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TRESIBA

®

 FlexTouch

®

 (insulin degludec injection) 200 units/mL

13

TRESIBA

®

 FlexTouch

®

 (insulin degludec injection) 100 units/mL

13

Instructions for Use
TRESIBA

®

 (tre-SI-bah) FlexTouch

®

 Pen 100 units/mL 

(insulin degludec injection)

• Do not share your TRESIBA

®

 FlexTouch

®

 Pen with 

other people, even if the needle is changed. You 

may give other people a serious infection, or get a 

serious infection from them. 

• 

TRESIBA

®

 FlexTouch

®

 Pen 100 units/mL (“Pen”) 

is a prefilled disposable pen

 containing 300 units of 

TRESIBA

®

 (insulin degludec injection) 100 units/mL insulin. 

You can inject from 1 to 80 units in a single injection. The 

units can be increased by 1 unit at a time.

• This Pen is not recommended for use by the blind or 

visually impaired without the assistance of a person 

trained in the proper use of the product.

Supplies you will need to give your TRESIBA

®

 

injection:

• TRESIBA

®

 FlexTouch

®

 Pen

• a new NovoFine

®

 or NovoTwist

®

 needle

• alcohol swab
• a sharps container for throwing away used Pens and needles. 

See “After your injection” at the end of these 

instructions.

Preparing your TRESIBA

®

 FlexTouch

®

 Pen:

• Wash your hands with soap and water.

• Before you start to prepare your injection, check the 

TRESIBA

®

 FlexTouch

®

 Pen label to make sure you 

are taking the right type of insulin. This is especially 

important if you take more than 1 type of insulin.

• TRESIBA

®

 should look clear and colorless. 

Do not

 use 

TRESIBA

®

 if it is cloudy or colored.

• 

Do not

 use TRESIBA

®

 past the expiration date printed on the 

label or 56 days after you start using the Pen.

• 

Always use a new needle for each injection to help 

ensure sterility and prevent blocked needles. Do not 

reuse or share needles with another person. You 

may give other people a serious infection, or get a 

serious infection from them.

NovoFine

®

Outer

needle cap

Inner

needle cap Needle

Paper

tab

NovoTwist

®

Outer

needle cap

Inner

needle cap Needle

Paper

tab

Pen cap

0

2

FlexTouch

®

(insulin degludec injection)
For Single Patient Use Only

250

200

150

100

50

Insulin

scale

Insulin

window

Dose

counter

Dose

selector

Dose

pointer

Dose

button

(Figure A)

Step 1:

• Pull Pen cap straight off 

(See Figure B).

(Figure B)

Step 2:

• 

Check the liquid in 

the Pen

 (See Figure 

C). TRESIBA

®

 should 

look clear and colorless. 

Do not

 use it if it looks 

cloudy or colored.

(Figure C)

Step 3:

• Select a new 

needle.

• Pull off the paper tab 

from the outer needle 

cap (See Figure D).

NovoFine

®

NovoTwist

®

(Figure D)

Step 4:

• Push the capped 

needle straight onto 

the Pen and twist the 

needle on until it is 

tight (See Figure E).

NovoFine

®

NovoTwist

®

(Figure E)

Step 5:

• Pull off the outer 

needle cap. 

Do not

 

throw it away 

(See Figure F).

NovoFine

®

NovoTwist

®

(Figure F)

Step 6:

• Pull off the inner 

needle cap and 

throw it away 

(See Figure G).

NovoFine

®

NovoTwist

®

(Figure G)

Priming your TRESIBA

®

 FlexTouch

®

 Pen:

Step 7:

• Turn the dose selector 

to 

select 2 units

 

(See Figure H).

0

2

2 units

selected

2

0

4

(Figure H)

Step 8:

• Hold the Pen with the 

needle pointing up. Tap 

the top of the Pen gently 

a few times to let any air 

bubbles rise to the top 

(See Figure I).

(Figure I)

Step 9:

• 

Hold the Pen with 

the needle pointing 

up.

 Press and hold in 

the dose button until the 

dose counter shows “0”. 

The “0” must line up with 

the dose pointer.

• A drop of insulin should 

be seen at the needle tip 

(See Figure J).

o

 If you 

do not

 see a 

drop of insulin, repeat 

steps 7 to 9, no more 

than 6 times.

o

 If you 

still do not

 

see a drop of insulin, 

change the needle and 

repeat steps 7 to 9.

0

2

(Figure J)

Selecting your dose:

Step 10:

TRESIBA

®

 FlexTouch

®

 

Pen 100 units/mL is 

made to deliver the 

number of insulin units 

that your healthcare 

provider prescribed. 

Do 

not perform any dose 

conversion.
Check to make sure 

the dose selector is 

set at 0.

• 

Turn the dose 

selector to select the 

number of units you 

need to inject.

 The 

dose pointer should line 

up with your dose (See 

Figure K).

o

 If you select the 

wrong dose, you 

can turn the dose 

selector forwards 

or backwards to the 

correct dose. 

o

 The 

even

 numbers 

are printed on the 

dial.

o

 The 

odd

 numbers are 

shown as lines.

0

2

24 units

selected

22

24

26

5 units

selected

Examples

4

6

10

0

(Figure K)

• The TRESIBA

®

 

FlexTouch

®

 Pen insulin 

scale will show you how 

much insulin is left in 

your Pen (See Figure L).

250

200

150

100

50

Example:

Approx.

200 units 

left

(Figure L)

Summary of Contents for FlexTouch

Page 1: ...heart failure with concomitant use of Thiazolidinediones TZDs Observe for signs and symptoms of heart failure consider dosage reduction or discontinuation if heart failure occurs 5 7 ADVERSE REACTIONS...

Page 2: ...le prefilled pens should never be shared between patients even if the needle is changed Patients using TRESIBA vials should never share needles or syringes with another person Sharing poses a risk for...

Page 3: ...etes percentages of adult and pediatric patients with type 1 diabetes randomized to TRESIBA who experienced at least one episode of hypoglycemia in clinical trials see Clinical Studies 14 and adults w...

Page 4: ...observed with human insulin which were probably secondary to maternal hypoglycemia 8 2 Lactation Risk Summary There are no data on the presence of insulin degludec in human milk the effects on the bre...

Page 5: ...TRESIBA at steady state was independent of age Geriatrics Pharmacokinetic and pharmacodynamic response of TRESIBA was compared in 13 younger adult 18 35 years and 14 geriatric 65 years subjects with t...

Page 6: ...once daily according to the approved labeling The any time each day TRESIBA arm was designed to simulate a worst case scenario injection schedule of alternating short and long once daily dosing inter...

Page 7: ...in HbA1c was analyzed using ANOVA with treatment region sex and anti diabetic treatment at screening as fixed effects and age and baseline HbA1c as covariates In Study E there were 12 3 of subjects in...

Page 8: ...administered in both treatment arms The mean age of the trial population was 55 7 years and mean duration of diabetes was 7 7 years 58 6 were male 61 3 were White 7 6 Black or African American 21 0 w...

Page 9: ...vial pack U 200 single patient use FlexTouch Pen 3 mL 200 units mL 600 Units 0169 2550 13 160 Units 2 Unit 3 pens pack TRESIBA U 100 FlexTouch dials in 1 unit increments TRESIBA U 200 FlexTouch dials...

Page 10: ...hem Never inject TRESIBA into a vein or muscle Never use a syringe to remove TRESIBA from the FlexTouch pen What should I avoid while taking TRESIBA While taking TRESIBA do not Drive or operate heavy...

Page 11: ...e Figure B Figure B Step 2 Check the liquid in the Pen See Figure C TRESIBA should look clear and colorless Do not use it if it looks cloudy or colored Figure C Step 3 Select a new needle Pull off the...

Page 12: ...ing the Pen NovoFine NovoTwist Figure R Figure S Step 16 Replace the Pen cap by pushing it straight on See Figure T Figure T After your injection Put your used TRESIBA FlexTouch Pen and needles in a F...

Page 13: ...se counter Dose selector Dose pointer Dose button Figure A Step 1 Pull Pen cap straight off See Figure B Figure B Step 2 Check the liquid in the Pen See Figure C TRESIBA should look clear and colorles...

Page 14: ...needle attached Storing without the needle attached helps prevent leaking blocking of the needle and air from entering the Pen NovoFine NovoTwist Figure R Figure S Step 16 Replace the Pen cap by push...

Page 15: ...let any air bubbles rise to the top See Figure G Figure G Step 7 Slowly push the plunger up until the tip of the plunger reaches the line for your prescribed TRESIBA dose See Figure H Figure H Step 8...

Page 16: ...are kept in the refrigerator After 56 days throw away TRESIBA vials that have been kept at room temperature below 86 F 30 C Vial in use Store the TRESIBA vial you are currently using in the refrigera...

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