№ lp_1_2_18415
File format: docx
Character count: 5037
File size: 94 KB
Year:
2023
Region / city:
United Kingdom
Topic:
Medicines Optimisation, SGLT2 inhibitors
Document Type:
Protocol
Author:
NHS England
Target Audience:
Healthcare professionals, clinicians, systems involved in diabetes and heart failure treatment
Period of Validity:
Ongoing
Approval Date:
September 25, 2023
Date of Changes:
Not specified
Clinical Area:
Type 2 diabetes, heart failure, chronic kidney disease
Inclusion Criteria:
Patients aged 18 years and older prescribed empagliflozin, canagliflozin, ertugliflozin, or branded dapagliflozin for T2DM and/or HF
Exclusion Criteria:
Severe renal impairment, diabetic ketoacidosis, and other contraindications as per SPC
Background:
Dapagliflozin is now the first-line SGLT2i in England due to cost reduction following patent expiry.
Implementation Date:
Not specified
Post-switch:
No need for additional eGFR monitoring unless clinical concerns arise
Description:
Protocol outlining the process for switching eligible patients from other SGLT2 inhibitors to dapagliflozin for the management of Type 2 diabetes and heart failure in primary care.
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2023
Region / city:
United Kingdom
Topic:
Medicine optimisation, diabetes, heart failure, chronic kidney disease
Document type:
Protocol
Organisation:
NHS England
Author:
Not specified
Target audience:
Healthcare professionals
Period of validity:
Ongoing
Approval date:
September 25, 2023
Modification date:
Not specified
Clinical condition:
Type 2 diabetes mellitus, heart failure, chronic kidney disease
Medication:
Dapagliflozin, Empagliflozin, Canagliflozin, Ertugliflozin
Intended use:
Generic dapagliflozin
Switch criteria:
Based on patient needs and clinical appropriateness
Inclusion criteria:
Patients aged 18 years and older currently prescribed certain SGLT2 inhibitors
Exclusion criteria:
History of adverse reactions or specific clinical conditions
Recommended dosage:
10mg once daily, with adjustments for hepatic or renal impairment
Monitoring:
HbA1c, blood tests, signs of infections or DKA
Drug interactions:
Fewer interactions compared to other SGLT2 inhibitors
Patient communication:
Information leaflets, SMS, letters
Post-switch monitoring:
Routine HbA1c checks, watch for DKA
Clinical recommendation:
Consider shared decision-making and patient discussions
References:
NICE guidelines, NHS guidance, formulary recommendations
Year:
2023
Region / city:
United Kingdom
Topic:
Medicines optimisation, SGLT2 inhibitors, diabetes, heart failure
Document type:
Protocol
Organ / institution:
NHS England
Author:
NHS
Target audience:
Clinicians, healthcare providers
Period of validity:
Ongoing
Approval date:
Not specified
Modification date:
Not specified
Year:
2023
Region / city:
United Kingdom
Topic:
Medicine optimisation, diabetes, heart failure, chronic kidney disease
Document type:
Protocol
Organisation:
NHS England
Author:
Not specified
Target audience:
Healthcare professionals
Period of validity:
Ongoing
Approval date:
September 25, 2023
Modification date:
Not specified
Clinical condition:
Type 2 diabetes mellitus, heart failure, chronic kidney disease
Medication:
Dapagliflozin, Empagliflozin, Canagliflozin, Ertugliflozin
Intended use:
Generic dapagliflozin
Switch criteria:
Based on patient needs and clinical appropriateness
Inclusion criteria:
Patients aged 18 years and older currently prescribed certain SGLT2 inhibitors
Exclusion criteria:
History of adverse reactions or specific clinical conditions
Recommended dosage:
10mg once daily, with adjustments for hepatic or renal impairment
Monitoring:
HbA1c, blood tests, signs of infections or DKA
Drug interactions:
Fewer interactions compared to other SGLT2 inhibitors
Patient communication:
Information leaflets, SMS, letters
Post-switch monitoring:
Routine HbA1c checks, watch for DKA
Clinical recommendation:
Consider shared decision-making and patient discussions
References:
NICE guidelines, NHS guidance, formulary recommendations
Year:
2014
Region / city:
Australia
Topic:
Pharmaceutical product submission
Document type:
Application for listing
Organization / institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
AstraZeneca Pty Ltd
Target audience:
Health professionals, regulatory authorities
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
1 April 2014
Year:
2021
Country:
Australia
Drug:
Dapagliflozin
Brand name:
Forxiga
Dosage form and strength:
Tablet, 10 mg
Sponsor:
AstraZeneca Pty Ltd
Indication:
Chronic kidney disease
Submission type:
Category 1 submission
Requested listing:
Authority Required (Streamlined), General Schedule
Regulatory bodies:
Pharmaceutical Benefits Advisory Committee; Therapeutic Goods Administration
Target population:
Adults with chronic kidney disease with specified eGFR and UACR ranges
Comparator:
Placebo plus standard of care
Intervention:
Dapagliflozin plus standard of care
Clinical claims:
Superior efficacy and non-inferior safety versus standard of care alone
Related indications:
Type 2 diabetes mellitus; heart failure with reduced ejection fraction
Regulatory status date:
Priority review granted 13 November 2020
Year:
2023
Region / city:
United Kingdom
Topic:
Medicines optimisation, SGLT2 inhibitors, diabetes, heart failure
Document type:
Protocol
Organ / institution:
NHS England
Author:
NHS
Target audience:
Clinicians, healthcare providers
Period of validity:
Ongoing
Approval date:
Not specified
Modification date:
Not specified
Country:
England
Healthcare system:
National Health Service (NHS)
Issuing body:
NHS England
Medicines mentioned:
Dapagliflozin; Forxiga; Empagliflozin; Canagliflozin; Ertugliflozin
Therapeutic class:
SGLT2 inhibitors
Indications:
Heart failure; Diabetes mellitus
Document type:
Patient information leaflet
Subject:
Change of prescribed SGLT2 inhibitor medication
Dosage information:
10mg once daily; 5mg starting dose in patients with liver problems
Target audience:
Patients prescribed SGLT2 inhibitors for heart failure and/or diabetes
Geographical scope:
England
Year:
2023
Region / city:
United Kingdom
Topic:
Medicine optimisation, diabetes, heart failure, chronic kidney disease
Document type:
Protocol
Organisation:
NHS England
Author:
Not specified
Target audience:
Healthcare professionals
Period of validity:
Ongoing
Approval date:
September 25, 2023
Modification date:
Not specified
Clinical condition:
Type 2 diabetes mellitus, heart failure, chronic kidney disease
Medication:
Dapagliflozin, Empagliflozin, Canagliflozin, Ertugliflozin
Intended use:
Generic dapagliflozin
Switch criteria:
Based on patient needs and clinical appropriateness
Inclusion criteria:
Patients aged 18 years and older currently prescribed certain SGLT2 inhibitors
Exclusion criteria:
History of adverse reactions or specific clinical conditions
Recommended dosage:
10mg once daily, with adjustments for hepatic or renal impairment
Monitoring:
HbA1c, blood tests, signs of infections or DKA
Drug interactions:
Fewer interactions compared to other SGLT2 inhibitors
Patient communication:
Information leaflets, SMS, letters
Post-switch monitoring:
Routine HbA1c checks, watch for DKA
Clinical recommendation:
Consider shared decision-making and patient discussions
References:
NICE guidelines, NHS guidance, formulary recommendations