Farxiga is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. New oral option for type 2 diabetes approved by fda. Because of this, dapagliflozin prescribing information advises not initiating it in patients with an egfr less than 60 mlmin1. Dapagliflozin s updated package insert confirms efficacy and safety profile for patients with moderate chronic kidney disease.
It contributes to a multitude of complications, such as heart disease, eye damage, kidney failure, and lowerlimb amputations. Dapagliflozin farxiga is the first of a new class of medication used to treat type 2 diabetes mellitus by increasing urinary glucose excretion. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. For patients requiring a dose of 5 mg dapagliflozin and 2000 mg metformin hcl extendedrelease, use two of the 2. Once you download your card, you can even add it to apple wallet or android pay, where you can get helpful reminders sent right to your phone.
It is similar to canagliflozin and empagliflozin jardiance. This medication works by enhancing glucose elimination via urine. Farxiga increases the risk of genital mycotic infections, so patients should be monitored and treated appropriately. Farxiga is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. List of approved drug products containing dapagliflozin in the fda orange book on.
Farxiga dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus see clinical studies 14. Farxiga dapagliflozin type 2 diabetes medication for adults. Fda approves the sglt2 inhibitor farxiga dapagliflozin. Patients using farxiga typically reduce their a1c by an. Farxiga dapagliflozenpdf prior authorization criteria.
Forxiga is indicated in adults for the treatment of insufficiently controlled type 2. Farxiga dapagliflozin mechanism of action moa type. Does not meet above criteria has any contraindications to treatment. Dapagliflozin is 78% bioavailable and rapidly absorbed. Effects of dapagliflozin, an sglt2 inhibitor, on hba1c, body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Sodiumglucose cotransporter2 inhibitors for treating. Three sglt2is available canagliflozin invokana 100mg and 300mg dapagliflozin dapazinfarxiga 5mg and 10mg empagliflozin jardiance 10 and 25mg canagliflozin 1.
Farxiga by astrazeneca and bristolmyers squibb company. To reduce the risk of hospitalization for heart failure, the recommended dose for dapagliflozin is 10 mg once daily. The fda has approved astrazeneca and bristolmyers squibb companys farxiga dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. View import data from india, price, monthly trends, major countries, major ports for dapagliflozin innusan finished dosage formulations. Xigduo xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dailymed farxiga dapagliflozin tablet, film coated. Highlights of prescribing information these highlights do not include all the information needed to use glyxambi with low systolic blood pressure, and in patients on diuretics. Although many medications can be used to treat type 2 diabetes t2d, sodiumglucose. Dapagliflozin is dosed starting at 5 mg orally in the morning and can be titrated up to 10 mg orally in the morning if clinically indicated. Treatment for type 2 diabetes mellitus in adults xigduo.
Dapagliflozin innusan finished formulations import. Dapagliflozin is a cglycosyl comprising betadglucose in which the anomeric hydroxy group is replaced by a 4chloro34ethoxybenzylphenyl group. To reduce the risk of hospitalization for heart failure, the recommended dose of. Farxiga dapagliflozen pdf prior authorization criteria. Farxiga, created by bristolmyers squibb and astrazeneca pharmaceuticals, is only the second medication in the united states to utilize this novel mechanism in. Update on longterm efficacy and safety of dapagliflozin in patients. Sodium glucose cotransporter type 2 sglt2 inhibitors moving beyond targets nicholas cole helbling pharmd bcps. Farxiga dapagliflozin dose, indications, adverse effects. Forxiga should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic. Full prescribing information 1 indications and usage jardiance is indicated. Forxiga is indicated in adults aged 18 years and older with type 2 diabetes forxiga can be taken orally once daily at any time of day with or without food. Fda approves farxiga dapagliflozin tablets for the.
No dosage adjustment is necessary for patients with mild or moderate hepatic impairment. Pdr drug summaries are concise pointofcare prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice pdr s drug summaries are available free of charge and serve as a great resource for us based mds, dos, nps and pas in patient practice. Dapagliflozin fda orange book approved drug product. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Dapagliflozins updated package insert confirms efficacy and safety profile for patients with moderate chronic kidney disease. The printed package leaflet of the medicinal product must state the name and. Farxiga dapagliflozin is a sodiumglucose cotransporter 2 sglt2 inhibitor indicated. Forxiga, inndapagliflozin european medicines agency. Farxiga is a sodiumglucose cotransporter 2 sglt2 inhibitor indicated. Dapagliflozin is an antidiabetic agent that belongs to the class of sodiumglucose cotransporter 2 sglt2 inhibitors.
Sodium glucose cotransporter type 2 sglt2 inhibitors. Farxiga is the brandname form of the drug dapagliflozin, which is used along with diet and exercise to treat type 2 diabetes type 2 diabetes is a condition where the body does not produce or. Fda approves farxiga dapagliflozin tablets for the treatment of adult patients with type 2 diabetes. October 21, 2019 astrazeneca announced the fda approval of farxiga dapagliflozin, to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus t2dm and established cardiovascular disease cvd or multiple cardiovascular cv risk factors. Farxiga headtohead comparisons of medication uses, side effects, ratings, and more. Dapagliflozin versus glipizide as addon therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin. Physicians may also fax or mail the attached form to the address above. Dapagliflozin farxiga is an oral medication used to improve glycemia blood glucose control in patients with type 2 diabetes. On january 8, the fda approved farxiga dapaglifozin for the treatment of type 2 diabetes. Dapagliflozins updated package insert fda extension.
Fda warns that sglt2 inhibitors for diabetes may result in. Medication guide farxiga far see guh dapagliflozin tablets what is the most important information i should know about farxiga. Fda warns that sglt2 inhibitors for diabetes may result in a serious condition of too much acid in the blood. Farxiga dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus see. It was developed by bristolmyers squibb in partnership with astrazeneca. This communication provides updated information to the fda drug safety communication. Cell tumors in rodents, semaglutide causes dosedependent and treatmentduration. Farxiga dapagliflozin, an adult type 2 diabetes medication used with diet. Nevertheless, the approved summary of product characteristics in europe. Farxiga dapagliflozin dosing, indications, interactions. 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. New oral option for type 2 diabetes approved by fda in january 2014, the fda approved farxiga dapagliflozin, an orallyactive sodium glucose cotransporter type 2 sglt2 inhibitor.
Sglt2 is found in the kidney tubules and is responsible for reabsorbing the majority of glucose filtered out of the blood by the kidneys. History of serious hypersensitivity reaction to farxiga severe renal impairment, esrd, or on dialysis not approved if. Highlights of prescribing information these highlights. The formulary exceptionprior authorization form is included as part of this document for physicians to submit for patients who do not. Please see full prescribing information and medication guide for farxiga. Forxiga dapagliflozin is indicated for use as an adjunct to diet and exercise. Type 2 diabetes medication jardiance empagliflozin tablets. Please read us full prescribing information and medication guide for farxiga. Indication and limitation of use for farxiga dapagliflozin.
Cardiovascular outcomes trial farxiga dapagliflozin. Bms512148, costeffectiveness, dapagliflozin, farxiga, forxiga. Dapagliflozin is a sodiumglucose cotransporter sglt2 inhibitor. Talk to your healthcare provider about what to do if you get symptoms of. Dapagliflozin is indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease. Finally, on january 8, 2014, the fda approved farxiga dapagliflozin for use in treatment of type 2 diabetics. Sanford health largest, notforprofit rural health system in the nation 43 hospitals. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for farxiga dapagliflozin. Xigduo xr is a combination of dapagliflozin, a sodiumglucose cotransporter 2 sglt2 inhibitor, and metformin, a biguanide, 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.
Longterm efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin. In patients with severe hepatic impairment, a starting dose of 5 mg is. The drug is called forxiga in europe, where it has been approved since november 2012. Treatment for type 2 diabetes mellitus in adults farxiga. Used in the formo f its propanediol monohydrate to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. For adults with type 2 diabetes, farxiga is a prescription medicine used to reduce the risk of hospitalization for heart failure in patients with known cardiovascular cv disease or multiple cv risk factors, and to improve blood sugar control along with diet and exercise. Fda revises labels of sglt2 inhibitors for diabetes to. Data sources include ibm watson micromedex updated 28 feb 2020, cerner multum updated 2 mar 2020. Farxiga dapagliflozin can be used together with other diabetes medicines to help lower your blood sugar, but it can be expensive because its brand name.
125 1137 779 112 371 1148 331 1238 251 852 319 627 1205 1263 640 362 1496 42 5 988 526 405 94 300 133 506 1548 1077 287 1172 318 880 1044 395 292 949 568 1359 1333 43 642 419 71 745 346 553 8