PRINCETON, N.J., Jan. 26 /PRNewswire-FirstCall/ -- Novo Nordisk today announced that Norditropin NordiFlex(R) (somatropin [rDNA] injection), the prefilled, multi-dose, liquid growth hormone in a disposable pen is now available in the United States for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone and adults with growth hormone deficiency (GHDA).(1) Norditropin NordiFlex was approved by the Food and Drug Administration (FDA) in October 2004. Norditropin was approved for children in 1997 and for adults in November 2004.
(Photo: http://www.newscom.com/cgi-bin/prnh/20050126/NYW069http://www.newscom.com/cgi-bin/prnh/20020404/NVOLOGO )
The characteristics of Norditropin NordiFlex make it convenient, comfortable and easy for patients to use and healthcare professionals to teach. Norditropin NordiFlex is available in 5 mg and 15 mg delivery pens.(2)
"Norditropin NordiFlex benefits the patient and the healthcare provider as it is an easy-to-use growth hormone delivery system. Patient training is simplified as it only requires a few steps for preparation and injection," said Dr. Alan Rogol, professor of pediatrics at the University of Virginia. "This treatment is optimal for patients who are newly initiating growth hormone therapy and those who are beginning to self-inject."
Key features of Norditropin NordiFlex include:
* Ease of use: no loading, no mixing (reconstitution)
* Ease of training and handling time: for the nurse to teach and the
parent and patient to use
* Easy dial-back reset: The dose scale of Norditropin NordiFlex can be
dialed back easily if too big of a dose has been dialed
* End-of-content feature: When the cartridge is nearly empty the patient
can only dial what is left in the cartridge making it easy to see how
much growth hormone is being injected
* Disposable: made of fully degradable plastic
* Fine dosing increments starting from 0.025 mg allow user to set a
precise dose which may lead to reduced waste of growth hormone
* Flexible dosing: a total of 100 dose settings between the two pens
(5 mg/1.5 ml and 15 mg/1.5 ml), allowing the same product to cover
many patients with different needs
In conjunction with the launch of this new system, Novo Nordisk is introducing a special demonstration kit for healthcare professionals called "Simplicity in Hand." This kit is designed to introduce Norditropin NordiFlex to healthcare professionals, enabling them to instruct their patients on using Norditropin NordiFlex. The kit includes:
* Something New is at Hand: an informational brochure on how to use
* Support in Hand with NordiCare(R): a brochure with information about
all of the many support services that Novo Nordisk provides, such as
financial assistance and online support.
For more information about Norditropin NordiFlex and the starter kit, healthcare professionals can visit http://www.norditropin-us.com/ or call 888-NOVO-HGH.
With its history of successful insulin delivery devices for people with diabetes, Novo Nordisk has led the way in developing patient-friendly methods of administering human growth hormone. Novo Nordisk introduced a new pen system to deliver liquid hGH with one of the thinnest and finest needles available to Europe in 1999 and to Japan in 2000. The premixed Norditropin(R) cartridge and NordiPen(R) delivery system were introduced in the United States in 2000, and the NordiPenMate(R) auto-insertion device became available in 2001.
Norditropin cartridges from Novo Nordisk contain growth hormone that has been biosynthetically produced to be as close as possible to the growth hormone your body makes naturally.
Novo Nordisk first produced biosynthetic growth hormone in 1985. In 1999, the company introduced a liquid growth hormone formulation that did not require a reconstitution or mixing procedure before injection. This was a major advancement in simplifying growth hormone therapy for patients.
Norditropin is indicated for the long-term treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone and growth hormone deficiency in adults. Norditropin should not be used in patients who are allergic to phenol or any other ingredients in the medicine. Side effects may include headache, muscle pain, weakness, mild hyperglycemia, glucosuria, peripheral edema and fluid retention, and localized reactions at the injection site.
Full prescribing information for Norditropin is available by contacting Novo Nordisk Inc. or visiting http://www.novonordisk-us.com/
Norditropin, Norditropin NordiFlex, NordiPen, and NordiPenMate are registered trademarks of Novo Nordisk A/S.
Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy and hormone therapy for women. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 20,000 full-time employees in 69 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit novonordisk.com, or in the US, http://www.novonordisk-us.com/.
(1) Novo Nordisk Inc. Norditropin (somatropin [rDNA] injection). Package
insert. Novo Nordisk Inc. Princeton, NJ. October 2004.
(2) Lawton S Berg B. Comparative Evaluation of FlexPen(TM) among patients
and healthcare professionals. Diabetes 2001;50 (suppl 2): A440
AP Archive: http://photoarchive.ap.org AP PhotoExpress Network: PRN3 PRN Photo Desk, firstname.lastname@example.orgWeb sites: http://www.norditropin-us.com http://www.novonordisk-us.com
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20050126/NYW069http://www.newscom.com/cgi-bin/prnh/20020404/NVOLOGO