Nursing in Practice Autumn 2023 issue | Page 27

This advertorial has been initiated and funded by Novartis Pharmaceuticals UK Ltd . between Novartis and the NHSE & I aims to develop and / or optimise patient pathways to support improved lipid management . 18

With CVD being primarily managed in primary care , identification , and treatment for patients suitable for LEQVIO are critical to meet these new QOF indicators . 5 , 19 If you are seeing secondary prevention patients who have persistently elevated LDL-C levels ( ≥2.6 mmol / L ) despite maximum tolerated statins , LEQVIO could be your next step . 20

Prescribe LEQVIO ® with confidence in your eligible patients and help them reach QOF LDL-C targets . 1 , 8 , 13

† Data from the Third Annual Audit Report for the CVDPREVENT covering the period up to March 2022 , at a national level . Data was received from 96.6 % of GP practices , including approximately 18 million patients .

‡ ASCVD was defined as coronary heart disease , cerebrovascular disease or peripheral arterial disease . 13 ASCVD risk equivalents included type 2 diabetes , HeFH , or a 10-year risk of a cardiovascular event of ≥20 % as assessed by the Framingham Risk Score for Cardiovascular Disease or equivalent .

§ From a pooled cohort of 3,576 patients treated with LEQVIO ®, assuming a dosing frequency of two injections per year , with an average treatment duration of 2.8 years . 17

Great Britain Prescribing Information : LEQVIO ® ▼ ( inclisiran ) Important note : Before prescribing , consult the Summary of Product Characteristics ( SmPC ). Presentation : Pre-filled syringe containing inclisiran sodium equivalent to 284 mg inclisiran in 1.5 ml solution . Indication ( s ): Leqvio is indicated in adults with primary hypercholesterolaemia ( heterozygous familial and non-familial ) or mixed dyslipidaemia , as an adjunct to diet : - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin , or - alone or in combination with other lipid lowering therapies in patients who are statin intolerant , or for whom a statin is contraindicated . Dosage and administration : The recommended dose is 284 mg inclisiran administered as a single subcutaneous injection : initially , again at 3 months , followed by every 6 months . Missed doses : If a planned dose is missed by less than 3 months , inclisiran should be administered and dosing continued according to the patient ’ s original schedule . If a planned dose is missed by more than 3 months , a new dosing schedule should be started – inclisiran should be administered initially , again at 3 months , followed by every 6 months . Treatment transition from monoclonal antibody PCSK9 inhibitors : Inclisiran can be administered immediately after the last dose of a monoclonal antibody PCSK9 inhibitor . To maintain LDL C lowering it is recommended that inclisiran is administered within 2 weeks after the last dose of a monoclonal antibody PCSK9 inhibitor . Special populations : No dose adjustment required for patients with mild or moderate hepatic impairment , mild , moderate or severe renal impairment or end-stage renal disease ( use with caution in severe renal impairment ) or elderly patients . Administration : Subcutaneous injection into abdomen ( alternatively , the upper arm or thigh ). Injections should not be given into areas of active skin disease or injury such as sunburns , skin rashes , inflammation or skin infections . Inclisiran is intended for administration by a healthcare professional . Contraindications : Hypersensitivity to active ingredient or any of the excipients . Warnings / Precautions : Haemodialysis : The effect of haemodialysis on inclisiran pharmacokinetics has not been studied . Considering that inclisiran is eliminated renally , haemodialysis should not be performed for at least 72 hours after inclisiran dosing . Interactions : Inclisiran is not a substrate for common drug transporters and , although in vitro studies were not conducted , it is not anticipated to be a substrate for cytochrome P450 . Inclisiran is not an inhibitor or inducer of cytochrome P450 enzymes or common drug transporters . Therefore , inclisiran is not expected to have clinically significant interactions with other medicinal products . Based on the limited data available , clinically meaningful interactions with atorvastatin , rosuvastatin or other statins are not expected . Fertility , pregnancy and lactation : Pregnancy : No or limited data available from the use of inclisiran in pregnant women . Animal studies do not indicate any harmful effects with respect to reproductive toxicity . As a precautionary measure , it is preferable to avoid the use of inclisiran during pregnancy . Breast feeding : It is unknown whether inclisiran is excreted in human milk . Data in animals have shown excretion of inclisiran in milk . A risk to newborns / infants cannot be excluded . A decision must be made whether to discontinue breast-feeding or to discontinue / abstain from inclisiran therapy , taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman . Fertility : No data on the effect of inclisiran on human fertility are available . Animal studies did not show any effects on fertility . Undesirable effects : Common ( ≥1 / 100 to < 1 / 10 ): adverse reactions at injection site including site reaction , pain , erythema and rash . All reactions were mild or moderate in severity , transient and resolved without sequelae . Other Adverse Effects : Please consult the Summary of Product Characteristics for a detailed listing of all adverse events before prescribing . Legal classification : POM Marketing Authorisation ( MA ) number , quantities and price : PLGB 00101 / 1202 Leqvio 284mg pre-filled syringe £ 1987.36 ( ex . VAT ) per pack ( 1 pre-filled syringe ). Date of last revision of prescribing information : October 2022 ( ID 244658 ) Full Prescribing Information available from : Novartis Pharmaceuticals UK Limited , 2nd Floor , The WestWorks Building , White City Place , 195 Wood Lane , London , W12 7FQ . Telephone : ( 01276 ) 692255 .

Northern Ireland Prescribing Information : LEQVIO ® ▼ ( inclisiran ) Important note : Before prescribing , consult the Summary of Product Characteristics ( SmPC ). Presentation : Pre-filled syringe containing inclisiran sodium equivalent to 284 mg inclisiran in 1.5 ml solution . Indication ( s ): Leqvio is indicated in adults with primary hypercholesterolaemia ( heterozygous familial and non-familial ) or mixed dyslipidaemia , as an adjunct to diet : - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin , or- alone or in combination with other lipid lowering therapies in patients who are statin intolerant , or for whom a statin is contraindicated . Dosage and administration : The recommended dose is 284 mg inclisiran administered as a single subcutaneous injection : initially , again at 3 months , followed by every 6 months . Missed doses : If a planned dose is missed by less than 3 months , inclisiran should be administered and dosing continued according to the patient ’ s original schedule . If a planned dose is missed by more than 3 months , a new dosing schedule should be started – inclisiran should be administered initially , again at 3 months , followed by every 6 months . Treatment transition from monoclonal antibody PCSK9 inhibitors : Inclisiran can be administered immediately after the last dose of a monoclonal antibody PCSK9 inhibitor . To maintain LDL C lowering it is recommended that inclisiran is administered within 2 weeks after the last dose of a monoclonal antibody PCSK9 inhibitor . Special populations : No dose adjustment required for patients with mild or moderate hepatic impairment , mild , moderate or severe renal impairment or end-stage renal disease ( use with caution in severe renal impairment ) or elderly patients . Administration : Subcutaneous injection into abdomen ( alternatively , the upper arm or thigh ). Injections should not be given into areas of active skin disease or injury such as sunburns , skin rashes , inflammation or skin infections . Inclisiran is intended for administration by a healthcare professional . Contraindications : Hypersensitivity to active ingredient or any of the excipients . Warnings / Precautions : Haemodialysis : The effect of haemodialysis on inclisiran pharmacokinetics has not been studied . Considering that inclisiran is eliminated renally , haemodialysis should not be performed for at least 72 hours after inclisiran dosing . Interactions : Inclisiran is not a substrate for common drug transporters and , although in vitro studies were not conducted , it is not anticipated to be a substrate for cytochrome P450 . Inclisiran is not an inhibitor or inducer of cytochrome P450 enzymes or common drug transporters . Therefore , inclisiran is not expected to have clinically significant interactions with other medicinal products . Based on the limited data available , clinically meaningful interactions with atorvastatin , rosuvastatin or other statins are not expected . Fertility , pregnancy and lactation : Pregnancy : No or limited data available from the use of inclisiran in pregnant women . Animal studies do not indicate any harmful effects with respect to reproductive toxicity . As a precautionary measure , it is preferable to avoid the use of inclisiran during pregnancy . Breast feeding : It is unknown whether inclisiran is excreted in human milk . Data in animals have shown excretion of inclisiran in milk . A risk to newborns / infants cannot be excluded . A decision must be made whether to discontinue breast-feeding or to discontinue / abstain from inclisiran therapy , taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman . Fertility : No data on the effect of inclisiran on human fertility are available . Animal studies did not show any effects on fertility . Undesirable effects : Common ( ≥1 / 100 to < 1 / 10 ): adverse reactions at injection site including site reaction , pain , erythema and rash . All reactions were mild or moderate in severity , transient and resolved without sequelae . Other Adverse Effects : Please consult the Summary of Product Characteristics for a detailed listing of all adverse events before prescribing . Legal classification : POM Marketing Authorisation ( MA ) number , quantities and price : EU / 1 / 20 / 1494 / 001 Leqvio 284mg pre-filled syringe £ 1987.36 ( ex . VAT ) per pack ( 1 pre-filled syringe ); EU / 1 / 20 / 1494 / 002 Leqvio 284mg pre-filled syringe with needle guard £ 1987.36 ( ex . VAT ) per pack ( 1 pre-filled syringe ). Date of last revision of prescribing information : October 2022 ( ID 244660 ) Full Prescribing Information available from : Novartis Pharmaceuticals UK Limited , 2nd Floor , The WestWorks Building , White City Place , 195 Wood Lane , London , W12 7FQ . Telephone : ( 01276 ) 692255 .

Adverse Event Reporting : Adverse events should be reported . Reporting forms and information can be found at www . mhra . gov . uk / yellowcard . Adverse events should also be reported to Novartis via uk . patientsafety @ novartis . com or online through the pharmacovigilance intake ( PVI ) tool at novartis . com / report

If you have a question about the product , please contact Medical Information on 01276698370 or by email at medioinfo . uk @ novartis . com

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