FDA Approves Updates to Lilly’s Humalog (insulin lispro injection [rDNA origin]) Label

INDIANAPOLIS, June 8, 2011 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY)
today announced that the U.S. Food and Drug Administration (FDA) approved the
company’s supplemental new drug application (sNDA) with the following updates to
the Humalog label:

– continuous insulin infusion pump therapy in children 4 years of age and
over with type 1 diabetes
– extension of the time-in-use in the external pump reservoir to a maximum
of seven days; and
– extension of the time-in-use of the infusion set and of the infusion set
subcutaneous insertion site to a maximum of three days.
Based on the updated label, people with type 1 diabetes using Humalog for pump
therapy can use the insulin in the pump reservoir for up to seven days and
should change the infusion set and infusion set insertion site at least every
three days. The previous label indicated that Humalog in the external insulin
pump reservoir should be replaced and a new infusion site selected every 48
hours or less.

Humalog, which contains 100 units per mL, is used to treat people with diabetes
for the control of high blood sugar. Humalog should not be taken by someone with
low blood sugar (hypoglycemia) or by someone who is allergic to insulin lispro
or any of the ingredients in Humalog. Humalog is recommended for use in pump
systems indicated for continuous delivery of fast-acting insulin. All people
treated with insulin should closely monitor their blood glucose and make changes
to their insulin regimen cautiously and only under medical supervision. See
Important Safety Information below, and additional information about Humalog is
available at www.humalog.com.

Insulin pumps deliver insulin 24 hours a day through a catheter placed under the
skin. Rapid-acting insulin is delivered continuously to help keep blood glucose
levels in a specified range between meals, after meals and overnight.

“Insulin pumps can be an additional option for people using rapid-acting insulin
and allow people to manage their type 1 diabetes around their lifestyle,” said
Dana Hardin, MD, a pediatric endocrinologist and clinical research physician at
Lilly. “These Humalog label updates reflect Lilly Diabetes’ commitment to
providing people with personalized solutions that meet their everyday needs.”

In coordination with these label updates, the package insert for Humalog also
was updated in accordance with the Physician’s Labeling Rule (PLR) format.

Important Safety Information for Humalog

What is the most important information I should know about Humalog®?

– Do not change the insulin you use without talking to your healthcare
provider.Any change in insulin strength, manufacturer, or type may need
a change in the dose you are using. Doses of oral antidiabetic medicines
may also need to change if your insulin is changed.
– You must test your blood sugar levels while using an insulin such as
Humalog.Your healthcare provider will tell you how often you should test
your blood sugar level.
– When used in a pump, do not mix Humalog with any other insulin or
liquid.
Who should not takeHumalog?

Do not take Humalog if:

– your blood sugar is too low (hypoglycemia).
– you are allergic to insulin lispro or any of the ingredients in Humalog.
What should I tell my healthcare providers before using Humalog?

Tell all of your healthcare providers:

– about all of your medical conditions, including liver or kidney
problems.
– if you are pregnant or breastfeeding. Humaloghas not been studied in
pregnant or nursing women.
– about all the medicines you take,including prescription and
non-prescription medicines, vitamins, and herbal supplements. Your
Humalog dose may need to change if you take other medicines because they
may:
o change your risk for low blood sugar (hypoglycemia) or high blood
sugar (hyperglycemia).
o keep you from having symptoms when your blood sugar is low.
How should I use Humalog?

– Humalogcan be used with a syringe, prefilled pen, reusable pen, or
external insulin pump. Read the instructions for use that come with your
Humalog product.Your healthcare provider should show you how to inject
Humalogbefore you start taking it.
– Humalog is a rapid-acting insulin. You should take Humalogwithin fifteen
minutes before eating or right after eating a meal.
– Only use Humalogthat is clear and colorless. If your Humalog is cloudy,
colored, or has solid particles or clumps in it, return it to your
pharmacy for a replacement.
– Do not mix Humalog with any type of insulin other than NPH when used
with injections by syringe or with any other insulin or liquid when used
in a pump.
– If your doctor recommends diluting Humalog(that is, a smaller number of
units of Humalogfor a certain amount of liquid), follow your doctor’s
instructions exactly. Do not use diluted insulin in a pump.
– Inject Humalog under your skin (subcutaneously)in your upper arm,
abdomen (stomach area), thigh (upper leg), or buttocks. Never inject it
into a vein or muscle. Change (rotate) your injection sitewith each
dose.
– 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 oral antidiabetic
medicines and/or a longer-acting insulin in addition to Humalog.
– Always make sure that you received the correct type of Humalogfrom the
pharmacy and make sure you inject the correct insulin and dose.
– If you take too much Humalog, your blood sugar may fall low
(hypoglycemia).You can treat mild low blood sugar by drinking or eating
a quick source of sugar right away. It is important to treat low blood
sugar right away because it could get worse and you could pass out
(become unconscious). If you pass out, you will need help from another
person or emergency medical services right away, and will need treatment
with glucagon injection or treatment at a hospital.
– If you forget to take your dose of Humalog, your blood sugar may go too
high (hyperglycemia).If high blood sugar is not treated it can lead to
serious problems, like loss of consciousness (passing out), coma, or
even death. Follow your healthcare provider’s instructions for treating
high blood sugar. Know your symptoms of high blood sugar, which may
include increased thirst, frequent urination, drowsiness, loss of
appetite, a hard time breathing, fruity smell on the breath, high
amounts of sugar and ketones in your urine, nausea, vomiting (throwing
up), or stomach pain, or other symptoms.
– Your insulin dosage may need to change because ofillness, stress, other
medicines you take, change in diet, or change in physical activity or
exercise.
What are the possible side effects of Humalog?

– Low blood sugar (hypoglycemia).Symptoms of low blood sugar may include
sweating, dizziness or lightheadedness, shakiness, hunger, fast
heartbeat, tingling of lips and tongue, trouble concentrating or
confusion, blurred vision, slurred speech, anxiety, irritability or mood
changes, and headache.
– Severe low blood sugar can cause unconsciousness (passing out),
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. Follow your healthcare provider’s
instructions for treating low blood sugar. Talk to your healthcare
providers if low blood sugar is a problem for you.
– Serious allergic reactions (whole body reaction).Get medical help right
away if you develop a rash over your whole body, have trouble breathing,
have a fast heartbeat, or are sweating.
– Reactions at the injection site (local allergic reaction). You may get
redness, swelling, and itching at the injection site. If you keep having
skin reactions or if they are serious, talk to 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).Do not
inject insulin into skin with these types of changes.
– Other side effects of Humalog include swelling of your hands and feet,
low potassium in your blood (hypokalemia), and weight gain.
– These are not all of the possible side effects from Humalog. Ask your
healthcare providers for more information or for medical advice about
side effects.

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 degrees F to 46 degrees F (2 degrees C to 8 degrees
C).Do not freeze. Do not use Humalog if it has been frozen. Keep
unopened Humalog in the carton to protect it from light.
– After starting use (open):
o Vials:Keep in the refrigerator or at room temperature below 86 degrees
F (30 degrees C) for up to 28 days. Keep vials away from direct heat
or light. Throw away an opened vial after 28 days of use, even if
there is insulin left in the vial. Unopened vials can be used until
the expiration date on the Humalog carton and label, if the medicine
has been stored in a refrigerator.
o Cartridge and Prefilled Pens:Keep at room temperature below 86 degrees
F (30 degrees C) for up to 28 days. Do not store a cartridge or
prefilled pen that you are using in the refrigerator. Keep cartridges
and prefilled pens away from direct heat or light. A cartridge used in
the D-Tron®(1) or D-Tronplus®(1) pump may be used for up to 7 days.
Throw away a used cartridge or prefilled pen after 28 days, even if
there is insulin left in the cartridge or the pen.
What is some general information about the use of Humalog in a pump?

– Humalog in the pump reservoir and the complete external pump infusion
set:
o The infusion set and infusion site should be changed at least every 3
days or changed more oftenif you have high blood sugar
(hyperglycemia), the pump alarms sounds, or the insulin flow is
blocked (occlusion).
o The insulin in the reservoir should be changed at least every 7
dayseven if you have not used all of the insulin.
Humalog is available by prescription only.

For more information about Humalog, please see the Full Prescribing Information
(http://pi.lilly.com/us/humalog-pen-pi.pdf) and Patient Prescribing Information
(http://pi.lilly.com/us/humalog-pen-ppi.pdf).

Please see full user manual that accompanies the pen.

(1) D-Tron® and D-Tronplus® are registered trademarks of Roche Diagnostics GmbH.

HI CON ISI 24MAY2011

About Eli Lilly and Company

Lilly, a leading, innovation-driven corporation, is developing a growing
portfolio of pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides
answers–through medicines and information–for some of the world’s most urgent
medical needs. Additional information about Lilly is available at www.lilly.com.

About Lilly Diabetes

For more than 85 years, Lilly has been a worldwide leader in pioneering
industry-leading solutions to support people living with and treating diabetes.
Lilly introduced the world’s first commercial insulin in 1923 and remains at the
forefront of medical and delivery device innovation to manage diabetes. Lilly is
also committed to providing solutions beyond therapy -practical tools,
education, and support programs to help overcome barriers to success along the
diabetes journey. At Lilly, the journeys of each person living with or treating
diabetes inspire ours.

Humalog® is a registered trademark of Eli Lilly and Company and is available by
prescription only.

P-LLY

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

SOURCE Eli Lilly and Company