Drugplain

FARXIGA 5 mg/1

DAPAGLIFLOZIN · TABLET, FILM COATED · A-S Medication Solutions

No Recall History
Plain English

FARXIGA is a tablet, film coated containing dapagliflozin at 5 mg/1, taken oral. Manufactured by A-S Medication Solutions.

Key Facts

Brand Name
FARXIGA
Generic Name
DAPAGLIFLOZIN
NDC Code (Product)
50090-3482
Manufacturer
A-S Medication Solutions
Strength
5 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
NDA202293
Marketing Start
01/14/2008

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

death7,496 reports
fatigue2,383 reports
nausea2,344 reports
dizziness2,206 reports
diarrhoea2,191 reports
dyspnoea2,065 reports
weight decreased1,903 reports
blood glucose increased1,901 reports
off label use1,862 reports
acute kidney injury1,787 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE FARXIGA (dapagliflozin) is indicated: • To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. • To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. • To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. • As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use • FARXIGA is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ] . • FARXIGA 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 . FARXIGA is likely to be ineffective in this setting based upon its mechanism of action. • FARXIGA is not recommended for the treatment of chronic kidney disease in patients with polycystic kidne…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Assess volume status and correct volume depletion before initiating. (2.1) eGFR (mL/min/1.73 m 2 ) Recommended Dose eGFR 45 or greater To improve glycemic control, the recommended starting dose is 5 mg orally once daily. Dose can be increased to 10 mg orally once daily for additional glycemic control. For all other indications, the recommended starting dose is 10 mg orally once daily. eGFR 25 to less than 45 10 mg orally once daily eGFR less than 25 Initiation is not recommended; however, patients may continue 10 mg orally once daily to reduce the risk of eGFR decline, ESKD, CV death and hHF. • Withhold FARXIGA for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. (2.3) 2.1 Prior to Initiation of FARXIGA Assess renal function prior to initiation of FARXIGA therapy and then as clinically indicated [see Warnings and Precautions (5.2) ]. Assess volume status. In patients with volume depletion, correct this condition before initiating FARXIGA [see Warnings and Precautions (5.2) and Use in Specific Populations (8.5 , 8.6) ] . 2.2 Recommended Dosage See Table 1 for dosage recommendations based on estimated …

Contraindications

4 CONTRAINDICATIONS • History of a serious hypersensitivity reaction to FARXIGA, such as anaphylactic reactions or angioedema [see Adverse Reactions (6.1) ] . • History of serious hypersensitivity reaction to FARXIGA. (4)

Drug Interactions

7 DRUG INTERACTIONS Table 5: Clinically Relevant Interactions with FARXIGA Insulin or Insulin Secretagogues Clinical Impact The risk of hypoglycemia may be increased when FARXIGA is used concomitantly with insulin or insulin secretagogues (e.g., sulfonylurea) [see Warnings and Precautions (5.4) ] . Intervention Concomitant use may require lower doses of insulin or the insulin secretagogue to reduce the risk of hypoglycemia. Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently during FARXIGA initiation and dosage changes. Positive Urine Glucose Test Clinical Impact SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Intervention Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control. Interference with 1,5-anhydroglucitol (1,5-AG) Assay Clinical Impact Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Intervention Monitoring glycemic control with 1,5-A…

Adverse Reactions

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: • Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.1) ] • Volume Depletion [see Warnings and Precautions (5.2) ] • Urosepsis and Pyelonephritis [see Warnings and Precautions (5.3) ] • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.4) ] • Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) [see Warnings and Precautions (5.5) ] • Genital Mycotic Infections [see Warnings and Precautions (5.6) ] • Most common adverse reactions (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates obs…

Frequently Asked Questions

What is FARXIGA used for?

FARXIGA contains DAPAGLIFLOZIN. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is FARXIGA a controlled substance?

FARXIGA is not classified as a controlled substance by the DEA.

What is the generic name for FARXIGA?

The generic name for FARXIGA is DAPAGLIFLOZIN. There are 11 other brand versions of DAPAGLIFLOZIN.

What is the NDC code for FARXIGA 5 mg/1?

The NDC (National Drug Code) for FARXIGA 5 mg/1 is 50090-3482, listed by A-S Medication Solutions.

Product NDC

50090-3482

Package NDC

50090-3482-0

Other FARXIGA Dosages

Other Dapagliflozin Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)