Introduction
Inclisiran is recommended as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet in adults with a history of cardiovascular disease whose LDL cholesterol concentrations are persistently 2.6mmol/l or more despite maximum tolerated lipid-lowering therapy.
Indication
Primary hypercholesterolaemia or mixed dyslipidaemia (in combination with a statin, or with a statin and other lipid-lowering therapies, or with other lipid-lowering therapies or alone if a statin contra-indicated or not tolerated).
https://bnf.nice.org.uk/drug/inclisiran.html [Accessed 18/02/2022].
No dose adjustment in patients over 65, mild or moderate hepatic impairment (use with caution in severe), or renal impairment (any stage, but use with caution in severe).
Administration
Inclisiran may be administered by a trained nurse following recent prescription which should be visible on EMIS medications record, or a Patient Specific Direction (PSD).
Leqvio® 284 mg solution for injection in pre-filled syringe.
Inject subcutaneously into the abdomen; alternatively inject subcutaneously into the thigh or upper arm.
Initial doses 0 and 3 months, maintenance dose 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.
https://www.medicines.org.uk/emc/product/12039/smpc#gref [Accessed 18/02/2022].
Storage
This medicinal product does not require any special storage conditions. Do not freeze.
A stock will be kept in room 7.
Monitoring
50% reduction in LDL cholesterol concentrations should be seen 30-60 days after treatment.
Repeat full lipid profile 30-60 days following 2nd initial dose (given at 3 months).
If possible, blood test should be booked by nurse administering second initial dose, otherwise patient should be instructed to book via reception.
Documentation
Problem – CVD/Dyslipidaemia/Hypercholesterolaemia.
Procedure – use code ‘subcutaneous injection’, and free text in manufacturer, expiry date, batch number, route.
Follow-up – use lipid lowering therapy code and put date when next injection due. Also add Ardens diary recall for repeat lipids 1/12 after 2nd dose (at 3 months).
Prescription
Nurse administering injection to add prescription to EMIS (medication, add drug, issue, approve and complete).
Recalls
Recall code in diary – lipid lowering therapy.
LDT/CST will run monthly lipid lowering therapy report.
References
BNF https://bnf.nice.org.uk/drug/inclisiran.html [Accessed 18/02/2022]
EMC https://www.medicines.org.uk/emc/product/12039/smpc#PRODUCTINFO [Accessed 18/02/2022]
NICE https://www.nice.org.uk/guidance/ta733/resources/inclisiran-for-treating-primary-hypercholesterolaemia-or-mixed-dyslipidaemia-pdf-82611252825541 [Accessed 18/02/2022]
Changes Register
| Date | Version | Author | Changes |
| 01/02/2022 | 1 | LT | New SOP |
| 05/05/2023 | 2 | LT | Full Review |