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BASAGLAR- insulin glargine injection, solution


  1. Patient Information
  2. Do Not Use Basaglar If You:
  3. Have An Allergy To Insulin Glargine Or Any Of The Ingredients In Basaglar. Before Using Basaglar, Tell Your Healthcare Provider About All Your Medical Conditions, Including If You:
  4. How Should I Use Basaglar?
  5. Your Dose Of Basaglar May Need To Change Because Of:
  6. While Using Basaglar Do Not:
  7. Basaglar May Cause Serious Side Effects That Can Lead To Death, Including:
  8. Severe Allergic Reaction (whole Body Reaction). Get Medical Help Right Away If You Have Any Of These Signs Or Symptoms Of A Severe Allergic Reaction:
  9. Treatment With Tzds And Basaglar May Need To Be Changed Or Stopped By Your Healthcare Provider If You Have New Or Worse Heart Failure.get Emergency Medical Help If You Have:
  10. The Most Common Side Effects Of Basaglar Include:
  11. Active Ingredient:
  12. Inactive Ingredients:
  13. How To Recognize Your Basaglar Kwikpen:
  14. Supplies Needed To Give Your Injection:
  15. If You Need To Inject More Than The Number Of Units Left In The Pen, You May Either:
  16. Step 10:
  17. Step 11:
  18. Step 12:
  19. Step 13:
  20. Step 14:
  21. Step 15:
  22. If You Do Not Have A Fda-cleared Sharps Disposal Container, You May Use A Household Container That Is:
  23. If The Dose Knob Is Hard To Push:
  24. Revised: 1/2019document Id:

Patient Information 


  • BASAGLAR is a long-acting man made insulin used to control high blood sugar in adults and children with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.
  • BASAGLAR is not for use to treat diabetic ketoacidosis.
  • It is not known if BASAGLAR is safe and effective in children less than 6 years of age with type 1 diabetes mellitus or in children with type 2 diabetes mellitus.

Do Not Use Basaglar If You: 


  • are having an episode of low blood sugar (hypoglycemia).

Have An Allergy To Insulin Glargine Or Any Of The Ingredients In Basaglar. Before Using Basaglar, Tell Your Healthcare Provider About All Your Medical Conditions, Including If You: 


  • have liver or kidney problems.
  • take any other medicines, especially ones commonly called TZDs (thiazolidinediones).
  • have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with BASAGLAR.
  • are pregnant, planning to become pregnant, or are breastfeeding. It is not known if BASAGLAR may harm your unborn or breastfeeding baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Before you start using BASAGLAR, talk to your healthcare provider about low blood sugar and how to manage it.

How Should I Use Basaglar? 


  • Read the detailedInstructions for Usethat come with your BASAGLAR.
  • Use BASAGLAR exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much BASAGLAR to use and when to use it.
  • Know the amount of BASAGLAR you use. Do not change the amount of BASAGLAR you use unless your healthcare provider tells you to.
  • Check your insulin label each time you give your injection to make sure you are using the correct insulin.
  • BASAGLAR may be used at any time during the day, but BASAGLAR should be used at the same time each day.
  • Only use BASAGLAR that is clear and colorless. If your BASAGLAR is cloudy or slightly colored, return it to your pharmacy for a replacement.
  • BASAGLAR is injected under your skin (subcutaneously). Do not use BASAGLAR in an insulin pump or inject BASAGLAR into your vein (intravenously).
  • Change (rotate) your injection sites within the area you chose with each dose. Do not use the exact spot for each injection.
  • Do not mix BASAGLAR with any other type of insulin.
  • Check your blood sugar levels.Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.
  • Do not share your BASAGLARKwikPenwith other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
Keep BASAGLAR and all medicines out of the reach of children.

Your Dose Of Basaglar May Need To Change Because Of: 


  • change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

While Using Basaglar Do Not: 


  • drive or operate heavy machinery, until you know how BASAGLAR affects you.
  • drink alcohol or use over-the-counter medicines that contain alcohol.

Basaglar May Cause Serious Side Effects That Can Lead To Death, Including: 


  • low blood sugar (hypoglycemia).Signs and symptoms that may indicate low blood sugar include:
    • dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger.

Severe Allergic Reaction (whole Body Reaction). Get Medical Help Right Away If You Have Any Of These Signs Or Symptoms Of A Severe Allergic Reaction: 

  • a rash over your whole body, trouble breathing, a fast heartbeat, or sweating.
  • low potassium in your blood (hypokalemia).
    • heart failure.Taking certain diabetes pills called thiazolidinediones or TZDs with BASAGLAR may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with BASAGLAR. Your healthcare provider should monitor you closely while you are taking TZDs with BASAGLAR. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
  • shortness of breath, swelling of your ankles or feet, sudden weight gain.
  • Treatment With Tzds And Basaglar May Need To Be Changed Or Stopped By Your Healthcare Provider If You Have New Or Worse Heart Failure.get Emergency Medical Help If You Have: 


    • trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

    The Most Common Side Effects Of Basaglar Include: 


    • low blood sugar (hypoglycemia), allergic reactions, including reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy).
    These are not all the possible side effects of BASAGLAR.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).General information about the safe and effective use of BASAGLAR.
    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BASAGLAR for a condition for which it was not prescribed. Do not give BASAGLAR to other people, even if they have the same symptoms that you have. It may harm them.
    This Patient Information leaflet summarizes the most important information about BASAGLAR. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about BASAGLAR that is written for health professionals. For more information, go to www.basaglar.com or call 1-800-545-5979.

    Active Ingredient: 

    insulin glargine

    Inactive Ingredients: 

    zinc, metacresol, glycerin and water for injection as inactive ingredients. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH.Patient Information revised: June 1, 2016

    Marketed By: Lilly USA, LLC, Indianapolis, IN 46285 USA and Boehringer Ingelheim Pharmaceutical, Inc., Ridgefield, CT 06877, USA
    Copyright 2015, 2016, Eli Lilly and Company. All rights reserved.

    Instructions for Use

    BASAGLARKwikPen

    insulin glargine injection (100 units/mL, 3 mL pen)

    Figure

    Read the Instructions for Use before you start using BASAGLAR and each time you get another BASAGLARKwikPen. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

    Do not share your BASAGLAR KwikPen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

    BASAGLAR KwikPen ("Pen") is a disposable prefilled pen containing 300 units (3mL) of BASAGLAR. One pen contains multiple doses of medicine.

    • Your healthcare provider will tell you how many units to give as your dose and how to inject your prescribed dose of medicine.
    • You can give a dose of 1 to 80 units in a single injection.
    • If your prescribed dose is more than 80 units, you will need to give yourself more than 1 injection.
    • The plunger only moves a little with each injection, and you may not notice that it moves. When the plunger reaches the end of the cartridge, you have used all 300 units in the Pen.

    People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.

    Figure

    How To Recognize Your Basaglar Kwikpen: 

    • Pen color: Light grey
    • Dose Knob: Light grey with green ring on the end
    • Labels: Light grey with green color bars

    Supplies Needed To Give Your Injection: 

    • BASAGLAR KwikPen
    • KwikPen compatible Needle (Becton, Dickinson and Company Pen Needles recommended)
    • Alcohol swab

    Preparing your Pen

    • Wash your hands with soap and water.
    • Check the Pen to make sure you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
    • Do notuse your Pen past the expiration date printed on the Label or for more than 28 days after you first start using the Pen.
    • Always use anew needlefor each injection to help prevent infections and blocked needles.Do not reuse or share your needles with other people. You may give other people a serious infection or get a serious infection from them.
    Step 1:

    • Pull the Pen Cap straight off.
      -Do notremove the Pen Label.
    • Wipe the Rubber Seal with an alcohol swab.

    Figure
    Step 2:
    • Check the liquid in the Pen.

    BASAGLAR should look clear and colorless.Do notuse if it is cloudy, colored, or has particles or clumps in it.

    Figure
    Step 3:
    • Select a new Needle.
    • Pull off the Paper Tab from the Outer Needle Shield.

    Figure
    Step 4:
    • Push the capped Needle straight onto the Pen and twist the Needle on until it is tight.


    Figure
    Step 5:
    • Pull off the Outer Needle Shield.
      Do notthrow it away.
    • Pull off the Inner Needle Shield and throw it away.

    Figure

    Priming your Pen

    Prime before each injection.

    • Priming means removing the air from the Needle and Cartridge that may collect during normal use. It is important to prime your Pen before each injection so that it will work correctly.
    • If youdo notprime before each injection, you may get too much or too little insulin.
    Step 6:
    • To prime your Pen, turn the Dose Knob toselect 2 units.

    Figure
    Step 7:
    • Hold your Pen with the Needle pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top.

    Figure
    Step 8:
    • Continue holding your Pen with Needle pointing up. Push the Dose Knob in until it stops, and0is seen in the Dose Window. Hold the Dose Knob in andcount to 5 slowly.


      You should see insulin at the tip of the Needle.


      - If youdo notsee insulin, repeat the priming steps, but not more than 4 times.
      - If you stilldo notsee insulin, change the Needle and repeat the priming steps.
    Small air bubbles are normal and will not affect your dose.

    Figure
    Figure

    Selecting your dose

    • If your dose is more than 80 units, you will need to give more than 1 injection.
      - Talk to your healthcare provider about how to give your dose.
      - Use a new Needle for each injection and repeat the priming step.
    Step 9:
    • Turn the Dose Knob to select the number of units you need to inject. The Dose Indicator should line up with your dose.

      - The Pen dials 1 unit at a time.
      - The Dose Knob clicks as you turn it.
      -Do notdial your dose by counting the clicks because you may dial the wrong dose.
      - The dose can be corrected by turning the Dose Knob in either direction until the correct dose lines up with the Dose Indicator.
      - Theevennumbers are printed on the dial.
      - Theoddnumbers, after the number 1, are shown as full lines.


    • Always check the number in the Dose Window to make sure you have dialed the correct dose.

    Figure
    Figure
    (Example: 12 units shown in the Dose Window)

    Figure
    (Example: 25 units shown in the Dose Window)
    • The Pen will not let you dial more than the number of units left in the Pen.

    If You Need To Inject More Than The Number Of Units Left In The Pen, You May Either: 

    - inject the amount left in your Pen and then use a new Pen to give the rest of your dose,or
    - get a new Pen and inject the full dose.
  • It is normal to see a small amount of insulin left in the Pen that you can not inject.
  • Giving your injection

    • Inject your insulin as your healthcare provider has shown you.
    • Change (rotate) your injection site for each injection.
    • Do nottry to change your dose while injecting.

    Step 10: 


    Choose your injection site.
    • BASAGLAR is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms.
    • Wipe the skin with an alcohol swab, and let the injection site dry before you inject your dose.

    Figure

    Step 11: 

    • Insert the Needle into your skin.
    • Push the Dose Knob all the way in.

    Figure
    • Continue to hold the Dose Knob in andslowly count to 5before removing the needle.


    Figure Note: Do nottry to inject your insulin by turning the Dose Knob. You willnotreceive your insulin by turning the Dose Knob.

    Step 12: 

    • Pull the Needle out of your skin.
      - A drop of insulin at the Needle tip is normal. It will not affect your dose.
    • Check the number in the Dose Window
      - If you see 0 in the Dose Window, you have received the full amount you dialed.
      - If you do not see 0 in the Dose Window you did not receive your full dose. Do not redial. Insert the needle into your skin and finish your injection.
      - If you still do not think you received the full amount you dialed for your injection, do not start over or repeat that injection. Monitor your blood glucose and call your healthcare provider for further instructions.
      - If you normally need to give 2 injections for your full dose, be sure to give your second injection.
    The plunger only moves a little with each injection, and you may not notice that it moves.
    If you see blood after you take the Needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab.Do notrub the area.
    Figure

    After your injection

    Step 13: 

    • Carefully replace the Outer Needle Shield.

    Figure

    Step 14: 

    • Unscrew the capped Needle and throw it away (seeDisposing of Pens and Needlessection below).
    • Do not store the Pen with the Needle attached to prevent leaking, blocking the Needle, and air from entering the Pen.

    Figure

    Step 15: 

    • Replace the Pen Cap by lining up the Cap Clip with the Dose Indicator and pushing straight on.

    Figure

    Disposing of Pens and Needles

    • Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash.

    If You Do Not Have A Fda-cleared Sharps Disposal Container, You May Use A Household Container That Is: 

    - made of a heavy-duty plastic,
    - can be closed with a tight-fitting, puncture-resistant lid, without sharps 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 state or local laws about how you should throw away used needles and syringes. 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 used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
  • The used Pen may be discarded in your household trash after you have removed the needle.
  • Storing your BASAGLAR KwikPen

    Unused Pens

    • Store unused Pens in the refrigerator at 36 F to 46 F (2 C to 8 C).
    • Do notfreeze BASAGLAR.Do notuse if it has been frozen.
    • Unused Pens may be used until the expiration date printed on the Label, if the Pen has been kept in the refrigerator.

    In-use Pen

    • Store the Pen you are currently using at room temperature [up to 86 F (30 C)] and away from heat and light.
    • Throw away the Pen you are using after 28 days, even if it still has insulin left in it.

    General information about the safe and effective use of your Pen

    • Keep your Pen and needles out of the sight and reach of children.
    • Alwaysuse a new needle for each injection.
    • Do not share your Pen or needles with other people. You may give other people a serious infection or get a serious infection from them.
    • Do notuse your Pen if any part looks broken or damaged.
    • Always carry an extra Pen in case yours is lost or damaged.

    Troubleshooting

    • If you can not remove the Pen Cap, gently twist the cap back and forth, and then pull the cap straight off.

    If The Dose Knob Is Hard To Push: 

    - Pushing the Dose Knob more slowly will make it easier to inject.
    - Your Needle may be blocked. Put on a new Needle and prime the Pen.
    - You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new Pen.

    If you have any questions or problems with your BASAGLAR KwikPen, contact Lilly at 1-800-LillyRx (1-800-545-5979) or call your healthcare provider for help. For more information on BASAGLAR KwikPen and insulin, go to www.basaglar.com.

    Figure

    Scan this code to launch www.basaglar.com

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

    BASAGLARand BASAGLARKwikPenare trademarks of Eli Lilly and Company.

    Instructions for Use revised: September 2018

    Marketed by: Lilly USA, LLC
    Indianapolis, IN 46285, USA
    and
    Boehringer Ingelheim Pharmaceuticals, Inc.
    Ridgefield, CT 06877, USA

    Copyright 2015, 2018, Eli Lilly and Company. All rights reserved.

    BASAGLAR KwikPenmeets the current dose accuracy and functional requirements of ISO 11608-1:2014.

    BI(logo)

    Lilly(red script)

    BASKP-0005-IFU-20180905

    PACKAGE CARTON BASAGLAR KwikPen 80 UNIT PEN

    NDC 0002-7715-59

    Basaglar

    KwikPen

    insulin glargine injection

    For Single Patient Use Only

    U-100

    100 units per mL

    5 x 3 mL prefilled pens

    prefilled insulin delivery device

    Can inject from 1 to 80 units in a single injection

    Rx only

    For subcutaneous use.

    Read BasaglarKwikPenInstructions for Use.

    NEEDLES NOT INCLUDED

    This device is recommended for use with Becton, Dickinson & Company's insulin pen needles.

    Boehringer Ingelheim

    Lilly

    PACKAGE CARTON     BASAGLAR KwikPen
    BASAGLAR
    insulin glargine injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0002-7715
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Insulin glargine(UNII: 2ZM8CX04RZ) (Insulin glargine - UNII:2ZM8CX04RZ)Insulin glargine100 [iU] in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin(UNII: PDC6A3C0OX)17 mg in 1 mL
    Metacresol(UNII: GGO4Y809LO)2.7 mg in 1 mL
    Zinc(UNII: J41CSQ7QDS)0.03 mg in 1 mL
    Water(UNII: 059QF0KO0R)
    Hydrochloric acid(UNII: QTT17582CB)
    Sodium hydroxide(UNII: 55X04QC32I)
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0002-7715-595 in 1 CARTON06/17/2016
    1NDC:0002-7715-013 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:0002-7715-631 in 1 CARTON07/15/2016
    23 mL in 1 SYRINGE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20569212/16/2015
    Labeler -Eli Lilly and Company (006421325)

    Revised: 1/2019document Id: 

    0cb55987-d725-420c-8eb2-f6e554e20280Set id: 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aaeVersion: 19Effective Time: 20190128Eli Lilly and Company



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