Dapagliflozin 5 mg Tablet, Film Coated, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Sodium-Glucose Cotransporter 2 Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Dapagliflozin is used to lower blood sugar in people with type 2 diabetes (condition in which blood sugar is too high because the body does not make or use insulin normally). to reduce the risk of being hospitalized for heart failure in certain adults with type 2 diabetes to reduce the risk of being hospitalized for heart failure and death in adults with heart failure to reduce the risk of worsening of kidney disease, being hospitalized for heart failure, and death in certain adults with kidney disease Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SG...
Read the full MedlinePlus article ↗- No, it's used for more than just blood sugar control. Dapagliflozin is approved to help manage type 2 diabetes, but it's also used to reduce the risk of serious heart failure compl...
- What is dapagliflozin actually used for — is it just for diabetes?
- You can take it either way — with or without food. A high-fat meal may slow how quickly it absorbs slightly, but it doesn't change the overall amount that gets into your system. Ju...
- Can I take this tablet with food, or does it have to be on an empty stomach?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Dapagliflozin — tap one for details:
Dapagliflozin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII G2M7P15E5P
Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
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UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
10 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.185 | $5.54 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $6.05 | $181.59 / 30 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dapagliflozin 5 mg 00480-3527-05 | Teva | 500 tablets | $0.185 | AB | Availability likely | — |
| Dapagliflozin 5 mg 27241-0151-01 | Ajanta | 30 tablets | $0.185 | AB | Availability likely | — |
| dapagliflozin 5 mg 33342-0585-07 | Macleods | 30 tablets | $0.185 | AB | Availability likely | — |
| Dapagliflozin 5 mg 59651-0159-30 | Aurobindo | 30 tablets | $0.185 | AB | Availability likely | — |
| Dapagliflozin 5 mg 60505-4911-03 | Apotex | 30 tablets | $0.185 | AB | Availability likely | — |
| Dapagliflozin 5 mg 62332-0392-30 | Alembic | 30 tablets | $0.185 | AB | Availability likely | — |
| Dapagliflozin 5 mg 66993-0456-30 | Prasco | 30 tablets | $0.185 | AB | Availability likely | — |
| Dapagliflozin 5 mg 69097-0388-02 | Cipla | 30 tablets | $0.185 | AB | Availability likely | — |
| Dapagliflozin 5 mg 70710-1380-03 | Zydus | 30 tablets | $0.185 | AB | Availability likely | — |
| Dapagliflozin 5 mg 70748-0105-06 | Lupin | 30 tablets | $0.185 | AB | Availability likely | — |
| Dapagliflozin 5 mg 70954-0856-10 | ANI | 30 tablets | $0.185 | AB | Availability likely | — |
| Dapagliflozin 5 mgthis 72205-0432-01 | Novadoz | 30 tablets | $0.185 | AB | Availability likely | — |
| Farxiga 5 mg 00310-6205-30 | AstraZeneca | 30 tablets | $12.076 | AB | Availability likely | +6444% |
| Dapagliflozin 5 mg 00781-5985-01 | Sandoz | 100 tablets | — | AB | FDA listed | — |
| Dapagliflozin 5 mg 46708-0392-30 | Alembic | 30 tablets | — | AB | FDA listed | — |
| Farxiga 5 mg 50090-3482-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Dapagliflozin 5 mg 50090-7056-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Dapagliflozin 5 mg 50090-7971-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Dapagliflozin 5 mg 67877-0608-05 | Ascend | 500 tablets | — | AB | FDA listed | — |
| Dapagliflozin 2,3-BUTANEDIOL MONOHYDRATE 5 mg 70377-0023-11 | Biocon | 30 tablets | — | AB | FDA listed | — |
| Farxiga 5 mg 70518-4614-00 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| Dapagliflozin 5 mg 70771-1714-03 | Zydus | 30 tablets | — | AB | FDA listed | — |
| Dapagliflozin 5 mg 71921-0420-09 | Florida | 90 tablets | — | AB | FDA listed | — |
| Dapagliflozin 5 mg 73190-0072-30 | AvKARE | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 72205-0432-01 You're viewing this | 30 TABLET, FILM COATED in 1 BOTTLE (72205-432-01) | $0.1845 / ea | $5.54 | 2026-04-07 | Active |
| 72205-0432-02 | 500 TABLET, FILM COATED in 1 BOTTLE (72205-432-02) | — | — | 2026-04-07 | Active |
| 72205-0432-03 | 90 TABLET, FILM COATED in 1 BOTTLE (72205-432-03) | $0.1845 / ea | $16.61 | 2026-04-07 | Active |
You're viewing the smallest of 3 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1845 NADAC).
Pack size FAQ
What quantity is in NDC 72205-0432-01?
What is the difference between NDC 72205-0432-01 and NDC 72205-0432-03?
What NDC number is used to bill for this package of Dapagliflozin 5 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Dapagliflozin tablet is indicated: 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 Dapagliflozin tablet is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ] .
Dapagliflozin tablet is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . Dapagliflozin tablet is likely to be in effective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga® (dapagliflozin) Tablets.
However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information. Dapagliflozin tablet is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated: • To reduce the risk of hospitalization for heart failure in adults with type 2diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. ( 1 ) • As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
( 1 ) Limitations of use: • Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 ) • Not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . Dapagliflozin tablet is likely to be ineffective in this setting based upon its mechanism of action.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Assess renal function prior to initiation and then as clinically indicated. Assess volume status and correct volume depletion before initiating. ( 2.1 ) To improve glycemic control, the recommended starting dosage is 5 mg orally once daily.
Dosage can be increased to 10 mg orally once daily for additional glycemic control. ( 2.2 ) For all other indications, the recommended dosage is 10 mg orally once daily. (2.3) See full prescribing information for dosage recommendations in patients with renal impairment.
( 2.2 , 2.3 ) Withhold dapagliflozin tablet for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. ( 2.4 )
2.1Testing Prior to Initiation of Dapagliflozin Tablets Assess renal function prior to initiation of dapagliflozin tablets and then as clinically indicated [see Warnings and Precautions (5.2) ]. Assess volume status. In patients with volume depletion, correct this condition before initiating of dapagliflozin tablets [see Warnings and Precautions (5.2) and Use in Specific Populations (8.5 , 8.6) ].
2.2Recommended Dosage for Glycemic Control in Adults with Type 2 Diabetes Mellitus In adults with type 2 diabetes mellitus, the recommended starting dosage of dapagliflozin tablet is 5 mg orally once daily to improve glycemic control. For additional glycemic control, the dosage can be increased to 10 mg orally once daily. For Adult Patients with Type 2 Diabetes Mellitus and Renal Impairment: The recommended dosage for dapagliflozin tablet in patients with an eGFR greater than or equal to 45 mL/min/1.73 m 2 is the same as the recommended dosage in patients with normal renal function.
Dapagliflozin tablet is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . Dapagliflozin tablet is likely to be ineffective to improve glycemic control in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga ® (dapagliflozin) Tablets.
However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.
2.3Recommended Dosage for Other Indications in Adults The recommended dosage of dapagliflozin tablet is 10 mg orally once daily in adults for the following indications: To reduce the risk of hHF in patients with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. For Adults with Renal Impairment Receiving Dapagliflozin tablet for Indications Other than Glycemic Control: The recommended dosage of dapagliflozin tablet in patients with an eGFR greater than or equal to 25 mL/min/1.73 m 2 is the same as the recommended dosage in patients with normal renal function.
Initiation with dapagliflozin tablet is not recommended in patients with an eGFR less than 25 mL/min/1.73 m 2 .
2.4Temporary Interruption for Surgery Withhold dapagliflozin tablet for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. Resume dapagliflozin tablet when the patient is clinically stable and has resumed oral intake [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2) ].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablets: • 5 mg, yellow coloured, round, biconvex, film-coated tablets debossed with “D1” on one side and “M” on other side. • 10 mg, yellow coloured, diamond, biconvex, film-coated tablets debossed with “D2” on one side and “M” on other side. Tablets: 5 mg and 10 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Dapagliflozin tablet is contraindicated in patients with a history of a serious hypersensitivity reaction to dapagliflozin or any of the excipients in dapagliflozin. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with dapagliflozin [see Adverse Reactions (6.1) ]. • History of serious hypersensitivity reaction to dapagliflozin or any of the excipients in dapagliflozin tablet. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue dapagliflozin if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting.
( 5.1 ) Volume depletion: Before initiating dapagliflozin, assess volume status and renal function in the elderly, patients with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy. ( 5.2 ) Urosepsis and Pyelonephritis: Evaluate for signs and symptoms of urinary tract infections and treat promptly, if indicated.
( 5.3 ) Hypoglycemia: Consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia when used in combination with dapagliflozin. ( 5.4 ) Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases have occurred in patients with diabetes, both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise.
If suspected, institute prompt treatment. ( 5.5 ) Genital Mycotic Infections: Monitor and treat if indicated. ( 5.6 )
5.1Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis In patients with type 1 diabetes mellitus, dapagliflozin significantly increases the risk of diabetic ketoacidosis, a life-threatening event, beyond the background rate. In placebo-controlled trials of patients with type 1 diabetes mellitus, the risk of ketoacidosis was markedly increased in patients who received sodium-glucose cotransporter 2 (SGLT2) inhibitors compared to patients who received placebo. Dapagliflozin is not indicated for glycemic control in patients with type 1 diabetes mellitus.
Type 2 diabetes mellitus and pancreatic disorders (e.g., history of pancreatitis or pancreatic surgery) are also risk factors for ketoacidosis. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes mellitus using SGLT2 inhibitors, including dapagliflozin. Precipitating conditions for diabetic ketoacidosis or other ketoacidosis include under-insulinization due to insulin dose reduction or missed insulin doses, acute febrile illness, reduced caloric intake, ketogenic diet, surgery, volume depletion, and alcohol abuse.
Signs and symptoms are consistent with dehydration and severe metabolic acidosis and include nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. Blood glucose levels at presentation may be below those typically expected for diabetic ketoacidosis (e.g., less than 250 mg/dL). Ketoacidosis and glucosuria may persist longer than typically expected.
Urinary glucose excretion persists for 3 days after discontinuing dapagliflozin [see Clinical Pharmacology (12.2) ] ; however, there have been postmarketing reports of ketoacidosis and/or glucosuria lasting greater than 6 days and some up to 2 weeks after discontinuation of SGLT2 inhibitors. Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis if indicated by the clinical situation. Assess for ketoacidosis regardless of presenting blood glucose levels in patients who present with signs and symptoms consistent with severe metabolic acidosis.
If ketoacidosis is suspected, discontinue dapagliflozin, promptly evaluate, and treat ketoacidosis, if confirmed. Monitor patients for resolution of ketoacidosis before restarting dapagliflozin. Withhold dapagliflozin, if possible, in temporary clinical situations that could predispose patients to ketoacidosis.
Resume dapagliflozin when the patient is clinically stable and has resumed oral intake…
🤒 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 Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 observed in clinical practice. Dapagliflozin has been evaluated in clinical trials in adult patients with type 2 diabetes mellitus. The overall safety profile of dapagliflozin was consistent across the studied indications.
Severe hypoglycemia and diabetic ketoacidosis (DKA) were observed only in patients with diabetes mellitus. Clinical Trials for Glycemic Control in Adult Patients with Type 2 Diabetes Mellitus Pool of 12 Placebo-Controlled Adult Trials for Dapagliflozin 5 and 10 mg for Glycemic Control The data in Table 1 is derived from 12 glycemic control placebo-controlled trials in adult patients with type 2 diabetes mellitus ranging from 12 to 24 weeks. In 4 trials dapagliflozin was used as monotherapy, and in 8 trials dapagliflozin was used as add-on to background antidiabetic therapy or as combination therapy with metformin [see Clinical Studies (14.1) ].
These data reflect exposure of 2,338 adult patients to dapagliflozin with a mean exposure duration of 21 weeks. Patients received placebo (N=1,393), dapagliflozin 5 mg (N=1,145), or dapagliflozin 10 mg (N=1,193) once daily. The mean age of the population was 55 years and 2% were older than 75 years of age.
Fifty percent (50%) of the population were male; 81% were White, 14% were Asian, and 3% were Black or African American. At baseline, the population had diabetes for an average of 6 years, had a mean hemoglobin A1c (HbA1c) of 8.3%, and 21% had established microvascular complications of diabetes. Baseline renal function was normal or mildly impaired in 92% of patients and moderately impaired in 8% of patients (mean eGFR 86 mL/min/1.73 m 2 ).
Table 1 shows common adverse reactions in adults associated with the use of dapagliflozin. These adverse reactions were not present at baseline, occurred more commonly on dapagliflozin than on placebo, and occurred in at least 2% of patients treated with either dapagliflozin 5 mg or dapagliflozin 10 mg. Table 1: Adverse Reactions in Placebo-Controlled Trials of Glycemic Control Reported in ≥2% of Adults Treated with Dapagliflozin Adverse Reaction % of Patients Pool of 12 Placebo-Controlled Trials Placebo N=1,393 Dapagliflozin 5 mg N=1,145 Dapagliflozin 10 mg N=1,193 Female genital mycotic infections* 1.5 8.4
6.9Nasopharyngitis 6.2 6.6
6.3Urinary tract infections † 3.7 5.7
4.3Back pain 3.2 3.1
4.2Increased urination ‡ 1.7 2.9
3.8Male genital mycotic infections § 0.3 2.8
2.7Nausea 2.4 2.8
2.5Influenza 2.3 2.7
2.3Dyslipidemia 1.5 2.1
2.5Constipation 1.5 2.2
1.9Discomfort with urination 0.7 1.6
2.1Pain in extremity 1.4 2.0 1.7 *Genital mycotic infections include the following adverse reactions, listed in order of frequency reported for females: vulvovaginal mycotic infection, vaginal infection, vulvovaginal candidiasis, vulvovaginitis, genital inf…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 4: Clinically Relevant Interactions with Dapagliflozin Insulin or Insulin Secretagogues Clinical Impact The risk of hypoglycemia may be increased when dapagliflozin 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 dapagliflozin 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-AG assay is not recommended.
Use alternative methods to monitor glycemic control. • See full prescribing information for information on drug interactions and interference of dapagliflozin with laboratory tests. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Advise females of the potential risk to a fetus especially during the second and third trimesters. ( 8.1 ) Lactation: Not recommended when breastfeeding. ( 8.2 ) Geriatrics: Higher incidence of adverse reactions related to hypotension.
( 8.5 ) Renal Impairment: Higher incidence of adverse reactions related to volume depletion. ( 8.6 ) Pediatric use information is approved for AstraZeneca AB’s Farxiga® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.
8.1Pregnancy Risk Summary Based on animal data showing adverse renal effects, dapagliflozin is not recommended during the second and third trimesters of pregnancy. Limited data with dapagliflozin in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes and untreated heart failure in pregnancy (see Clinical Considerations).
In animal studies, adverse renal pelvic and tubule dilatations, that were not fully reversible, were observed in rats when dapagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy, at all doses tested; the lowest of which provided an exposure 15-times the 10 mg clinical dose ( see Data). The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a HbA1c greater than 7% and has been reported to be as high as 20 to 25% in women with HbA1c greater than 10%.
The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryofetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications.
Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Animal Data Dapagliflozin dosed directly to juvenile rats from postnatal day (PND) 21 until PND 90 at doses of 1, 15, or 75 mg/kg/day, increased kidney weights and increased the incidence of renal pelvic and tubular dilatations at all dose levels. Exposure at the lowest dose tested was 15-times the 10 mg clinical dose (based on AUC).
The renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within a 1-month recovery period. In a prenatal and postnatal development study, dapagliflozin was administered to maternal rats from gestation day 6 through lactation day 21 at doses of 1, 15, or 75 mg/kg/day, and pups were indirectly exposed in utero and throughout lactation. Increased incidence or severity of renal pelvic dilatation was observed in 21-day-old pups offspring of treated dams at 75 mg/kg/day (maternal and pup dapagliflozin exposures were 1,415-times and 137-times, respectively, the human values at the 10 mg clinical dose, based on AUC).
Dose-related reductions in pup body weights were observed at greater or equal to 29-times the 10 mg clinical dose (based on AUC). No adverse effects on developmental endpoints were noted at 1 mg/kg/day (19-times the 10 mg clinical dose, based on AUC). These outcomes occurred with drug exposure during periods of renal development in rats that corresponds to the late second and third trimester of human development.
In embryofetal development studies in rats and rabbits, dapagliflozin was administered throughout organogenesis, corresponding to the first trimester of human pregnancy. In rats, dapagliflozin was neither embryolethal nor teratogenic at doses up to 75 mg/kg/day (1,441-times the 10 mg clinical dose, base…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on animal data showing adverse renal effects, dapagliflozin is not recommended during the second and third trimesters of pregnancy. Limited data with dapagliflozin in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes and untreated heart failure in pregnancy (see Clinical Considerations).
In animal studies, adverse renal pelvic and tubule dilatations, that were not fully reversible, were observed in rats when dapagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy, at all doses tested; the lowest of which provided an exposure 15-times the 10 mg clinical dose ( see Data). The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a HbA1c greater than 7% and has been reported to be as high as 20 to 25% in women with HbA1c greater than 10%.
The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryofetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications.
Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Animal Data Dapagliflozin dosed directly to juvenile rats from postnatal day (PND) 21 until PND 90 at doses of 1, 15, or 75 mg/kg/day, increased kidney weights and increased the incidence of renal pelvic and tubular dilatations at all dose levels. Exposure at the lowest dose tested was 15-times the 10 mg clinical dose (based on AUC).
The renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within a 1-month recovery period. In a prenatal and postnatal development study, dapagliflozin was administered to maternal rats from gestation day 6 through lactation day 21 at doses of 1, 15, or 75 mg/kg/day, and pups were indirectly exposed in utero and throughout lactation. Increased incidence or severity of renal pelvic dilatation was observed in 21-day-old pups offspring of treated dams at 75 mg/kg/day (maternal and pup dapagliflozin exposures were 1,415-times and 137-times, respectively, the human values at the 10 mg clinical dose, based on AUC).
Dose-related reductions in pup body weights were observed at greater or equal to 29-times the 10 mg clinical dose (based on AUC). No adverse effects on developmental endpoints were noted at 1 mg/kg/day (19-times the 10 mg clinical dose, based on AUC). These outcomes occurred with drug exposure during periods of renal development in rats that corresponds to the late second and third trimester of human development.
In embryofetal development studies in rats and rabbits, dapagliflozin was administered throughout organogenesis, corresponding to the first trimester of human pregnancy. In rats, dapagliflozin was neither embryolethal nor teratogenic at doses up to 75 mg/kg/day (1,441-times the 10 mg clinical dose, based on AUC). Dose related effects on the rat fetus (structural abnormalities and reduced body weight) occurred only at higher dosages, equal to or greater than 150 mg/kg (more than 2,344-times the 10 mg clinical dose, based on AUC), which were associated with maternal toxicity.
No developmental toxicities were observed in rabbits at doses up to 180 mg/kg/day (1,191-times the 10 mg clinical dose, based on AUC).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of dapagliflozin for glycemic control in type 2 diabetes mellitus have not been established in pediatric patients less than 10 years of age. The safety and effectiveness of dapagliflozin have not been established in pediatric patients to reduce the risk of [see Indications and Usage (1) ]: • hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. Pediatric use information is approved for AstraZeneca AB’s Farxiga ® (dapagliflozin) Tablets.
However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.
🧓 Geriatric Use ▾
8.5Geriatric Use No dapagliflozin dosage change is recommended based on age. A total of 1,424 (24%) of the 5,936 dapagliflozin-treated patients were 65 years and older and 207 (3.5%) patients were 75 years and older in a pool of 21 double-blind, controlled, clinical trials assessing the efficacy of dapagliflozin in improving glycemic control in type 2 diabetes mellitus. After controlling for level of renal function (eGFR), efficacy was similar for patients under age 65 years and those 65 years and older.
In patients ≥65 years of age, a higher proportion of patients treated with dapagliflozin for glycemic control had adverse reactions of hypotension [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ].
🆘 Overdosage ▾
10 OVERDOSAGE There were no reports of overdose during the clinical development program for dapagliflozin. In the event of an overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. It is also reasonable to employ supportive measures as dictated by the patient’s clinical status. The removal of dapagliflozin by hemodialysis has not been studied.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion.
Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This may influence several physiological functions including, but not restricted to, lowering both pre- and afterload of the heart and downregulation of sympathetic activity.
12.2Pharmacodynamics General Increases in the amount of glucose excreted in the urine were observed in healthy subjects and in patients with type 2 diabetes mellitus following the administration of dapagliflozin (see Figure 1). Dapagliflozin doses of 5 or 10 mg per day in patients with type 2 diabetes mellitus for 12 weeks resulted in excretion of approximately 70 grams of glucose in the urine per day at Week 12. A near maximum glucose excretion was observed at the dapagliflozin daily dosage of 20 mg.
This urinary glucose excretion with dapagliflozin also results in increases in urinary volume [ see Adverse Reactions (6.1)]. After discontinuation of dapagliflozin, on average, the elevation in urinary glucose excretion approaches baseline by about 3 days for the 10 mg dosage. Figure 1: Scatter Plot and Fitted Line of Change from Baseline in 24-Hour Urinary Glucose Amount versus Dapagliflozin Dose in Healthy Subjects and Subjects with Type 2 Diabetes Mellitus (T2DM) (Semi-Log Plot) Cardiac Electrophysiology Dapagliflozin was not associated with clinically meaningful prolongation of QTc interval at daily doses up to 150 mg (15-times the recommended maximum dose) in a study of healthy subjects.
In addition, no clinically meaningful effect on QTc interval was observed following single doses of up to 500 mg (50-times the recommended maximum dose) of dapagliflozin in healthy subjects. fig1
12.3Pharmacokinetics Absorption Following oral administration of dapagliflozin, the maximum plasma concentration (C max ) is usually attained within 2 hours under fasting state. The C max and AUC values increase dose proportionally with increase in dapagliflozin dose in the therapeutic dose range. The absolute oral bioavailability of dapagliflozin following the administration of a 10 mg dose is 78%.
Administration of dapagliflozin with a high-fat 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. These changes are not considered to be clinically meaningful and dapagliflozin can be administered with or without food. Distribution Dapagliflozin is approximately 91% protein bound.
Protein binding is not altered in patients with renal or hepatic impairment. Metabolism The metabolism of dapagliflozin is primarily mediated by UGT1A9; CYP-mediated metabolism is a minor clearance pathway in humans. Dapagliflozin is extensively metabolized, primarily to yield dapagliflozin 3-O-glucuronide, which is an inactive metabolite.
Dapagliflozin 3-O-glucuronide accounted for 61% of a 50 mg [ 14 C]-dapagliflozin dose and is the predominant drug-related component in human plasma. Elimination Dapagliflozin and related metabolites are primarily eliminated via the renal pathway. Following a single 50 mg dose of [ 14 C]-dapagliflozin, 75% and 21% total radioactivity is excreted in urine and feces, respectively.
In urine, less than 2% of the dose is excreted as parent drug. In feces, approximately 15% of the dose is excreted as parent drug. The mean plasma terminal half-life (t ½ ) for dapagliflozin is approximately 12.9 hours following a single oral dose of dapagliflozin 10 mg.
Specific Populations Effects of Age, Gender, Race, and Body Weight on Pharmacokinetics Based on a population pharmacokinetic analysis, age, gender, ra…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion.
Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This may influence several physiological functions including, but not restricted to, lowering both pre- and afterload of the heart and downregulation of sympathetic activity.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Dapagliflozin tablets, USP have markings on both sides and are available in the strengths and packages listed in Table 18. Table 18: Dapagliflozin Tablet, USP Presentations Tablet Strength Film-CoatedTablet Color/Shape Tablet Markings Package Size NDC Code 5 mg yellow, biconvex, round debossed with “D1” one side and “M” on other side. Bottles of 30 Bottles of 90 Bottles of 500 72205-432-01 72205-432-03 72205-432-02 10 mg yellow, biconvex, diamond-shaped debossed with “D2” one side and “M” on other side.
Bottles of 30 Bottles of 90 Bottles of 500 72205-433-01 72205-433-03 72205-433-02 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Dapagliflozin, an inhibitor of SGL T2, is described chemically as (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C 21 H 25 ClO 6 and the molecular weight is 408.88. The structural formula is: Dapagliflozin tablets, USP is available as a film-coated tablet for oral administration containing the 5 mg dapagliflozin or 10 mg dapagliflozin, and the following inactive ingredients: crospovidone, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, sodium lauryl sulphate.
In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, and iron oxide yellow. str
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis In patients with type 1 diabetes mellitus, inform them that using dapagliflozin can increase their risk of life-threatening diabetic ketoacidosis. For all other patients, inform them that dapagliflozin can cause potentially fatal ketoacidosis and that type 2 diabetes mellitus and pancreatic disorders (e.g., history of pancreatitis or pancreatic surgery) are risk factors.
Educate all patients on precipitating factors (such as insulin dose reduction or missed insulin doses, infection, reduced caloric intake, ketogenic diet, surgery, dehydration, and alcohol abuse) and symptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, and labored breathing). Inform patients that blood glucose may be normal even in the presence of ketoacidosis. Advise patients that they may be asked to monitor ketones.
If symptoms of ketoacidosis occur, instruct patients to discontinue dapagliflozin and seek medical attention immediately [see Warnings and Precautions (5.1) ]. Volume Depletion Inform patients that symptomatic hypotension may occur with dapagliflozin and advise them to contact their healthcare provider if they experience such symptoms [see Warnings and Precautions ( 5.2 )]. Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake.
Serious Urinary Tract Infections Inform patients of the potential for urinary tract infections, which may be serious. Provide them with information on the symptoms of urinary tract infections. Advise them to seek medical advice promptly if such symptoms occur [ see Warnings and Precautions (5.3)].
Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues Inform patients that the incidence of hypoglycemia may increase when dapagliflozin is added to an insulin secretagogue (e.g., sulfonylurea) and/or insulin. Educate patients on the signs and symptoms of hypoglycemia [see Warnings and Precautions (5.4) ]. Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) Inform patients that necrotizing infections of the perineum (Fournier’s Gangrene) have occurred with dapagliflozin in patients with diabetes mellitus.
Counsel patients to promptly seek medical attention if they develop pain or tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, along with a fever above 100.4°F or malaise [see Warnings and Precautions (5.5)] . Genital Mycotic Infections in Females (e.g., Vulvovaginitis) Inform female patients that vaginal yeast infections may occur and provide them with information on the signs and symptoms of vaginal yeast infections. Advise them of treatment options and when to seek medical advice [see Warnings and Precautions (5.6)] .
Genital Mycotic Infections in Males (e.g., Balanitis) Inform male patients that yeast infections of the penis (e.g., balanitis or balanoposthitis) may occur, especially in patients with prior history. Provide them with information on the signs and symptoms of balanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis). Advise them of treatment options and when to seek medical advice [ see Warnings and Precautions (5.6) ].
Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions (e.g., urticaria, anaphylactic reactions, and angioedema) have been reported with dapagliflozin. Advise patients to immediately report any signs or symptoms suggesting allergic reaction or angioedema, and to take no more of the drug until they have consulted prescribing physicians. Pregnancy Advise pregnant patients of the potential risk to a fetus with treatment with dapagliflozin.
Instruct patients to immediately inform their healthcare provider if pregnant or planning to become pregnant [ see Use in Specific Populations (8.1)]. Lactat…