![]() It may increase the risk of diabetic ketoacidosis in these patients.įARXIGA is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2. as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusįARXIGA is not recommended for patients with type 1 diabetes mellitus.to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple CV risk factors.to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction.to reduce the risk of sustained eGFR decline, end‑stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.Lactation: FARXIGA is not recommended when breastfeeding.Pregnancy: Advise females of potential risk to a fetus especially during the second and third trimesters.In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%). Genital Mycotic Infections: FARXIGA increases the risk of genital mycotic infections, particularly in patients with prior genital mycotic infections.If suspected, institute prompt treatment and discontinue FARXIGA Assess patients presenting with pain or tenderness, erythema, swelling in the genital or perineal area, along with fever or malaise. Serious outcomes have included hospitalization, surgeries, and death. Cases have been reported in females and males. Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Rare but serious, life-threatening cases have been reported in patients with diabetes mellitus receiving SGLT2 inhibitors including FARXIGA.Consider lowering the dose of these agents when coadministered with FARXIGA Hypoglycemia: FARXIGA can increase the risk of hypoglycemia when coadministered with insulin and insulin secretagogues.Evaluate for signs and symptoms of UTIs and treat promptly Urosepsis and Pyelonephritis: SGLT2 inhibitors increase the risk for urinary tract infections (UTIs) and serious UTIs have been reported with FARXIGA.After initiating therapy, monitor for signs and symptoms of hypotension and renal function Before initiating FARXIGA in these patients, assess volume status and renal function. Patients with impaired renal function (eGFR less than 60 mL/min/1.73 m 2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Acute kidney injury requiring hospitalization and dialysis has been reported in patients with type 2 diabetes receiving SGLT2 inhibitors, including FARXIGA. Volume Depletion: FARXIGA can cause intravascular volume depletion which may manifest as symptomatic hypotension or acute transient changes in creatinine.Patients on FARXIGA may require monitoring and temporary discontinuation in situations known to predispose to ketoacidosis Before initiating FARXIGA, consider risk factors for ketoacidosis. If suspected, discontinue FARXIGA, evaluate and treat promptly. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. In placebo-controlled trials of patients with type 1 diabetes, the risk of ketoacidosis was increased in patients who received SGLT2 inhibitors compared to patients who received placebo. Ketoacidosis in Diabetes Mellitus has been reported in patients with type 1 and type 2 diabetes receiving FARXIGA. ![]() Prior serious hypersensitivity reaction to FARXIGA. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |