Fiasp Injection

Injection: 100 units of insulin aspart per mL (U-100) is available as a clear and colorless solution in:

• 10 mL multiple-dose vial • 3 mL single-patient-use FIASP FlexTouch pen

FIASP is contraindicated

• During episodes of hypoglycemia [see Warnings and Precautions (5.3)]. • In patients with known hypersensitivity to insulin aspart or one of the excipients in FIASP [see Warnings and Precautions (5.6)].

The following adverse reactions are also discussed elsewhere:

• Hypoglycemia [see Warnings and Precautions (5.3)] • Hypokalemia [see Warnings and Precautions (5.5)] • Hypersensitivity and allergic reactions [see Warnings and Precautions (5.6)]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates actually observed in clinical practice.

The data in Table 1 reflect the exposure of 763 patients with type 1 diabetes to FIASP in one clinical trial with a mean exposure duration of 25 weeks [see Clinical Studies (14)]. The mean age was 44.4 years and the mean duration of diabetes was 19.9 years. 59% were male, 93% were Caucasian, 2% were Black or African American and 7% were Hispanic. The mean BMI was 26.7 kg/m2 and the mean HbA1c at baseline was 7.6%.

The data in Table 2 reflect the exposure of 341 patients with type 2 diabetes to FIASP in one clinical trial with a mean exposure duration of 24 weeks [see Clinical Studies (14)]. The mean age was 59.6 years and the mean duration of diabetes was 13.2 years. 47% were male, 80% were Caucasian, 6% were Black or African American and 8% were Hispanic. The mean BMI was 31.5 kg/m2 and the mean HbA1c at baseline was 8.0%.

Common adverse reactions, excluding hypoglycemia, were defined as events occurring in ≥5% and occurring at the same rate or greater for FIASP-treated subjects than comparator-treated subjects.

Table 1. Adverse Reactions (%*) in Patients with Type 1 Diabetes

	Mealtime FIASP + Insulin detemir (N=386)	Postmeal FIASP + Insulin detemir (N=377)
Nasopharyngitis	20.2	23.9
Upper respiratory tract infection	9.1	7.4
Nausea	4.9	5.0
Diarrhea	5.4	3.2
Back pain	5.2	4.0

*Incidence ≥ 5% and occurring at the same rate or greater with FIASP than comparator

Table 2. Adverse Reactions (%*) in Patients with Type 2 Diabetes

	FIASP + Insulin glargine (N=341)
Urinary tract infection	5.9

*Incidence ≥ 5% and occurring at the same rate or greater with FIASP than comparator

Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including FIASP[see Warnings and Precautions (5.3)]. The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for FIASP with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that occur in clinical practice.

Incidence rates for severe hypoglycemia in adults with type 1 and type 2 diabetes mellitus treated with FIASP in clinical trials are shown in Table 3 [see Clinical Studies (14)].

Table 3. Proportion (%) of Patients with Type 1 Diabetes and Type 2 Diabetes Experiencing at Least One Episode of Severe Hypoglycemia in Adult Clinical Trials

	Study A (Type 1)		Study B (Type 2)
	Mealtime FIASP + Insulin detemir (N=386)	Postmeal FIASP + Insulin detemir (N=377)	FIASP + Insulin glargine (N=341)
Severe hypoglycemia*	6.7	8.0	3.2

  *Severe hypoglycemia: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions

Allergic Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including FIASP, and may be life threatening [see Warnings and Precautions (5.6)]. In the clinical program, generalized hypersensitivity reactions (manifested by generalized skin rash and facial edema) was reported in 0.4% of patients treated with FIASP. Allergic skin manifestations reported with FIASP in 1.7% of patients from the clinical program include eczema, rash, rash pruritic, urticaria and dermatitis.

Lipodystrophy

Administration of insulin, including FIASP, has resulted in lipohypertrophy (enlargement or thickening of tissue) and lipoatrophy (depression in the skin). In the clinical program, lipodystrophy was reported in 0.4% of patients treated with FIASP [see Dosage and Administration (2.2)].

Injection Site Reactions

As with other insulin therapy, patients may experience rash, redness, inflammation, bruising or itching at the site of Fiasp Injection. These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation of FIASP. In the clinical program, injection site reactions occurred in 1.6% of patients treated with FIASP. In Study A, patients with type 1 diabetes treated with FIASP reported 2.2% injection site reactions.

Weight Gain

Weight gain can occur with insulin therapy, including FIASP, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria. In Study A, patients with type 1 diabetes treated with FIASP gained an average of 0.7 kg and in Study B, patients with type 2 diabetes treated with FIASP gained an average of 2.7 kg.

Peripheral Edema

Insulin, including FIASP, may cause sodium retention and edema, particularly if previous poor metabolic control is improved by intensified insulin therapy. In the clinical program, peripheral edema occurred in 0.8% of patients treated with FIASP.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to FIASP in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

In a 26-week study in adult subjects with type 1 diabetes (Study A [see Clinical Studies (14)]), among the 763 subjects who received FIASP, 97.2% were positive for cross-reacting anti-insulin antibodies (AIA) at least once during the study, including 90.3% that were positive at baseline. A total of 24.8% of patients who received FIASP were positive for anti-drug (insulin aspart) antibodies (ADA) at least once during the study, including 17.3% that were positive at baseline.

Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.5)]. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise, may be needed. More severe episodes with coma, seizure or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

FIASP® (fee’ asp)
(insulin aspart injection)

for subcutaneous or intravenous use

Do not share your FIASP with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

What is FIASP?

• FIASP is a man-made insulin that is used to control high blood sugar in adults with diabetes mellitus. • It is not known if FIASP is safe and effective in children.

Who should not take FIASP?
Do not take FIASP if you:

• are having an episode of low blood sugar (hypoglycemia). • have an allergy to insulin aspart or any of the ingredients in FIASP.

Before taking FIASP, tell your healthcare provider about all your medical conditions including, if you:

• have kidney problems. • have liver problems. • are pregnant or plan to become pregnant. Talk with your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant. • are breastfeeding or plan to breastfeed. It is not known if FIASP passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while using FIASP. • are taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.

Before you start taking FIASP, talk to your healthcare provider about low blood sugar and how to manage it.

How should I take FIASP?

• Read the Instructions for Use that come with your FIASP. • Take FIASP exactly as your healthcare provider tells you to. • FIASP starts acting fast. You should take your dose of FIASP at the beginning of the meal or within 20 minutes after starting a meal. • Know the type and strength of insulin you take. Do not change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin. • If you miss a dose of FIASP, monitor your blood sugar levels to decide if an insulin dose is needed. Continue with your regular dosing schedule at the next meal. • Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels. • Do not reuse or share needles with other people. You may give other people a serious infection or get a serious infection from them.

What should I avoid while taking FIASP?
While taking FIASP do not:

• Drive or operate heavy machinery until you know how FIASP affects you. • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of FIASP?
FIASP may cause serious side effects that can lead to death, including:

• low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: • dizziness or light-headedness • blurred vision • anxiety, irritability, or mood changes • sweating • slurred speech • hunger • confusion • shakiness • headache • fast heart beat

Your insulin dose may need to change because of:

• change in level of physical activity or exercise • increased stress • change in diet • weight gain or loss • illness • low potassium in your blood (hypokalemia). • serious allergic reactions (whole body reactions). Get emergency medical help right away, if you have any of these signs or symptoms of a severe allergic reaction: • a rash over your whole body, trouble breathing, a fast heartbeat, swelling of your face, tongue or throat, sweating, extreme drowsiness, dizziness, confusion. • heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with FIASP may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with FIASP. Your healthcare provider should monitor you closely while you are taking TZDs with FIASP. Tell your healthcare provider if you have any new or worse symptoms of heart failure including: • Shortness of breath, swelling of your ankles or feet, sudden weight gain.   Treatment with TZDs and FIASP may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

Common side effects of FIASP may include:

• skin problems such as eczema, rash, itching, redness and swelling of your skin (dermatitis) • reactions at the injection site such as itching, rash • skin thickening or pits at the injection site (lipodystrophy) • weight gain

These are not all the possible side effects of FIASP. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of FIASP.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about FIASP that is written for health professionals. Do not use FIASP for a condition for which it was not prescribed. Do not give FIASP to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in FIASP?

Active Ingredient: insulin aspart

Inactive Ingredients: glycerol, phenol, metacresol, zinc, disodium phosphate dihydrate, arginine hydrochloride, niacinamide and water for injections

Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark

For more information, go to www.novonordisk-us.com or call 1-800-727-6500.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 09/2017

Instructions for Use

FIASP (fee’ asp)

(insulin aspart injection)

10 mL vial (100 units/mL, U-100)

Read this Instructions for Use before you start taking FIASP and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. The vial 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 and insulin syringe.

Do not reuse or share syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.

Supplies you will need to give your Fiasp Injection:

• a 10 mL FIASP vial • a U-100 insulin syringe and needle • 2 alcohol swabs • 1 sharps container for throwing away used needles and syringes. See “Disposing of your used needles and syringes” at the end of these instructions.

Preparing your FIASP dose:

• Do not roll or shake the FIASP vial. Shaking the FIASP vial right before the dose is drawn into the syringe may cause bubbles or foam. This can cause you to draw up the wrong dose of insulin. • The tamper-resistant cap should not be loose or damaged before the first use. Do not use if the tamper-resistant cap is loose or damaged before using FIASP for the first time. • Wash your hands with soap and water. • Before you start to prepare your injection, check the FIASP label to make sure that you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin. • Check that the FIASP vial is not cracked or damaged. Do not use if the FIASP vial is cracked or damaged.   . • FIASP should look clear and colorless. Do not use FIASP if it is thick, cloudy, or is colored. • Do not use FIASP past the expiration date printed on the label.

Step 1: Pull off the tamper-resistant cap (See Figure A). Step 2: Wipe the rubber stopper with an alcohol swab (See Figure B).	(Figure A Figure B)
Step 3: Hold the syringe with the needle pointing up.Pull down on the plunger until the tip of the plunger reaches the line for the number of units for your prescribed dose (See Figure C).	(Figure C)
Step 4: Push the needle through the rubber stopper of the FIASP vial (See Figure D).	(Figure D)
Step 5: Push the plunger all the way in. This puts air into the FIASP vial (See Figure E).	(Figure E)
Step 6: Turn the FIASP vial and syringe upside down and slowly pull the plunger down until the tip of the plunger is a few units past the line for your dose (See Figure F). If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top (See Figure G).	(Figure F) (Figure G)
Step 7: Slowly push the plunger up until the tip of the plunger reaches the line for your prescribed FIASP dose (See Figure H).	(Figure H)
Step 8: Check the syringe to make sure you have the right dose of FIASP.
Step 9: Pull the syringe out of the rubber stopper on the vial (See Figure I).	(Figure I)

Giving your Fiasp Injection:

• Inject your FIASP exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting. • You should take your dose of FIASP at the start of a meal or within 20 minutes after starting a meal. • FIASPcan be injected under the skin (subcutaneously) of your stomach area, upper legs, or upper arms. Do not inject FIASP into your muscle. • Change (rotate) your injection site for each injection. Do not use the same injection site for each injection. • Do not dilute ormix FIASP with any other type of insulin products or solutions.

Step 10: Choose your injection site and wipe the skin with an alcohol swab (See Figure J). Let the injection site dry before you inject your dose.	(Figure J)
Step 11: Insert the needle into your skin. Push down on the plunger to inject your dose (See Figure K). Make sure you have injected all the insulin in the syringe.	(Figure K)
Step 12: Pull the needle out of your skin. After your injection you may see a drop of FIASP at the needle tip. This is normal and does not affect the dose you just received (See Figure L). • 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 L)

After your injection:

• Do not recap the needle. Recapping the needle can lead to needle stick injury.

Disposing of your used needles and syringes:

• Put your used insulin needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash. • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: • made of a heavy-duty plastic; • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out; • upright and stable during use; • leak-resistant, and • 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 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.

How should I store FIASP?

• Do not freeze FIASP. Do not use FIASP if it has been frozen. • Keep FIASP away from excessive heat or light. • Store unopened FIASP vials in the refrigerator at 36°F to 46°F (2°C to 8°C) or at room temperature below 86°F (30°C). • Store opened FIASPvials in the refrigerator at 36°F to 46°F (2°C to 8°C) or at room temperature below 86°F (30°C). • Unopened FIASP vials may be used until the expiration date printed on the label, if they are kept in the refrigerator. • If FIASP vials are stored at room temperature prior to first use, they should be used or thrown away within 28 days. • Opened FIASP vials should be thrown away after 28 days, even if they still have insulin left in them.

General information about the safe and effective use of FIASP

• Always use a new syringe and needle for each injection to help ensure sterility and prevent blocked needles. • Do not reuse or share syringes or needles with other people. You may give other people a serious infection or get a serious infection from them. • Keep FIASPvials, syringes, and needles out of the reach of children.

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

FIASP® is a registered trademark of Novo Nordisk A/S.

PATENT Information: http://novonordisk-us.com/patients/products/product-patents.html

© 2017 Novo Nordisk

For information about FIASP® contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, New Jersey 08536

1-800-727-6500

www.novonordisk-us.com

Revised: 09/2017

Instructions for Use

FIASP® (fee’ asp)FlexTouch® Pen

(insulin aspart injection)

• Do not share your FIASP 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. • FIASP FlexTouch Pen (“Pen”)is a prefilled disposable pen containing 300 units of U-100 FIASP (insulin aspart injection). 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 persontrained in the proper use of the product. • Do not use a syringe to remove FIASP from the FlexTouch Pen.

Supplies you will need to give your Fiasp Injection:

• FIASP FlexTouch Pen • a new NovoFine, NovoFine Plus 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 FIASP FlexTouch Pen:

• Wash your hands with soap and water. • Before you start to prepare your injection, check the FIASP 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. • FIASP should look clear and colorless. Do not use FIASP if it is thick, cloudy, or is colored. • Do not use FIASP past the expiration date printed on the label or 28 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.

Step 1: • Pull Pen cap straight off (See Figure B).
Step 2: • Check the liquid in the Pen (See Figure C). FIASP should look clear and colorless. Do not use it if it looks cloudy or colored.
Step 3: • Select a new needle. • Pull off the paper tab from the outer needle cap (See Figure D).
Step 4 • Push the capped needle straight onto the Pen and twist the needle on until it is tight (See Figure E).
Step 5: • Pull off the outer needle cap. Do not throw it away (See Figure F).
Step 6: • Pull off the inner needle cap and throw it away (See Figure G).

Priming your FIASP FlexTouch Pen:

Step 7: • Turn the dose selector to select 2 units (See 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).
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). • If you do not see a drop of insulin, repeat steps 7 to 9, no more than 6 times. • If you still do not see a drop of insulin, change the needle and repeat steps 7 to 9.

Selecting your dose:

Step 10: 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). • If you select the wrong dose, you can turn the dose selector forwards or backwards to the correct dose. • The even numbers are printed on the dial. • The odd numbers are shown as lines.
The FIASP FlexTouch Pen insulin scale will show you how much insulin is left in your Pen (See Figure L).
• To see how much insulin is left in your FIASP FlexTouch Pen: • 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. • 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 FIASP exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting. • You should take your dose of FIASP at the start of a meal or within 20 minutes after starting a meal. • FIASPcan be injected under the skin (subcutaneously) of your stomach area (abdomen), upper legs (thighs) or upper arms. Do not inject FIASP into your muscle. • 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. Let the injection site dry before you inject your dose (See Figure M).
Step 12: • Insert the needle into your skin (See Figure N). • Make sure you can see the dose counter. Do not cover it with your fingers; this can stop your injection.
Step 13: • Press and hold down the dose button until the dose counter shows “0” (See Figure 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 slowlycount to 6 (See Figure P). • When the dose counter returns to “0”, you will not get your full dose until 6 seconds later. • If the needle is removed before you count to 6, you may see a stream of insulin coming from the needle tip. • 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). • 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.
Step 15: • Carefully remove the needle from the Pen and throw it away (See Figure R). • 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. • 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.
Step 16: • Replace the Pen cap by pushing it straight on (See Figure T).

After your injection:

• Put your used FIASP 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: • made of a heavy-duty plastic • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out • upright and stable during use • leak-resistant • 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 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.

How should I store my FIASP FlexTouch Pen?

Before use:

• Store unused FIASP FlexTouch Pens in the refrigerator at 36°F to 46°F (2°C to 8°C) or at room temperature below 86°F (30°C). • Do not freeze FIASP. Do not use FIASP if it has been frozen. • Unused Pens may be used until the expiration date printed on the label, if kept in the refrigerator. • If FIASP FlexTouch Pens are stored at room temperature prior to first use, it should be used or thrown away within 28 days.

Pen in use:

• Store the Pen you are currently using without the needle attached at room temperature below 86°F (30°C) or in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 28 days. • Keep FIASP away from excessive heat or light. • The FIASP FlexTouch Pen you are using is to be thrown away after 28 days, 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 FIASP:

• KeepFIASP FlexTouch Pens and needles out of the reach of children. • Always use a new needle for each injection. • Do not share FIASP FlexTouch Pens or needles with other people. You may give other people a serious infection, or get a serious infection from them.

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: 09/2017

For more information go to

www.FIASPflextouch.com

© 2017 Novo Nordisk

NDC 0169-3201-11 List 320111

FIASP®

(insulin apart injection)

10 mL 100 units/mL (U-100)

Rx only