(insulin glargine injection) 100 units per mL (U-100) for
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
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
- 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
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines, vitamins and
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
- 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
- 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.
Keep BASAGLAR and all medicines out of the reach of
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
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
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 signsor symptoms of a severe
- 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,
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
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 1-800545-5979.
What are the ingredients in BASAGLAR? • 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.
This Patient Information has been approved by the U.S.
Food and Drug Administration
Instructions for Use
insulin glargine injection (100 units/mL, 3 mL pen)
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. Youmay 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
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
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.
How to recognize your
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:
KwikPen compatible Needle (Becton, Dickinson and Company
Pen Needles recommended)
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
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
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
aserious infection from them.
Pull the Pen Cap straight off.
Do not remove the Pen Label.
Wipe the Rubber Seal with an alcohol swab.
Check the liquid in the Pen.
BASAGLAR should look clear and
colorless. Do not use if it is cloudy, colored, or has particles or
Select a new Needle.
Pull off the Paper Tab from the
Outer Needle Shield.
Push the capped Needle straight onto the Pen and twist
the Needle on until it is tight.
Pull off the Outer Needle Shield. Do not throw it
Pull off the Inner Needle Shield and throw it away.
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.
To prime your Pen, turn the Dose Knob to select 2
Hold your Pen with the Needle pointing up. Tap the
Cartridge Holder gently to collect air bubbles at the top.
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.
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
Use a new Needle for each injection and repeat the
Turn the Dose Knob to select
the number of units you need to inject. The Dose Indicator should line up with
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 DoseWindow to make sure
you have dialed thecorrect dose.
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
Change (rotate) your injection site for each injection.
Do not try to change your dose while injecting.
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.
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.
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
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.
After your injection
Carefully replace the Outer
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.
Replace the Pen Cap by lining up the Cap Clip with the
Dose Indicator and pushing straight on.
Disposing of Pens and
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,
properly labeled to warn of hazardous waste inside the
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:
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
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.
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
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 infectionor get a serious infection from
Do not use your Pen if any part looks broken or
Always carry an extra Pen in case yours is lost or
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
Your Needle may be blocked. Put on a new Needle and prime
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
(1-800545-5979) or call your healthcare provider for help. For more information
on BASAGLAR KwikPen and insulin, go to www.basaglar.com.
This Instructions for Use have been approved by the U.S.
Food and Drug Administration.