Forxiga

dapagliflozin

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

Forxiga is a diabetes medicine used for adults whose condition is not controlled well enough.

In type 2 diabetes, it is used with appropriate diet and exercise to improve blood sugar control. It can be used on its own in patients who cannot take metformin (another diabetes medicine). It can also be used as ‘add-on’ treatment to other diabetes medicines.

In type 1 diabetes, Forxiga is used with insulin in overweight patients (body mass index of at least 27 kg/m²) when insulin on its own does not control blood sugar well enough.

Forxiga contains the active substance dapagliflozin.

: Forxiga is available as tablets (5 and 10 mg) and can only be obtained with a prescription.

For type 2 diabetes, the dose of Forxiga is 10 mg once a day. If it is used with insulin or medicines that help the body produce insulin, the doses of these medicines may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels).

For type 1 diabetes, treatment with Forxiga should be started and supervised by a specialist in type 1 diabetes. The dose is 5 mg once a day and the medicine should be used with precautions to prevent diabetic ketoacidosis (a serious complication of diabetes with high levels of ketones in the blood).

Because Forxiga relies on the working of the kidneys for its effect, it should not be used in patients with moderately or severely reduced kidney function. For more information about using Forxiga, see the package leaflet or contact your doctor or pharmacist.

: Diabetes can occur when the body does not make enough insulin to control the amount of glucose (sugar) in the blood or when the body cannot use insulin effectively. This leads to high levels of glucose in the blood.

The active substance in Forxiga, dapagliflozin, blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed out into the urine. By blocking the action of SGLT2, dapagliflozin causes the kidney to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.

: Forxiga was found effective in several studies in patients with type 2 and type 1 diabetes. The main measure of effectiveness was the level of glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.

Type 2 diabetes

In two studies involving 840 patients with type 2 diabetes, Forxiga when used alone decreased HbA1c levels by 0.66% more than placebo (a dummy treatment) after 24 weeks. In four other studies involving 2,370 patients, adding Forxiga to other diabetes medicines decreased HbA1c levels by 0.54-0.68% more than adding placebo after 24 weeks.

In a study involving 814 patients with type 2 diabetes, Forxiga used in combination with metformin was at least as effective as a sulphonylurea (another type of diabetes medicines) used with metformin. Both combinations reduced HbA1c levels by 0.52% after 52 weeks.

Type 1 diabetes

In two studies involving 1,648 patients with type 1 diabetes whose blood sugar was not controlled well enough on insulin alone, adding Forxiga 5 mg decreased HbA1c levels after 24 hours by 0.37% and by 0.42% more than adding placebo.

: The most common side effect with Forxiga in patients with type 2 diabetes (which may affect more than 1 in 10 people) is hypoglycaemia, especially when used in combination with a sulphonylurea or insulin. The most common side effect in patients with type 1 diabetes (which may affect up to 1 in 10 people) is genital infection, especially in women and a common side effect (which may affect up to 1 in 100 people) is diabetic ketoacidosis.

For the full list of side effects and restrictions with Forxiga, see the package leaflet.

: The European Medicines Agency considered that Forxiga was effective in lowering blood glucose levels in patients with type 2 diabetes when given alone or in combination with other diabetes medicines which work in different ways. Adding Forxiga to insulin treatment in patients with type 1 diabetes whose blood sugar could not be controlled well enough with insulin was also effective in decreasing HbA1c moderately. In addition, beneficial reductions in weight and blood pressure occurred in patients treated with Forxiga.

Forxiga’s common side effects were related to the way the medicine works, such as increased genital and, to a smaller degree, urinary tract infection (infection of the structures that carry urine), and are considered manageable. Forxiga increased the risk of diabetic ketoacidosis considerably in patients with type 1 diabetes and it is recommended for this condition only in overweight and obese patients. Precautions have been recommended to reduce the risk of diabetic ketoacidosis and the Agency has asked for further studies to determine its frequency in patients with type 1 diabetes treated with Forxiga.

The Agency concluded that the benefits of Forxiga outweigh its risks and recommended that it be granted marketing authorisation.

: The company that markets Forxiga will provide information on precautions to prevent diabetic ketoacidosis in patients with type 1 diabetes, including a patient alert card and guide for patients and their carers, as well as a guide for healthcare professionals, including a prescriber’s checklist. The company will also conduct a study to estimate the frequency of diabetic ketoacidosis in patients with type 1 diabetes treated with Forxiga.

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

As for all medicines, data on the use of Forxiga are continuously monitored. Side effects reported with Forxiga are carefully evaluated and any necessary action taken to protect patients.

: Forxiga received a marketing authorisation valid throughout the EU on 11 November 2012.

List item

Forxiga : EPAR - Medicine overview (PDF/79.83 KB) (updated)

First published: 07/12/2012
Last updated: 08/04/2019
EMA/142775/2019
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  (PDF/106.43 KB)
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  (PDF/100.34 KB)
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  (PDF/77.91 KB)
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Forxiga : EPAR - Risk-management-plan summary (PDF/76.38 KB)

First published: 08/04/2019

More detail is available in the summary of product characteristics

This EPAR was last updated on 08/04/2019

Authorisation details

Product details
Name	Forxiga
Agency product number	EMEA/H/C/002322
Active substance	dapagliflozin propanediol monohydrate
International non-proprietary name (INN) or common name	dapagliflozin
Therapeutic area (MeSH)	Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code	A10BK01

Publication details
Marketing-authorisation holder	AstraZeneca AB
Revision	14
Date of issue of marketing authorisation valid throughout the European Union	11/11/2012
Contact address	151 85 Sodertalje Sweden

Product information

20/03/2019 Forxiga - EMEA/H/C/002322 - WS/1344

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Forxiga : EPAR - Product Information (PDF/398.98 KB) (updated)

First published: 07/12/2012
Last updated: 08/04/2019
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  (PDF/491.34 KB)
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- Swedish
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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.

List item

Forxiga : EPAR - All Authorised presentations (PDF/23.66 KB)

First published: 07/12/2012
Last updated: 07/12/2012
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  (PDF/46.81 KB)
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  (PDF/38.97 KB)
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Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Edistride is indicated in adults for the treatment of insufficiently controlled

type 2 diabetes mellitus as an adjunct to diet and exercise, to improve glycaemic control,
as monotherapy when metformin is considered inappropriate due to intolerance.
in addition to other medicinal products for the treatment of type 2 diabetes.
type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m², when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.

For clinical study results with respect to populations studied, effects on glycaemic control and combinations with other medicinal products see sections 4.4, 4.5 and 5.1.

Assessment history

Changes since initial authorisation of medicine

List item

Forxiga : EPAR - Procedural steps taken and scientific information after authorisation (PDF/202.48 KB) (updated)

First published: 16/09/2013
Last updated: 08/04/2019
List item

Forxiga-H-C-2322-WS-1344 : EPAR - Assessment report - Variation (PDF/5.61 MB)

Adopted

First published: 08/04/2019
EMA/CHMP/213138/2019
List item

CHMP post-authorisation summary of positive opinion for Forxiga (WS-1344) (PDF/75.98 KB)

Adopted

First published: 01/02/2019
EMA/56302/2019
List item

Forxiga-H-C-PSUSA-00010029-201610 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/67.22 KB)

First published: 27/07/2017
Last updated: 27/07/2017
EMA/465597/2017
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Forxiga-H-A20-1442-C-2322-0029 : EPAR - Assessment Report - Article 20 (PDF/254.07 KB)

Adopted

First published: 05/07/2017
Last updated: 05/07/2017
EMA/PRAC/637349/2016
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Forxiga-H-A20-1442-C-2322-0029 : EPAR - Scientific Conclusion - Article 20 (PDF/41.36 KB)

First published: 05/07/2017
Last updated: 05/07/2017
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  (PDF/84.18 KB)
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- Latvian
  (PDF/76.13 KB)
- Lithuanian
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- Maltese
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- Norwegian
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- Polish
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- Portuguese
  (PDF/42.06 KB)
- Romanian
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- Slovak
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- Slovenian
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- Spanish
  (PDF/41.99 KB)
- Swedish
  (PDF/41.68 KB)
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Forxiga-H-C-2322-A20-1419-0021 : EPAR - Assessment Report - Article 20 (PDF/264.09 KB)

Adopted

First published: 18/05/2016
Last updated: 18/05/2016
EMA/PRAC/50218/2016
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Forxiga : EPAR - Scientific Conclusion (PDF/44.81 KB)

First published: 18/05/2016
Last updated: 18/05/2016
- Bulgarian
  (PDF/78.43 KB)
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  (PDF/70.99 KB)
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  (PDF/76.84 KB)
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  (PDF/43.59 KB)
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- Greek
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- Hungarian
  (PDF/63.53 KB)
- Italian
  (PDF/41.93 KB)
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  (PDF/70.95 KB)
- Lithuanian
  (PDF/76.52 KB)
- Maltese
  (PDF/79.84 KB)
- Polish
  (PDF/65.88 KB)
- Portuguese
  (PDF/43.27 KB)
- Romanian
  (PDF/75.81 KB)
- Slovak
  (PDF/74.17 KB)
- Slovenian
  (PDF/70.64 KB)
- Spanish
  (PDF/43.44 KB)
- Swedish
  (PDF/44.07 KB)
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Forxiga-H-C-2322-P46-016 : EPAR - Assessment report (PDF/1.11 MB)

Adopted

First published: 05/01/2016
Last updated: 05/01/2016
EMA/CHMP/784877/2015

Forxiga

Table of contents

Overview

Forxiga : EPAR - Medicine overview (PDF/79.83 KB) (updated)

Forxiga : EPAR - Risk-management-plan summary (PDF/76.38 KB)

Authorisation details

Product information

Forxiga : EPAR - Product Information (PDF/398.98 KB) (updated)

Contents

Forxiga : EPAR - All Authorised presentations (PDF/23.66 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Forxiga : EPAR - Procedural steps taken and scientific information after authorisation (PDF/202.48 KB) (updated)

Forxiga-H-C-2322-WS-1344 : EPAR - Assessment report - Variation (PDF/5.61 MB)

CHMP post-authorisation summary of positive opinion for Forxiga (WS-1344) (PDF/75.98 KB)

Forxiga-H-C-PSUSA-00010029-201610 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/67.22 KB)

Forxiga-H-A20-1442-C-2322-0029 : EPAR - Assessment Report - Article 20 (PDF/254.07 KB)

Forxiga-H-A20-1442-C-2322-0029 : EPAR - Scientific Conclusion - Article 20 (PDF/41.36 KB)

Forxiga-H-C-2322-A20-1419-0021 : EPAR - Assessment Report - Article 20 (PDF/264.09 KB)

Forxiga : EPAR - Scientific Conclusion (PDF/44.81 KB)

Forxiga-H-C-2322-P46-016 : EPAR - Assessment report (PDF/1.11 MB)

Initial marketing-authorisation documents

Forxiga : EPAR - Public assessment report (PDF/2.23 MB)

CHMP summary of positive opinion for Forxiga (PDF/57.03 KB)

News

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Forxiga

Table of contents

Overview

Forxiga : EPAR - Medicine overview (PDF/79.83 KB) (updated)

Forxiga : EPAR - Risk-management-plan summary (PDF/76.38 KB)

Authorisation details

Product information

Forxiga : EPAR - Product Information (PDF/398.98 KB) (updated)

Contents

Forxiga : EPAR - All Authorised presentations (PDF/23.66 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Forxiga : EPAR - Procedural steps taken and scientific information after authorisation (PDF/202.48 KB) (updated)

Forxiga-H-C-2322-WS-1344 : EPAR - Assessment report - Variation (PDF/5.61 MB)

CHMP post-authorisation summary of positive opinion for Forxiga (WS-1344) (PDF/75.98 KB)

Forxiga-H-C-PSUSA-00010029-201610 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/67.22 KB)

Forxiga-H-A20-1442-C-2322-0029 : EPAR - Assessment Report - Article 20 (PDF/254.07 KB)

Forxiga-H-A20-1442-C-2322-0029 : EPAR - Scientific Conclusion - Article 20 (PDF/41.36 KB)

Forxiga-H-C-2322-A20-1419-0021 : EPAR - Assessment Report - Article 20 (PDF/264.09 KB)

Forxiga : EPAR - Scientific Conclusion (PDF/44.81 KB)

Forxiga-H-C-2322-P46-016 : EPAR - Assessment report (PDF/1.11 MB)

Initial marketing-authorisation documents

Forxiga : EPAR - Public assessment report (PDF/2.23 MB)

CHMP summary of positive opinion for Forxiga (PDF/57.03 KB)

News

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