Reviews reflect personal experiences and are not medical advice. Always consult your doctor.
ATC Code
A10BK01
Source
EMA · EMEA/H/C/002322
(
ARTG
)
Type 2 diabetes mellitus
Glycaemic control
FORXIGA is indicated in adults with type 2 diabetes mellitus:
as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwise indicated but was not tolerated.
as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycaemic control when diet and exercise have failed to provide adequate glycaemic control and there are poor prospects for response to metformin monotherapy (for example, high initial haemoglobin A1c [HbA1c] levels).
in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 Pharmacodynamic properties Clinical trials and section 4.4 Special warnings and precautions for use for available data on different add-on combination therapies).
Prevention of hospitalisation for heart failure
FORXIGA is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure (see section 5.1 Pharmacodynamic properties Clinical trials).
Heart failure
FORXIGA is indicated in adults for the treatment of symptomatic heart failure independent of left ventricular ejection fraction, as an adjunct to standard of care therapy (see section 5.1 Pharmacodynamic properties).
Chronic kidney disease
FORXIGA is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (CKD Stage 2, 3 or 4) (see Section 5.1 Pharmacodynamic properties, Clinical trial Chronic kidney disease).
⚠️ Warnings
• Dapagliflozin may cause serious kidney problems, therefore monitor kidney functions while taking the drug.
• • Consult the doctor before having any surgery, even a dental surgery, while taking medicine.
• • Get up slowly from the lying position; dapagliflozin may cause low blood pressure resulting in dizziness, lightheadedness or fainting.
• • Dapagliflozin interacts with the urine glucose test. A urine glucose test is often carried out to measure the quantity of glucose present in the urine sample of diabetes patients. The urine may test positive for glucose if the patient is taking dapagliflozin even if glucose is absent. Therefore, alternative methods have to be followed to test sugar levels in patients taking dapagliflozin.
