Fiasp

insulin aspart

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This is a summary of the European public assessment report (EPAR) for Fiasp. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Fiasp.

For practical information about using Fiasp, patients should read the package leaflet or contact their doctor or pharmacist.

What is Fiasp and what is it used for?

Fiasp is a medicine that is used to treat adults with diabetes. It contains the active substance insulin aspart, a rapid-acting insulin.

How is Fiasp used?

Fiasp is a solution for injection available in vials, cartridges or pre-filled pens and can only be obtained with a prescription. It is usually injected under the skin, immediately before a meal, although it may be given up to 20 minutes after starting a meal if necessary. The dose depends on the patient’s blood glucose, which should be tested regularly to find the lowest effective dose. When given by injection under the skin, Fiasp should be used in combination with an intermediate- or long-acting insulin that is given at least once a day. Fiasp is normally injected under the skin of the belly or upper arm.

Fiasp can also be used in a pump system for continuous insulin infusion under the skin or alternatively, it can be given into a vein but only by a doctor or a nurse.

For further information, see the package leaflet.

How does Fiasp work?

Diabetes is a disease in which blood glucose is high, either because the body cannot produce insulin (type 1 diabetes) or because the body does not make enough insulin or cannot use it effectively (type 2 diabetes). The replacement insulin in Fiasp acts in the same way as the body’s own insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced. Insulin aspart enters the bloodstream faster than human insulin after injection and therefore works more quickly.

What benefits of Fiasp have been shown in studies?

The benefits of Fiasp in reducing blood glucose as part of diabetes treatment have been shown in 3 main studies.

In two studies Fiasp was shown to be at least as effective as another insulin, NovoRapid. Both Fiasp and NovoRapid contain insulin aspart but Fiasp contains some different ingredients intended to help it be absorbed rapidly. The main measure of effectiveness was the medicine’s ability to decrease the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled over time. One study involving 1,143 patients with type 1 diabetes whose starting HbA1c was around 7.6% found that after 6 months of treatment HbA1c decreased by 0.32 percentage points with a mealtime dose of Fiasp, compared with 0.17 points with the other insulin. In the second study involving 689 patients with type 2 diabetes, the fall after 6 months of treatment (from a starting value of 7.96% and 7.89% respectively) was 1.38 points with Fiasp and 1.36 points with the comparator.

A third study involving 236 patients with type 2 diabetes and a starting HbA1c of around 7.9% found that adding mealtime Fiasp to treatment with a long-acting insulin and the diabetes medicine metformin improved blood glucose control. (There was no direct comparison between Fiasp and another mealtime insulin in this study.) In patients given Fiasp the fall in HbA1c after 18 weeks was 1.16 percentage points, compared with 0.22 points in those on long-acting insulin and metformin alone.

What are the risks associated with Fiasp?

The most common side effect with Fiasp (which may affect more than 1 in 10 people) is hypoglycaemia (excessively low blood sugar). Hypoglycaemia may occur more quickly with Fiasp than with other mealtime insulins. For the full list of all side effects and restrictions with Fiasp, see the package leaflet.

Why is Fiasp approved?

A clinically relevant benefit in lowering blood glucose has been shown in studies with Fiasp.

Compared with the already authorised insulin aspart medicine NovoRapid, the lowering of blood glucose develops earlier with Fiasp, although the total extent of the lowering effect is similar. However, it is unclear whether this would result in a difference in the risk of diabetic complications. With regard to safety the overall rate and severity of side effects was comparable with NovoRapid, although hypoglycaemia occurred more often in the first 2 hours after a dose of Fiasp.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that Fiasp’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Fiasp?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fiasp have been included in the summary of product characteristics and the package leaflet.

Other information about Fiasp

The European Commission granted a marketing authorisation valid throughout the European Union for Fiasp on 9 January 2017.

Name Language First published Last updated
Fiasp : EPAR - Summary for the public BG = bălgarski 2017-02-03  
Fiasp : EPAR - Summary for the public ES = español 2017-02-03  
Fiasp : EPAR - Summary for the public CS = čeština 2017-02-03  
Fiasp : EPAR - Summary for the public DA = dansk 2017-02-03  
Fiasp : EPAR - Summary for the public DE = Deutsch 2017-02-03  
Fiasp : EPAR - Summary for the public ET = eesti keel 2017-02-03  
Fiasp : EPAR - Summary for the public EL = elliniká 2017-02-03  
Fiasp : EPAR - Summary for the public EN = English 2017-02-03  
Fiasp : EPAR - Summary for the public FR = français 2017-02-03  
Fiasp : EPAR - Summary for the public IT = italiano 2017-02-03  
Fiasp : EPAR - Summary for the public LV = latviešu valoda 2017-02-03  
Fiasp : EPAR - Summary for the public LT = lietuvių kalba 2017-02-03  
Fiasp : EPAR - Summary for the public HU = magyar 2017-02-03  
Fiasp : EPAR - Summary for the public MT = Malti 2017-02-03  
Fiasp : EPAR - Summary for the public NL = Nederlands 2017-02-03  
Fiasp : EPAR - Summary for the public PL = polski 2017-02-03  
Fiasp : EPAR - Summary for the public PT = português 2017-02-03  
Fiasp : EPAR - Summary for the public RO = română 2017-02-03  
Fiasp : EPAR - Summary for the public SK = slovenčina 2017-02-03  
Fiasp : EPAR - Summary for the public SL = slovenščina 2017-02-03  
Fiasp : EPAR - Summary for the public FI = suomi 2017-02-03  
Fiasp : EPAR - Summary for the public SV = svenska 2017-02-03  
Fiasp : EPAR - Summary for the public HR = Hrvatski 2017-02-03  

This EPAR was last updated on 03/02/2017 .

Authorisation details

Product details

Product details for Fiasp
NameFiasp
Agency product numberEMEA/H/C/004046
Active substance

insulin aspart

International non-proprietary name (INN) or common name

insulin aspart

Therapeutic area Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code A10AB05
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Fiasp
Marketing-authorisation holder

Novo Nordisk A/S

Revision0
Date of issue of marketing authorisation valid throughout the European Union09/01/2017

Contact address:

Novo Nordisk A/S
Novo Alle 
2880 Bagsvaerd
Denmark

Product information

Product information

11/11/2016  Fiasp -EMEA/H/C/004046 --

Name Language First published Last updated
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  
Fiasp : EPAR - Product Information HR = Hrvatski 2017-02-03  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Fiasp : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  

Pharmacotherapeutic group

Insulins and analogues for injection, fast-acting

Therapeutic indication

Treatment of diabetes mellitus in adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Fiasp : EPAR - Public assessment report HR = Hrvatski 2017-02-03  
CHMP summary of positive opinion for Fiasp HR = Hrvatski 2016-11-11  

Authorised

This medicine is approved for use in the European Union