Dapagliflozin: Difference between revisions

Dapagliflozin
	Black Box Warning
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

VisualWikitext

Revision as of 20:36, 15 January 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

Disclaimer

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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.

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 (FDA):

Pregnancy Category

Pregnancy Category (AUS):

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

File:Dapagliflozin01.png

This image is provided by the National Library of Medicine.

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

{{#ask: Page Name::Dapagliflozin |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Dapagliflozin |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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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↑ "http://www.ismp.org". External link in |title= (help)

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[1] Empty citation (help)

[www.ismp.org-2] "http://www.ismp.org". External link in |title= (help)

[1]

[2]

@@ Line 4: / Line 4: @@
 |aOrAn=a
 |indicationType=treatment
+|indication=type 2 diabetes mellitus
 |hasBlackBoxWarning=Yes
-|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.
 |blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
 |blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
@@ Line 17: / Line 16: @@
 <!--FDA-Labeled Indications and Dosage (Adult)-->
 |fdaLIADAdult======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
-:* 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 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=====
@@ Line 268: / Line 288: @@
 <!--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 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.