for adults with diabetes fiasp with your first biteª a ...€¦ · ªinjected at the start of a...

ª Injected at the start of a meal or within 20 minutes after starting a meal.

Fiasp® with your first biteª A mealtime insulin that is designed to work fastLearn how Fiasp® can help control blood sugar when you eat and may help you reach your A1C goal.

For adults with diabetes

Indications and UsageWhat is Fiasp®?• Fiasp® is a man-made insulin used to control high blood

sugar in adults with diabetes mellitus. It is not known if Fiasp® is safe and effective in children.

Important Safety InformationDo 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.

Please see Important Safety Information for Fiasp® throughout brochure. Please see Important Safety Information for NovoLog® (insulin aspart injection) 100 U/mL on pages 22-23. Please see Fiasp® Prescribing Information. Please see NovoLog® Prescribing Information.

https://www.novo-pi.com/fiasp.pdf

https://www.novo-pi.com/novolog.pdf

3

Important Safety Information (cont’d)Who should not take Fiasp®? Do not take Fiasp® if:• your blood sugar is too low (hypoglycemia) or you are

allergic to any of its ingredients.

Before taking Fiasp® tell your health care provider about all your medical conditions including, if you:• have kidney or liver problems• are pregnant or breastfeeding or plan to become

pregnant or breastfeed. It is not known if Fiasp® passes into your breast milk.

• are taking new prescription or over-the-counter medicines, including supplements.

Talk to your health care provider about low blood sugar and how to manage it.

Fiasp® is a formulation of NovoLog® (insulin aspart injection) 100 U/mL that is proven to help control blood sugar when you eat.

32

Contents

Taking a mealtime insulin with a long-acting insulin 4

Fiasp® with your first bite 6

Ways to take Fiasp® 8

How to use your Fiasp® FlexTouch® 9

How to use your Fiasp® Vial 10

Fast facts about diabetes 12

Support from Cornerstones4Care® 14

Save on Fiasp® 16

Frequently asked questions 18

A fast look at Fiasp® mealtime insulinFiasp® is an injectable prescription medication used to help improve blood sugar in adults with type 1 and type 2 diabetes.

Fiasp® at its core:• Fiasp® is designed to work fast. Two ingredients were added

to NovoLog® (insulin aspart injection) 100 U/mL to create Fiasp®: vitamin B3 (niacinamide), which increases the speed of initial insulin absorption, and an amino acid to provide insulin stability

• Fiasp® appears in the bloodstream 2 times faster than NovoLog®, entering in ~2.5 minutes versus ~5.2 minutesa

• Fiasp® gives you options for when you can take it: at the start of a meal or 20 minutes after starting a meal

• Fiasp® has demonstrated A1C reductions in adults with diabetes

If your treatment isn’t giving you the control you need at mealtime, consider a different option. Ask your health care provider about Fiasp®. Visit MyFiasp.com for more information.

Please see Important Safety Information for Fiasp® throughout brochure. Please see Important Safety Information for NovoLog® (insulin aspart injection) 100 U/mL on pages 22-23. Please see Fiasp® Prescribing Information. Please see NovoLog® Prescribing Information.

a The clinical relevance of these results is unknown.



Please see Important Safety Information for Fiasp®

throughout brochure. Please see Important Safety Information for NovoLog® (insulin aspart injection) 100 U/mL on pages 22-23. Please see Fiasp® Prescribing Information. Please see NovoLog® Prescribing Information.

Taking a mealtime insulin with a long-acting insulinWhen you eat, some of your food is broken down into a type of sugar (also called glucose). This sugar travels in your blood to fat and muscle cells in your body, where it is needed for energy. A hormone called insulin helps sugar move from your blood into your cells.

When you have diabetes:

• Your pancreas makes little or no insulin, or • Your body prevents the insulin you do make from working right As a result, sugar can’t get into your cells, so it stays in your blood. That’s why your blood sugar gets high.

Important Safety Information (cont’d) How should I take Fiasp®?• Read the Instructions for Use and take Fiasp® exactly as

your health care 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.

Important Safety Information (cont’d) How should I take Fiasp®? (cont’d)• Know the type and strength of your insulin. Do not

change your insulin type unless your health care provider tells you to.

• 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 health care provider what your blood sugar levels should be and when you should check them.

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

Why you may need to take 2 types of insulin:Basal-Bolus Insulin Therapy

Basal: You may take long-acting, or basal, insulin at night or in the morning (sometimes both) to help control blood sugar between meals and when you sleep.

Bolus: A fast-acting insulin, also called mealtime insulin. It helps control your blood sugar when taken with a meal.

Basal-Bolus: This therapy combines both types of insulin to more closely mimic the way your body’s natural insulin works throughout the day.

Adding a mealtime insulin can help give you the additional blood sugar control you may need when you eat

Breakfast Lunch Dinner

A healthy body’s natural insulin pattern

(Basal) Long-acting insulin pattern

(Bolus) Fast-acting/mealtime insulin pattern

Insulin therapy should mimic the body’s normal insulin patterns as closely as possible throughout the day

Fast-acting (bolus) insulin helps to control the rise in blood sugar that happens when you eat, making it a useful addition to

long-acting (basal) insulin.

Graph for illustrative purposes only.

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Fiasp® with your first biteFiasp® is designed to work fastIt enters your bloodstream in approximately 2½ minutes.

You can take Fiasp®: • At the start of the meal, or• Within 20 minutes after the start of a meal Talk with your health care provider. He or she will let you know what time is right for you.

Fiasp® was proven to lower A1C when taken with long-acting insulin in adults with type 1 and type 2 diabetes.

Fiasp® vs NovoLog® (insulin aspart injection) 100 U/mLYou can take Fiasp® and eat sooner than you can with NovoLog®.

“ Having a mealtime insulin I can take at the start of a meal, or even 20 minutes after I start eating, gives me options when I eat.”

—Vivian Age 58, type 2 diabetes

Models are for illustrative purposes only. Individual results may vary.

MealtimePremeal Postmeal

At the start of a meal

Within 20 minutes after starting a meal

NovoLog® dosing Fiasp® dosing

OR

5-10 minutes before a meal

Fiasp® is designed to work fast at mealtime; it appears in the bloodstream 2 times faster than NovoLog®, entering in ~2.5 minutes versus ~5.2 minutes.a Controlling blood sugar at mealtime may help you reach your A1C goals.Important Safety Information (cont’d)

What should I avoid while taking Fiasp®?• Do not drive or operate heavy machinery, until you

know how Fiasp® affects you.• Do not drink alcohol or use medicines that

contain alcohol.

What are the possible side effects of Fiasp®? Serious side effects can lead to death, including:Low blood sugar (hypoglycemia). Some signs and symptoms include:• anxiety, irritability, mood changes, dizziness or light-

headedness, sweating, confusion, and headache.

76

a The clinical relevance of these results is unknown.





8

Storage conditions for Fiasp® Vials and FlexTouch® pens

Not in-use (unopened) 10-mL vial 3-mL FlexTouch®

Room temperature (below 86°F / 30°C)

28 days 28 days

Refrigerated (36°F to 46°F / 2°C to 8°C)

Until expiration date

Until expiration date

In-use (opened) 10-mL vial 3-mL FlexTouch®

Room temperature (below 86°F / 30°C)

28 days 28 days

Refrigerated (36°F to 46°F / 2°C to 8°C)

28 days 28 days

How to use your Fiasp® FlexTouch®

This is a Quick Guide. Please see Instructions for Use for full information.

1 2

43

5 6

Important Safety Information (cont’d)Your insulin dose may need to change because of:• weight gain or loss, increased stress, illness, or change

in diet or level of physical activity.• low potassium in your blood (hypokalemia). • serious allergic reactions (whole body reactions).

Get emergency medical help right away if you have a rash over your whole body; trouble breathing; a fast heartbeat; swelling of your face, tongue or throat; sweating; extreme drowsiness; dizziness, or confusion.

Ways to take Fiasp®

Fiasp® gives you delivery options:

• FlexTouch®—the latest prefilled insulin pen from Novo Nordisk. Needles are sold separately and may require a prescription in some states

• 10-mL vials—a multidose vial

NovoFine®

NovoFine® Plus NovoTwist®

5 units selected

24 units selected

Examples

NovoFine® NovoFine® Plus NovoTwist®

Prepare your pen

Check your FlexTouch® pen. Read the label to check that your pen contains Fiasp®. Make sure that the liquid in your pen is clear and colorless.

Inject your dose

Insert the needle. Press and hold down the dose button. After the dose counter reaches 0, slowly count to 6.

After your injection

Carefully remove the needle and place it in a sharps container. Put the pen cap back on.

Attach a new needle

Tear off paper tab. Push and turn the needle until it is tight. Pull off both needle caps.

Select your dose

Turn the dose selector to select the number of units you need to inject.

Prime your pen

Turn the dose selector to select 2 units. Holding the pen with the needle pointing up, press and hold in the dose button until the dose counter shows “0.” Make sure a drop of insulin appears at the tip of the needle.

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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 immediately 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 made of heavy-duty plastic like an empty detergent container.

How to use your Fiasp® Vial This is a Quick Guide. Please see Instructions for Use for full information.

1

6

2

8

43

7

5

Important Safety Information (cont’d)Your insulin dose may need to change because of: (cont’d)• 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 health care provider should monitor you closely while you are taking TZDs with Fiasp®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, swelling of your ankles or feet, or sudden weight gain.

Prepare your vial

Pull off the tamper-resistant cap and wipe the rubber stopper with an alcohol swab.

Select your dose

Slowly push the plunger up until the tip of the plunger reaches the line for your prescribed dose.

Check your syringe

If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top.

Prepare your syringe (cont’d)

Put the syringe into the vial. Push the plunger all the way in. This puts air into the vial.

Filling your syringe Turn the 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.

Prepare your syringe 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.

Inject your dose

Insert the needle into your skin. Push down on the plunger to inject your dose. Make sure you have injected all the insulin in the syringe.

Choose your injection site

Wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose.

1110





Fast facts about diabetesDiabetes is a condition in which the body does not make any or enough insulin, or does not correctly use insulin.

What is insulin and how is it used in the body?

• The insulin your body makes naturally is a hormone that helps the body use sugar

• The body turns the food you eat into sugar (or glucose)

• As blood sugar rises, the body produces more insulin, a hormone that helps sugar move from your blood into your cells

• With diabetes, the body doesn’t make any or enough insulin, or cannot correctly use the insulin it does make, leaving too much sugar in the blood

Important Safety Information (cont’d)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), or weight gain.

What is A1C, and why is it important?• A1C measures how well your blood sugar has been controlled

over the past 2 to 3 months and gives you and your health care provider an idea of how well your overall diabetes care plan is working

• Healthy eating, physical activity, and taking diabetes medicine may be parts of your diabetes care plan and are ways to help reduce your A1C

If your current mealtime insulin isn’t giving you the control you need, ask your health care provider if Fiasp® may be right for you. Visit MyFiasp.com for more information.

Why it is important to track your blood sugarChecking and tracking your blood sugar lets you and your health care provider know if your current treatment is working. He or she will tell you when and how often to check your blood sugar. Start tracking today. Download a blood sugar tracker at Cornerstones4Care.com.

When should I test my blood sugar when taking Fiasp®?

You and your health care provider will decide when and how often you should check your blood sugar.

Here are some times when you may be instructed to check:

When you wake up Before meals or large snacks

1 to 2 hours after meals

Before, during, and within minutes after

physical activity

Adjustable dosing You and your health care provider can adjust your Fiasp® dose according to the amount you eat, how active you are, and your blood sugar readings.

Why add mealtime insulin?While most people with type 1 diabetes start out on basal-bolus insulin therapy, many people with type 2 diabetes may not need it right away. But type 2 diabetes can change over time, making it harder to get to your A1C goal, even if you’ve been doing everything right with your care plan. And while you can’t always control these changes, you can control the next step you take— like adding a mealtime insulin.

If you are already taking NovoLog® (insulin aspart injection) 100 U/mL, or another mealtime insulin, talk to your health care provider about whether Fiasp® may be right for you.

Visit MyFiasp.com for additional information. 1312





Support from Cornerstones4Care®

Join Cornerstones4Care® for free support that will help you get started with your new medication.

The program focuses on 4 cornerstones of diabetes care:

Being Active Find ways to stay active without necessarily having to join a gym—small steps in physical activity can make a big difference

Healthy Eating Balancing what, when, and the amount you eat will help you make smart choices

Tracking Checking your blood sugar levels on a regular basis helps to identify patterns and to better inform your health care provider at your next appointment

Medicine

Put the treatment plan your health care provider prescribed into action and create a routine for yourself

Get started. You can sign up at MyFiaspSupport.com or over the phone at 1-877-304-6862.

Stay on track with your treatment plan between visits with your health care provider with this powerful set of Cornerstones4Care® resources:

• Meal Planning Tools—A way to plan and track your meals, and create a menu of tasty, diabetes-friendly dishes

• Diabetes Fact Sheets—Free, downloadable sheets designed to help you learn more about diabetes

• Interactive Trackers—Including A1C, weight, and blood sugar tracking tools

You’ll also have access to the Cornerstones4Care® Diabetes Health Coach—a step-by-step program to help you better manage your diabetes. • Get e-coaching sessions focused on your first 90 days • Track your progress to see how far you’ve come in making

healthy changes • If eligible, you may request phone calls from a Certified

Diabetes Educator (CDE) for additional support when you need it

1514





Save on Fiasp®

Sign up for Cornerstones4Care® to receive an Instant Savings Card. Eligible commercially insured patients can use it to:

• Pay as little as $25 per 30-day supply up to 2 years (maximum savings up to $100 per 30-day supply) when you start Fiasp®

And get a free box of Novo Nordisk needlesa

when you activate your card and enroll in the program.

Activate your card before you go to fill your prescription. And don’t forget to bring your

card when you go to the pharmacy!

aNeedles are sold separately and may need a prescription in some states.

1716

Eligibility and other restrictions apply. For more details, go to novocare.com.





Frequently asked questions1. How is Fiasp® different from

NovoLog® (insulin aspart injection) 100 U/mL? Fiasp® is a formulation of NovoLog® that is proven to help control blood sugar in adults when you eat. Two ingredients were added to NovoLog® to create Fiasp®: niacinamide (vitamin B3), which increases the speed of initial insulin absorption, and an amino acid to aid stability.

2. How is Fiasp® dosing different from NovoLog®? You can take Fiasp® at the start of the meal or within 20 minutes after starting a meal. NovoLog® is taken 5 to 10 minutes before a meal.

Your health care provider will let you know which time is right for you.

3. Do I need to use a new pen every time I dose? While you don’t need to use a new pen for every dose, you should always use a new needle to help ensure sterility and prevent blocked needles. Full instructions for how to use your pen can be found at the end of the Prescribing Information.

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

4. What if I dial up the wrong dose on Fiasp® FlexTouch® before injecting? Turn the dose selector to select the number of units you need to inject. If you select the wrong dose, you can turn the dose selector forwards or backwards to the correct dose.

5. What type of needles should I use with Fiasp® FlexTouch®? Fiasp® FlexTouch® is designed to work with all Novo Nordisk needles—NovoFine® Plus, NovoFine®, and NovoTwist®.

6. How do I discard my pens and needles? Do not recap the needle. Recapping can lead to a needle stick injury. Remove the needle from the Fiasp® FlexTouch® after each injection and dispose of it in a FDA-cleared sharps container. Storing the pen without the needle attached helps prevent leaking, blocking of the needle, and air from entering the pen.

Put your used Fiasp® FlexTouch® and needles in a FDA- cleared sharps disposal container immediately after use. Do not throw away (dispose of) loose needles and pens in your household trash.

If you do not have a sharps container, carefully slip the needle into the outer needle cap. Safely remove the needle and throw it away as soon as you can.

If you do not have a FDA-cleared sharps disposal container, you may use a household container made of heavy-duty plastic like a detergent bottle.

7. What is the most common side effect of Fiasp®? The most common side effect of Fiasp® is low blood sugar.

Some signs and symptoms of low blood sugar include anxiety, irritability, mood changes, dizziness, sweating, confusion, and headache. Severe low blood sugar can be life-threatening. For a list of possible side effects, please see full Prescribing Information.

Call 1-877-304-6862 or visit MyFiasp.com for more information.

Important Safety Information (cont’d)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.

Who should not take Fiasp®? Do not take Fiasp® if:• your blood sugar is too low (hypoglycemia) or you are

allergic to any of its ingredients.Before taking Fiasp® tell your health care provider about all your medical conditions including, if you:• have kidney or liver problems• are pregnant or breastfeeding or plan to become



1918





Please see Fiasp® Prescribing Information.

Indications and UsageWhat is Fiasp®?• Fiasp® is a man-made insulin used to control high blood

sugar in adults with diabetes mellitus. It is not known if Fiasp® is safe and effective in children.

Important Safety InformationDo 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.

Who should not take Fiasp®? Do not take Fiasp® if:• your blood sugar is too low (hypoglycemia) or you are

allergic to any of its ingredients.

Before taking Fiasp® tell your health care provider about all your medical conditions including, if you:• have kidney or liver problems• are pregnant or breastfeeding or plan to become



Talk to your health care provider about low blood sugar and how to manage it.

How should I take Fiasp®?• Read the Instructions for Use and take Fiasp® exactly as

your health care 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 your insulin. Do not change your insulin type unless your health care provider tells you to.

• 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.


• Do not reuse or share your 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®?• Do not drive or operate heavy machinery, until you know

how Fiasp® affects you.• Do not drink alcohol or use medicines that contain

alcohol.

What are the possible side effects of Fiasp®? Serious side effects can lead to death, including:Low blood sugar (hypoglycemia). Some signs and symptoms include:• anxiety, irritability, mood changes, dizziness or light-

headedness, sweating, confusion, and headache.

Your insulin dose may need to change because of:• weight gain or loss, increased stress, illness, or change in

diet or level of physical activity.• low potassium in your blood (hypokalemia).• serious allergic reactions (whole body reactions). Get

emergency medical help right away if you have a rash over your whole body; trouble breathing; a fast heartbeat; swelling of your face, tongue or throat; sweating; extreme drowsiness; dizziness, or 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 health care provider should monitor you closely while you are taking TZDs with Fiasp®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, swelling of your ankles or feet, or sudden weight gain.

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), or weight gain.

2120


22

Please see Important Safety Information for Fiasp® throughout brochure. Please see Important Safety Information for NovoLog® (insulin aspart injection) 100 U/mL on pages 22-23. Please see enclosed Prescribing Information.

Indications and UsageWhat is NovoLog® (insulin aspart injection) 100 U/mL? • NovoLog® is a man-made insulin used to control high blood

sugar in adults and children with diabetes mellitus.

Important Safety Information Do not share your NovoLog® FlexPen®, NovoLog® FlexTouch®, PenFill® cartridge or PenFill® cartridge compatible insulin delivery device 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.

Who should not take NovoLog®? Do not take NovoLog® if: • your blood sugar is too low (hypoglycemia) or you are allergic

to any of its ingredients.

Before taking NovoLog®, tell your health care provider about all your medical conditions including, if you are:

• pregnant, plan to become pregnant, or are breastfeeding.

• taking new prescription or over-the-counter medicines, including supplements.

Talk to your health care provider about how to manage low blood sugar. How should I take NovoLog®?

• Read the Instructions for Use and take exactly as directed.

• NovoLog® is fast-acting. Eat a meal within 5 to 10 minutes after taking it.

• Know the type and strength of your insulin. Do not change your insulin type unless your health care provider tells you to.


• Do not reuse or share your 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 NovoLog®? • Do not drive or operate heavy machinery, until you know

how NovoLog® affects you.

• Do not drink alcohol or use medicines that contain alcohol.

What are the possible side effects of NovoLog®? Serious side effects can lead to death, including: Low blood sugar. Some signs and symptoms include: • anxiety, irritability, mood changes, dizziness, sweating,

confusion, and headache.

Your insulin dose may need to change because of: • weight gain or loss, increased stress, illness, or change in

diet or level of physical activity.

Other common side effects may include: • low potassium in your blood, injection site reactions, itching,

rash, serious whole body allergic reactions, skin thickening or pits at the injection site, weight gain, and swelling of your hands and feet and if taken with thiazolidinediones (TZDs), possible heart failure.

Get emergency medical help if you have: • trouble breathing, shortness of breath, fast heartbeat,

swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.

Please see NovoLog® Prescribing Information.2322


Ask your health care provider if Fiasp® may be

right for you.

Cornerstones4Care®, Fiasp®, FlexPen®, FlexTouch®, NovoFine®, NovoLog®, NovoTwist®, and PenFill® are registered trademarks of Novo Nordisk A/S.Novo Nordisk is a registered trademark of Novo Nordisk A/S.© 2019 Novo Nordisk All rights reserved. US19FSP00019 February 2019

If you need assistance with prescription costs, help may be available. Visit pparx.org or call 1-888-4PPA-NOW.

Call 1-877-304-6862 or visit MyFiasp.com for more information.

Fiasp® is a prescription medicine.

Talk to your doctor about the importance of diet and exercise in your treatment plan.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.





for adults with diabetes fiasp with your first biteª a ...€¦ · ªinjected at the start of a...

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