INDIANAPOLIS, May 27, 2015 /PRNewswire/ -- The U.S. Food
and Drug Administration (FDA) has approved Humalog® 200
units/mL KwikPen® (insulin lispro 200 units/mL;
U-200), a pre-filled 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, Eli Lilly and Company (NYSE: LLY) announced today.
Humalog U-200 KwikPen marks the first FDA approval of a
concentrated mealtime insulin analog.
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. This offers patients a pen that lasts
longer between pen changes, allowing for fewer changes every
month.* Humalog U-200 KwikPen delivers the same dose in half the
volume of Humalog U-100 KwikPen with no dose conversions required,
and can be dialed in one-unit increments to a maximum of 60 units
per injection.
"Diabetes is a progressive disease that often requires increased
doses of insulin over time to better control a patient's blood
sugar levels," said David Kendall,
M.D., vice president, Medical Affairs, Lilly Diabetes. "Humalog
U-200 KwikPen represents a new option for people with diabetes.
Fewer pen changes per month may help people who require higher
daily doses of mealtime insulin better fit their treatment in their
daily lives."
Approval was based on a demonstration of the bioequivalence of
Humalog 200 units/mL relative to Humalog 100 units/mL in a
pharmacokinetic/pharmacodynamic study. The most common side effect
of Humalog is hypoglycemia (low blood sugar) that may be severe and
cause unconsciousness, seizures and death. See the Important
Safety Information at the end of this press release, Prescribing
Information, and Patient Information.
"We are proud to advance our commitment to supporting people
with diabetes," said Mike Mason,
vice president, U.S., Lilly Diabetes. "Humalog U-200 KwikPen is an
example of our work to improve the patient experience. This product
is the newest addition to Lilly's growing portfolio of diabetes
treatment options for people in the
United States."
The U.S. approval follows the approval of Humalog 200 units/ml
KwikPen in the European Union on October 3,
2014.
*Once opened, Humalog prefilled pens should be thrown away after
28 days, even if insulin remains.
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
CONTRAINDICATIONS
- Humalog is contraindicated during episodes of hypoglycemia and
in patients who are hypersensitive to Humalog or any of its
excipients.
WARNINGS AND PRECAUTIONS
- Never Share a Humalog KwikPen, Cartridge, Reusable Pen
Compatible with Lilly 3 mL Cartridges, or Syringe Between
Patients: Humalog KwikPens, cartridges, and reusable pens
compatible with Lilly 3 mL cartridges must never be shared between
patients, even if the needle is changed. Patients using Humalog
vials must never share needles or syringes with another person.
Sharing poses a risk for transmission of blood-borne pathogens.
- Changes in Insulin Regimen: Changes may
affect glycemic control and predispose to hypoglycemia or
hyperglycemia. These changes should be made cautiously under close
medical supervision and the frequency of blood glucose monitoring
should be increased.
- Hypoglycemia: Severe hypoglycemia may be life
threatening and can cause seizures or death. Hypoglycemia is the
most common adverse reaction of Humalog. The patient's ability to
concentrate and react may be impaired as a result of hypoglycemia.
Hypoglycemia can happen suddenly and symptoms may vary for each
person and may change over time. Early warning symptoms of
hypoglycemia may be different or less pronounced under conditions
such as long-standing diabetes, diabetic nerve disease, use of
medications such as beta-blockers, or in patients who experience
recurrent hypoglycemia. These situations may result in severe
hypoglycemia and possibly loss of consciousness prior to the
patient's awareness of hypoglycemia.
Timing of hypoglycemia usually reflects the time-action profile of
administered insulins which may vary in different individuals or at
different times in the same individual. Other factors such as
changes in food intake, injection site, exercise, and concomitant
medications may increase the risk of hypoglycemia.
Educate patients to recognize and manage hypoglycemia. In
patients at higher risk for hypoglycemia and patients with reduced
symptomatic awareness, increased frequency of blood glucose
monitoring is recommended. Patients with renal or hepatic
impairment may be at higher risk of hypoglycemia.
- Hypoglycemia Due to Medication Errors: Instruct
patients to always check the insulin label before each injection to
avoid medication errors.
Humalog U-200 should not be transferred from the Humalog KwikPen to
a syringe as overdose and severe hypoglycemia can occur.
- Hypersensitivity Reactions:
Severe, life-threatening, generalized allergy, including
anaphylaxis, can occur with Humalog. If hypersensitivity reactions
occur, discontinue Humalog and treat per standard of care until
signs and symptoms resolve.
- Hypokalemia: Hypokalemia may be life threatening.
Insulins, including Humalog, cause a shift in potassium from the
extracellular to intracellular space possibly leading to
hypokalemia, which, if untreated, may result in respiratory
paralysis, ventricular arrhythmia, and death. Monitor potassium
levels in patients at risk for hypokalemia (eg, patients using
potassium-lowering medications or medications sensitive to serum
potassium concentrations).
- Fluid Retention and Heart Failure with Concomitant Use of
PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are
PPAR-gamma agonists, can cause dose-related fluid retention,
particularly when used in combination with insulin, including
Humalog. This may lead to or exacerbate heart failure. Observe
patients for signs and symptoms of heart failure and consider
discontinuation or dose reduction of the PPAR-gamma agonist.
- Hyperglycemia and Ketoacidosis Due to Insulin Pump Device
Malfunction: Malfunction of the insulin pump device, infusion
set, or insulin degradation can rapidly lead to hyperglycemia and
ketoacidosis. Patients using subcutaneous insulin infusion pumps
must be trained to administer insulin by injection and have
alternate insulin therapy available in case of pump failure.
DRUG INTERACTIONS: Some medications may alter glucose
metabolism, insulin requirements, and the risk for hypoglycemia or
hyperglycemia. Signs of hypoglycemia may be reduced or absent in
patients taking anti-adrenergic drugs. Particularly close
monitoring may be required.
ADVERSE REACTIONS: Adverse reactions associated with
Humalog include hypoglycemia, hypokalemia, allergic reactions,
injection-site reactions, lipodystrophy, pruritus, rash, weight
gain, and peripheral edema.
USE IN SPECIFIC POPULATIONS: Humalog has not been studied
in children with type 1 diabetes less than 3 years of age or in
children with type 2 diabetes.
DOSAGE AND ADMINISTRATION
- Humalog should be given within 15 minutes before or immediately
after a meal.
- Humalog U‑100 can be administered intravenously under medical
supervision with close monitoring of blood glucose and potassium
levels to avoid hypoglycemia and hypokalemia. Do NOT administer
Humalog U-200 intravenously.
- Humalog U-100 for subcutaneous injection should only be mixed
with NPH insulin. If Humalog U-100 is mixed with NPH insulin,
Humalog should be drawn into the syringe first. Injection should
occur immediately after mixing. Do NOT mix Humalog U-200 in a
syringe with any other insulin.
- Humalog U-100 should not be diluted or mixed when used in an
external insulin pump. Change Humalog U-100 in the reservoir at
least every 7 days. Change the infusion set and insertion site at
least every 3 days. Do NOT use Humalog U-200 in a subcutaneous
insulin infusion pump.
- Do NOT perform dose conversion when using either the Humalog
U-100 or Humalog U-200 KwikPens. The dose window shows the number
of insulin units to be delivered and no conversion is needed.
Please click to access Full Prescribing Information and Patient
Information.
Please see Instructions for Use included with the pen.
HI U200 HCP 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.
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.
|
LD96350 05/2015 ©Lilly USA, LLC
2015. All rights reserved.
P-LLY
Refer to: +1 (317) 627-4056; williamsju@lilly.com;
Julie Williams
Logo -
http://photos.prnewswire.com/prnh/20150526/218405LOGO
Logo - http://photos.prnewswire.com/prnh/20031219/LLYLOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/us-food-and-drug-administration-approves-humalog-200-unitsml-kwikpen-300089341.html
SOURCE Eli Lilly and Company