BASAGLAR KwikPen (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

BASAGLAR (insulin glargine injection) is a clear, colorless, sterile solution, with no visible particles, 100 units per mL (U-100) available as:

a Tempo Pen contains a component that allows for data connectivity when used with a compatible transmitter.

BASAGLAR Total Volume NDC Number Package Size
BASAGLAR single-patient-use KwikPen 3 mL 0002-7715-59 (HP-7715) 5 pens
BASAGLAR single-patient-use Tempo Pena 3 mL 0002-8214-05 (HP-8214) 5 pens

The BASAGLAR KwikPen and Tempo Pen dial in 1 unit increments.

Needles are not included.

This device is recommended for use with Becton, Dickinson & Company’s insulin pen needles which are sold separately.

16.2 Storage and Handling

Dispense in the original sealed carton with the enclosed Instructions for Use.

Do not freeze BASAGLAR. Do not use BASAGLAR if it has been frozen.

BASAGLAR must be protected from direct heat and light.

Do not use after the expiration date. In-use BASAGLAR prefilled pens must be used within 28 days or be discarded, even if they still contain BASAGLAR.

Storage conditions are summarized in the following table:

Not In-Use (Unopened) Room Temperature (up to 86°F [30°C]) Not In-Use (Unopened) Refrigerated (36°F to 46°F [2°C to 8°C]) In-Use (Opened) Room Temperature, (up to 86°F [30°C])
3 mL single-patient-use BASAGLAR KwikPen 28 days Until expiration date 28 days, Do not refrigerate.
3 mL single-patient-use BASAGAR Tempo Pen 28 days Until expiration date 28 days, Do not refrigerate.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use).

Never Share a BASAGLAR Prefilled Pen Between Patients

Advise patients that they must never share a BASAGLAR prefilled pen with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions (5.1)].

Hyperglycemia or Hypoglycemia

Inform patients that hypoglycemia is the most common adverse reaction with insulin. Inform patients of the symptoms of hypoglycemia. Inform patients that the ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery.

Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions (5.2)].

Medication errors

Inform patients to always check the insulin label before each injection [see Warnings and Precautions (5.4)].

Administration

BASAGLAR must only be used if the solution is clear and colorless with no particles visible. Patients must be advised that BASAGLAR must NOT be diluted or mixed with any other insulin or solution [see Dosage and Administration (2.1)].

Management of Hypoglycemia and Handling of Special Situations

Patients should be instructed on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia. Patients must be instructed on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals [see Warnings and Precautions (5.3)]. Refer patients to the BASAGLAR “Patient Information” for additional information about the potential side effects of insulin therapy, including lipodystrophy (and the need to rotate injection sites within the same body region), weight gain, allergic reactions, and hypoglycemia.

Literature revised November 2019

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA

Copyright © 2015, 2019, Eli Lilly and Company. All rights reserved.

BAS-0005-USPI-20191125

This Patient Information has been approved by the U.S. Food and Drug Administration

Patient Information BASAGLAR ® (baz-a-glar)(insulin glargine injection) 100 units per mL (U-100) for subcutaneous use
What is BASAGLAR?
  • 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.
Who should not use BASAGLAR? 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. See the end of this Patient Information leaflet for a complete list of ingredients in BASAGLAR.
What should I tell my healthcare provider before using 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 detailed Instructions for Use that 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 the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. 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 to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
    • Do not use the exact same spot for each injection.
    • Do not inject where the skin has pits, is thickened, or has lumps.
    • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
  • Do not mix BASAGLAR with any other type of insulin.
  • Always use a new needle for 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.
  • 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 single-patient-use BASAGLAR® prefilled pen 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.
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.
What should I avoid while using BASAGLAR? 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.
What are the possible side effects of BASAGLAR? 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.
What are the ingredients in BASAGLAR?
  • Active ingredient: insulin glargine
  • Inactive ingredients: glycerin, metacresol, zinc, and Water for Injection, USP as inactive ingredients. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH.
Patient Information revised: November 2019
Marketed By: Lilly USA, LLC, Indianapolis, IN 46285 USA Copyright © 2015, 2019, Eli Lilly and Company. All rights reserved.

BAS-0004-PPI-20191125

Instructions for Use

BASAGLAR ® KwikPen ®

insulin glargine injection (100 units/mL, 3 mL single-patient-use pen)

Figure
(click image for full-size original)

Read the Instructions for Use before you start using BASAGLAR and each time you get another BASAGLAR® KwikPen®. 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 single-patient-use 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
(click image for full-size original)

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 not use 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 a new needle for 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 not remove 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 not use 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 not throw 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 you do not prime before each injection, you may get too much or too little insulin.
Step 6:
  • To prime your Pen, turn the Dose Knob to select 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, and “0” is seen in the Dose Window. Hold the Dose Knob in and count to 5 slowly.You should see insulin at the tip of the Needle.
    If you do not see insulin, repeat the priming steps, but not more than 4 times.
    If you still do not see 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 not dial 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.
    The even numbers are printed on the dial.
    The odd numbers, 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 sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not inject where the skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
  • Do not try 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.
  • Continue to hold the Dose Knob in and slowly count to 5 before removing the needle.Note: Do not try to inject your insulin by turning the Dose Knob. You will not receive your insulin by turning the Dose Knob.
Figure
Figure
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 not rub 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 (see Disposing of Pens and Needles section 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 not freeze BASAGLAR. Do not use 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.
  • Always use 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 not use 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. BASAGLAR® and BASAGLAR® KwikPen® are trademarks of Eli Lilly and Company.

Instructions for Use revised: November 2019

Marketed by:

Lilly USA, LLC

Indianapolis, IN 46285, USA

Copyright © 2015, 2019, Eli Lilly and Company. All rights reserved.

BASAGLAR KwikPen meets the current dose accuracy and functional requirements of ISO 11608-1.

BASKP-0007-IFU-20191125

Instructions for Use

BASAGLAR ® Tempo Pen™

insulin glargine injection (100 units/mL, 3 mL pen, single-patient-use)

Figure
(click image for full-size original)

Read the Instructions for Use before you start using BASAGLAR and each time you get another BASAGLAR Tempo Pen. 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 Tempo Pen 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 Tempo Pen (“Pen”) is a disposable single-patient-use 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.

This BASAGLAR Tempo Pen contains a component that allows for data connectivity when used with a compatible transmitter.

Figure
(click image for full-size original)
Figure
(click image for full-size original)

How to recognize your BASAGLAR Tempo Pen

  • Pen color: Light grey
  • Dose Knob: Light grey
  • Labels: Light grey with green color bars

Supplies needed to give your injection

  • BASAGLAR Tempo Pen
  • Tempo Pen 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 not use 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 a new needle for 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 not remove 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 not use 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 not throw 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 you do not prime before each injection, you may get too much or too little insulin.
Step 6:
  • To prime your Pen, turn the Dose Knob to select 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 the Needle pointing up. Push the Dose Knob in until it stops, and “0 ” is seen in the Dose Window. Hold the Dose Knob in and count to 5 slowly.You should see insulin at the tip of the Needle.
    If you do not see insulin, repeat the priming steps 6 to 8, but not more than 4 times.
    If you still do not see insulin, change the Needle and repeat the priming steps 6 to 8.
Figure
Figure

Selecting your dose

  • You can give a dose of 1 to 80 units in a single injection.
  • 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 not dial 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.
    The even numbers are printed on the dial.
    The odd numbers, 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 cannot inject.

Giving your injection

  • Inject your insulin as your healthcare provider has shown you.
  • Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not inject where skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
  • Do not try 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 and slowly count to 5 before removing the needle.Note: Do not try to inject your insulin by turning the Dose Knob. You will not receive your insulin by turning the Dose Knob.
Figure
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 sugar (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 not rub 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 (see Disposing of Pens and Needles section 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 thrown away (discarded) in your household trash after you have removed the needle.

Storing your BASAGLAR Tempo Pen

Unopened Pens

  • Store unopened Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Do not freeze BASAGLAR. Do not use if it has been frozen.
  • Unopened 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.
  • Always use 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 not use your Pen if any part looks broken or damaged.
  • Always carry an extra Pen in case yours is lost or damaged.

Troubleshooting

  • If you cannot 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 Tempo Pen, contact Lilly at 1-800-LillyRx (1-800-545-5979) or call your healthcare provider for help. For more information on BASAGLAR Tempo Pen 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.

BASAGLAR® is a registered trademark and Tempo PenTM is a trademark of Eli Lilly and Company.

Instructions for Use issued: 11/2019

Marketed by:
Lilly USA, LLCIndianapolis, IN 46285, USA

Copyright © 2019, Eli Lilly and Company. All rights reserved.

BASAGLAR Tempo Pen meets the current dose accuracy and functional requirements of ISO 11608-1.

BASTP-0002-IFU-20191125

PACKAGE CARTON – BASAGLAR KwikPen 80 UNIT PEN

Dispense in this sealed carton.

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 Basaglar® KwikPen® Instructions for Use.

NEEDLES NOT INCLUDED

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

Lilly

PACKAGE CARTON – BASAGLAR KwikPen
(click image for full-size original)

PACKAGE CARTON – BASAGLAR Tempo Pen 80 UNIT PEN

Dispense in this sealed carton.

NDC 0002-8214-05

Basaglar®

Tempo Pen™

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 only.

Read Basaglar® Tempo Pen™ Instructions for Use.

NEEDLES NOT INCLUDED

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

Lilly

PACKAGE CARTON – BASAGLAR Tempo Pen
(click image for full-size original)
BASAGLAR KWIKPEN insulin glargine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-7715
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Insulin glargine (Insulin glargine) Insulin glargine 100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin 17 mg in 1 mL
Metacresol 2.7 mg in 1 mL
Zinc 0.03 mg in 1 mL
Water
Hydrochloric acid
Sodium hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0002-7715-59 5 SYRINGE in 1 CARTON contains a SYRINGE (0002-7715-01)
1 NDC:0002-7715-01 3 mL in 1 SYRINGE This package is contained within the CARTON (0002-7715-59)
2 NDC:0002-7715-63 1 SYRINGE in 1 CARTON contains a SYRINGE
2 3 mL in 1 SYRINGE This package is contained within the CARTON (0002-7715-63)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA205692 12/16/2015
BASAGLAR TEMPO PEN insulin glargine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-8214
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Insulin glargine (Insulin glargine) Insulin glargine 100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin 17 mg in 1 mL
Metacresol 2.7 mg in 1 mL
Zinc 0.03 mg in 1 mL
Water
Hydrochloric acid
Sodium hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0002-8214-05 5 SYRINGE in 1 CARTON contains a SYRINGE (0002-8214-01)
1 NDC:0002-8214-01 3 mL in 1 SYRINGE This package is contained within the CARTON (0002-8214-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA205692 12/16/2015
Labeler — Eli Lilly and Company (006421325)

Revised: 02/2021 Eli Lilly and Company

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.