•
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 or damaged needle, instruct them to change the needle as described in Step 15 of the Instructions for Use and repeat all steps in the IFU starting with a new needle and the section Preparing your TRESIBA FlexTouch Pen. Make sure the patient selects the full dose needed.
If patients routinely do not hold the needle under the skin as recommended, the patient may need to slightly increase the dialed insulin dose to achieve the patient’s glycemic targets.

Instruct patients to not re-use needles. A new needle must be attached before each injection. Reuse of needles increases the risk of blocked needles which may cause under-dosing or overdosing.

Instruct Patients to never use a syringe to remove TRESIBA from the FlexTouch disposable insulin prefilled pen.

Administration

TRESIBA must only be used if the solution is clear and colorless with no particles visible.

Patients must be advised that TRESIBA must NOT be diluted or mixed with any other insulin or solution [see Dosage and Administration (2.1)].

Management of Hypoglycemia and Handling of Special Situations

Patients should be instructed on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia. Patients must be instructed on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals [see Warnings and Precautions (5.3)].

Refer patients to the TRESIBA “Patient Information” for additional information about the potential side effects of insulin therapy, including lipodystrophy (and the need to rotate injection sites within the same body region), weight gain, allergic reactions, and hypoglycemia.

Women of Reproductive Potential

Advise patients to inform their health care professional if they are pregnant or are contemplating pregnancy.

Rx Only

Date of Issue: 12/2015

Version: 2

Novo Nordisk®, TRESIBA®, FlexTouch®, LEVEMIR®, NOVOLOG®, NovoFine® and NovoTwist® are registered trademarks of Novo Nordisk A/S.

© 2015 Novo Nordisk

TRESIBA® is covered by US Patent No. 7,615,532 and other patents pending.

FlexTouch® is covered by US Patent Nos. 6,899,699, 7,686,786, 8,672,898, 8,684,969, 8,920,383, D724,721, D734,450 and other patents pending.

Manufactured by:

Novo Nordisk A/S

DK-2880 Bagsvaerd, Denmark

For information about TRESIBA contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

1-800-727-6500

www.novonordisk-us.com

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Patient Information

TRESIBA® (tre–SI-bah)
(insulin degludec injection)

Do not share your TRESIBA FlexTouch insulin delivery device with other people, even if the needle has changed. You may give other people a serious infection, or get a serious infection from them.

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