INDIANAPOLIS, Aug. 18, 2015 /PRNewswire/
-- Humalog® 200 units/mL KwikPen®
(insulin lispro 200 units/mL; U-200), the first and only
concentrated mealtime insulin analog in the U.S., is now available
in pharmacies, Eli Lilly and Company (NYSE: LLY) announced today.
Humalog U-200 KwikPen is a prefilled pen containing a concentrated
formulation of Lilly's rapid-acting insulin Humalog®
(insulin lispro 100 units/mL) to improve glycemic control in
people with type 1 and type 2 diabetes. It is intended for people
who are already taking mealtime insulin.
Humalog U-200 KwikPen holds twice as many units of insulin (600
units vs. 300 units) as the U-100 formulation in the same
three-milliliter cartridge volume, offering patients a pen that
lasts longer, which facilitates fewer pen changes every month. This
may help patients who require higher daily doses of mealtime
insulin fit their treatment into their lives.
"This is an important new option for many people with diabetes,"
said David Kendall, M.D., vice
president, Medical Affairs, Lilly Diabetes. "Like everyone else,
people with diabetes have busy lives. More rapid-acting insulin in
a single pen may help patients worry less about running out when
their plans change unexpectedly."
"For nearly 20 years, the Humalog brand has offered people who
require mealtime insulin an array of options to meet their needs,"
Kendall said. "Lilly is pleased to offer another choice to help
people with diabetes improve their glycemic control."
The most common side effect of Humalog is hypoglycemia (low
blood sugar) that may be severe and cause unconsciousness, seizures
and death. Humalog U-200 KwikPen delivers the same dose in half the
volume of U-100 mealtime insulin pens, with no dose conversions
required, and can be dialed in one-unit increments to a maximum of
60 units per injection.
As with other mealtime insulin pens, Humalog U-200 KwikPen must
be used within 28 days after initial use, even if insulin remains.
Unused pens should be stored in the refrigerator, but once a pen
has been used for the first time, it should be kept at room
temperature.
For more information on Humalog U-200 KwikPen, visit
http://Humalog.com/u200.
Indication: HUMALOG is a rapid-acting human insulin
analog indicated to improve glycemic control in adults and children
with diabetes mellitus.
Important Safety Information for Humalog 100 units/mL and
Humalog 200 units/mL KwikPen
What is the most important information I should know about
Humalog?
- Do not share your Humalog KwikPen, cartridges, reusable pen
compatible with Lilly 3 mL cartridges, or syringes 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.
- Humalog 200 units/mL KwikPen contains 2 times as much insulin
(200 U/mL) in 1 mL as standard insulin (100 U/mL).
- The Humalog contained in the Humalog U-200 KwikPen should ONLY
be injected with the Humalog U-200 KwikPen. Do not withdraw Humalog
U-200 from the pen using a syringe. It could result in an overdose
causing severe low blood sugar which may put your life in
danger.
- Do not change the insulin you use without talking to your
healthcare provider. Changes may make you more likely to experience
low or high blood sugar. Changes should be made cautiously under
the supervision of your healthcare provider.
- Test your blood sugar levels as your healthcare provider
instructs.
- Your insulin dose may need to change because of illness,
stress, other medicines you take, change in diet, or change in
physical activity or exercise.
- When used in a pump, do not mix or dilute Humalog U-100 with
any other insulin or liquid. Do not use Humalog U-200 in an insulin
pump.
Who should not take Humalog?
- Do not take Humalog if your blood sugar is too low
(hypoglycemia) or if you are allergic to insulin lispro or any of
the ingredients in Humalog.
Before using Humalog, what should I tell my healthcare
providers?
- About all of your medical conditions, including liver, kidney,
or heart failure or other heart problems.
- If you are pregnant, planning to become pregnant, or are
breastfeeding.
- About all the medicines you take, including prescription
(especially ones commonly called TZDs [thiazolidinediones]) and
nonprescription medicines, vitamins, and herbal supplements.
How should I use Humalog?
- Humalog is a rapid-acting insulin. Take Humalog within fifteen
minutes before eating or right after eating a meal.
- Always make sure you receive the correct type of Humalog from
the pharmacy.
- Do not use Humalog if it is cloudy, colored, or has solid
particles or clumps in it.
- Do not mix Humalog U-200 with any other insulin.
- Inject Humalog under your skin (subcutaneously). Never inject
into a vein or muscle. Change (rotate) your injection site with
each dose. Make sure you inject the correct insulin and dose.
- Do not re-use needles. Always use a new needle for each
injection. Re-use of needles can cause you to receive the wrong
dose of Humalog and result in infection.
- Do not drive or operate heavy machinery until you know how
Humalog affects you. Do not use alcohol while using Humalog.
What are the possible side effects of Humalog?
- Severe low blood sugar can cause unconsciousness (passing out),
seizures, and death. Low blood sugar is the most common side
effect. There are many causes of low blood sugar, including taking
too much Humalog. It is important to treat it quickly. You can
treat mild to moderate low blood sugar by drinking or eating a
quick source of sugar right away. Symptoms may be different for
each person. Be sure to talk to your healthcare provider about low
blood sugar symptoms and treatment.
- Severe life-threatening allergic reactions (whole-body
reactions) can happen. Get medical help right away if you develop a
rash over your whole body, have trouble breathing, have a fast
heartbeat, or are sweating.
- Humalog can cause life-threatening low potassium in your blood
(hypokalemia), which can cause severe breathing problems, irregular
heartbeat, and death.
- Serious side effects can include swelling of your hands and
feet and heart failure when taking certain pills called
thiazolidinediones or "TZDs" with Humalog. This may occur in some
people even if they have not had heart problems before. Tell your
healthcare provider if you have shortness of breath, swelling of
your ankles or feet, or sudden weight gain, which may be symptoms
of heart failure. Your healthcare provider may need to adjust or
stop your treatment with TZDs or Humalog.
- Failure of your insulin pump or infusion set or degradation of
the insulin in the pump can cause hyperglycemia and ketoacidosis.
Always carry an alternate form of insulin administration in case of
pump failure. The most common side effects of Humalog include low
blood sugar, allergic reactions, including reactions at your
injection site, skin thickening or pits at the injection site
(lipodystrophy), itching, and rash. These are not all of the
possible side effects. Ask your healthcare provider 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.
Humalog is available by prescription only.
For additional information, talk to your healthcare providers
and please click to access Full Prescribing Information
and Patient Prescribing Information.
Please see Instructions for Use included with the
pen.
HI U200 CON ISI 26MAY2015
About Diabetes
Approximately 29 million Americans have
type 1 and type 2 diabetes.1 Type 2 diabetes is the most
common type, accounting for an estimated 90 to 95 percent of all
diabetes cases.1 Diabetes is a chronic disease that
occurs when the body either does not properly produce or use the
hormone insulin.1
About Lilly Diabetes
Lilly has been a global leader in
diabetes care since 1923, when we introduced the world's first
commercial insulin. Today we are building upon this heritage by
working to meet the diverse needs of people with diabetes and those
who care for them. Through research and collaboration, a broad and
growing product portfolio and a continued determination to provide
real solutions—from medicines to support programs and more—we
strive to make life better for all those affected by diabetes
around the world. For more information, visit www.lillydiabetes.com
and follow @LillyDiabetes on Twitter.
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to make life
better for people around the world. We were founded more than a
century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover
and bring life-changing medicines to those who need them, improve
the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at www.lilly.com and
newsroom.lilly.com/social-channels.
P-LLY
This press release contains forward-looking statements about
Humalog 200 units/mL KwikPen for use in the treatment of diabetes.
It reflects Lilly's current beliefs; however, as with any such
undertaking, there are substantial risks and uncertainties in the
process of drug development and commercialization. There is no
guarantee that future study results and patient experience will be
consistent with study findings to date or that Humalog 200 units/mL
KwikPen will be commercially successful. For further discussion of
these and other risks and uncertainties, please see Lilly's latest
Forms 10-Q and 10-K filed with the U.S. Securities and Exchange
Commission. Lilly undertakes no duty to update forward-looking
statements.
1 Centers for Disease Control and Prevention.
National Diabetes Statistics Report: Estimates of Diabetes and
Its Burden in the United
States, 2014. Atlanta,
GA: U.S. Department of Health and Human Services; 2014.
HI97227 06/2015 ® Lilly USA,
LLC 2015. All rights reserved.
Refer to: Julie Williams;
williamsju@lilly.com; +1-317-627-4056
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