Dapagliflozin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]
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Black Box Warning
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See full prescribing information for complete Boxed Warning.
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Overview
Dapagliflozin is a {{{drugClass}}} that is FDA approved for the treatment of type 2 diabetes mellitus. There is a Black Box Warning for this drug as shown here. Common adverse reactions include female genital mycotic infections, nasopharyngitis, and urinary tract infections.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Type 2 diabetes mellitus
- FARXIGA (dapagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitation of Use
- FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
- Dosing Information
- 2.1 Recommended Dosing
The recommended starting dose of FARXIGA is 5 mg once daily, taken in the morning, with or without food. In patients tolerating FARXIGA 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily.
In patients with volume depletion, correcting this condition prior to initiation of FARXIGA is recommended [see Warnings and Precautions (5.1), Use in Specific Populations (8.5, 8.6), and Patient Counseling Information (17)].
2.2 Patients with Renal Impairment
Assessment of renal function is recommended prior to initiation of FARXIGA therapy and periodically thereafter.
FARXIGA should not be initiated in patients with an eGFR less than 60 mL/min/1.73 m2.
No dose adjustment is needed in patients with mild renal impairment (eGFR of 60 mL/min/1.73 m2 or greater).
FARXIGA should be discontinued when eGFR is persistently less than 60 mL/min/1.73 m2 [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)].
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- Dosing Information
- Dosage
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- Dosing Information
- Dosage
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- Dosing Information
- Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
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- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
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There is limited information regarding Off-Label Guideline-Supported Use of Dapagliflozin in adult patients.
Non–Guideline-Supported Use
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- Dosing Information
- Dosage
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There is limited information regarding Off-Label Non–Guideline-Supported Use of Dapagliflozin in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
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- Dosing Information
- Dosage
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There is limited information regarding FDA-Labeled Use of Dapagliflozin in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Dapagliflozin in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Dapagliflozin in pediatric patients.
Contraindications
- Condition1
Warnings
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See full prescribing information for complete Boxed Warning.
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- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Dapagliflozin in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Dapagliflozin in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dapagliflozin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Dapagliflozin during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Dapagliflozin with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Dapagliflozin with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Dapagliflozin with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Dapagliflozin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Dapagliflozin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Dapagliflozin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Dapagliflozin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Dapagliflozin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Dapagliflozin in patients who are immunocompromised.
Administration and Monitoring
Administration
2.1 Recommended Dosing
The recommended starting dose of FARXIGA is 5 mg once daily, taken in the morning, with or without food. In patients tolerating FARXIGA 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily.
In patients with volume depletion, correcting this condition prior to initiation of FARXIGA is recommended [see Warnings and Precautions (5.1), Use in Specific Populations (8.5, 8.6), and Patient Counseling Information (17)].
2.2 Patients with Renal Impairment
Assessment of renal function is recommended prior to initiation of FARXIGA therapy and periodically thereafter.
FARXIGA should not be initiated in patients with an eGFR less than 60 mL/min/1.73 m2.
No dose adjustment is needed in patients with mild renal impairment (eGFR of 60 mL/min/1.73 m2 or greater).
FARXIGA should be discontinued when eGFR is persistently less than 60 mL/min/1.73 m2 [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)].
DOSAGE FORMS AND STRENGTHS
FARXIGA 5 mg tablets are yellow, biconvex, round, film-coated tablets with “5” engraved on one side and “1427” engraved on the other side. FARXIGA 10 mg tablets are yellow, biconvex, diamond-shaped, film-coated tablets with “10” engraved on one side and “1428” engraved on the other side.
Monitoring
There is limited information regarding Monitoring of Dapagliflozin in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Dapagliflozin in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Dapagliflozin in the drug label.
Pharmacology
There is limited information regarding Dapagliflozin Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Dapagliflozin in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Dapagliflozin in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Dapagliflozin in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Dapagliflozin in the drug label.
How Supplied
Storage
There is limited information regarding Dapagliflozin Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Dapagliflozin in the drug label.
Precautions with Alcohol
- Alcohol-Dapagliflozin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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