Consumer medicine information

Fiasp FlexTouch

Insulin aspart

BRAND INFORMATION

Brand name

Fiasp

Active ingredient

Insulin aspart

Schedule

SUMMARY CMI

Fiasp^® FlexTouch^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor, diabetes education nurse, or pharmacist.

▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details.

1. Why am I using Fiasp^® FlexTouch^®?

Fiasp^® contains the active ingredient insulin aspart. Insulin aspart is a rapid-acting insulin used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above.

For more information, see Section 1. Why am I using Fiasp^®? in the full CMI.

2. What should I know before I use Fiasp^® FlexTouch^®?

Do not use if you have ever had an allergic reaction to insulin aspart or any of the ingredients listed at the end of the CMI.

Talk to your doctor or pharmacist if you have any other medical conditions (especially kidney, liver or gland problems), take any other medicines, or are pregnant or plan to become pregnant or are breast-feeding.

For more information, see Section 2. What should I know before I use Fiasp^® FlexTouch^®? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Fiasp^® and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Fiasp^® FlexTouch^®?

Use at the start of a meal (with an option to use up to 20 minutes after starting a meal). Inject into the abdomen, thighs, or upper arms.
Change your injection site regularly. Carefully follow the advice on how to inject under the skin.

Detailed instructions can be found in Section 4. How do I use Fiasp^® FlexTouch^®?.

5. What should I know while using Fiasp^® FlexTouch^®?

Things you should do	Remind any doctor, dentist, pharmacist or diabetes education nurse you visit that you have diabetes and are using insulin. Tell your doctor if you often have hypos (low blood sugar levels). Always carry some sugary food or fruit juice with you.
Things you should not do	Do not stop using your medicine unless your doctor tells you to. Do not use the medicine if you think it has been frozen or exposed to excessive heat.
Driving or using machines	If your blood sugar is low or high your concentration and ability to react might be affected, and therefore also your ability to drive or operate a machine.
Drinking alcohol	Alcohol may mask the symptoms of hypos. If you drink alcohol, your need for insulin may change. Careful monitoring is recommended.
Looking after your medicine	Store Fiasp^® FlexTouch^® that is not being used between 2°C and 8°C in a refrigerator (not in or too near the freezer section or cooling element). You can keep the Fiasp^® FlexTouch^® that you are using, or that you are carrying as a spare, either at room temperature (not above 30°C) or in a refrigerator (2°C to 8°C), for up to 4 weeks.

For more information, see Section 5. What should I know while using Fiasp^®? in the full CMI.

6. Are there any side effects?

The most common side effect when using insulin is low blood sugar levels (a hypo). Tell your relatives, friends, close workmates, teachers or carers that you have diabetes. It is important that they can recognise the signs and symptoms of a hypo. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

FULL CMI

Fiasp^® FlexTouch^®

Active ingredient(s): Insulin aspart

Consumer Medicine Information (CMI)

This leaflet provides important information about using Fiasp^® FlexTouch^®. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Fiasp^® FlexTouch^®.

Where to find information in this leaflet:

1. Why am I using Fiasp^®?
2. What should I know before I use Fiasp^®?
3. What if I am taking other medicines?
4. How do I use Fiasp^® FlexTouch^®?
5. What should I know while using Fiasp^®?
6. Are there any side effects?
7. Product details

1. Why am I using Fiasp^®?

The insulin aspart, or “Fiasp^®”, in Fiasp^® FlexTouch^® is a fast-acting insulin.

Fiasp^® is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above. Diabetes mellitus is a condition where your pancreas does not produce enough insulin to control your blood sugar (glucose) level. Extra insulin is therefore needed.

There are two types of diabetes mellitus:

Type 1 diabetes
Type 2 diabetes

Patients with type 1 diabetes always require insulin to control their blood sugar levels.

Some patients with type 2 diabetes may also require insulin after initial treatment with diet, exercise and tablets.

Fiasp^® lowers your blood sugar level after injection. When injected under your skin, Fiasp^® has a faster onset of action than NovoRapid^®. Fiasp^® can be injected at the start of a meal, with an option to inject up to 20 minutes after starting a meal. A maximum effect occurs between 1 and 3 hours after the injection and the effect lasts for 3-5 hours.

Fiasp^® should normally be used in combination with intermediate-acting or long-acting insulin preparations.

As with all insulins, the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.

FlexTouch^® is a pre-filled dial-a-dose insulin pen able to deliver from 1 to 80 units of Fiasp^® in one injection in steps of 1 unit.

Fiasp^® is not addictive.

Fiasp^® FlexTouch^® is available only with a doctor's prescription.

2. What should I know before I use Fiasp^®?

Warnings

Do not use Fiasp^® if:

you are allergic to a medicine containing insulin, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction may include:
- redness, swelling, rash and itching at the injection site
- rash, itching or hives on the skin
- shortness of breath
- wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body.
you are experiencing a low blood sugar level (a “hypo”) when the dose is due.
If you have a lot of hypos discuss appropriate treatment with your doctor.
the expiry date printed on the pack has passed, or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal. The expiry date refers to the last day of that month.

Check with your doctor or pharmacist if you:

have or have had any other medical conditions such as kidney or liver problems, adrenal, pituitary or thyroid gland problems
take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breast-feeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

Fiasp^® can be used during pregnancy. Pregnancy may make managing your diabetes more difficult. Insulin needs usually decrease during the first three months of pregnancy and increase during the last six months. Your doctor can discuss with you the risks and benefits involved.

Talk to your doctor or pharmacist if you are breast-feeding or intend to breast-feed.

There are no restrictions on treatment with Fiasp^® during breast-feeding.

Heart disease or stroke history

Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who are treated with thiazolidinediones in combination with insulin may develop heart failure.

Use in children

Do not use Fiasp^® in children below the age of 1 year.
There is no experience with the use of Fiasp^® in children below the age of 1 year.
Ensure the correct length of needle is selected for use in children.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines affect your blood sugar level. Your dose of insulin may need to change if you take other medicines.

Medicines that may cause your blood sugar to fall (hypoglycaemia):

other medicines (oral and injectable) used for the treatment of diabetes
sulphonamides – used to treat bacterial infections
monoamine oxidase inhibitors (MAOI) – used for the treatment of depression
beta-blocking agents - used for the treatment of certain heart conditions and high blood pressure
angiotensin converting enzyme (ACE) inhibitors - used for the treatment of certain heart conditions, high blood pressure or elevated protein/albumin in the urine
salicylates e.g. aspirin - used to relieve pain and lower fever
anabolic steroids – used to promote growth.

Medicines that may cause your blood sugar to rise (hyperglycaemia):

glucocorticoids (except when applied locally) – used to treat inflammatory conditions
oral contraceptives (“the pill”) – used for birth control
thiazides – used for the treatment of high blood pressure or fluid retention (oedema)
thyroid hormones – used for the treatment of malfunction of the thyroid gland
sympathomimetics – used for the treatment of asthma
growth hormone – used to treat growth disorders
danazol – used to treat endometriosis, menorrhagia, fibrocystic breast disease and hereditary angioedema.

Medicines that may cause your blood sugar to rise or fall:

octreotide – used to treat gastrointestinal endocrine tumours and enlargement of parts of the body (e.g. hands, feet, head) caused by abnormal growth hormone levels
lanreotide – used to treat enlargement of parts of the body (e.g. hands, feet, head) caused by abnormal hormone levels.

Tell your doctor about any other medicines that you are taking. This is very important. Your doctor will advise you if it is all right to keep taking them or if you should stop taking them.

4. How do I use Fiasp^® FlexTouch^®?

If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use Fiasp^® FlexTouch^®.

Your doctor, diabetes education nurse or pharmacist will have given you advice on how to use your medicine. Carefully follow all the directions. They may differ from the information contained in this leaflet.

Any change in dose or type of insulin should be made cautiously and only under medical supervision.

If you change the type of insulin that you use, you may have to use more or less than before. This may happen with the first dose or over a period of time.

If you do not understand the instructions, ask your doctor, diabetes education nurse or pharmacist for help.

When to use Fiasp^®

Fiasp^® is a mealtime insulin. It can be injected at the start of a meal, with an option to inject up to 20 minutes after starting a meal.

How much to use

It is very important that you manage your diabetes carefully. Too much or too little insulin can cause serious effects.

Dose for type 1 and type 2 diabetes

Your doctor or diabetes education nurse will decide together with you:

how much Fiasp^® you will need at each meal
when to check your blood sugar level and if you need a higher or lower dose.

Check with your doctor, diabetes education nurse or pharmacist first if you want to change your usual diet.

A change in diet may alter your need for insulin.

When using other medicines, ask your doctor if your treatment needs to be adjusted.

Dose adjustment for type 2 diabetes

The dose each day for Fiasp^® should be based on your blood sugar level at mealtimes and bedtime from the previous day.

Before breakfast - dose should be adjusted according to the blood sugar level before lunch the previous day
Before lunch - dose should be adjusted according to the blood sugar level before dinner the previous day
Before dinner - dose should be adjusted according to the bedtime blood sugar level the previous day.

Table 1 Dose adjustment
Mealtime or bedtime plasma glucose	Dose adjustment
mmol/L	Unit
less than 4.0	-1
4.0 - 6.0	no adjustment
more than 6.0	+1

Talk to your doctor about changes in your dose if you are elderly (65 years' or older).

Fiasp^® can be used in elderly patients but if you are elderly you may need to check your blood sugar level more often.

How to use Fiasp^®

Fiasp^® is for injection under the skin (subcutaneous injection). Before you use Fiasp^® for the first time, your doctor or diabetes education nurse will show you how to use the pre-filled pen.
Fiasp^® may be injected into the front of the waist (abdomen), thighs or upper arms.
Do not inject into a vein or muscle.
Remember to rotate your injection site regularly within the same region as shown to you by your doctor or diabetes education nurse.

Checking your Fiasp^® FlexTouch^®:

Check your Fiasp^® FlexTouch^® before each preparation and injection. Make sure you are using the correct type of insulin.
Do not use this medicine if it is thickened, coloured, or has solid bits in it.

Follow the detailed instructions on how to inject Fiasp^® FlexTouch^® in the instructions for use supplied with the product. These instructions are also available via the following hyperlink:
medsinfo.com.au/media/noifiaft

How long to use it

Do not stop using Fiasp^® FlexTouch^® unless your doctor tells you to.

If you use too much Fiasp^® (overdose) – Hypoglycaemia

Your blood sugar level may become too low (you may experience hypoglycaemia or a “hypo”) if you:

accidentally use too much of this medicine
have too much or unexpected exercise
delay eating meals or snacks
eat too little food
are ill.

The first symptoms of mild to moderate hypos can come on suddenly. They may include:

cold sweat, cool pale skin
fatigue, drowsiness, unusual tiredness and weakness
nervousness, anxious feeling, tremor, rapid heart beat
confusion, difficulty concentrating
excessive hunger
vision changes
headache, nausea.

Always carry some sugary food or fruit juice with you.

If you experience any of these symptoms of a hypo, immediately eat some sugary food or have a sugary drink, e.g. lollies, biscuits or fruit juice, and measure your blood sugar level.

Tell your relatives, friends, close workmates, teachers or carers that you have diabetes. It is important that they recognise the signs and symptoms of a hypo.

Make sure they know to give you some sugary food or fruit juice for mild to moderate symptoms of a hypo.

If you lose consciousness, make sure they know:

to turn you on your side and get medical help immediately
not to give you anything to eat or drink.
This is because you could choke.

An injection of the hormone glucagon may speed up recovery from unconsciousness. This can be given by a relative, friend, workmate, teacher or carer who knows how to give it.

If glucagon is used, eat some sugary food or have a sugary drink as soon as you are conscious again.

If you do not feel better after this, contact your doctor, diabetes education nurse, or the closest hospital.

If you do not respond to glucagon treatment, you will require medical attention.

See your doctor if you keep having hypo reactions, or if you have ever become unconscious after using insulin.

Your insulin dose may need to be changed.

If a severe hypo is not treated, it can cause brain damage and even death.

If you think that you have used too much Fiasp^®, you may need urgent medical attention.

You should immediately:

contact your doctor, or
go to the Accident and Emergency department at your nearest hospital, or
phone the Poisons Information Centre
(by calling 13 11 26).

You should do this even if there are no signs of discomfort or poisoning.

If you miss a dose – Hyperglycaemia

If you forget your insulin dose, test your blood sugar level as soon as possible.

If you are not sure what to do, talk to your doctor, diabetes education nurse or pharmacist.

Do not use a double dose of your insulin.

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to.

Otherwise, use it as soon as you remember – don't forget to eat some carbohydrate within 10 minutes of your injection – and then go back to using it as you would normally.

Your blood sugar levels may become high (hyperglycaemia) if you:

miss doses of insulin or use less insulin than you need
have uncontrolled diabetes
exercise less than usual
eat more carbohydrates than usual
are ill or stressed.

High blood sugar levels over a long period of time can lead to too much acid in the blood (diabetic ketoacidosis).

Contact your doctor immediately if your blood sugar level is high or you recognise any of the following symptoms.

Symptoms of mild to moderate hyperglycaemia include:

drowsy feeling
flushed face
thirst, loss of appetite
fruity odour on the breath
blurred vision
passing larger amounts of urine than usual
getting up at night more often than usual to pass urine
high levels of glucose and acetone in the urine.

Symptoms of severe hyperglycaemia include:

heavy breathing
fast pulse
nausea, vomiting
dehydration
loss of consciousness.

Severe hyperglycaemia can lead to unconsciousness and in extreme cases death if untreated.

Discuss any worries you may have about this with your doctor, diabetes education nurse or pharmacist.

5. What should I know while using Fiasp^®?

Things you should do

Measure your blood sugar level regularly.

Make sure all friends, relatives, workmates, teachers or carers know that you have diabetes.

Keep using your insulin even if you feel well.

It helps to control your condition, but does not cure it.

Tell your doctor if you often have hypos (low blood sugar levels).

Your doctor may need to adjust your insulin dose.

Always carry some sugary food or fruit juice with you.

If you experience any of the symptoms of a hypo, immediately eat some sugary food or have a sugary drink, e.g. lollies, biscuits or fruit juice.

Tell your doctor if you have trouble recognising the symptoms of hypos.

Under certain conditions, the early warning signs of hypos can be different or less obvious. Your doctor may need to adjust your insulin dose.

Remind every doctor, dentist or pharmacist or other health professionals who are treating you that you have diabetes and are using insulin.

Tell your doctor, diabetes education nurse or pharmacist if you are travelling.

Ask them for a letter explaining why you are taking injecting devices with you. Each country you visit will need to see this letter, so you should take several copies.

You may need to inject your insulin and eat your meals at different times because of time differences in and between countries.

You may not be able to get the same type of insulin in the country you are visiting.

Things you should not do

Do not stop using your medicine unless your doctor tells you to.

Do not use the medicine if you think it has been frozen or exposed to excessive heat.

It will not work as well.

Do not use this medicine to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not share needles or pens.

Things to be careful of

Tell your doctor if you are ill.

Illness, especially with nausea and vomiting, may cause your insulin needs to change. Even if you are not eating, you still require insulin. You and your doctor should design an insulin plan for those times when you are sick.

Tell your doctor if you are exercising more than usual.

Exercise may lower your need for this medicine. Exercise may also speed up the effect of a dose of it, especially if the exercise involves the area of the injection site (e.g. the thigh should not be used for injection prior to jogging or running).

Tell your doctor if your diet changes.

Changes in diet may cause your insulin needs to change.

Tell your doctor if you notice any skin changes at the injection site.

If you inject insulin at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis). The insulin may not work very well if you inject into a lumpy, shrunken or thickened area. Change the injection site with each injection to help prevent these skin changes.

Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Driving or using machines

Be careful driving or operating machinery until you know how the insulin affects you.

If your blood sugar is low or high your concentration and ability to react might be affected, and therefore also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or others. Please ask your doctor whether you can drive a car:

if you have frequent hypos
if you find it hard to recognise hypoglycaemia.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Alcohol may mask the symptoms of hypos. If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.

Looking after your medicine

Store Fiasp^® FlexTouch^® that is not being used between 2°C and 8°C in a refrigerator (not in or too near the freezer section or cooling element).
You can carry the Fiasp^® FlexTouch^® that you are using, or that you are carrying as a spare, with you. You can keep it at room temperature (not above 30°C) or in a refrigerator (2°C - 8°C) for up to 4 weeks.
Discard Fiasp^® FlexTouch^® after 4 weeks even if there is still some Fiasp^® left in it.
Protect the Fiasp^® in Fiasp^® FlexTouch^® from light by always keeping the cap on the pen when not in use.
Never use Fiasp^® FlexTouch^® after the expiry date printed on the label and carton after ‘EXP.’ The expiry date refers to the last day of that month.
Never use Fiasp^® FlexTouch^® if the solution is not clear and colourless.
Keep out of the reach of children.

Disposal of your medicine

Dispose of used needles safely into a yellow plastic sharps container.
If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date. The expiry date refers to the last day of that month.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

Ask your doctor or pharmacist to answer any questions you have. Tell your doctor, diabetes education nurse or pharmacist as soon as possible if you do not feel well while you are using Fiasp^® FlexTouch^®.

Common side effects

Less serious side effects

What to do

The most common side effect when using insulin is low blood sugar levels (a hypo).

Mild to moderate

Other effects:

rash, redness, inflammation, bruising or itching at the injection site.
Usually these symptoms disappear within a few weeks during continued use.
If you have serious or continuing reactions, you may need to stop using Fiasp^® and use another insulin.
more widespread signs of allergy on the skin such as eczema, rash, itching, hives or dermatitis
a depression or thickening of the skin around the injection site (lipodystrophy).
lumps under your skin (cutaneous amyloidosis).
when you first start your insulin treatment you may get visual problems, nerve-related pain or swollen hands and feet.

Speak to your doctor, diabetes education nurse or pharmacist if you have any of these less serious side effects and they worry you.
They are usually mild and short-lived.

Serious side effects

Serious side effects

What to do

Symptoms of severe low blood sugar levels:

disorientation
seizures, fits or convulsions
loss of consciousness.

If a severe hypo is not treated, it can cause brain damage and death.

Other effects:

skin rashes over a large part of the body
shortness of breath, wheezing
swelling of the face, lips or tongue
fast pulse
sweating.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of these serious side effects.
You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

What Fiasp^® contains

Active ingredient (main ingredient)	insulin aspart 100 units per mL (100 U/mL)
Other ingredients (inactive ingredients)	phenol, metacresol, glycerol, zinc acetate, dibasic sodium phosphate dihydrate, arginine hydrochloride, nicotinamide (also known as niacinamide or vitamin B3), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

Fiasp^® FlexTouch^® contains less than 1 mmol sodium (23 mg) per dose. This means that the medicine is essentially ‘sodium-free’.

Do not take this medicine if you are allergic to any of these ingredients.

What Fiasp^® looks like

Fiasp^® is a clear, colourless solution for subcutaneous injection. Fiasp^® FlexTouch^® is a 3 mL pre-filled glass cartridge contained in a dial-a-dose insulin pen. Pack sizes of 1 and 5 pre-filled pens of 3 mL. (AUST R 275394)

Not all pack sizes may be marketed.

Who distributes Fiasp^®

Fiasp^® FlexTouch^® is supplied in Australia by:

Novo Nordisk Pharmaceuticals Pty Ltd
Level 10
118 Mount Street
North Sydney NSW 2060
Australia

Fiasp^® FlexTouch^® is supplied in New Zealand by:

Novo Nordisk Pharmaceuticals Ltd.
11-19 Customs Street West
Commercial Bay Tower, Level 18, Office 1834
Auckland 1010
New Zealand

Fiasp^®, FlexTouch^®, NovoRapid^®, NovoCare^® and NovoFine^® are registered trademarks of Novo Nordisk A/S.

For further information:

For further information call the NovoCare^® Customer Care Centre on 1800 668 626 (Australia) or 0800 733 737 (New Zealand).

You can also get more information about diabetes and insulin from:

Diabetes Australia:

freecall helpline 1300 136 588
www.diabetesaustralia.com.au

Diabetes New Zealand:

www.diabetes.org.nz

This leaflet was prepared on 02 November 2021.

Published by MIMS May 2024

BRAND INFORMATION

Brand name

Fiasp

Active ingredient

Insulin aspart

Schedule

1 Name of Medicine

Insulin aspart (rys).

2 Qualitative and Quantitative Composition

Insulin aspart is an analogue of human insulin, differing by the substitution of the amino acid proline by aspartic acid at position 28 on the B-chain. Insulin aspart is produced by recombinant DNA technology in Saccharomyces cerevisiae.
1 mL of the solution contains 100 units of insulin aspart (equivalent to 3.5 mg).
FlexTouch: 1 pre-filled pen contains 3 mL equivalent to 300 units.
Vial: 1 vial contains 10 mL equivalent to 1,000 units.
Penfill: 1 cartridge contains 3 mL equivalent to 300 units.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sterile, clear, colourless, aqueous, ultra-fast acting solution for subcutaneous injection, subcutaneous infusion or intravenous injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

4.2 Dose and Method of Administration

Dosage.

Fiasp should be administered 0-2 minutes prior to starting a meal. Administration of Fiasp up to 20 minutes after starting a meal in adults was as efficacious as NovoRapid given before a meal (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
Fiasp can be used for continuous subcutaneous insulin infusion (CSII) in pumps or be administrated intravenously by healthcare professionals.
The potency of insulin analogues, including Fiasp, is expressed in units. One (1) unit of Fiasp corresponds to 1 international unit of human insulin or 1 unit of other fast-acting insulin analogues.
Dosing with Fiasp is individual and determined in accordance with the needs of the patient, in particular the estimated carbohydrate consumption and glycaemic load of the meal.
The pharmacokinetic profiles of Fiasp and NovoRapid are distinct during the first hour following administration which is of particular importance for a mealtime insulin. The earlier onset of action of Fiasp and the subsequent increased glucose lowering effect compared with NovoRapid must be considered when prescribing Fiasp.

Injection therapy.

Fiasp should be used in combination with intermediate-acting or long-acting insulin given at least once a day. In a basal-bolus treatment regimen approximately 50% of this requirement may be provided by Fiasp and the remainder by intermediate acting or long-acting insulin.

CSII.

Fiasp can be used for continuous subcutaneous insulin infusion (CSII) in pumps. In this case, Fiasp will cover both the need for bolus insulin (approximately 50%) and basal insulin. The timing of basal and bolus doses may require alterations when changing insulin formulations.
Blood glucose monitoring and insulin dose adjustment are recommended to achieve optimal glycaemic control.

Missed dose.

Patients on basal-bolus treatment who forget a mealtime dose are advised to monitor their blood glucose level to decide if an insulin dose is needed. Patients should resume their usual dosing schedule at the next meal.

Initiation.

Patients with type 1 diabetes mellitus.

The recommended starting dose of Fiasp in insulin naïve patients with type 1 diabetes is approximately 50% of the total daily insulin dose and should be divided between each daily meal. The remainder of the total daily insulin dose should be administered as intermediate-acting or long-acting insulin. As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin naïve patients with type 1 diabetes.

Patients with type 2 diabetes mellitus.

Suggested initial dose is 4 units at one or more meals. Number of injections and subsequent titration will depend on individual glycaemic target.

Transfer from other insulin medicinal product.

Close glucose monitoring is recommended during the transfer from other mealtime insulins and in the initial weeks thereafter.
Converting from another mealtime insulin can be done on a unit-to-unit basis. Due to the faster onset of insulin action, Fiasp should be injected at the start of a meal or postmeal (within 20 minutes after starting a meal).
Due to the earlier onset of action of Fiasp and the subsequent increased glucose lowering effect, transferring a patient from another type, brand or manufacturer of insulin including NovoRapid or other insulin aspart products, to Fiasp must be done under medical supervision and may result in the need for a change in dosage. Patients transferring from other insulins will require training.
Doses and timing of concurrent intermediate or long-acting insulin products or other concomitant antidiabetic treatment may need to be adjusted.

Use in the elderly (≥ 65 years old).

The safety and efficacy of Fiasp have been established in elderly patients. Close glucose monitoring is recommended and the insulin dose should be adjusted on an individual basis (see Section 5 Pharmacological Properties).

Renal impairment.

Renal impairment may reduce the patient's insulin requirements. In patients with renal impairment, glucose monitoring should be intensified and the dose adjusted on an individual basis (see Section 5.2 Pharmacokinetic Properties).

Hepatic impairment.

Hepatic impairment may reduce the patient's insulin requirements. In patients with hepatic impairment, glucose monitoring should be intensified and the dose adjusted on an individual basis (see Section 5.2 Pharmacokinetic Properties).

Paediatric population.

There is no clinical experience with the use of Fiasp in children below the age of 2 year.
Fiasp is recommended to be administered prior to the meal (0-2 minutes).

Method of administration.

Fiasp comes in a prefilled pen (FlexTouch) designed to be used with NovoFine or NovoFine Plus injection needles. Fiasp FlexTouch delivers 1-80 units in steps of 1 unit. Fiasp FlexTouch is colour-coded and accompanied by a package leaflet with detailed instructions for use to be followed.
Fiasp comes in a vial to be used with insulin syringes with the corresponding unit scale (U-100 or 100 U/mL).
Fiasp comes in a cartridge (Penfill) designed to be used with Novo Nordisk insulin delivery systems (NovoPen) and NovoFine or NovoFine Plus injection needles.

Penfill/FlexTouch.

Needles and Fiasp Penfill/Fiasp FlexTouch must not be shared. The cartridge must not be refilled.

Fiasp vial.

Needles and syringes must not be shared.
Fiasp must not be used if the solution does not appear clear and colourless.
Fiasp which has been frozen must not be used.
The patient should discard the needle after each injection.

Subcutaneous injection.

Fiasp is administered subcutaneously in the abdominal wall, the upper arm or the thigh. Injection sites should be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).
The duration of action of Fiasp may vary according to the dose, injection site, blood flow, temperature and level of physical activity.

Continuous subcutaneous insulin infusion (CSII).

Fiasp can be used for Continuous Subcutaneous Insulin Infusion (CSII) in pumps suitable for insulin infusion. Fiasp can be administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy. When used with an insulin infusion pump, Fiasp should not be diluted or mixed with any other insulin products.
Patients using CSII should be instructed in the use of the pump and use the correct reservoir and tubing for pump (see Section 6 Pharmaceutical Particulars). The infusion set (tubing and cannula) should be changed in accordance with the instructions in the product information supplied with the infusion set.
Insulin pumps manufactured by Medtronic and Animas have been used in clinical or in vitro studies.
MiniMed Paradigm 515/715;
MiniMed Paradigm 522/722 REAL-time;
MiniMed Paradigm 523/723 REAL-time Revel;
Animas Vibe.
Patients administering Fiasp by CSII must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

Intravenous use.

If necessary, Fiasp can be administered intravenously by health care professionals. For intravenous use Fiasp should be used at concentrations from 0.5 unit/mL to 1.0 unit/mL insulin aspart in infusion systems using polypropylene infusion bags. Fiasp has been shown to be stable at room temperature for 24 hours in the infusion fluids such as 0.9% sodium chloride or 5% dextrose. Monitoring of blood glucose is necessary during insulin infusion. Care should be taken to ensure that the insulin is injected into the infusion bag and not simply the entry port.

Dosage adjustment.

The individual total daily insulin requirement in adults, adolescents and children may vary and is usually between 0.5 and 1.0 unit/kg/day. Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness. Blood glucose levels should be monitored adequately under these conditions.

Patients with type 2 diabetes mellitus.

Fiasp adjustment may be considered daily based on mealtime and bedtime SMPG on the previous day according to Table 1.
Pre-breakfast Fiasp should be adjusted according to the pre-lunch SMPG the previous day.
Pre-lunch Fiasp should be adjusted according to the pre-dinner SMPG the previous day.
Pre-dinner Fiasp should be adjusted according to the bedtime SMPG the previous day.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients listed in Section 6.1 List of Excipients.

4.4 Special Warnings and Precautions for Use

Regular blood glucose monitoring is essential in patients on intensive insulin therapy and when there is a change in insulin type or dose.

Hypoglycaemia.

Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see Section 4.8 Adverse Effects (Undesirable Effects); Section 4.9 Overdose.)
Patients who have frequent hypoglycaemia or asymptomatic hypoglycaemia may require a reduction in insulin dose or a change in glycaemic targets. Patients whose blood glucose control is greatly improved e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly. Usual warning symptoms may disappear in patients with longstanding diabetes or who have frequent episodes of hypoglycaemia.
The timing of hypoglycaemia usually reflects the time-action profile of the administered insulin formulation. Fiasp has a distinct time action profile (see Section 5 Pharmacological Properties), which impacts the timing of hypoglycaemia. A consequence of the pharmacodynamics of Fiasp is that if hypoglycaemia occurs, it may occur earlier after an injection/infusion when compared to other mealtime insulins.
The fast onset of action should be considered in patients with delayed gastric emptying.
Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland may require changes in the insulin dose.

Paediatric population.

Closer monitoring of blood glucose levels in the evening and before bedtime is recommended if administering this medicine after the start of the last meal of the day, in order to avoid nocturnal hypoglycaemia.

Hyperglycaemia.

The use of inadequate doses or discontinuation of treatment, especially in patients requiring insulin, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.

Skin and subcutaneous tissue disorders.

Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site from an affected to an unaffected area, and dose adjustment of antidiabetic medications may be considered.

Continuous subcutaneous insulin infusion (CSII).

Pump or infusion set malfunctions can lead to a fast onset of hyperglycaemia and ketosis. Prompt identification and correction of the cause of hyperglycaemia or ketosis is necessary. Interim therapy with subcutaneous injection may be required.

Transfer from other insulin medicinal products.

See Section 4.2 Dose and Method of Administration.

Combination of thiazolidinediones and insulin medicinal products.

Cases of congestive heart failure have been reported when thiazolidinediones were used in combination with insulin, especially in patients with risk factors for development of congestive heart failure. This should be kept in mind if treatment with the combination of thiazolidinediones and insulin medicinal products is considered. If the combination is used, patients should be observed for signs and symptoms of congestive heart failure, weight gain and oedema. Thiazolidinediones should be discontinued if any deterioration in cardiac symptoms occurs.

Insulin initiation and glucose control intensification.

Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, acute painful peripheral neuropathy, and peripheral oedema. However, long-term glycaemic control decreases the risk of diabetic retinopathy and neuropathy.

Insulin antibodies.

Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.

Avoidance of accidental mix-ups/medication errors.

Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between Fiasp and other insulin products.
Patients must visually verify the units of the dose prior to administering Fiasp. Therefore, the requirement for patients to self-administer is that they can read the dose scale. Patients, who are blind or have poor vision, must be instructed to always get assistance from another person who has good vision and is trained in administration of insulins.

Use in hepatic impairment.

Use in renal impairment.

Use in elderly.

Paediatric use.

The efficacy and safety of Fiasp in children below 1 year of age have not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

A number of medicinal products are known to interact with the glucose metabolism.
The following substances may reduce insulin requirement:
Oral antidiabetic products, monoamine oxidase inhibitors (MAOIs), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids, sulphonamides and GLP-1 receptor agonists.
The following substances may increase insulin requirement:
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Beta-blocking agents may mask the symptoms of hypoglycaemia.
Octreotide/lanreotide may either increase or decrease the insulin requirement.
Alcohol may intensify or reduce the hypoglycaemic effect of insulin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

In reproductive toxicity studies, insulin aspart did not affect the fertility of male and female rats but caused a slight increase in pre-implantation loss at subcutaneous doses greater than 10 U/kg/day. Similar effects were seen with human insulin.
(Category A)
Fiasp can be used in pregnancy. Data from two randomised controlled clinical trials conducted with insulin aspart (157 + 14 insulin aspart-exposed pregnancies, respectively) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/new born when compared to soluble human insulin. Intensified blood glucose control and monitoring of pregnant women with diabetes (type 1 diabetes, type 2 diabetes or gestational diabetes) are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters. After delivery, insulin requirements normally return rapidly to pre-pregnancy values.
Although no clinical trial data are available with insulin aspart products during lactation, there are no restrictions on treatment with Fiasp during breast-feeding. Insulin treatment of the nursing mother should not affect the baby. However, the Fiasp dosage may need to be adjusted.

4.7 Effects on Ability to Drive and Use Machines

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery). Patients should be advised to take precautions to avoid hypoglycaemia while driving. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.

4.8 Adverse Effects (Undesirable Effects)

Summary of safety profile.

The most frequently reported adverse drug reaction (ADR) during treatment with insulin, including Fiasp, is hypoglycaemia (see section Description of selected ADRs below).

Adverse events from clinical trials.

See Table 2.

Adverse reactions listed below are based on post-marketing source data and classified according to MedDRA system organ class. See Table 3.

Tabulated list of adverse reactions.

Adverse reactions (ADRs) listed below are considered expected with the medicinal product.
Less common ADRs from clinical trials (< 1%). Adverse reactions are listed by system organ class using the frequency category 'uncommon' (≥ 1/1,000 to < 1/100).

Immune system disorders.

Uncommon - hypersensitivity.

Skin and subcutaneous tissue disorders.

Uncommon - lipodystrophy.

ADRs from postmarketing sources.

No additional types of adverse reactions have been identified during postmarketing use.

Description of selected ADRs.

Allergic reactions.

Allergic skin manifestations reported with Fiasp (1.8% vs. 1.5% for comparator) include eczema, rash, rash pruritic, urticaria and dermatitis.
With Fiasp generalised hypersensitivity reactions (manifested by generalised skin rash and facial oedema) was reported uncommonly (0.2% vs. 0.3% for comparator). Based on post-marketing data, serious forms of systemic allergic reactions may occur. Immediate-type allergic reactions to either insulin itself or the excipients may potentially be life-threatening.

Hypoglycaemia.

Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. The symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentrating, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.

Skin and subcutaneous tissue disorders.

Lipodystrophy (including lipohypertrophy, lipoatrophy) and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Lipodystrophy was reported at the injection/infusion site in patients treated with Fiasp (0.5% vs. 0.2% in comparator). Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions (see Section 4.4 Special Warnings and Precautions for Use).

Injection/infusion site reactions.

As with any insulin therapy, injection site reactions (including rash, redness, inflammation, pain and bruising) were reported in patients treated with Fiasp (1.3% vs. 1.0% in comparator). Infusion site reactions (including redness, inflammation, irritation, pain, bruising, and itching) were reported in patients treated with Fiasp (10.0% vs. 8.3% in comparator). These reactions are usually mild and transient and they normally disappear during continued treatment.

Paediatric population.

Fiasp has been administered to children and adolescents from 6 years up to 18 years of age for the investigation of pharmacokinetic properties (see Section 5 Pharmacological Properties). Safety and efficacy have been investigated in a therapeutic confirmatory trial in children with type 1 diabetes mellitus aged 2 to less than 18 years. In the trial, 519 patients were treated with Fiasp. Overall the frequency, type and severity of adverse reactions in the paediatric population do not indicate differences to the experience in the adult population. Lipodystrophy (including lipohypertrophy, lipoatrophy) at the injection site was reported more often in paediatric patients compared to adults. In the paediatric population lipodystrophy was reported with a frequency of 2.1% for Fiasp vs. 1.6% for NovoRapid.
Additional information on paediatric patients is provided in Table 6, see Section 5.1 Pharmacodynamic Properties, Clinical trials.

Other special populations.

Based on results from clinical trials, the frequency, type and severity of ADRs observed in elderly patients and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population. Fiasp has been administered to elderly patients for the investigation of pharmacokinetic properties (see Section 5 Pharmacological Properties).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

ADRs listed in this section are considered expected with the medicinal product.
A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if a patient is dosed with more insulin than required: Mild hypoglycaemic episodes can be treated by oral administration of glucose or other products containing sugar. It is therefore recommended that the diabetic patient always carries glucose containing products.
Severe hypoglycaemic episodes, where the patient is not able to treat him/herself, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional. Glucose must be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes. Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent a relapse.
For information on the management of overdose (in non-emergency situations), contact the Poison Information Centre on 131 126 (Australia).

5 Pharmacological Properties

Pharmacotherapeutic group: Drugs used in diabetes. Insulins and analogues for injection, fast-acting. ATC code A10AB05.

5.1 Pharmacodynamic Properties

Mechanism of action.

Fiasp is a fast-acting insulin aspart formulation. The primary activity of insulin, including insulin aspart, is the regulation of glucose metabolism. Insulin and its analogues exert their specific action through binding to insulin receptors. Receptor-bound insulin lowers blood glucose by facilitating cellular uptake of glucose into skeletal muscle and adipose tissue and by inhibiting the output of glucose from the liver. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.
Fiasp is an insulin aspart formulation in which the addition of nicotinamide (niacinamide; vitamin B₃) results in a faster initial absorption of insulin, leading to an earlier onset of action and greater early glucose-lowering effect compared to NovoRapid. The onset of action was 5 minutes faster and time to maximum glucose infusion rate was 11 minutes earlier with Fiasp than with NovoRapid. The glucose lowering effect (AUC_GIR) was 74% larger during the first 30 minutes with Fiasp than with NovoRapid. The total glucose lowering effect over the mealtime phase and maximum (GIR_max) glucose lowering effect were comparable between Fiasp and NovoRapid. Total and maximum glucose lowering effect of Fiasp increase linearly with increasing dose within the therapeutic dose range similar to NovoRapid.
The duration of action was shorter and the late glucose lowering effect was 10% smaller for Fiasp compared to that of NovoRapid. Fiasp injected at the start of a meal produced a significantly greater postmeal glucose lowering effect after a standardised mixed meal test (80 g carbohydrate; 'Ensure' liquid shake) compared to NovoRapid. The treatment difference in reduction of 2-hour postmeal glucose increment was statistically significant in favour of Fiasp (-0.67 mmol/L [-1.29; -0.04]_95%CI). The treatment difference in reduction of 1-hour postmeal glucose increment was -1.18 mmol/L [-1.65; -0.71]_95%CI) consistent with the earlier absorption profile (see Table 4, in Clinical trials and Figure 1).

The day-to-day variability within-patients in glucose-lowering-effect was low for Fiasp both for early (AUC_{GIR, 0-1 h}, CV~26%), total (AUC_{GIR, 0-12 h}, CV~18%) and maximum glucose lowering effect (GIR_max, CV 19%).

Continuous subcutaneous insulin infusion (CSII).

Fiasp showed a greater postmeal glucose lowering effect after a standardised meal test with regard to 1-hour and 2-hour PPG response (treatment difference: -0.50 mmol/L [-1.07; 0.07]_{95% CI} and -0.99 mmol/L [-1.95; -0.03]_{95% CI}), respectively compared to NovoRapid (Figure 2) in a CSII setting.

Elderly.

In elderly patients with type 1 diabetes, Fiasp showed an earlier onset of action and a greater early glucose-lowering effect whilst maintaining a similar total and maximum glucose-lowering effect compared to NovoRapid. The total and the maximum glucose-lowering effect with Fiasp were comparable between elderly and younger adults.

Obesity.

The effect of BMI on the pharmacodynamics of Fiasp was explored in a cross-trial analysis of pharmacodynamic studies. Fiasp had a greater early glucose-lowering effect whilst maintaining a total and maximum glucose-lowering effect comparable to NovoRapid across BMI levels in patients with type 1 diabetes.
A trend for decrease in glucose-lowering effect of Fiasp with increasing BMI was observed in patients with type 1 diabetes.

Paediatric population.

For children, the glucose-lowering effect of Fiasp at 1 and 2 hours was > 30% greater than with NovoRapid, measured by mean changes in plasma glucose at 1 and 2 hours. There is no clinically relevant difference in the pharmacodynamic properties of Fiasp between children (6-11 years), adolescents (12-18 years) and adult patients with type 1 diabetes.

Clinical trials.

Clinical efficacy and safety data. Fiasp has been studied in 2068 randomised adult patients with type 1 diabetes mellitus (1143 patients) and type 2 diabetes mellitus (925 patients) in 3 long-term (18 - 26 weeks of treatment) efficacy and safety trials. Furthermore, Fiasp has been studied in 777 randomised adolescents and children aged 1 to less than 18 years with type 1 diabetes mellitus in a long-term (26 weeks of treatment) efficacy and safety trial.