Navigation Links
FDA Approves NovoLog(R) Labeling Update

PRINCETON, N.J., July 15 /PRNewswire-FirstCall/ -- Diabetes patients taking NovoLog((R)) (insulin aspart [rDNA origin] injection) can now use the insulin in their pump for up to six days following the U.S. Food and Drug Administration (FDA) approval of a labeling change, diabetes care company Novo Nordisk announced today.(1) The previous label allowed for NovoLog((R)) to be stored in the pump reservoir for two days. This makes NovoLog((R)) the first and only rapid-acting insulin with this extended in-use time.

An insulin pump is a small, battery powered device designed to constantly deliver insulin into the patient's body 24 hours a day according to a preset program. Approximately the size of a pager, the pump system is composed of a reservoir for the insulin, a small battery, the pump, and a thin plastic tube with a needle on the end that passes insulin into the body, called the infusion set.

The updated NovoLog((R)) label also states that patients using NovoLog((R)) in their pumps should change the infusion set and the infusion set insertion site at least every three days. The previous label stated that NovoLog((R)) in the pump reservoir, infusion set and the infusion set insertion site be changed at least every 48 hours. The revised label keeps the same recommendation that NovoLog((R)) should be discarded after exposure to temperatures that exceed 37 degrees C (98.6 degrees F).

"The ability to go longer between changes of insulin in the pump allows people with diabetes to have more active and flexible lifestyles, which are integral to the success of long-term diabetes management," said Richard R. Rubin, PhD, professor, medicine and pediatrics, The Johns Hopkins University School of Medicine.

The label change is based on the FDA's review of data from Novo Nordisk that showed the stability of NovoLog((R)) in the pump for up to six days.

NovoLog((R)) is a rapid-acting insulin analog, meaning it works faster and for a shorter period of time compared with regular human insulin. NovoLog((R)) is also available in FlexPen((R)), the world's #1 selling prefilled insulin pen. Diabetes patients who take NovoLog((R)) can eat within 5-10 minutes of use, rather than the typical 30 minutes required with regular human insulin.

NovoLog((R)) was first approved by the FDA in 2000 and approved for use in pumps in 2001.

Prescribing information for NovoLog((R)) is available by contacting Novo Nordisk or visiting

About NovoLog (R) (insulin aspart [rDNA origin] injection)

NovoLog (R) 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(R) if your blood sugar is too low (hypoglycemia) or if you are allergic to anything in NovoLog(R). If you take too much NovoLog(R) your blood sugar may fall too low.

NovoLog(R) is a fast-acting insulin. You should eat a meal within 5 to 10 minutes after using NovoLog(R) to avoid low blood sugar. Do not inject NovoLog(R) if you do not plan to eat right after using NovoLog(R). 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(R).

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(R) with any other insulins when used in a pump or with any insulins other than NPH when used with injections by syringe.

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(R) dose may change if you take other medicines.

NovoLog(R) 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(R) 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.

About Novo Nordisk

Novo Nordisk is a healthcare company with an 86-year history of innovation and achievement 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 to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers. With headquarters in Denmark, Novo Nordisk employs more than 27,000 employees in 81 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 global information, visit; for United States information, visit

(1) Revised NovoLog Prescribing Information. "Dosage and Administration." Section 2.3. "Continuous subcutaneous insulin infusion (CSII) by external pump."

NovoLog(R) is a registered trademark of Novo Nordisk A/S.

SOURCE Novo Nordisk
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Fitness Management Group, Inc. Approves Sale of the Company
2. Cardinal Health Board of Directors Approves CareFusion Spinoff
3. Video: FDA Approves Hologics Adiana(R) Permanent Contraception System
4. European Medicines Agency (EMEA) Approves Cell Therapeutics, Inc.s September Meeting Request to Discuss OPAXIO(TM) Marketing Authorization Application
5. FDA Approves Multaq(R) for Patients with Atrial Fibrillation or Atrial Flutter
6. FDA Approves Lamictal(R)XR(TM); An Extended-Release Once-Daily, New Generation Treatment for Epilepsy
7. FDA Approves Reclast(R) to Prevent Osteoporosis in Postmenopausal Women With Convenient Less Frequent Dosing
8. FDA Approves SAMSCA(TM) (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia
9. ClearWay Minnesota(SM) Board Approves Four Regional Grants
10. Department of Defense Approves ISSA as Fitness Education Provider to Military Spouses
11. FDA Approves ACTOplus met(R) XR (pioglitazone HCl and metformin HCl extended-release) Tablets for the Treatment of Type 2 Diabetes
Post Your Comments:
(Date:11/24/2015)... ... November 24, 2015 , ... The Trustees, ... paid entry and parking fees at several of their most popular properties, including ... Barrington in support of REI’s Black Friday #OptOutside Campaign. The Trustees encourage families ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... ... across the United States to support their local poison centers through donations on ... as #GivingTuesday: calls it “a day that inspires people to collaborate in ...
(Date:11/24/2015)... ... 2015 , ... Cold Shoulder , LLC launched their Pro Vest, the latest version of ... goal of $20,000 in under 10 hours. , The campaign, which will ... Loss Vest to the market. , The PRO Vest provides consumers with a less expensive, ...
(Date:11/24/2015)... ... November 24, 2015 , ... American Specialty Health ... have announced their endorsement of the Medical Fitness Network (MFN), a national ... to have the MFN as one of our endorsed organizations,” said ASH Fitness ...
(Date:11/24/2015)... ... November 24, 2015 , ... All her life, Don Peck’s mother wondered if she was a ... might have been. After a 25-year search for information, Don and his aunt discovered ... a last name. Turns out, it was Don’s father who was descended from not ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... 24, 2015 Teledyne DALSA , a Teledyne ... technology, will introduce its CMOS X-Ray detector for mammography ... 29 to December 3, at McCormick Place in ... diagnostic and interventional imaging will be on display in the ... of advanced CMOS X-Ray detectors is the industry benchmark for ...
(Date:11/24/2015)... , Nov. 24, 2015  Enova Illumination is ... of Helsinki, Finland to combine ... are at the cutting edge of medical visualization: Enova ... the United States and Novocam ... Together, they provide the world,s most powerful battery-operated LED ...
(Date:11/24/2015)... Nov. 24, 2015  Freudenberg Medical has developed specialty tubing ... outside of medical facilities. Africa ... care is sparse. Nevertheless, prompt diagnosis is important to treat ... the virus. With the help of a portable mini-lab or ... to village in affected areas and perform rapid testing for ...
Breaking Medicine Technology: