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Novo Nordisk Announces U.S. Launch of NovoTwist® for Use with Levemir® FlexPen®, NovoLog® FlexPen® and Victoza® Pen Devices

April 21, 2011

PRINCETON, N.J., April 21, 2011 /PRNewswire/ — Today, Novo Nordisk announced the launch of the NovoTwist® needle in the United States. The NovoTwist® needle, which is now available for use with several Novo Nordisk pre-filled delivery devices, including Levemir® (insulin detemir [rDNA origin] injection) FlexPen®, NovoLog® (insulin aspart [rDNA origin] injection) FlexPen®, Victoza® (liraglutide [rDNA origin] injection) Pen and other Novo Nordisk pens, is the first single-twist needle cleared for use in the United States.

To view the multimedia assets associated with this release, please click: http://multivu.prnewswire.com/mnr/novonordisk/49814/

The NovoTwist® needle has a unique fitting that allows users to ‘just twist’ when attaching the needle with compatible Novo Nordisk pens. An audible and tactile ‘click’ confirms attachment of the needle and this can be less time consuming for patients. NovoTwist® comes in 32G Tip (5mm) and 30G (8mm) versions.

“We’re excited that the NovoTwist® needle is now available in the U.S. and glad that patients here can benefit from the needle’s simplistic and user-friendly design,” said Camille Lee, Vice President, Diabetes Marketing, Novo Nordisk Inc.

Earlier this year, Novo Nordisk announced that the company was awarded the 2010 GOOD DESIGN(TM) Award for NovoTwist®. The GOOD DESIGN(TM) Award is judged based on design innovation beyond what is considered ordinary, and on whether a product can enrich society and people’s lives. Founded in 1950, the GOOD DESIGN(TM) Award is among the most coveted awards for design and innovation.

NovoTwist® is also available in South Africa, Italy, Turkey and Thailand and is slated for launch in the United Kingdom later this year.

NovoTwist® needles are sold separately and may require a prescription in some states.

For more information on Novo Nordisk products, please visit: www.novonordisk-us.com.

FlexPen®, Levemir®, NovoLog®, NovoTwist® and Victoza® are registered trademarks of Novo Nordisk A/S.

About Novo Nordisk

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 87 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit www.novonordisk-us.com.

About Diabetes

In the United States, 25.8 million people, have diabetes(i), 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.

Victoza® Indications and Usage:

Victoza® (liraglutide [rDNA origin] injection) is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes when used along with diet and exercise.

Victoza® is not recommended as the first medication to treat diabetes. Victoza® is not insulin and has not been studied in combination with insulin. Victoza® is not for people with type 1 diabetes or people with diabetic ketoacidosis. It is not known if Victoza® is safe and effective in children. Victoza® is not recommended for use in children.

Important Safety Information:

In animal studies, Victoza® caused thyroid tumors–including thyroid cancer–in some rats and mice. It is not known whether Victoza® causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people which may be fatal if not detected and treated early. Do not use Victoza® if you or any of your family members have a history of MTC or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). While taking Victoza®, tell your doctor if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

Inflammation of the pancreas (pancreatitis) may be severe and lead to death. Before taking Victoza®, tell your doctor if you have had pancreatitis, gallstones, a history of alcoholism, or high blood triglyceride levels since these medical conditions make you more likely to get pancreatitis.

Stop taking Victoza® and call your doctor right away if you have pain in your stomach area that is severe and will not go away, occurs with or without vomiting, or is felt going from your stomach area through to your back. These may be symptoms of pancreatitis.

Before using Victoza®, tell your doctor about all the medicines you take, especially sulfonylurea medicines or insulin, as taking them with Victoza® may affect how each medicine works.

Also tell your doctor if you are allergic to any of the ingredients in Victoza®; have severe stomach problems such as slowed emptying of your stomach (gastroparesis) or problems with digesting food; have or have had kidney or liver problems; have any other medical conditions; are pregnant or plan to become pregnant. Tell your doctor if you are breastfeeding or plan to breastfeed. It is unknown if Victoza® will harm your unborn baby or if Victoza® passes into your breast milk.

Your risk for getting hypoglycemia, or low blood sugar, is higher if you take Victoza® (liraglutide [rDNA origin] injection) with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea medicine may need to be lowered while taking Victoza®.

The most common side effects with Victoza® include headache, nausea, and diarrhea. Nausea is most common when first starting Victoza®, but decreases over time in most people. Immune system related reactions, including hives, were more common in people treated with Victoza® compared to people treated with other diabetes drugs in medical studies.

For full Prescribing Information and Medication Guide, please see www.victoza.com or call 1-877-VICTOZA (1-877-484-2869).

Levemir® Indications and Usage:

Levemir® (insulin detemir [rDNA origin] injection) is a man-made long-acting insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

Important Safety Information:

Do not take Levemir® if your blood sugar is too low (hypoglycemia) or if you are allergic to anything in Levemir®. If you take too much Levemir® your blood sugar may fall too low.

Check your blood sugar levels. Ask your health care provider what your blood sugars should be and when you should check your blood sugar levels. Alcohol, including beer and wine, may affect your blood sugar when you take Levemir®.

Do not change the type of insulin you use unless told to do so by your health care provider. The amount of insulin you take as well as the best time for you to take your insulin may need to change if you take a different type of insulin.

Never mix Levemir® with other insulin products or use in an insulin pump.

Needles and Levemir® FlexPen® must not be shared.

Tell your health care provider about all medicines you take and all of your medical conditions, including if you are pregnant or breastfeeding. Your Levemir® dose may change if you take other medicines.

The most common side effect of insulin therapy, including Levemir®, is low blood sugar (hypoglycemia). Other possible side effects include reactions at the injection site (like redness, swelling and itching), and allergic reactions. Get medical help right away if you experience signs of serious allergic reaction such as body rash, trouble with your breathing, fast heartbeat, or sweating. Ask your doctor or pharmacist for further information.

Please see www.levemir-us.com for Levemir® complete Prescribing Information.

NovoLog® Indications and Usage:

NovoLog® (insulin aspart [rDNA origin] injection) is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

Important Safety Information:

Do not take NovoLog® if your blood sugar is too low (hypoglycemia) or if you are allergic to anything in NovoLog®. If you take too much NovoLog® your blood sugar may fall too low.

NovoLog® is a fast-acting insulin. You should eat a meal within 5 to 10 minutes after using NovoLog® to avoid low blood sugar. Do not inject NovoLog® if you do not plan to eat right after using NovoLog®. Check your blood sugar levels. Ask your health care provider what your blood sugars should be and when you should check your blood sugar levels. Alcohol, including beer and wine, may affect your blood sugar when you take NovoLog®.

Do not change the type of insulin you use unless told to do so by your health care provider. The amount of insulin you take as well as the best time for you to take your insulin may need to change if you take a different type of insulin.

Do not mix NovoLog® with any other insulins when used in a pump or with any insulins other than NPH when used with injections by syringe.

Needles and NovoLog® FlexPen® must not be shared.

Tell your health care provider about all medicines you take and all of your medical conditions, including if you are pregnant or breastfeeding. Your NovoLog® dose may change if you take other medicines.

NovoLog® has not been studied in children with type 2 diabetes or in children with type 1 diabetes under the age of two.

The most common side effect of NovoLog® is low blood sugar (hypoglycemia). Other possible side effects include reactions at the injection site (like redness, swelling and itching), and allergic reactions. Get medical help right away if you experience signs of serious allergic reaction such as body rash, trouble with your breathing, fast heartbeat, or sweating. Ask your doctor or pharmacist for further information.

Please see www.novolog.com for NovoLog® complete Prescribing Information.

(i) 2011 National Diabetes Fact Sheet. Centers for Disease Control Website. http://www.cdc.gov/diabetes/pubs/factsheet11.htm

SOURCE Novo Nordisk


Source: newswire



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