Novo Nordisk Launches Tresiba® (insulin degludec injection 200 Units/mL) in the United States

Long-acting Tresiba® U-200 now available for adults living with diabetes

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Jan 26, 2016, 08:00 ET

PLAINSBORO, N.J., Jan. 26, 2016 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, today announced the availability of its newest insulin, Tresiba^® (insulin degludec injection), a once-daily, long-acting basal insulin, at pharmacies nationwide. Tresiba^®, approved by the U.S. Food and Drug Administration (FDA) in September 2015, is indicated to improve glycemic control in adults with diabetes.¹

Adults with diabetes who require insulin therapy often must plan their schedules to accommodate the need to take insulin at the same time every day. Tresiba^® is a long-acting insulin that is released over time, lasts at least 42 hours after eight once-daily injections and has a consistently flat and steady profile at steady state. Tresiba^® allows patients to dose at any time of day to accommodate their schedules. Patients who miss a dose of Tresiba^® should take their medication upon discovering the missed dose as long as at least eight hours have elapsed between consecutive Tresiba^® injections.¹

Tresiba^® is not recommended for the treatment of diabetic ketoacidosis and it is not known if Tresiba^® is safe and effective in children under 18 years of age.

"When developing new therapies, Novo Nordisk keeps patients' needs top of mind. With its long-acting blood glucose lowering effect, lasting for at least 42 hours, Tresiba^® is a shining example of that," said Camille Lee, senior vice president, Diabetes Marketing, Novo Nordisk Inc. "We're proud to offer this new treatment for adults living with diabetes and are excited to see the impact it may have on management of their blood sugar."

Eligible patients with commercial insurance can use the Tresiba^®Instant Savings Card to reduce co-pays to as low as $15 a month for up to 24 months. Novo Nordisk is working quickly to secure coverage for Tresiba^®on health plans nationwide and has already secured Lowest Brand Co-pay status on the national formulary for CVS Caremark.

For terms and conditions and any questions regarding eligibility or benefits, visit https://www.tresiba.com/instant-savings-card/eligibility.html or call 1-855-834-3466.

Tresiba^® (insulin degludec injection 200 Units/mL) will also be reimbursed at the Lowest Brand Co-pay on SilverScript, Humana^® Medicare Part D and Humana^® Medicare Advantage.

Tresiba^® is available in Novo Nordisk's newest insulin delivery device – FlexTouch^® – as a 100 units/mL or 200 units/mL pen. Tresiba^® U-200 FlexTouch^® can dose up to 160 units in a single injection, which will allow some people who are on more than 80 units of insulin per day to take fewer injections. Tresiba^® U-100 FlexTouch^® can deliver up to 80 units of insulin in a single injection. FlexTouch^® is also the only prefilled insulin pen with no push-button extension.¹

Important Safety Information

Do not share your Tresiba^® FlexTouch^® 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.

Who should not take Tresiba^®?

Do not take Tresiba^® if you:

are having an episode of low blood sugar
are allergic to Tresiba^® or any of the ingredients in Tresiba^®

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

pregnant, planning to become pregnant, or are breastfeeding
taking new prescription or over-the-counter medicines, vitamins, or herbal supplements

Talk to your health care provider about low blood sugar and how to manage it.
How should I take Tresiba^®?

Read the Instructions for Use and take Tresiba^® exactly as your health care provider tells you to
Do not do any conversion of your dose. The dose counter always shows the selected dose in units
Know the type and strength of insulin you take. Do not change the type of insulin you take unless your health care provider tells you to
If you miss or are delayed in taking your dose of Tresiba^®:
- Take your dose as soon as you remember, then continue with your regular dosing schedule
- Make sure there are at least 8 hours between doses
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 reuse or share your needles with other people. You may give them a serious infection, or get a serious infection from them
Never inject Tresiba^® (insulin degludec injection 200 Units/mL) into a vein or muscle
Never use a syringe to remove Tresiba^® from the FlexTouch^® pen

What should I avoid while taking Tresiba^®?

Do not drive or operate heavy machinery, until you know how Tresiba^® affects you
Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol

What are the possible side effects of Tresiba^®?

Tresiba^® may cause serious side effects that can be life-threatening, including:

Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include anxiety, irritability, mood changes, dizziness, sweating, confusion, and headache
Low potassium in your blood (hypokalemia)
Heart failure in some people if taken with thiazolidinediones (TZDs). This can happen even if you have never had heart failure or heart problems. If you already have heart failure, it may get worse while you take TZDs with Tresiba^®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet and sudden weight gain.

Your insulin dose may need to change because of change in level of physical activity or exercise, increased stress, change in diet, weight gain or loss, or illness.

Common side effects may include reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or pits at the injection site (lipodystrophy), weight gain, and swelling of your hands and feet.

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 click here for Prescribing Information.

For more information about Tresiba^®, please visit Media.Tresiba.com.

About Diabetes
In the United States, more than 29 million people are affected by diabetes.² Type 2 diabetes accounts for 90 to 95 percent of all diabetes cases.² Diabetes is emerging as one of the most serious health problems of our time; the number of Americans with diabetes has almost quadrupled over the past 30 years.³

About Novo Nordisk
Novo Nordisk is a global health care company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk-us.com or follow us on Twitter.

References

Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; September 2015.
Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2014. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Accessed January 19, 2016.
Centers for Disease Control and Prevention. Number (in Millions) of Civilian, Noninstitutionalized Adults with Diagnosed Diabetes, United States, 1980–2014. http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm. Accessed January 19, 2016.

FlexTouch^® and Tresiba^® are registered trademarks of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.

SOURCE Novo Nordisk