Forxiga

dapagliflozin

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

Forxiga is a medicine used to treat adults with diabetes, heart failure and chronic (long-term) kidney disease.

In diabetes, the medicine is used in adults whose condition is not controlled well enough.

• In type 2 diabetes, it is used with appropriate diet and exercise 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.

In heart failure, Forxiga is used in adults who have symptoms of the disease and reduced ejection fraction (a measure of how well the heart pumps blood). Heart failure is the inability of the heart to pump enough blood around the body.

In chronic kidney disease, Forxiga is used in adults with reduced kidney function.

Forxiga contains the active substance dapagliflozin.

: Forxiga is available as tablets and can only be obtained with a prescription.

For type 2 diabetes, heart failure and chronic kidney disease the recommended dose of Forxiga is 10 mg once a day.

For type 2 diabetes, 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 prevent 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).
For more information about using Forxiga, see the package leaflet or contact your doctor or pharmacist.

: 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 the kidneys passing glucose from the blood into the urine. Patients with diabetes have high levels of glucose in the blood. By blocking the action of SGLT2, dapagliflozin causes the kidney to pass more glucose into the urine, thereby reducing the levels of glucose in the blood.

Blocking the action of SGLT2 also supports heart function in patients with heart failure and kidney function in patients with chronic kidney disease, regardless of having diabetes. Dapagliflozin’s actions lead to a diuretic effect, that is it increases the elimination of salt and water in the urine. This decreases the overall blood volume, reducing the effort needed for the heart to pump blood, thereby improving its function in patients with heart failure.

: Diabetes
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.

In two studies involving 840 patients with type 2 diabetes, Forxiga when used alone decreased HbA1c levels by 0.66 percentage points 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 percentage points 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 percentage points after 52 weeks.

A long-term study, involving over 17,000 patients with type 2 diabetes, looked at the effects of dapagliflozin on cardiovascular (heart and circulation) disease. The study indicated that dapagliflozin's effects were in line with those of other diabetes medicines that also work by blocking SGLT2.

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 percentage points and by 0.42 percentage points more than adding placebo.
Heart failure
Forxiga was effective at reducing the risk of death, hospitalisation or urgent medical visit due to heart failure in a main study involving 4,744 patients with heart failure with reduced ejection fraction. Forxiga was compared with placebo, both added to patients’ usual heart failure treatment. The rate of death and hospitalisation or urgent medical visit per 100 patient-years was 11.6 in the Forxiga group compared with 15.6 in the placebo group; the risk was 26% lower with Forxiga than with placebo.
Chronic kidney disease
Forxiga was effective in treating patients with chronic kidney disease based on a study involving 4,304 patients. When Forxiga was added to the patients’ usual treatment for chronic kidney disease, the proportion of patients that experienced a decline in kidney function, severe kidney disease or death was 9.2% in the Forxiga group compared with 14.5% in the placebo group; the risk was 39% lower with Forxiga than with 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 (low blood sugar levels) when used in combination with a sulphonylurea or insulin. Overall, common side effects (which may affect up to 1 in 10 people) include genital infections, dizziness, rash, back pain, dysuria (painful urination) and polyuria (increase in urine production), and, in patients with type 1 diabetes, 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 for treating 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 diabetes could not be controlled well enough with insulin was also effective. In addition, beneficial reductions in weight and blood pressure occurred in patients treated with Forxiga. In heart failure, Forxiga can reduce the risk of death or serious complications in patients with heart failure with reduced ejection fraction. In patients with chronic kidney disease Forxiga can reduce the risk of kidney function decline or death to kidney or
heart problems, when added to the patient’s usual treatment.

Forxiga’s common side effects were related to raised levels of sugar in the urine, such as increased genital and, to a smaller degree, urinary infection, and are considered manageable. Forxiga increased the risk of diabetic ketoacidosis considerably in patients with type 1 diabetes and for this condition it is recommended only in overweight 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.

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Forxiga : EPAR - Medicine overview (PDF/152.91 KB) (updated)

First published: 07/12/2012
Last updated: 02/09/2021
EMA/84150/2021
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Forxiga : EPAR - Risk-management-plan summary (PDF/145.11 KB) (updated)

First published: 08/04/2019
Last updated: 02/09/2021

More detail is available in the summary of product characteristics

This EPAR was last updated on 02/09/2021

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 Diabetes Mellitus, Type 1
Anatomical therapeutic chemical (ATC) code	A10BK01

Publication details
Marketing-authorisation holder	AstraZeneca AB
Revision	21
Date of issue of marketing authorisation valid throughout the European Union	11/11/2012
Contact address	151 85 Sodertalje Sweden

Product information

05/08/2021 Forxiga - EMEA/H/C/002322 - WS1941

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Forxiga : EPAR - Product Information (PDF/1.31 MB) (updated)

First published: 07/12/2012
Last updated: 02/09/2021
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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.

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Forxiga : EPAR - All Authorised presentations (PDF/32.46 KB)

First published: 07/12/2012
Last updated: 19/05/2021
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  (PDF/34.99 KB)
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  (PDF/34.18 KB)
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Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Type 2 diabetes mellitus
Forxiga is indicated in adults for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
- as monotherapy when metformin is considered inappropriate due to intolerance.
-- in addition to other medicinal products for the treatment of type 2 diabetes.
For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Type 1 diabetes mellitus
Forxiga is indicated in adults for the treatment of insufficiently controlled 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.

Heart failure
Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.

Chronic kidney disease
Forxiga is indicated in adults for the treatment of chronic kidney disease.

Assessment history

Changes since initial authorisation of medicine

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Forxiga : EPAR - Procedural steps taken and scientific information after authorisation (PDF/322.62 KB) (updated)

First published: 16/09/2013
Last updated: 02/09/2021
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Forxiga-H-C-WS-1941 : EPAR - Assessment report - Variation (PDF/5.42 MB) (new)

Adopted

First published: 02/09/2021
EMA/431093/2021
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Forxiga-H-C-2322-WS-1737: EPAR - Assessment report - Variation (PDF/6.72 MB)

Adopted

First published: 26/11/2020
EMA/574301/2020
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CHMP post-authorisation summary of positive opinion for Forxiga (WS-1737) (PDF/143.48 KB)

Adopted

First published: 16/10/2020
EMA/CHMP/535224/2020
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Forxiga-H-C-2322-WS-1539: EPAR - Assessment report - Variation (PDF/1.46 MB)

Adopted

First published: 28/08/2019
EMA/476671/2019
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Forxiga-H-C-2322-WS-1344 : EPAR - Assessment report - Variation (PDF/5.61 MB)

Adopted

First published: 08/04/2019
EMA/CHMP/213138/2019
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CHMP post-authorisation summary of positive opinion for Forxiga (WS-1344) (PDF/75.98 KB)

Adopted

First published: 01/02/2019
EMA/56302/2019
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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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- Swedish
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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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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/152.91 KB) (updated)

Forxiga : EPAR - Risk-management-plan summary (PDF/145.11 KB) (updated)

Authorisation details

Product information

Forxiga : EPAR - Product Information (PDF/1.31 MB) (updated)

Contents

Forxiga : EPAR - All Authorised presentations (PDF/32.46 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Forxiga : EPAR - Procedural steps taken and scientific information after authorisation (PDF/322.62 KB) (updated)

Forxiga-H-C-WS-1941 : EPAR - Assessment report - Variation (PDF/5.42 MB) (new)

Forxiga-H-C-2322-WS-1737: EPAR - Assessment report - Variation (PDF/6.72 MB)

CHMP post-authorisation summary of positive opinion for Forxiga (WS-1737) (PDF/143.48 KB)

Forxiga-H-C-2322-WS-1539: EPAR - Assessment report - Variation (PDF/1.46 MB)

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)

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