Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, sold under the brand name farxiga among others, is a medication used to treat. Finding and evaluating generic and branded drug market entry opportunities. What are some things i need to know or do while i take dapagliflozin. Xigduo xr dapagliflozin and metformin hcl extended. Xigduo xr 5 mg mg, the equivalent of 10 mg dapagliflozin as. Dapagliflozin is an oral diabetes medicine that helps control blood sugar levels. Dapagliflozin propanediol pharmacokinetics absorption bioavailability. Dapagliflozin propanediol monograph for professionals. Fhea, fbphs, in medical pharmacology and therapeutics fifth edition, 2018. An fda advisory committee recommended against approving the drug at a july meeting by a 96 vote, citing concern over potential breast and bladder cancer risks dapagliflozin.
Farxiga dapagliflozin is indicated as an adjunct to diet and exercise to. It is a combination of dapagliflozin and metformin. You may report side effects to fda at 1800 fda 1088. In patients treated with dapagliflozin, a nonsignificant excess number of breast and bladder. In february 2017, the fda approved a oncedaily combination of dapagliflozin. Dailymed farxiga dapagliflozin tablet, film coated. Farxiga dapagliflozin dosing, indications, interactions.
The prescription drug user fee act date, the fda action date for this. Farxiga dapagliflozin is indicated as an adjunct to diet and exercise to improve. Headtohead comparison of empagliflozin and dapagliflozin. Dapagliflozin is a sodiumglucose cotransporter sglt2. Dapagliflozin is the international nonproprietary name inn, and the united states adopted name usan. What links here related changes upload file special pages permanent link page information.
Pdf pharmacokinetics, pharmacodynamics and clinical efficacy of. Information on submitting spl files using elist may be found in the guidance for industry spl. Dapagliflozin a breakthrough in the search for drugs to. On 19 january 2012 the us food and drug administration fda did not approve the use of dapagliflozin due to concerns of increased risk of breast and. Act fdca for farxiga dapagliflozin tablets 5 mg and 10 mg. Addendum to fda briefing document advisory committee meeting december 12 20 for dapagliflozin. The fda submission file reported nine breast cancers in 4 287 patients receiving. Sodium glucose cotransporter type 2 sglt2 inhibitors. Dapagliflozin metformin was approved for use in the european union in january 2014, 4 and for use in the united states in february. Dapagliflozin is a sodiumglucose cotransporter2 inhibitor that lowers plasma glucose by decreasing its renal reabsorption. Pdf dapagliflozin for the treatment of type 2 diabetes. Sodiumglucose cotransporter 2 sglt2 inhibitors are a novel class of antihyperglycaemic agents with an insulinindependent mode of action.
You must check to make sure that it is safe for you to take dapagliflozin with all of your drugs and health problems. Xigduo xr dapagliflozin and metformin hcl extendedrelease. Dapagliflozin in patients with type 2 diabetes mellitus ncbi. Sanford health largest, notforprofit rural health system in. Adverse effects and safety of sglt2 inhibitors emconsulte. Update on longterm efficacy and safety of dapagliflozin in patients. Efficacy and safety of dapagliflozin, added to therapy of patients with type 2 diabetes with inadequate glycemic control on insulin the safety and scientific validity of this. Dapagliflozin is not known to have any meaningful drug drug.
Dapagliflozin is a cglycosyl comprising betadglucose in which the anomeric hydroxy group is replaced by a 4chloro34ethoxybenzylphenyl group. Dapagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Fda warns that sglt2 inhibitors for diabetes may result in. Find information on dapagliflozin farxiga in daviss drug guide including dosage, side effects, interactions, nursing implications, mechanism of action, half life, administration, and more. Fda rejects dapagliflozin for type 2 diabetes medpage today. There is a combination product dapagliflozin metformin extendedrelease, called xigduo xr. Persons with disabilities having problems accessing the pdf files below may. Empagliflozin or dapagliflozin as an addon drug for inadequately controlled t2d patients who are already receiving a regimen of three distinct oads, including metformin. Used in the formo f its propanediol monohydrate to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. In 2012 fda delayed the approval of dapagliflozin partly because of concerns. Dapagliflozin 3oglucuronide accounted for 61% of a 50 mg 14 c dapagliflozin dose and is the predominant drug related component in human plasma.
The fda granted the approval of qternmet xr to astrazeneca. What is known about this drug in comparison with other combination therapies, both dapagliflozin and canagliflozin provide similar improvements in hba 1c level when combined. The secondary composite outcome hospitalization for hf or death from cardiovascular causes was also lower in the dapagliflozin group than in the placebo group. There is a vast, ambitious, and promising ongoing clinical investigation program with dapagliflozin and other sglt2 inhibitors, which may result in changes to the therapeutic approach to hf in a relatively short time. Fda strengthens kidney warnings for diabetes medicines canagliflozin invokana, invokamet and dapagliflozin farxiga, xigduo xr. Effect of dapagliflozin on worsening heart failure and. Farxiga drug profile send this page by email email this page to a colleague. National pbm drug monograph dapagliflozin farxiga vha pharmacy benefits management strategic healthcare group medical advisory panel and visn pharmacist executives the purpose of vaco pbmshg drug monographs is to provide a comprehensive drug. Sodium glucose cotransporter type 2 sglt2 inhibitors moving beyond targets nicholas cole helbling pharmd bcps. Dapagliflozin was the first of its class inhibitors of sodiumglucose cotransporter to be approved in europe, usa, and brazil. Farxiga dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic. Farxiga dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus see. Dapagliflozin is used along with diet and exercise, and sometimes with other medications, to lower blood sugar levels in patients with type 2 diabetes condition in which blood sugar is too. Fda requires additional data to assess imbalances in bladder cancer and drug.
Dapagliflozin reduced the risk of worsening heart failure events and cardiovascular death and improved symptoms. Administration with a highfat meal decreased peak plasma concentration by up to 50% and prolonged time to peak plasma concentration by approximately 1 hour, but did. Drugdrug interactions with sglt2 inhibitors, new oral. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The recommended dose of qtern is a 10 mg dapagliflozin5 mg saxagliptin. Data sources include ibm watson micromedex updated 28 feb 2020, cerner multum updated 2 mar 2020, wolters kluwer updated. Farxiga dapagliflozin is a firstinclass, oral oncedaily sglt2. Do not start, stop, or change the dose of any drug without checking with your doctor.
Efficacy and safety of dapagliflozin, added to therapy of. As the drug was recently approved, there is the need for. Bristolmyers squibb application no 202293 approval date. Dapagliflozin is an oral, oncedaily, sodium glucose cotransporter type 2 sglt2 inhibitor that was developed by bristolmyers squibb bms and its licensee.
Each tablet contains 5 mg dapagliflozin equivalent to 6. Fda warns that sglt2 inhibitors for diabetes may result in a serious condition of too much acid in the blood. Advisory committee meeting december 12 december 6, 20. Dapagliflozin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Dapagliflozin farxiga is an oral medication used to improve glycemia blood glucose control in patients with type 2 diabetes. Update on longterm efficacy and safety of dapagliflozin. Revised version submitted to clinical pharmacokinetics drugdrug interactions with sglt2 inhibitors, new oral glucoselowering agents for the management of type 2 diabetes. The us food and drug administration fda, followed by the european medicine agency. Farxiga is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Dapagliflozin is 78% bioavailable and rapidly absorbed. Chairman and members of the endocrinologic and metabolic drugs advisory committee.
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