Novo Nordisk Announces U.S. Launch of New Insulin Device Levemir® FlexTouch®

PLAINSBORO, N.J., June 19, 2014 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, today announced the availability of its newest prefilled insulin delivery device Levemir^® FlexTouch^® (insulin detemir [rDNA origin] injection) in the United States. This device represents an advancement in insulin delivery and is based on years of feedback from endocrinologists, certified diabetes educators, primary care physicians and other health care professionals, providing a new way patients with diabetes can administer their insulin.

To view the multimedia assets associated with this release, please click: http://www.multivu.com/players/English/7254251-novo-nordisk-launches-new-diabetes-insulin-device-levemir-flextouch

When a dose is dialed with traditional prefilled insulin pens, the push button extends, and at larger doses this may present delivery challenges for the patient. Levemir^® FlexTouch^® is the first and only prefilled insulin delivery device with no push-button extension.  Due to the unique dosing mechanism of FlexTouch^®, the push button does not extend at any dose and allows insulin to be administered by pressing the low injection force button.

"The features of FlexTouch^® were designed to help patients administer their insulin," said Michael Shannon, MD, Chair of Endocrinology and Diabetes Clinical Advancement, Providence Health and Services. "The reduced reach and low injection force button are both advancements in improving the insulin delivery experience."

FlexTouch^® is the latest insulin delivery system to be offered by Novo Nordisk and was approved by the Food and Drug Administration (FDA) in November 2013 and the European Medicines Agency (EMA) in July 2011. The device has also launched in several countries, including the United Kingdom, Canada, Denmark, and Japan.

"At Novo Nordisk, we are committed to developing devices to help the more than 29 million people with diabetes in the United States," said Camille Lee, senior vice president, Diabetes Marketing, Novo Nordisk, Inc. "Levemir^® FlexTouch^® was designed to address the needs of these individuals, providing patients and their health care professionals with a new tool to help improve the way they manage their diabetes."

Levemir^® FlexTouch^® is available on more than 96% of Commercial and Medicare Part D plans nationwide, including exclusive Tier 1 status on UnitedHealthcare and preferred status on Coventry. For more information on Novo Nordisk products, visit www.novonordisk-us.com.

About Levemir^® FlexTouch^®

Levemir^® FlexTouch^® is a prefilled insulin pen containing 300 units of insulin detemir. The pen doses in 1-unit increments, from 1 to 80 units and is compatible with both NovoFine^® and the latest NovoTwist^® needles.

An audible and tactile "click" confirms attachment of the needle.

Needles are sold separately and may require a prescription in some states.                                          

What is Levemir^® (insulin detemir [rDNA origin] injection)?

• Levemir^® is a man-made long-acting insulin used to control high blood sugar in adults and children with diabetes mellitus.
• Levemir^® is not meant for use to treat diabetic ketoacidosis.

Important Safety Information

Who should not take Levemir^®?
Do not take Levemir^® if:

• you have an allergy to Levemir^® or any of the ingredients in Levemir^®.

Before taking Levemir^®, tell your health care provider about all your medical conditions including, if you are:

• pregnant, plan to become pregnant, or are breastfeeding.
• taking new prescription or over-the-counter medicines, including supplements.

Talk to your health care provider about how to manage low blood sugar.

How should I take Levemir^®?

• Read the Instructions for Use and take exactly as directed.
• Know the type and strength of your insulin. Do not change your insulin type unless your health care provider tells you to.
• Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them.
• Do not share needles, insulin pens, or syringes. You may give or get an infection from another person.
• Never inject Levemir^® into a vein or muscle.

What should I avoid while taking Levemir^®?

• Do not drive or operate heavy machinery, until you know how it affects you.
• Do not drink alcohol or use medicines that contain alcohol.

What are the possible side effects of Levemir^®?
Serious side effects can lead to death, including:
Low blood sugar. Some signs and symptoms include:

• anxiety, irritability, mood changes, dizziness, sweating, confusion, and headache.

Your insulin dose may need to change because of:

• change in level of physical activity, weight gain or loss, increased stress, illness, or change in diet.

Other common side effects may include:

• reactions at the injection site, serious allergic reactions (whole body reactions) skin thickening or pits at the injection site (lipodystrophy), weight gain, swelling of your hands and feet and if taken with thiazolidinediones (TZDs) possible heart failure.

Get emergency medical help if you have:

• trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.

Please visit levemir.com for Prescribing Information.

About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately 40,000 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk-us.com or follow our news in the U.S. on Twitter: @NovoNordiskUS.

About Diabetes
In the United States, 29.1 million people have diabetes,^[1] a condition in which the body does not produce enough or properly use insulin, the hormone needed to convert sugar, starches and other food into energy needed for daily life.

FlexTouch^®, Levemir^®, NovoFine^®, and NovoTwist^® are registered trademarks of Novo Nordisk A/S.

© 2014 Novo Nordisk   All rights reserved.   0414-00021166-1 June 2014  

To view the multimedia assets associated with this release, please click: http://www.multivu.com/players/English/7254251-novo-nordisk-launches-new-diabetes-insulin-device-levemir-flextouch

SOURCE Novo Nordisk