Farxiga package insert pdf

Choose the answer you think fits best for each question, and learn how each decision impacts your overall health. Postmarketing cases of metforminassociated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Highlights of prescribing information zerbaxa 750 mg 250 mg. Assess and correct volume status before initiating farxiga in patients with impaired renal function, elderly patients, or patients on loop diuretics. Food and drug administration fda approved farxiga farseega dapagliflozin, a oncedaily oral treatment indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Highlights of prescribing information farxiga may require. This leaflet is a summary and will not tell you everything about this drug. Dapagliflozins updated package insert fda extension. In order to monitor the safety of astrazeneca products, we encourage reporting any side effects experienced while taking an astrazeneca product to the az information center at 18002369933. Highlights of prescribing information these highlights do not include all the information needed to use basaglar safely and effectively. May 05, 2020 farxiga is available as a filmcoated tablet for oral administration containing the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol or the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol, and the following inactive ingredients. Highlights of prescribing information hyperglycemiaor.

You may require medicines in addition to healthy consuming and exercise routines to manage your type 2 diabetes. This medication works by enhancing glucose elimination via urine. Farxiga is a prescription medicine used in adults with type 2 diabetes to improve blood sugar control along with diet and exercise, and to reduce the risk of hospitalization for heart failure in patients with. Breo ellipta fluticasone furoate and vilanterol inhalation.

Farxiga is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. The onset of metformin associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Dapagliflozin is effective as addon fwrxiga to sitagliptin with or without metformin. Postmarketing cases of metforminassociated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant. Zerbaxa ceftolozane and tazobactam for injection, for intravenous use initial u. In patients with prior history of bladder cancer, the benefits of glycemic control versus unknown risks for cancer recurrence with farxiga should be considered. Page 1 lbl014003 rev 001 dexcom g6 user guide page 2. Latuda lurasidone hydrochloride tablets, for oral use initial u. Steglatro is contraindicated in patients with severe renal impairment, endstage renal disease, or on dialysis, andor a history of a serious hypersensitivity. If you have any further questions, ask your doctor, pharmacist or nurse. You can take lots of diabetes medications by mouth. Dapagliflozin versus glipizide as addon therapy in patients with type 2. Highlights of prescribing information these highlights do not include all the information needed to use xigduo xr safely and. View the prescribing information for janumet in pdf format.

Highlights of prescribing information adjust adult. Dapagliflozin is an antidiabetic agent that belongs to the class of sodiumglucose cotransporter 2 sglt2 inhibitors. Type 2 diabetes medication jardiance empagliflozin tablets. Ketoacidosis has been reported in patients with type 1 and type 2. Prescribing information for janumet sitagliptin and. Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections.

Consequently, farxiga should not be used in patients with active bladder cancer. Jardiance is the first type 2 diabetes pill proven to go beyond lowering a1c to reduce the risk of cardiovascular cv death for adults who have type 2 diabetes and known heart disease. Highlights of prescribing information zerbaxa 750 mg 250. There are insufficient data to determine whether farxiga has an effect on preexisting bladder tumors. Highlights of prescribing information these highlights do not include all the information needed to use zerbaxasafely and effectively.

Sanford health largest, notforprofit rural health system in the nation 43. Farxiga is available as a filmcoated tablet for oral administration containing the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol or the equivalent of 10 mg dapagliflozin. To improve glycemic control, the recommended starting dose of farxiga is 5 mg once daily, taken in the morning, with or without food. Fetal toxicity when pregnancy is detected, discontinue entresto as soon as possible 5. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. In june 2016, the fda issued a safety alert for canagliflozin invokana, invokamet, used to treat type 2 diabetes now, another warning has been issued, for invokana and invokamet along with.

Forxiga should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic. Highlights of prescribing information before initiating. Get dosing information on farxiga dapagliflozin, for the treatment of type 2 diabetes mellitus. Highlights of prescribing information zerbaxa 750 mg 250 mg and 125 mg 500 mg and 250 mg intravenously every 8 hours a single loading dose of a single loading dose zerbaxa 750 mg of zerbaxa 2. Alternatively, you can report any side effects of prescription drugs directly to the fda. An increased risk of lowerlimb amputations associated with invokana use versus placebo was observed in canvas 5. Invokana is not recommended in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. See full prescribing information for basaglar basaglar insulin glargine injection, for subcutaneous use initial u. Sodium glucose cotransporter type 2 sglt2 inhibitors moving beyond targets nicholas cole helbling pharmd. Dailymed farxiga dapagliflozin tablet, film coated. Farxiga dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus see.

Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for farxiga dapagliflozin skip to. Farxiga should not be used to farsiga people with type 1 diabetes or diabetic ketoacidosis increased ketones in your blood or urine. Dapagliflozins updated package insert confirms efficacy and safety profile for patients with moderate chronic kidney disease. See full prescribing information for complete boxed warning. Fda approves farxiga dapagliflozin tablets for the. To improve glycemic control, the recommended starting dose of farxiga is 5 mg once daily, taken in the morning, with or. Sodium glucose cotransporter type 2 sglt2 inhibitors moving beyond targets nicholas cole helbling pharmd bcps. Assess renal function prior to initiation of farxiga therapy and then as clinically indicated see warnings and precautions 5. Indications and limitations of use for farxiga farxiga is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure nyha class iiiv with reduced. Highlights of prescribing information adjust adult doses. Highlights of prescribing information these highlights. Forxiga is a registered trademark of astrazeneca ab, used under. Farxiga causes intravascular volume contraction, and symptomatic hypotension can occur. Farxiga pi pdf get dosing information on farxiga dapagliflozin, for the treatment of type 2 diabetes mellitus.

Highlights of prescribing information these highlights do not include all the information needed to use latuda safely and effectively. If a serious infection develops, interrupt xeljanzxeljanz xr until the infection is controlled. Food and drug administration fda approved farxiga farseega dapagliflozin, a once. In patients tolerating farxiga 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily. Farxiga is contraindicated in patients with an egfr less than 30 mlmin1. Highlights of prescribing information these highlights do not. Samples, vouchers, and coupons for steglatro ertugliflozin. Dosage forms and strengths these highlights do not include.

Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for farxiga dapagliflozin. Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred. If metforminassociated lactic acidosis is suspected, immediately discontinue janumet and. Find out more about farxiga, consider a lower dose of insulin or the insulin secretagogue to farxiga is not recommended for patients with type 1 diabetes mellitus or for the 1 apr 2015 dapagliflozin forxiga with insulin, an option for type 2 diabetes addon treatment. Cytomel liothyronine sodium this product information is intended only for residents of the united states. Highlights of prescribing information these highlights do not include all the information needed to use dupixent safely and effectively. Farxiga is a sodiumglucose cotransporter 2 sglt2 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Farxiga fda prescribing information, side effects and uses.

The incidence of syncopal episodes is approximately 1% in patients. Farxiga is a prescription medicine used in adults with type 2 diabetes to improve blood sugar control along with diet and exercise, and to reduce the risk of hospitalization for heart failure in patients with known cardiovascular cv disease or multiple cv risk factors. Highlights of prescribing information patients who have known. Sodium glucose cotransporter type 2 sglt2 inhibitors. Farxiga dapagliflozin type 2 diabetes medication for adults. Dapagliflozin versus glipizide as addon therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin. Talk to your healthcare professional about your medical condition and. Dapagliflozin is an antidiabetic agent that belongs to the class of sodium.

Serious infections and malignancies 1 indications and usage 1. Highlights of prescribing information an initial dose. Highlights of prescribing information patients who. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for jardiance empagliflozin.