לפני מתן מרשם יש לעיין בעלון לרופא כפי שאושר על ידי משרד הבריאות

1.FORXIGA prescribing information, MOH approved
2.XIGDUO ® XR prescribing information, MOH approved

INDICATIONS:
Type 2 diabetes mellitus
FORXIGA® is indicated in adults aged 18 years and older 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.
Heart failure
Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure
Chronic kidney disease
Forxiga is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
LIMITATIONS OF USE:
FORXIGA® is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease.
FORXIGA is not expected to be effective in these populations..
CONTRAINDICATIONS:
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients on dialysis
XIGDUO® XR (dapagliflozin and metformin hydrochloride extended-release) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate [see Clinical Studies (14)].
LIMITATIONS OF USE:
XIGDUO® XR is not recommended for patients with type 1 diabetes mellitus or diabetic ketoacidosis
CONTRAINDICATIONS:
XIGDUO® XR is contraindicated in patients with:
• severe renal impairment (eGFR below 30 mL/min/1.73 m2 end stage renal disease or patients on dialysis [see Warnings and Precautions (5.1)].
• History of a serious hypersensitivity reaction to dapagliflozin such as anaphylactic reactions or angioedema or hypersensitivity to metformin hydrochloride [see Adverse Reactions (6.1)].
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin [see Warnings and Precautions (5.1) and
Warnings and Precautions (5.2)].

IL-4292 August 2023