FDA Approves NovoLog Labeling Update
FDA Approves NovoLog Labeling Update
Increasing the Time Patients Can Use and Store NovoLogĀ® in Their Pumps from Two Days to Six Days
PRINCETON, N.J., July 15 /PRNewswire-FirstCall/
-- Diabetes patients taking NovoLog (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 to be stored in
the pump reservoir for two days. This makes NovoLog 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 label also states that
patients using NovoLog 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 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 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 in
the pump for up to six days.
NovoLog is a rapid-acting insulin analog,
meaning it works faster and for a shorter period of time compared
with regular human insulin. NovoLog is also available in FlexPen ,
the world's #1 selling prefilled insulin pen. Diabetes patients who
take NovoLog can eat within 5-10 minutes of use, rather than the
typical 30 minutes required with regular human
insulin.
NovoLog was first approved by the FDA in 2000
and approved for use in pumps in 2001.
Prescribing information for NovoLog is
available by contacting Novo Nordisk or visiting http://www.novolog.com/.
About NovoLog (insulin aspart [rDNA origin]
injection)
NovoLog 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.
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.
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 is a registered trademark of Novo
Nordisk A/S.
Source: Novo Nordisk
CONTACT: Media: Ambre Morley, +1-609-514-8400,
or Investors: Hans
Rommer, +1-609-514-8480, both for Novo Nordisk
Rommer, +1-609-514-8480, both for Novo Nordisk
Web Site: http://www.novonordisk-us.com/
Ā
Posted: July 2009
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- FDA Approves NovoLog Category Change for Use in Pregnant Women withType 1 Diabetes - January 31, 2007
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