Quantcast

FDA Approves NovoLog(R) Labeling Update

July 15, 2009

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 http://www.novolog.com.

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 novonordisk.com; for United States information, visit www.novonordisk-us.com.

(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


Source: newswire



comments powered by Disqus