Fiasp 100 units/ml PumpCart solution for injection in cartridge

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fiasp 100 units/ml PumpCart cartridge for injection

insulin aspart

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Fiasp is and what it is used for
2. What you need to know before you use Fiasp
3. How to use Fiasp
4. Possible side effects
5. How to store Fiasp
6. Contents of the pack and other information

1. What Fiasp is and what it is used for

Fiasp is an insulin administered at mealtimes that rapidly lowers blood sugar levels. Fiasp is an injectable solution of insulin aspart and is used to treat diabetes mellitus in adults, adolescents, and children from 1 year of age. Diabetes is a condition in which the body does not produce enough insulin to control blood sugar levels. Treatment with Fiasp helps prevent complications of diabetes.

About PumpCart

The PumpCart cartridge is used in a pump designed to be used with this cartridge:

• It covers your total daily insulin requirements: both the insulin needed throughout the day (basal) and the insulin needed at mealtimes (bolus).
• Before using a PumpCart cartridge in the pump, you must have received detailed instructions from your doctor or nurse.

Day-long (basal) insulin requirement:

When you use Fiasp in a pump, insulin is continuously released into your body.

• This meets your basal insulin requirement throughout the day.

• Before setting or changing your basal dose, carefully read the pump user manual.

• If you stop the pump, note that the insulin effect will gradually decrease over 3 to 5 hours.

Mealtime (bolus) insulin requirement:

• It should be administered from 2 minutes before starting a meal, with the possibility of administration up to 20 minutes after the start of the meal (see section 3, How to use Fiasp).
  • Maximum effect occurs between 1 and 3 hours after administration at mealtimes.
  • The effect lasts from 3 to 5 hours.

2. What you need to know before using Fiasp

Do not use Fiasp

• if you are allergic to insulin aspart or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Fiasp. It is important that you are aware of the following:

• Low blood sugar (hypoglycemia): if your blood sugar level is too low, follow the instructions for low blood sugar provided in section 4 “Possible side effects”. Compared to other insulins taken at mealtimes, Fiasp begins to lower blood sugar more quickly. If you experience hypoglycemia, you may feel it sooner after an injection of Fiasp.
• High blood sugar (hyperglycemia): if your blood sugar level is too high, follow the instructions for high blood sugar provided in section 4 “Possible side effects”.
• Switching from other insulins: your doctor may need to advise you on your insulin dose.
• If you are combining your insulin treatment with pioglitazone (an oral antidiabetic medicine used to treat type 2 diabetes), speak to your doctor as soon as possible if you experience symptoms of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling due to fluid retention (edema).
• Eye disorders: a sudden improvement in blood sugar control may temporarily worsen diabetes-related eye disorders such as diabetic retinopathy.
• Nerve damage pain: if your blood sugar level improves very rapidly, you may experience nerve-related pain, which is usually temporary.
• Swelling of joints: when you first start using the medicine, your body may retain more fluid than normal, causing swelling of the ankles and other joints. This effect usually resolves quickly.
• Make sure you are using the correct type of insulin; always check the label on the insulin before each injection to avoid accidental mix-ups between insulins.
• Treatment with insulin may cause your body to produce antibodies against insulin (substances that act against insulin). However, this only very rarely requires a change in your insulin dose.

In case of reduced vision, see section 3 “How to use Fiasp”.

Certain conditions and activities may affect your insulin requirements. Consult your doctor:

• if you have kidney, liver, adrenal gland, pituitary gland, or thyroid gland problems.
• if you are doing more physical exercise than usual or wish to change your normal diet, as this may affect your blood sugar level.
• if you are unwell, continue your insulin treatment and consult your doctor.
• if you are travelling abroad, travelling across different time zones may affect your insulin needs and injection times.

When using Fiasp, it is strongly recommended that you record the name and batch number of each container to maintain a record of the batches used.

Fiasp PumpCart can only be used with the following insulin infusion pump systems: Accu-Chek Insight and YpsoPump insulin pumps. It must not be used with other pumps, as this may deliver an incorrect dose and cause high or low blood sugar levels.

Skin changes at the injection site

You should rotate your injection site to help prevent changes in fatty tissue such as thickening of the skin, skin shrinkage, or lumps under the skin. Insulin may not work well if injected into a lumpy, shrunken, or thickened area (see section 3 “How to use Fiasp”). Inform your doctor if you notice any changes at the injection site. Inform your doctor if you are currently injecting into these affected areas before switching to a different site. Your doctor may advise you to monitor your blood sugar levels more closely and may adjust your insulin dose or the dose of your other antidiabetic medicines.

Children and adolescents

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

Other medicines and Fiasp

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines affect your blood sugar level, which may require adjustment of your insulin dose.

The main medicines that may affect your insulin treatment are listed below.

Your blood sugar level may decrease (hypoglycemia) if you take:

• other antidiabetic medicines (oral and injectable)
• sulfa-type antibiotics (used to treat infections)
• anabolic steroids (such as testosterone)
• beta-blockers (used to treat high blood pressure or angina)
• salicylates (used to relieve pain and reduce fever)
• monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat certain heart conditions or high blood pressure).

Your blood sugar level may increase (hyperglycemia) if you take:

• danazol (a medicine that affects ovulation)
• oral contraceptives (birth control pills)
• thyroid hormones (to treat thyroid gland problems)
• growth hormone (to treat growth hormone deficiency)
• glucocorticoids (such as “cortisone”, to treat inflammation)
• sympathomimetics (such as epinephrine (adrenaline), salbutamol, or terbutaline, used to treat asthma)
• thiazides (used to treat high blood pressure or when the body retains too much fluid (fluid retention)).

Octreotide and lanreotide, used to treat acromegaly, a rare disorder characterized by excessive growth hormone production, may either increase or decrease your blood sugar level.

If you are in any of the above situations (or are unsure), consult your doctor or pharmacist.

Use of Fiasp with alcohol

Drinking alcohol may alter your insulin requirements, as it can either increase or decrease your blood sugar level. Therefore, you should monitor your blood sugar level more frequently than usual.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. This medicine can be used during pregnancy; however, your insulin dose may need to be adjusted during pregnancy and after delivery. The amount of insulin you need usually decreases during the first 3 months of pregnancy and increases during the remaining 6 months. Careful diabetes control is necessary during pregnancy. Avoiding low blood sugar (hypoglycemia) is especially important for your baby’s health. After delivery, your insulin requirements will likely return to what they were before pregnancy.

There are no restrictions on the use of Fiasp during breastfeeding.

Driving and using machines

Low blood sugar can impair your ability to drive or operate machinery. If you have low blood sugar, your concentration and reaction time may be affected. This could endanger your life or the lives of others. Ask your doctor whether you may drive if:

• you experience frequent episodes of hypoglycemia
• you have difficulty recognizing the symptoms of hypoglycemia.

Important information about some of the ingredients of Fiasp

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to use Fiasp

If you are blind or have reduced vision and cannot read the pump display, do not use this pump without assistance. Ask for help from a person with normal vision who has been trained in the use of the pump.

Dosage and when to use Fiasp

Always use your insulin and adjust your daily (basal) and mealtime (bolus) doses as instructed by your doctor. If in doubt, consult your doctor, nurse, or pharmacist.

• Adjust your prandial insulin (bolus) based on blood glucose measurements and food intake.

Adults

Fiasp mealtime doses should be administered just before (0 to 2 minutes) starting a meal, with the possibility of administering up to 20 minutes after the start of the meal.

Children

Fiasp mealtime doses should be administered just before (0 to 2 minutes) starting a meal, with the possibility of administering up to 20 minutes after the start of the meal in situations where it is uncertain when the child will eat. Consult your doctor about these situations.

If you wish to change your usual diet, consult your doctor, pharmacist, or nurse first, as a change in diet may alter your insulin requirements.

When using other medications, ask your doctor whether your treatment needs adjustment.

Use in elderly patients (65 years of age or older)

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

If you have kidney or liver problems

If you have kidney or liver problems, you may need to monitor your blood sugar levels more frequently. Talk to your doctor about possible dose adjustments.

Injecting Fiasp

This medicine is intended only for injection under the skin (subcutaneous injection). For use only with pumps designed to be used with this cartridge.

• Before using the PumpCart cartridge in the pump, you must have received detailed instructions from your doctor or nurse.
  • Consult your doctor if you need to inject insulin by another method.

Where to inject

• The usual site for insulin injection is the front of the waist (abdomen). However, if recommended by your doctor, you may inject into the upper arm.
• Do not inject into a vein or muscle.
• When changing the infusion set (catheter and cannula), make sure to change the injection site of the needle. This may reduce the risk of developing skin changes (see section 4 “Possible side effects”).

Do not use Fiasp

• if the cartridge or the device containing the cartridge you are using falls, becomes damaged, or crushed. Return it to your supplier.
• if the cartridge has not been stored properly (see section 5 “Storage of Fiasp”).
• if the insulin does not appear clear (e.g., cloudy) and colorless.

Detailed instructions on how to use PumpCart are provided on the reverse side of this leaflet.

How to inject Fiasp

• Read and follow the instructions in the pump user manual provided with your insulin pump.
• Make sure you use an appropriate infusion set (catheter and needle) compatible with your insulin pump.
• Check the name and concentration on the label of the cartridge (PumpCart) to ensure it is Fiasp.
• The infusion set (catheter and needle) and the PumpCart cartridge must not be shared.
• The infusion set (catheter and needle) must be changed according to the instructions provided in the product information accompanying the infusion set.

What to do if the pump fails

You should always have an alternative insulin delivery system available to inject insulin under the skin (e.g., an injection pen or syringes) in case the pump fails.

If you use more Fiasp than you should

If you use too much insulin, your blood sugar level may become very low (hypoglycemia); see section 4 “Low blood sugar level”.

If you forget to use Fiasp

If you forget to inject your insulin, your blood sugar level may become very high (hyperglycemia). See section 4 “High blood sugar level”.

Three simple steps that may help you avoid low or high blood sugar levels:

• Always carry spare Fiasp cartridges.
• Always carry something that indicates you are diabetic.
• Always carry sugary products with you. See section 4 “What to do if your blood sugar level is low”.

If you stop using Fiasp

Do not stop treatment with your insulin without consulting your doctor. Stopping insulin administration may lead to very high blood sugar levels (severe hyperglycemia) and ketoacidosis (a condition characterized by excessive acid in the blood, which can be life-threatening). See symptoms and recommendations in section 4 “High blood sugar level”.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Low blood sugar (hypoglycemia) is a very common adverse effect of insulin treatment (may affect more than 1 in 10 people). It can be very serious. Severe hypoglycemia can lead to loss of consciousness. Severe hypoglycemia may cause brain damage and can be life-threatening. If you experience symptoms of low blood sugar, take action to raise your blood sugar level immediately. See the recommendations below under “Low blood sugar”.

If you experience a severe allergic reaction (including anaphylactic shock) to insulin or any of the components of Fiasp (frequency unknown), stop using this medicine and contact emergency medical services immediately.

Symptoms of a severe allergic reaction may include:

• local reactions (e.g., rash, redness, itching) spreading to other parts of the body
• sudden feeling of illness with sweating
• onset of vomiting
• difficulty breathing
• palpitations or dizziness.

Allergic reactions such as generalized skin rash and facial swelling may occur. These are uncommon and may affect up to 1 in 100 people. Consult a doctor if symptoms worsen or do not improve within a few weeks.

Skin changes at the injection site: If you inject insulin in the same place repeatedly, fatty tissue may shrink (lipoatrophy) or become thicker (lipohypertrophy) (these are uncommon and may affect up to 1 in 100 people). Lumps under the skin may also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; frequency unknown). Insulin may not work as well if injected into a lumpy, shrunken, or thickened area. Change your injection site regularly to help prevent these skin changes.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

Reaction at the injection site: Local reactions at the injection site may occur. Symptoms may include rash, redness, swelling, bruising, irritation, pain, and itching. These reactions usually resolve within a few days.

Skin reactions: Skin allergy signs such as eczema, rash, itching, hives, and dermatitis may occur.

General effects of insulin treatment including Fiasp

• Low blood sugar (hypoglycemia) (very common)

Low blood sugar may occur if you:

Drink alcohol, inject too much insulin, exercise more than usual, eat very little, or skip a meal.

Warning signs of low blood sugar, which may appear suddenly: Headache, difficulty speaking, palpitations, cold sweat, cold and pale skin, nausea, excessive hunger, trembling, nervousness or anxiety, unusual tiredness, weakness, drowsiness, confusion, difficulty concentrating, temporary changes in vision.

What to do if your blood sugar is low

• If you are conscious, treat immediately with 15–20 g of fast-acting carbohydrates: take glucose tablets or a sugary product such as fruit juice, sweets, or biscuits (always carry glucose tablets or sugary products with you in case you need them), and adjust your insulin dose or stop your pump.
• It is recommended to recheck your blood glucose levels after 15–20 minutes and repeat treatment if your blood glucose remains below 4 mmol/l.
• Wait until symptoms of hypoglycemia have disappeared or your blood sugar has stabilized. Continue insulin treatment as usual.

What people close to you should do if you lose consciousness

Inform people you spend time with that you have diabetes. Let them know the possible consequences of low blood sugar, including the risk of losing consciousness.

Tell them that if you become unconscious, they should:

• lay you on your side to prevent choking
• seek immediate medical assistance
• not give you anything to eat or drink, as you could choke.

You may regain consciousness more quickly if someone trained administers a glucagon injection.

• If glucagon is administered, you should take glucose or a sugary product as soon as you regain consciousness.
• If there is no response to glucagon treatment, you must be treated in a hospital.

If severe hypoglycemia is not treated, it may over time cause brain damage, which may be temporary or permanent, and may even lead to death.

Talk to your doctor if:

• your blood sugar has dropped so low that you lost consciousness
• you received a glucagon injection
• you have recently experienced several episodes of low blood sugar.

You may need to adjust the dose or frequency of your insulin injections, your diet, or your exercise routine.

• High blood sugar (hyperglycemia)

High blood sugar may occur if you:

Eat more or exercise less than usual, drink alcohol, have an infection or fever, do not inject enough insulin, repeatedly inject less insulin than you need, forget to inject insulin, or interrupt insulin treatment.

Warning signs of high blood sugar, which usually appear gradually: Skin redness, dry skin, drowsiness or tiredness, dry mouth, fruity breath odor (acetone), increased need to urinate, thirst, loss of appetite, nausea, or vomiting.

These may be symptoms of a serious condition called ketoacidosis. This is an accumulation of acid in the blood due to the body metabolizing fat instead of sugar. If untreated, it could lead to diabetic coma and even death.

What to do if your blood sugar is high

• Check your blood sugar level.
• Administer a correction dose of insulin if you have been instructed how to do so.
• Check for ketones in your urine.
• If ketones are present, seek immediate medical assistance.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fiasp

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

Do not use this medicine after the expiry date stated on the label and packaging after EXP. The expiry date refers to the last day of the month indicated.

Before first use

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Keep away from the freezer. Keep the cartridge in the outer packaging to protect it from light.

After opening or when carried as a spare

• Do not refrigerate during use.
• You may store your cartridge (PumpCart) at room temperature (below 30°C) for up to 2 weeks.
• Thereafter, it may be used for up to 7 days at temperatures below 37°C in a pump designed for use with this cartridge.
• Keep the PumpCart cartridge in the outer packaging until use to protect it from damage. Always protect the cartridge from light during use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fiasp

• The active substance is insulin aspart. 1 ml of solution contains 100 units of insulin aspart. Each cartridge contains 160 units of insulin aspart in 1.6 ml of solution.
• The other components are phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see end of section 2 “Important information about some of the components of Fiasp”), and water for injections.

Appearance of Fiasp and contents of the pack

Fiasp is presented as a clear, colourless, aqueous, injectable solution in a cartridge.

Pack sizes of 5 or multiple pack with 25 (5 packs of 5) cartridges of 1.6 ml. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Novo Nordisk A/S,
Novo Allé,
DK-2880 Bagsværd, Denmark

Date of the most recent revision of this summary:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

Instructions for using the Fiasp PumpCart pre-filled cartridge.

The Fiasp PumpCart may only be used with an insulin pump infusion system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.

• It must not be used with other devices not designed for the PumpCart cartridge.
• Doing so may result in incorrect insulin dosing and lead to high blood sugar (hyperglycaemia) or low blood sugar (hypoglycaemia).

Read these instructions carefully before using your PumpCart cartridge.

Also read the pump user manual provided with the insulin pump.

• The PumpCart cartridge is ready for direct use in the pump.

• The PumpCart cartridge contains 1.6 ml of insulin aspart solution, equivalent to 160 units.

• This medicine must never be mixed with any other medicine.

• Do not refill the PumpCart cartridge. Once empty, it must be discarded.

• Always ensure you have a spare PumpCart cartridge available.

• Do not use the PumpCart cartridge in an insulin pen, as this may lead to incorrect dosing.

• The PumpCart cartridge must be protected from heat and excessive light during storage and use.

• The PumpCart cartridge must be kept out of the reach of other people, especially children.

1. Before inserting a PumpCart cartridge into your pump

• Bring the PumpCart cartridge to room temperature.

• Remove the PumpCart cartridge from its carton and blister pack.

• Check the label to make sure it is a Fiasp PumpCart cartridge.

• Check the expiry date shown on the label and on the packaging.

• Always check that the PumpCart cartridge looks as it should (Figure A). Do not use it if it is damaged, leaking insulin, or if the plunger has moved, making the bottom part of the plunger visible above the white band. This may indicate that insulin has leaked out. In Figure A, the bottom part of the plunger is hidden behind the white band as it should be. If you suspect the PumpCart cartridge is damaged, return it to your supplier.

• Check that the insulin in the PumpCart cartridge is clear and colourless. If the insulin appears cloudy, do not use the PumpCart cartridge. The cartridge may contain a small amount of air in the form of tiny bubbles.

2. Inserting a new Fiasp PumpCart cartridge into your pump

• Follow the instructions in the user manual supplied with your pump for inserting a new PumpCart cartridge into your pump.

• Insert a PumpCart cartridge into the pump’s cartridge compartment. The plunger end is inserted first.

• Connect the infusion set to the PumpCart cartridge by attaching the adapter to your pump.

• Follow the instructions in the pump’s user manual to continue using your pump.

3. Removing the empty Fiasp PumpCart cartridge from your pump

• Follow the instructions in the pump’s user manual to remove the empty PumpCart cartridge from your pump.

• Remove the infusion set adapter from the empty PumpCart cartridge.

• Dispose of the used PumpCart cartridge and infusion set according to the instructions provided by your doctor or nurse.

• Follow the steps described in sections 1 and 2 to prepare and insert a new PumpCart cartridge into your pump.