Highlights of prescribing information before initiating. Benefits may vary based on product line, group, or contract. By inhibiting sglt2, dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Forxiga 5 mg filmcoated tablets patient information. Farxiga dapagliflozin, invokana canagliflozin, jardiance empagliflozin and steglatro ertugliflozin are sodiumglucose cotransporter 2 sglt2 inhibitors indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. Realworld comparative effectiveness of canagliflozin versus. Invokana canagliflozin step therapy unitedhealthcare. These changes are not considered to be clinically meaningful and dapagliflozin can be administered with or without food. Sglt2 inhibitor dapagliflozin farxiga, for patients who have hfref, with or without t2dm. Patients with a history ofhypersensitivity reaction to the active substance or to any of the excipients. Forxiga dapagliflozin propanediol is a potent, highly selective and orally active inhibitor.
In type1 diabetes mellitus studies with dapagliflozin, patients had a higher number of dka events compared with the placebo group see section4. Farxiga dapagliflozin is an oral medication used to treat type 2 diabetes. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for farxiga dapagliflozin. Farxiga dapagliflozin prescribing information az medical. Reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation for patients with creatinine clearance crcl 30 mlmin, the recommended dose of pradaxa is 150 mg taken orally, twice daily. Dapagliflozin in patients with heart failure and reduced ejection fraction. Dapagliflozin versus glipizide as addon therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin.
Dapagliflozin is a new oral agent for type 2 diabetes with shortterm efficacy similar to. Included for board consideration are package inserts and a comparison chart. Forxiga 5 mg filmcoated tablets patient information leaflet pil. For a complete listing, see dosage forms, composition and packaging. Realworld comparative effectiveness of canagliflozin. New indication on may 5th 2020, fda approved dapagliflozin.
Forxiga, inndapagliflozin european medicines agency europa. The mo healthnet pharmacy program will implement a state specific preferred drug list. The hr for the comparison of dapagliflozin and pbo for the primary composite outcome was 0. It belongs to a group of medicines called sodium glucose cotransporter2 sglt2 inhibitors. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for farxiga dapagliflozin skip to. Pdf icon download leaflet view the patient leaflet in pdf format. Farxiga dapagliflozin tablets, for oral use initial u. Diabetic ketoacidosis in patients with type 2 diabetes. If you have any further questions, ask your doctor, pharmacist or nurse. Monitor for signs and symptoms of hypotension after initiating therapy and increase monitoring in clinical situations where volume contraction is expected. Highlights of prescribing information these highlights do not include all the information needed to use afrezza safely and effectively. Fda approves farxiga dapagliflozin tablets for the. In the eu, oral dapagliflozin once daily is approved for use as monotherapy in patients who are intolerant of met.
Invokana can cause serious side effects, including. Dapagliflozin has not been studied for the treatment of heart failure in patients with type1 diabetes mellitus. The printed package leaflet of the medicinal product must state the name and. Diabetic ketoacidosis dka is a serious acute metabolic complication of diabetes, characterized by hyperglycemia, ketosis, and metabolic acidosis. Following coadministration of dapagliflozin with mefenamicacid an inhibitor of ugt1a9, a 55% increase in dapagliflozin systemic exposure was seen, but with no clinically meaningful effect on 24hour urinary glucose excretion. Farxiga dapagliflozin tablets prescribing information. Xigduo xr dapagliflozin and metformin extendedrelease package insert. Each tablet contains the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol. Why issue type 2 diabetes mellitus is a significant health problem associated with excessive selected. Highlights of prescribing information o for patients. The effect of dapagliflozin on the primary composite outcome was generally consistent across prespecified subgroups. Bristolmyers squibb company 2014 farxiga package insert. Highlights of prescribing information o for patients with.
Dapagliflozin forxiga is a highly potent, reversible and selective sodiumglucose cotransporter2 inhibitor indicated worldwide for the treatment of type 2 diabetes t2d. Treatment of these patients with dapagliflozin 10mg is not recommended. Information for the patient is provided as a package insert in the. A comprehensive target drug utilization evaluationmedication use evaluation. To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction nyha class iiiv labeled contraindications also updated.
To reduce the risk of hospitalization for heart failure, the recommended dose for dapagliflozin is 10 mg once daily. Information for the patient forxiga 10 mg filmcoated tablets dapagliflozin read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Farxiga dapagliflozin us food and drug administration. New combinations of sglt2 inhibitorsmetformin and their extendedrelease formulations have since been approved by the fda. Metabolism of dapagliflozin is mediated predominantly by ugt1a9, producing inactive glucuronidated metabolites, mostly dapagliflozin 3oglucuronide. Page 1 of 3 louisiana medicaid sodium glucose cotransporter2 sglt2 inhibitors the louisiana uniform prescription drug prior authorization form should be utilized to request authorization for nonpreferred sglt2s. Forxiga contains the active substance dapagliflozin. Forxiga dapagliflozin is indicated for use as an adjunct to. In the canvas program, mean potassium levels were generally consistent with canagliflozin and placebo, overall and by baseline estimated glomerular filtration rate egfr. Dapagliflozin is eliminated mainly by metabolism through glucuronidation 66% of dose and oxidation 9% of dose. Farxiga for adults withtype 2 diabetes and multiple cv risk. Important safety information for qtern dapagliflozin and saxagliptin.
Dapackd trial recently ended early due to benefit in reducing adverse renal outcomes farxiga dapagliflozin package insert. As the prevalence of this metabolic disorder is rapidly increasing. Effects of canagliflozin on serum potassium in the. When adding dapagliflozin to therapy with an insulin secretagogue e. To improve glycemic control, the recommended starting dose of farxiga is 5 mg orally once daily, taken in the morning, with or without food. Nov 12, 2020 introduction while several sodium glucose cotransporter 2 sglt2 inhibitors are approved as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus t2dm, there are no clinical trial data providing headtohead comparisons of the efficacy and safety of these therapies. Invokana invokahnuh canagliflozin tablets, for oral.
The sodiumglucose cotransporter 2 sglt2 inhibitors canagliflozin, empagliflozin and dapagliflozin are glucoselowering agents that have been approved for reduction of the risk of major adverse cardiovascular cv events, cv death and hospitalization for heart failure, respectively, in patients with type 2 diabetes mellitus t2dm and high cv risk. Dapagliflozin, sold under the brand name farxiga among others, is a medication used to treat type 2 diabetes and, with certain restrictions, type 1 diabetes. Fda warns that sglt2 inhibitors for diabetes may result in. By blocking this protein, blood sugar glucose, salt sodium and water are removed from your body via the urine.
However, there has been no specific recommendation when to add it to existing therapy leaving it to clinical judgment. Jan 18, 2021 administration of dapagliflozin with a highfat meal decreases its c max by up to 50% and prolongs t max by approximately 1 hour but does not alter auc as compared with the fasted state. Dapagliflozin in patients with heart failure and reduced. Qtern dapagliflozin and saxagliptin package insert. Canagliflozin dapagliflozin empagliflozin efficacy a1c lowering monotherapy v 0. Moderate to severe renal impairment egfr 45 mlmin1. Highlights of prescribing information afrezza excipients 4. Feb 15, 2021 forxiga contains the active substance dapagliflozin.
Farxiga for adults withtype 2 diabetes and multiple cv. Use for farxiga dapagliflozin farxiga is indicated. Fda warns that sglt2 inhibitors for diabetes may result in a. May 05, 2020 dapagliflozin is an inhibitor of sglt2. In the eu, oral dapagliflozin once daily is approved for use as monotherapy in patients who are intolerant of metformin and as addon combination therapy with other glucoselowering agents, including insulin for t2d. The metabolism by cyp enzymes is less than 10% of the oral dose 58, 63. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. In patients tolerating 5 mg dapagliflozin and 5 mg saxagliptin once daily who require.
Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise. Sodium glucose cotransporter type 2 sglt2 inhibitors. It is also used to treat adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure. Page 2 of 3 references american diabetes association. For patients requiring a dose of 5 mg dapagliflozin and 2000 mg metformin hcl extendedrelease, use two of the 2. Jan, 2014 rosenstock j, vico m, wei l, salsali a, list j. Design and baseline characteristics of the evaluation of ertugliflozin efficacy and. Pdf each month, subscribers to the formulary monograph service receive 5 to 6. Jun 21, 2017 march 2014 pdl meeting and currently includes farxiga dapagliflozin, invokana canagliflozin, and jardiance empagliflozin. Dailymed farxiga dapagliflozin tablet, film coated.
Reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation for patients with creatinine clearance crcl 30 mlmin, the recommended dose of pradaxa is. Effects of dapagliflozin, a sodiumglucose cotransporter2 inhibitor, on hemoglobin a1c, body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. The recommended dose is 10mg dapagliflozin once daily. They work by blocking the sglt2 protein in your kidney. Medication guide invokana invokahnuh canagliflozin tablets, for oral use what is the most important information i should know about invokana. Fda warns that sglt2 inhibitors for diabetes may result in a serious condition of too much acid in the blood. Prior serious hypersensitivity reaction to qtern or its components.
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