    exenatide injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-5384(NDC:66780-210)
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    exenatide(UNII: 9P1872D4OL) (exenatide - UNII:9P1872D4OL)exenatide250 ug in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    metacresol(UNII: GGO4Y809LO)2.2 mg in 1 mL
    mannitol(UNII: 3OWL53L36A)
    acetic acid(UNII: Q40Q9N063P)
    sodium acetate(UNII: 4550K0SC9B)
    water(UNII: 059QF0KO0R)
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5384-01.2 mL in 1 CARTRIDGE
    2NDC:54868-5384-12.4 mL in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02177308/09/2005
    Labeler -Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel

    Revised: 3/2012document Id: 

    e0cceca4-759d-4ca9-be65-23a0199e5766Set id: c621d002-b7bf-4f3a-af68-4f70fd298d05Version: 3Effective Time: 20120312Physicians Total Care, Inc.



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