Novo Nordisk NovoLog, Instructions For Use Manual

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5 NovoLog ® (insulin aspart [rDNA origin] injection)
To avoid insulin degradation, infusion set occlusion, and loss
of the preservative (metacresol), insulin in the reservoir should
be replaced at least every 6 days; infusion sets and infusion set
insertion sites should be changed at least every 3 days.
Insulin exposed to temperatures higher than 37°C (98.6°F)
should be discarded. The temperature of the insulin may exceed ambient
temperature when the pump housing, cover, tubing, or sport case is exposed
to sunlight or radiant heat. Infusion sites that are erythematous, pruritic, or
thickened should be reported to medical personnel, and a new site selected
because continued infusion may increase the skin reaction and/or alter
the absorption of NovoLog ® . Pump or infusion set malfunctions or insulin
degradation can lead to hyperglycemia and ketosis in a short time because
of the small subcutaneous depot of insulin. This is especially pertinent for
rapid-acting insulin analogs that are more rapidly absorbed through skin and
have shorter duration of action. These differences are particularly relevant when
patients are switched from multiple injection therapy. Prompt identification and
correction of the cause of hyperglycemia or ketosis is necessary. Problems
include pump malfunction, infusion set occlusion, leakage, disconnection
or kinking, and degraded insulin. Less commonly, hypoglycemia from pump
malfunction may occur. If these problems cannot be promptly corrected,
patients should resume therapy with subcutaneous insulin injection and
contact their physician [ see Dosage and Administration (2), Warnings and
Precautions (5) and How Supplied/Storage and Handling (16.2) ].
17.3 FDA Approved Patient Labeling
See separate leaflet.
Pump:
NovoLog
®
in the pump reservoir should be discarded after at least every 6
days of use or after exposure to temperatures that exceed 37°C (98.6°F). The
infusion set and the infusion set insertion site should be changed at least every
3 days.
Summary of Storage Conditions:
The storage conditions are summarized in the following table:
Table 9. Storage conditions for vial, PenFill cartridges, NovoLog ®
FlexPen
®
, and NovoLog
®
FlexTouch
®
NovoLog ®
presentation
Not in-use (unopened)
Room Temperature
(below 30°C)
Not in-use
(unopened)
Refrigerated
In-use (opened)
Room Temperature
(below 30°C)
10 mL vial 28 days Until
expiration date
28 days
(refrigerated/room
temperature)
3 mL PenFill
®
cartridges
28 days Until
expiration date
28 days
(Do not refrigerate)
3 mL NovoLog
®
FlexPen ®
28 days Until
expiration date
28 days
(Do not refrigerate)
3 mL NovoLog ®
FlexTouch
®
28 days Until
expiration date
28 days
(Do not refrigerate)
Storage of Diluted NovoLog ®
NovoLog
®
diluted with Insulin Diluting Medium for NovoLog
®
to a
concentration equivalent to U-10 or equivalent to U-50 may remain in patient
use at temperatures below 30°C (86°F) for 28 days.
Storage of NovoLog
®
in Infusion Fluids
Infusion bags prepared as indicated under Dosage and Administration (2) are
stable at room temperature for 24 hours. Some insulin will be initially adsorbed
to the material of the infusion bag.
17 PATIENT COUNSELING INFORMATION
[ See FDA Approved Patient Labeling (17.3) ]
17.1 Physician Instructions
Maintenance of normal or near-normal glucose control is a treatment goal
in diabetes mellitus and has been associated with a reduction in diabetic
complications. Patients should be informed about potential risks and benefits
of NovoLog ® therapy including the possible adverse reactions. Patients should
also be offered continued education and advice on insulin therapies, injection
technique, life-style management, regular glucose monitoring, periodic
glycosylated hemoglobin testing, recognition and management of hypo-
and hyperglycemia, adherence to meal planning, complications of insulin
therapy, timing of dose, instruction in the use of injection or subcutaneous
infusion devices, and proper storage of insulin. Patients should be informed
that frequent, patient-performed blood glucose measurements are needed to
achieve optimal glycemic control and avoid both hyper- and hypoglycemia.
Patients should receive proper training on how to use NovoLog
®
. Instruct
patients that when injecting NovoLog ® , they must press and hold down the
dose button until the dose counter shows 0 and then keep the needle in the
skin and count slowly to 6. When the dose counter returns to 0, the prescribed
dose is not completely delivered until 6 seconds later. If the needle is removed
earlier, they may see a stream of insulin coming from the needle tip. If so, the
full dose will not be delivered (a possible under-dose may occur by as much as
20%), and they should increase the frequency of checking their blood glucose
levels and possible additional insulin administration may be necessary.
• If 0 does not appear in the dose counter after continuously pressing the
dose button, the patient may have used a blocked needle. In this case they
would not have received any insulin – even though the dose counter has
moved from the original dose that was set.
• If the patient did have a blocked needle, instruct them to change the needle
as described in Section 5 of the Instructions for Use and repeat all steps in
the IFU starting with Section 1: Prepare your pen with a new needle. Make
sure the patient selects the full dose needed.
The patient’s ability to concentrate and react may be impaired as a result of
hypoglycemia. This may present a risk in situations where these abilities are
especially important, such as driving or operating other machinery. Patients
who have frequent hypoglycemia or reduced or absent warning signs of
hypoglycemia should be advised to use caution when driving or operating
machinery.
Accidental substitutions between NovoLog
®
and other insulin products have
been reported. Patients should be instructed to always carefully check that they
are administering the appropriate insulin to avoid medication errors between
NovoLog
®
and any other insulin. The written prescription for NovoLog
®
should be written clearly, to avoid confusion with other insulin
products, for example, NovoLog
®
Mix 70/30.
17.2 Patients Using Pumps
Patients using external pump infusion therapy should be trained in intensive
insulin therapy with multiple injections and in the function of their pump and
pump accessories.
The following insulin pumps
†
have been used in NovoLog
®
clinical or in vitro
studies conducted by Novo Nordisk, the manufacturer of NovoLog ® :
• Medtronic Paradigm
®
512 and 712
• MiniMed 508
• Disetronic
®
D-TRON
®
and H-TRON
®
Before using another insulin pump with NovoLog ® , read the pump label to
make sure the pump has been evaluated with NovoLog
®
.
NovoLog ® is recommended for use in any reservoir and infusion sets that
are compatible with insulin and the specific pump. Please see recommended
reservoir and infusion sets in the pump manual.
Rx only
Date of Issue: April 25, 2014
Version: 22
Novo Nordisk
®
, NovoLog
®
, NovoPen
®
3, PenFill
®
, Novolin
®
, FlexPen
®
,
FlexTouch ® , PenMate ® , NovoFine ® , and NovoTwist ® are registered
trademarks of Novo Nordisk A/S.
NovoLog ® is covered by US Patent Nos. 5,618,913, 5,866,538, and other
patents pending.
FlexPen ® is covered by US Patent Nos. RE 41,956, 6,004,297, RE 43,834,
and other patents pending.
FlexTouch
®
pen is covered by US Patent Nos. 7,686,786, 6,899,699, and
other patents pending.
PenFill
®
is covered by US Patent No. 5,693,027.
† The brands listed are the registered trademarks of their respective owners
and are not trademarks of Novo Nordisk A/S.
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark
For information about NovoLog ® contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, New Jersey 08536
1-800-727-6500
www.novonordisk-us.com
© 2002-2014 Novo Nordisk
0714-00022409-1 7/2014