INDIANAPOLIS, Oct. 4, 2017 /PRNewswire/ -- Humalog®
Junior KwikPen® [insulin lispro injection 100 units/mL]
is now available by prescription for the treatment of diabetes in
the U.S. This innovation is the latest in the treatment and
delivery options Eli Lilly and Company (NYSE: LLY) offers for
people with type 1 or type 2 diabetes. Humalog Junior KwikPen is
the only prefilled, disposable half-unit insulin pen.
In June 2017, the U.S. Food and
Drug Administration (FDA) approved Humalog Junior KwikPen for the
treatment of diabetes. In September
2017, the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) issued a positive
opinion for Humalog Junior KwikPen in the European Union and is
pending final approval, expected later this year.
"Learning how to inject insulin can be overwhelming, especially
for newly diagnosed children and their caregivers. People often
feel shock and anxiety, and may struggle with the reality of
fitting diabetes into daily life," said Sherry Martin, M.D., vice president, Global
Medical Affairs, Lilly Diabetes. "We hope to help take away some of
the worries about the injection process with Humalog Junior
KwikPen. Because it is prefilled, there are fewer steps for people
to learn, and the half-unit increments make dosing more
precise."
Humalog Junior KwikPen, which is lighter and shorter than other
half-unit insulin pens, provides an option for people who prefer a
prefilled pen and need the precision of half-unit dosing, such as
those with insulin sensitivity and some older adults for whom
rounding to the nearest whole-unit dose is not adequate.
Until now, the only way to deliver half units of insulin with a
pen was through a reusable pen, which requires users to remove and
load cartridges. Humalog Junior KwikPen offers fine-tuned dosing in
a convenient prefilled disposable pen.
Humalog Junior KwikPen enables finer dose adjustment (0.5 vs 1
unit dose increments) for people who take relatively small doses
(≤30 units at mealtimes) of Humalog® U-100 (insulin
lispro injection 100 units/mL). The design of Humalog KwikPen meets
or exceeds the requirements and standards for needle-based
injections set by the International Organization for
Standardization.
For more information about Humalog Junior KwikPen, the support
resources, please visit www.Humalog.com.
Important Safety Information for Humalog
What is the most important information I should know about
Humalog?
- Do not share your Humalog Junior 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.
- 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.
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.
- 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.
- 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 see accompanying Full Prescribing Information
and Patient Prescribing Information.
Please see Instructions for Use included with the Humalog
Junior KwikPen.
HI J KP CON ISI 17JUNE2017
About Diabetes
Approximately 29 million
Americans1 and an estimated 415 million people worldwide
have type 1 and type 2 diabetes.2 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 does not either properly produce or use the
hormone insulin.
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 wide range
of therapies 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 or follow
us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.
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
www.lilly.com/newsroom/social-channels.
P-LLY
Humalog,®
Humalog® KwikPen® and
Humalog® Junior KwikPen® are registered
trademarks of Eli Lilly and Company, its subsidiaries, or
affiliates, and are available by prescription only.
This press release contains forward-looking statements (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about Humalog Junior KwikPen and Lilly's current
beliefs. However, as with any pharmaceutical product, there are
substantial risks and uncertainties in the process of development
and commercialization. Among other things, there can be no
guarantee that future study results will be consistent with study
findings to date, that Humalog Junior KwikPen will receive
additional regulatory approvals or that Humalog Junior KwikPen will
prove to be commercially successful. For further discussion of
these and other risks and uncertainties, see Lilly's most recent
Form 10-K and Form 10-Q filings with the United States Securities
and Exchange Commission. Except as required by law, Lilly
undertakes no duty to update forward-looking statements to reflect
events after the date of this release.
PP-HI-US-1019 10/2017 Lilly USA, LLC 2017. All rights reserved.
References
- Centers for Disease Control and Prevention. National Diabetes
Statistics Report, 2014. Available at:
http://www.thefdha.org/pdf/diabetes.pdf. October 2014.
- International Diabetes Federation. IDF Diabetes Atlas, 7th edn.
Brussels, Belgium: International
Diabetes Federation, 2015. http://www.idf.org/diabetesatlas.
Refer to: Julie Williams,
williamsju@lilly.com, (317) 627-4056
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SOURCE Eli Lilly and Company