Patient Information
Humalog® (HU-ma-log)
insulin lispro injection, USP (rDNA origin)
Important
Know your insulin. Do not change the type of insulin you use unless told to
do so by your healthcare provider. Your insulin dose and the time you take your
dose can change with different types of insulin.
Make sure you have the right type and strength of insulin prescribed for you.
Read the Patient Information that comes with Humalog before you start using it
and each time you get a refill. There may be new information. This leaflet does not
take the place of talking with your healthcare provider about your diabetes or
treatment. Make sure that you know how to manage your diabetes. Ask your
healthcare provider if you have questions about managing your diabetes.
What is Humalog?
Humalog is an injectable fast-acting man-made insulin. Humalog is used to
control high blood sugar (glucose) in people with diabetes.
Humalog comes in:
•
10
mL vials (bottles) for use with a syringe or external insulin pump
•
3
mL vials (bottles) for use with a syringe or external insulin pump
•3
mL prefilled pens
•
3
mL cartridges for use with a reusable pen or external insulin pump
Who should not take Humalog?
Do not take Humalog if:
•your blood sugar is too low (hypoglycemia). After treating your low blood
sugar, follow your healthcare provider's instructions on the use of Humalog.
• you are allergic to anything in Humalog. See the end of this leaflet for a complete
list of ingredients in Humalog.
Tell your healthcare provider:
• about all your medical conditions. Medical conditions can affect your insulin
needs and your dose of Humalog.
• if you are pregnant or breastfeeding. You and your healthcare provider should
talk about the best way to manage your diabetes while you are pregnant or
breastfeeding. Humalog has not been studied in pregnant or nursing women.
•about all the medicines you take, including prescription and non-prescription
medicines, vitamins and herbal supplements.
Many medicines can affect
your blood sugar levels and insulin needs. Your Humalog dose may need to change
if you take other medicines.
Know the medicines you take. Keep a list of your medicines with you to show to
all of your healthcare providers.
How should I use Humalog?
Humalog can be used with a syringe, prefilled pen, reusable pen or external insulin
pump. Talk to your healthcare provider if you have any questions. Your healthcare
provider will tell you the right syringes to use with Humalog vials. Your healthcare
provider should show you how to inject Humalog before you start using it.
• Read the User Manual that comes with your Humalog prefilled pen and the
manufacturer's instructions that comes with your external
insulin pump.
Use Humalog exactly as prescribed by your healthcare provider.
•If you have type 1
diabetes, you need to take a longer-acting insulin in
addition to Humalog (except when using an external insulin pump).
•If you have type 2 diabetes, you may be taking diabetes pills and/or a
longer-acting insulin in addition to Humalog.
•Humalog starts working faster than other insulins that contain regular
human insulin.
Inject Humalog within fifteen minutes before eating or right
after eating a meal.
• Check your blood sugar levels as told by your healthcare provider.
• Look at your Humalog before using. Humalog should be clear, have no color
and look like water. If your Humalog is cloudy, thickened, even slightly colored,
or has solid particles or clumps in it, do not use. Return it to your pharmacy
for new Humalog.
• Humalog can be mixed with a longer-acting human insulin, but only if you are told
to do so by your healthcare provider. If you are mixing two types of insulin,
always draw Humalog into the syringe first. Talk with your healthcare provider
about how to properly mix Humalog with a different insulin.
•Humalog can be used in an external insulin pump either by withdrawing
Humalog from a vial or using a
3
mL Humalog cartridge that is inserted into
the pump.
• Humalog was tested with MiniMed®1 Models
506
,
507
, and
508
insulin pumps
using
MiniMed Polyfin®1 infusion sets. Humalog was also tested with the
Disetronic®2 H-TRONplus®2 V
100
insulin pump (with plastic
3.15
mL insulin
reservoir), using the Disetronic Rapid®2 infusion set.
•A Humalog cartridge used in the D-TRON2 or D-TRONplus2 pump, may be used
for up to
7
days. Humalog in the external insulin pump reservoir and the complete
infusion set should be replaced and a new infusion site selected every
48
hours
or less.
• Humalog in an external insulin pump should not be exposed to temperature
above
98
.
6
°F (
37
°C), such as in a sauna or hot tub,
hot showers, direct
sunlight, or radiant heaters.
•Inject your dose of Humalog under the skin of your stomach area, upper
arm, upper leg, or buttocks. Never inject Humalog into a muscle or vein.
• Change (rotate) your injection site with each dose.
• Your insulin needs may change because of:
•illness
• stress
• other medicines you take
• changes in eating
• physical activity changes
Follow your healthcare provider’s instructions to make changes in your insulin dose.
• Never dilute or mix Humalog with another insulin in the same prefilled pen,
cartridge or external insulin pump.
•Always carry a quick source of sugar to treat low blood sugar, such as
glucose tablets, hard candy, or juice.
What are the possible side effects of Humalog?
Low Blood Sugar (Hypoglycemia). Symptoms of low blood sugar include:
•hunger
• dizziness
•feeling shaky or shakiness
• lightheadedness
•sweating
• irritability
• headache
•fast heartbeat
•confusion
Low blood sugar symptoms can happen suddenly. Symptoms of low blood sugar
may be different for each person and may change from time to time. Severe low
blood sugar can cause seizures and death. Low blood sugar may affect your ability
to drive a car or use mechanical equipment, risking injury to yourself or others.
Know your symptoms of low blood sugar. Low blood sugar can be treated by
drinking juice or regular soda or eating glucose tablets, sugar, or hard candy.
Follow your healthcare provider's instructions for treating low blood sugar. Talk
to your healthcare provider if low blood sugar is a problem for you.
•Serious allergic reactions (whole body allergic reaction). Severe, life-threatening
allergic reactions can happen with insulin. Get medical help right away if you
develop a rash over your whole body, have trouble breathing, wheezing, a fast
heartbeat, or sweating.
•Reactions at the injection site (local allergic reaction). You may get redness,
swelling, and itching at the injection site.
If you keep having injection site
reactions or they are serious, you need to call your healthcare provider. Do not
inject insulin into a skin area that is red, swollen, or itchy.
• Skin thickens or pits at the injection site (lipodystrophy). This can happen if
ou don't change (rotate)your injection sites enough,
ese are not all the side effects from Humalog. Ask your healthcare provider or
pharmacist for more information.
•You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.FDA.gov/medwatch or call
1
-
800
-FDA-
1088
.
How should I store Humalog?
• Store all unopened (unused) Humalog in the original carton in a refrigerator
at
36
°F to
46
5F (
2
°C to 8°C). Do not freeze.
• Do not use Humalog that has been frozen.
• Do not use after the expiration date printed on the carton and label.
• Protect Humalog from extreme heat, cold or light.
After starting use (open):
•Vials: Keep in the refrigerator or at room temperature below 86°F (
30
°C) for
up to
28
days. Keep open vials away from direct heat or light. Throw away an
opened vial
28
days after first use, even if there is insulin left in the vial.
•Cartridge and Prefilled Pens: Do not store a cartridge or prefilled pen that
you are using in the refrigerator. Keep at room temperature below 86°F (
30
°C)
for up to
28
days. Throw away a cartridge or pretilled pen
28
days after first
use, even if there is insulin left in the cartridge or the pen.
General information about Humalog
Use Humalog only to treat your diabetes. Do not share it with anyone else, even
if they also have diabetes. It may harm them.
This leaflet summarized the most important information about Humalog. If you
would like more information about Humalog or diabetes, talk with your healthcare
rovider. You can ask your healthcare provider or pharmacist for information about
umalog that is written for health professionals.
For questions you
may call
1
-
800
-LillyRx (
1
-
800
-
545
-
5979
)
or visit
www.humalog.com.
What are the ingredients in Humalog?
Active ingredient: insulin lispro.
Inactive ingredients: glycerin, dibasic sodium phosphate, metacresol, zinc
oxide (zinc ion), trace amounts of phenol and water for injection.
1
MiniMed® and Polyfin® are registered trademarks of MiniMed. Inc.
2
Disetronic®, H-TRONplus®, D-TRON®, D-TRONplus and
Rapid® are registered
trademarks of Roche Diagnostics GMBH.
Humalog® and
Humalog® KwikPen"'
are registered trademarks of Eli
Lilly
and Company.
Patient Information revised September
2
.
2009
PV
5561
AMP
PRINTED IN USA
Humalog KwikPen manufactured by
Eli Lilly and Company, Indianapolis, IN
46285
, USA
Pens manufactured by
Eli Lilly and Company, Indianapolis, IN
46285
, USA or
Lilly France, F
-67640
Fegersheim, France
1 0
mL.Vials manufactured by
Eli Lilly and Company, Indianapolis, IN
46285
, USA or
Hospira, Inc., Lake Forest, IL
60045
, USA or
Lilly France, F
-67640
Fegersheim, France
3
mL Vials manufactured by
Eli Lilly and Company, Indianapolis, IN
46285
, US
Cartridges manufactured by
Lilly France, F
-67640
Fegersheim, France
for Eli Lilly and Company, Indianapolis, IN
46285
, USA
www.humalog.com
Copyright ©
2007,2009
Eli Lilly and Company. All rights reserved.
