Fiasp 100 units-mL solution for injection in vial

  • Name:

    Fiasp 100 units-mL solution for injection in vial

  • Company:
    info
  • Active Ingredients:

    Insulin aspart

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/10/19

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Summary of Product Characteristics last updated on medicines.ie: 17/10/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Novo Nordisk Limited

Novo Nordisk Limited

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1 - 0 of 40 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 17 October 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8

Text updates as follows:

 

"Tabulated list of adverse reactions Adverse reactions listed below (Table 2) are based on data from 6 3 completed therapeutic confirmatory trials in adults.”

 

Description of selected adverse reactions

Allergic reactions

Allergic skin manifestations reported with Fiasp (1.8 1.5 % vs. 1.5 1.4 % 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 0.1 % for comparator).

 

Lipodystrophy

Lipodystrophy (including lipohypertrophy, lipoatrophy) was reported at the injection/infusion site in patients treated with Fiasp (0.5 0.2 % vs. 0.2 0% in comparator). Continuous rotation of the injection site within the particular injection area may help to reduce the risk of developing these reactions.

 

Injection/infusion site reactions

Injection site reactions (including rash, redness, inflammation, pain and bruising and itching) were was  reported in patients treated with Fiasp (1.3 1.0 % vs. 1.0 0.7 % in comparator). In patients using CSII (N=261): 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 transitory and they normally disappear during continued treatment.

 

 

Section 4.8 – Undesirable effects – how to report a side effect

Updated to list shortened contact details for the HPRA

 

Section 10

Revision of text updated to "09/2019"

Updated on 17 October 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 4.8

Addition of the following reactions

 

“Other side effects include: 

 Common (may affect up to 1 in 10 people)  

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.”

 

Section 4.8 – reporting of side effects

Updated to list shortened contact details for the HPRA

 

Section 6

revision date updated to “09/2019”

Updated on 4 September 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Section 1

Text update to expand indication:

“Fiasp® is a solution for injection containing insulin aspart and is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above.

 

Section 2, children and adolescents

Text updated to reflect updated indication of use from 1 year as follows:

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

 

Section 2, pregnancy and breast-feeding

Text updated:

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.

 

Section 3, How to use Fiasp®

Text updated:

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.”

 

Section 4

Flushed” updated to “flushed skin”

 

Updated on 4 September 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2:

Indication updated to include paediatrics as follows:

 

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

 “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.

 The early onset of action must be considered when prescribing Fiasp (see section 5.1).

 

Paediatric population updated as follows:

“Fiasp can be used in adolescents and children from the age of 1 year (see section 5.1). 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), with the flexibility to administer up to 20 minutes after starting the meal in situations, when there is uncertainty about the meal intake.”

“The safety and efficacy of Fiasp in children and adolescents below 18 years of age have not been established. Currently available data are described in section 5.2, but no recommendation on a posology can be made.”

 

Section 4.4

Text added:

Paediatric population

Close monitoring of blood glucose levels is recommended if administering this medicine after the start of the last meal of the day, in order to avoid nocturnal hypoglycaemia.”

 

Section 4.8:

Text added:

Paediatric population

Safety and efficacy have been investigated in a therapeutic confirmatory trial in children with type 1 diabetes 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 this study with paediatric patients compared to studies in adults (see above). In the paediatric population lipodystrophy was reported with a frequency of 2.1% for Fiasp vs. 1.6% for NovoRapid.

 

 

Section 5.1:

Text added as follows:

 

Pharmacodynamic effects:

Fiasp has an earlier onset of action compared to NovoRapid (see section 5.2), leading to a subsequent increased glucose-lowering effect. This must be considered when prescribing Fiasp.”

 

Clinical efficacy and safety:

“….Furthermore, Fiasp has been studied in 777 paediatric subjects with type 1 diabetes in a randomised efficacy and safety trial (26 weeks of treatment). No children below the age of 2 years were randomised in the trial.”

 

Paediatric population

The efficacy and safety of Fiasp have been studied in a 1:1:1 randomised active controlled clinical trial in children and adolescents with type 1 diabetes, aged 1 to 18 years, for a period of 26 weeks (N=777). In this trial the efficacy and safety of Fiasp administered at mealtime (0–2 minutes before meal) or postmeal (20 minutes after meal start) and NovoRapid administered at mealtime, both used in combination with insulin degludec, were compared.

Patients in the Fiasp mealtime arm included 16 children aged 2–5 years, 100 children aged 6–11 years and 144 adolescents aged 12–17 years. Patients in the Fiasp postmeal arm included 16 children aged 2–5 years, 100 children aged 6–11 years and 143 adolescents aged 12–17 years.

Fiasp administered at mealtime showed superior glycaemic control compared to NovoRapid mealtime with regards to change in HbA1c (ETD: -0.17% [-0.30; -0.03]95% CI). Fiasp administered postmeal showed non-inferior glycaemic control compared to NovoRapid mealtime (ETD: 0.13% [-0.01; 0.26]95% CI).

Fiasp mealtime showed a statistically significant improvement in 1– hour postmeal glucose increment mean over all three main meals compared to NovoRapid (measured by SMPG). For Fiasp postmeal this comparison favoured NovoRapid mealtime.

No overall increased risk of severe or blood glucose confirmed hypoglycaemia was observed compared to NovoRapid.

The observed effects and the safety profiles were comparable between all age groups.”

Updated on 19 July 2019 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 19 July 2019 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8:

- Addition of 'anaphylactic reactions' as frequency ‘Not known’ in table 2

- Deletion of "Anaphylactic reactions have not been reported with Fiasp. With insulin preparations in general, anaphylactic reactions may occur. Immediate-type allergic reactions to either insulin itself or the excipients may potentially be lifethreatening.

 

Section 6.3:

- Deletion of ‘At the end of this period the pen should be used or discarded’.

- Sentence update for Fiasp 100 units/mL solution for injection in vial as follows:
“After first opening, the medicinal product may be stored for a maximum of 4 weeks (including time in a pump reservoir, see section 6.6). At the end of this period the pen should be used or discarded’”


Section 6.6:
Shortening of the pump in-use time for the Fiasp vial from 9 to 6 days as follows:

“Fiasp 100 units/mL solution for injection in vial

Fiasp may be used in an infusion pump (CSII) for a maximum of 9 days, as described in section 4.2 and in the package leaflet.”

Updated on 20 November 2018 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 22 August 2018 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 27 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 21 May 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 18 May 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 10 May 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 18 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 18 October 2017 PIL

Reasons for updating

  • New PIL for new product