Unopened FlexTouch disposable prefilled pen:

Not in-use (unopened) TRESIBA disposable prefilled pen should be stored in a refrigerator (36°F - 46°F [2°C - 8°C]). Discard after expiration date.

Open (In-Use) FlexTouch disposable prefilled pen:

The in-use TRESIBA FlexTouch pen should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) TRESIBA FlexTouch pen may be used for up to 56 days (8 weeks) after being opened, if it is kept at room temperature.

The storage conditions are summarized in Table 15:

Table 15: Storage Conditions for TRESIBA FlexTouch

 Not in-use (unopened)

Refrigerated
(36°F - 46°F [2°C - 8°C])
 Not in-use (unopened)

Room Temperature
(below 86°F [30°C])
 In-use (opened)

Room Temperature
(below 86°F [30°C])
 
3 mL TRESIBA
U-100 FlexTouch
 Until expiration date
 56 days
(8 weeks)
 56 days
(8 weeks)
(Do not refrigerate)
 
3 mL TRESIBA
U-200 FlexTouch
 Until expiration date
 56 days
(8 weeks)
 56 days
(8 weeks)
(Do not refrigerate)
 
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17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (Patient Information and Instructions for Use)

Never Share a TRESIBA FlexTouch Pen Between Patients

Advise patients that they should never share a TRESIBA FlexTouch, pen device with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions (5.1)].

Hyperglycemia or Hypoglycemia

Inform patients that hypoglycemia is the most common adverse reaction with insulin. Inform patients of the symptoms of hypoglycemia. Inform patients that the 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. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery.

Advise patients that changes in insulin regimen can predispose to hyper- or hypoglycemia.

Advise patients that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions (5.2)].

Medication errors

Inform patients to always check the insulin label before each injection [see Warnings and Precautions (5.4)]. TRESIBA FlexTouch pen is available in concentrations of 100 units/mL or 200 units/mL.

Inform patients that the dose counter of TRESIBA FlexTouch pen shows the number of units of

TRESIBA to be injected. NO dose re-calculation is required [see Dosage and Administration (2.2)].

Instruct patients that when injecting TRESIBA, 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 leve