|adverseReactions= The most common adverse reactions associated with FARXIGA (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections. (6.1)
|adverseReactions=female genital mycotic infections, [[nasopharyngitis]], and [[urinary tract infections]]
To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
* 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
* Dosing Information
:* Dosage
:* 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)].
=====Condition2=====
=====Condition2=====
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<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
|administration=* Oral
|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'''
* Intravenous
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 <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
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Black Box Warning
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
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)].
Condition2
Dosing Information
Dosage
Condition3
Dosing Information
Dosage
Condition4
Dosing Information
Dosage
Off-Label Use and Dosage (Adult)
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 adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
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)
Condition1
Dosing Information
Dosage
Condition2
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
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
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.
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.
