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TRESIBA

®

 FlexTouch

®

 (insulin degludec injection) 200 units/mL

14

TRESIBA

®

 FlexTouch

®

 (insulin degludec injection) 100 units/mL

14

• To see how much insulin is left in your TRESIBA

®

 

FlexTouch

®

 Pen:

o

 Turn the dose selector until it stops. The dose counter will 

line up with the number of units of insulin that is left in 

your Pen. If the dose counter shows 80, there are 

at least 

80

 units left in your Pen.

o

 If the dose counter shows 

less than 80

, the number 

shown in the dose counter is the number of units left in 

your Pen.

Giving your injection:

• Inject your TRESIBA

®

 exactly as your healthcare provider has 

shown you. Your healthcare provider should tell you if you 

need to pinch the skin before injecting.

• TRESIBA

®

 can be injected under the skin (subcutaneously) 

of your upper legs (thighs), upper arms, or stomach area 

(abdomen).

• Change (rotate) your injection sites within the area you choose 

for each dose. 

Do not

 use the same injection site for each 

injection.

Step 11:

• Choose your injection 

site and wipe the skin 

with an alcohol swab 

(See Figure M). Let the 

injection site dry before 

you inject your dose.

(Figure M)

Step 12:

• 

Insert the needle into 

your skin

 (See Figure 

N).

o

 

Make sure you 

can see the dose 

counter. Do not

 

cover it with your 

fingers, this can stop 

your injection.

4 8

(Figure N)

Step 13:

• 

Press and hold down 

the dose button until 

the dose counter 

shows “0”

 (See Figure 

O).

o

 The “0” must line up 

with the dose pointer. 

You may then hear or 

feel a click.

• 

Keep the needle in 

your skin after 

the dose 

counter has returned to 

“0” and 

slowly count to 

6

 (See Figure P).

o

 

When the dose 

counter returns to 

“0”, you will not 

get your full dose 

until 6 seconds 

later.

o

 

If the needle is 

removed before 

you count to 6, you 

may see a stream 

of insulin coming 

from the needle tip.

0 2

0

2

(Figure O)

0 2

Count slowly:

1-2-3-4-5-6

(Figure P)

o

 

If you see a stream of insulin coming from the 

needle tip you will not get your full dose. If this 

happens you should check your blood sugar levels 

more often because you may need more insulin.

Step 14:

• 

Pull the needle out of 

your skin

 (See Figure 

Q).

o

 If you see blood after 

you take the needle 

out of your skin, press 

the injection site 

lightly with a piece of 

gauze or an alcohol 

swab. 

Do not

 rub the 

area.

(Figure Q)

Step 15:

• 

Carefully remove 

the needle from the 

Pen and throw it 

away

 (See Figure R).

o

 

Do not

 recap the 

needle. Recapping 

the needle can 

lead to needle stick 

injury.

• If you 

do not

 have 

a sharps container, 

carefully slip the 

needle into the outer 

needle cap (See Figure 

S). Safely remove the 

needle and throw it 

away as soon as you 

can.

o

 

Do not

 store the 

Pen with the 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 

pushing it straight on 

(See Figure T).

(Figure T)

After your injection:

• Put your used TRESIBA

®

 FlexTouch

®

 Pen and needles in a 

FDA-cleared sharps disposal container right away after use. 

Do not throw away (dispose of) loose needles and Pens in 

your household trash.

• If you do not have a FDA-cleared sharps disposal container, 

you may use a household container that is:

o

 made of a heavy-duty plastic

o

 can be closed with a tight-fitting, puncture-resistant lid, 

without sharps being able to come out

o

 upright and stable during use 

o

 leak-resistant

o

 properly labeled to warn of hazardous waste inside the 

container

• When your sharps disposal container is almost full, you will 

need to follow your community guidelines for the right way to 

dispose of your sharps disposal container. There may be state 

or local laws about how you should throw away used needles 

and syringes. Do not reuse or share needles or syringes with 

another person. For more information about the safe sharps 

disposal, and for specific information about sharps disposal 

in the state that you live in, go to the FDA’s website at: http://

www.fda.gov/safesharpsdisposal.

• Do not dispose of your used sharps disposal container in your 

household trash unless your community guidelines permit 

this. Do not recycle your used sharps disposal container.

This Instructions for Use has been approved by the U.S. Food 

and Drug Administration.

Manufactured by: 

Novo Nordisk A/S 

DK-2880 Bagsvaerd, Denmark

Revised: 12/2016

For more information go to  

www.TRESIBA.com

© 2015-2018 Novo Nordisk 

US18TSM00504      December 2018

How should I store my TRESIBA

®

 FlexTouch

®

 Pen?

Before use:

• Store unused TRESIBA

®

 FlexTouch

®

 Pens in the refrigerator at 

36°F to 46°F (2°C to 8°C).

• 

Do not

 freeze TRESIBA

®

Do not

 use TRESIBA

®

 if it has been 

frozen.

• Unused Pens may be used until the expiration date printed on 

the label, if kept in the refrigerator.

Pen in use:

• Store the Pen you are currently using in the refrigerator 

between 36ºF to 46ºF (2ºC to 8ºC) or keep at room temperature 

below 86ºF (30ºC).

• Keep TRESIBA

®

 away from heat or light.

• The TRESIBA

®

 FlexTouch

®

 Pen you are using should be 

thrown away after 56 days if it is refrigerated or kept at 

room temperature, even if it still has insulin left in it and the 

expiration date has not passed.

General Information about the safe and effective use of 

TRESIBA

®

.

• 

Keep TRESIBA

®

 FlexTouch

®

 Pens and needles out of 

the reach of children.

• 

Always

 use a new needle for each injection.

• 

Do not

 share TRESIBA

®

 FlexTouch

®

 Pens or needles with 

other people. You may give other people a serious infection, 

or get a serious infection from them.

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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