Fiasp should be injected up to 2 minutes before the start of the meal, with an option to inject up to 20 minutes after starting the meal.

This medicine has its maximum effect between 1 and 3 hours after the injection and the effect lasts for 3 to 5 hours.

This medicine should normally be used in combination with intermediate-acting or long-acting insulin preparations.

What you need to know before you use Fiasp

Be especially aware of the following:

• Low blood sugar (hypoglycaemia). Fiasp® starts to lower blood sugar faster if you are allergic to insulin aspart, or any of the other ingredients of this medicine compared to other mealtime insulins. If hypoglycaemia occurs, you may experience it earlier after an injection with Fiasp.

• High blood sugar (hyperglycaemia)

• Switching from other insulin medicinal products - the insulin dose may need to be changed

• Pioglitazone used together with insulin - this may increase the risk of heart failure

• Eye disorder - fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disorder.

• Pain due to nerve damage - if your blood sugar level improves very fast, you may get nerve related pain, this is usually temporary.

• Swelling around your joints - when you first start using your medicine, your body may keep more water than it should. This causes swelling around your ankles and other joints. This is usually only short-lasting.

Some conditions and activities can affect how much insulin you need. Talk to your doctor:

• if you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.

• if you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.

• if you are ill, carry on taking your insulin and talk to your doctor.

Children and adolescents

This medicine is not recommended for use in children below the age of 1 year.

Other medicines and Fiasp

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines affect your blood sugar level - this may mean your insulin dose has to change.

Listed below are the most common medicines which may affect your insulin treatment.

Your blood sugar level may fall (hypoglycaemia) if you take:

• other medicines for diabetes (oral and injectable)

• sulphonamides - for infections

• anabolic steroids - such as testosterone

• beta-blockers - for e.g., high blood pressure or angina. They may make it harder to recognise the warning signs of low blood sugar.

• acetylsalicylic acid (and other salicylates) - for pain and mild fever

• monoamine oxidase (MAO) inhibitors - for depression

• angiotensin converting enzyme (ACE) inhibitors - for some heart problems or high blood pressure.

Your blood sugar level may rise (hyperglycaemia) if you take:

• danazol - for endometriosis
• oral contraceptives (birth control pills)
• thyroid hormones - for thyroid problems
• growth hormone - for growth hormone deficiency
• glucocorticoids such as ‘cortisone’ - for inflammation
• sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline - for asthma
• thiazides - for high blood pressure or water retention

Octreotide and lanreotide - used to treat a rare condition involving too much growth hormone (acromegaly). They may increase or decrease your blood sugar level.

Pioglitazone it is an oral anti-diabetic medicine used to treat type 2 diabetes. Some patients with long- standing type 2 diabetes and heart disease or previous stroke who were treated with pioglitazone and insulin developed heart failure. Tell your doctor immediately if you have signs of heart failure such as unusual shortness of breath, rapid increase in weight or localised swelling (oedema).

Fiasp with alcohol

If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. You should therefore monitor your blood sugar level more often than usual.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. This medicine can be used during pregnancy; however your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes is needed in pregnancy. Avoiding low blood sugar (hypoglycaemia) is particularly important for the health of your baby.

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

Driving and using machines

Having low blood sugar can affect your ability to drive or use any tools or machines. If your blood sugar is low, your ability to concentrate or react might be affected. This could be dangerous to yourself or others. Ask your doctor whether you can drive if:

• you often get low blood sugar
• you find it hard to recognise low blood sugar.

How to use Fiasp

The pre-filled pen can provide a dose of 1–80 units in one injection in steps of 1 unit.

When to use Fiasp

Fiasp is a mealtime insulin.

Adults: Fiasp should be injected right before (0-2 minutes) the start of the meal, with an option to inject up to 20 minutes after starting the meal.

Children: Fiasp should be injected right before (0-2 minutes) the start of the meal, with the possibility to inject up to 20 minutes after starting the meal in situations, when there is uncertainty about how the child will eat. Ask your doctor for advice on these situations.

This medicine has its maximum effect between 1 and 3 hours after the injection and the effect lasts for 3 to 5 hours.

Fiasp dose

Patients with type 1 diabetes mellitus

The recommended starting dose in insulin naïve patients with type 1 diabetes is approximately 50% of the total daily insulin dose and should be divided between the meals based on the size and composition of the meals. 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 the individual glycaemic target and the size and composition of the meals.

Dose adjustment for type 2 diabetes

The daily dose 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.

Use in elderly patients (65 years or older)

This medicine can be used in elderly patients. Talk to your doctor about changes in your dose.

If you have kidney or liver problems

If you have kidney or liver problems you may need to check your blood sugar level more often. Talk to your doctor about changes in your dose.

Injecting Fiasp

This medicine is only suitable for injection under the skin (subcutaneous injection).

Where to inject

► The best places to inject are the front of your waist (abdomen) or upper arms.

► Do not inject into a vein or muscle.

► Change the place within the area where you inject each day to reduce the risk of developing changes under the skin.

Do not use Fiasp

• if the pen is damaged or if it has not been stored correctly.
• if the insulin does not appear clear (e.g., cloudy) and colourless.

If you use more Fiasp® than you should

If you use too much insulin your blood sugar may get too low (hypoglycaemia).

If you forget to use Fiasp®

If you forget to use your insulin your blood sugar may get too high (hyperglycaemia).

If you stop using Fiasp

Do not stop using your insulin without talking to your doctor. If you stop using your insulin this could lead to a very high blood sugar level (severe hyperglycaemia) and ketoacidosis (a condition with too much acid in the blood which is potentially life-threatening). 

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Low blood sugar (hypoglycaemia) is very common with insulin treatment (may affect more than 1 in 10 people). It can be very serious. If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If you have symptoms of low blood sugar, take actions immediately to increase your blood sugar level. 

Signs of a serious allergic reaction may include:

• local reactions (e.g., rash, redness and itching) spread to other parts of your body
• you suddenly feel unwell with sweating
• you start being sick (vomiting)
• you experience difficulty in breathing
• you experience rapid heartbeat or feeling dizzy.

Allergic reactions such as generalised skin rash and facial swelling may occur. See a doctor if the symptoms worsen or you see no improvement in a few weeks.

Other side effects include:

Common 

Reaction at administration site: Local reactions at the place you inject yourself may occur. The signs may include: rash, redness, inflammation, bruising, irritation, pain and itching. The reactions usually disappear after a few days.

Skin reactions: Signs of allergy on the skin such as eczema, rash, itching, hives and dermatitis may occur.

Uncommon

Changes under the skin where you use the injection (lipodystrophy): Fatty tissue under the skin may shrink (lipoatrophy) or get thicker (lipohypertrophy). Changing where you inject each time may reduce the risk of developing these skin changes. If you notice these skin changes, tell your doctor or nurse. If you keep injecting in the same place, these reactions can become more severe and affect the amount of medicine your body gets.

General effects from insulin treatment including Fiasp

Low blood sugar (hypoglycaemia) is very common. Low blood sugar may happen if you: drink alcohol; use too much insulin; exercise more than usual; eat too little or miss a meal.

Warning signs of low blood sugar – these may come on suddenly:

• headache

• slurred speech

• fast heartbeat

• cold sweat

• cool pale skin

• feeling sick

• feeling very hungry

• tremor or feeling nervous or worried

• feeling unusually tired, weak and sleepy

• feeling confused

• difficulty in concentrating

• short-lasting changes in your sight.

What to do if you get low blood sugar

► If you are conscious, treat your low blood sugar immediately with 15–20 g of fast-acting carbohydrate: eat glucose tablets or another high sugar snack, like fruit juice, sweets or biscuits (always carry glucose tablets or a high sugar snack, just in case).

► It is recommended that you retest your blood glucose levels after 15–20 minutes and re-treat if your blood glucose levels are still less than 4 mmol/L.

► Wait until the signs of low blood sugar have gone or when your blood sugar level has settled. Then carry on with your insulin treatment as usual.

What others need to do if you pass out

Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood sugar gets too low, including the risk of passing out.

Let them know that if you pass out, they must:

► turn you on your side to avoid choking

► get medical help straight away

► not give you any food or drink because you may choke.

You may recover more quickly from passing out with an injection of glucagon. This can only be given by someone who knows how to use it.

• If you are given glucagon you will need sugar or a sugary snack as soon as you come round.

• If you do not respond to a glucagon injection, you will have to be treated in a hospital.

If severe low blood sugar is not treated over time, it can cause brain damage. This can be short or long-lasting. It may even cause death.

Talk to your doctor if:

► your blood sugar got so low that you passed out

► you have been given an injection of glucagon

► you have had low blood sugar a few times recently.

This is because the dosing or timing of your insulin injections, food or exercise may need to be changed.

High blood sugar may happen if you:

Eat more or exercise less than usual; drink alcohol; get an infection or a fever; have not used enough insulin; keep using less insulin than you need; forget to use your insulin or stop using insulin.

Warning signs of high blood sugar – these normally appear gradually:

• flushed skin

• dry skin

• feeling sleepy or tired

• dry mouth

• fruity (acetone) breath

• urinating more often

• feeling thirsty

• losing your appetite

• feeling or being sick (nausea or vomiting).

These may be signs of a very serious condition called ketoacidosis. This is a build-up of acid in the blood because the body is breaking down fat instead of sugar. If not treated, this could lead to diabetic coma and eventually death.

What to do if you get high blood sugar

► Test your blood sugar level.

• Give a correction dose of insulin if you have been taught how to do this.
• Test your urine for ketones.

► If you have ketones, seek medical help straight away.

How to store Fiasp

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton, after ‘EXP’. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C–8°C). Do not freeze. Keep away from the freezing element. Keep the cap on the pen in order to protect from light.

After first opening or if carried as a spare: You can carry your pre-filled pen (FlexTouch®) with you and keep it at room temperature (not above 30°C) or in a refrigerator (2°C–8°C) for up to 4 weeks. Always keep the cap on the pen when you are not using it in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Instructions on how to use Fiasp FlexTouch

Please read these instructions carefully before using your FlexTouch pre-filled pen. If you do not follow the instructions carefully, you may get too little or too much insulin, which can lead to high or low blood sugar level.

Do not use the pen without proper training from your doctor or nurse.

Start by checking your pen to make sure that it contains Fiasp 100 units/mL, then look at the illustrations below to get to know the different parts of your pen and needle.

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 the FlexTouch pre-filled pen.

Your pen is a pre-filled dial-a-dose insulin pen containing 300 units of insulin. You can select a maximum of 80 units per dose, in steps of 1 unit. Your pen is designed to be used with NovoTwist, NovoFine or NovoFine Plus single-use, disposable needles up to a length of 8 mm.

Do not wash, soak or lubricate your pen. If necessary, clean it with mild detergent on a moistened cloth.

Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the insulin flow before you inject.

References:

1. https://www.medicines.org.uk/emc/files/pil.2447.pdf
2. https://www.medicines.org.uk/emc/product/8108/smpc
3. https://www.fiasppro.com
4. https://www.fiasppro.com/getting-patients-started.html
5. https://www.fiasppro.com/what-is-fiasp.html
6. https://www.rapidactinginsulin.com/fiasp/why-fiasp/how-fiasp-works.html