Inclisiran parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of inclisiran.
Drugs List
Therapeutic Indications
Uses
Mixed dyslipidaemia: adjunct to diet and exercise
Primary hypercholesterolaemia: lipid lowering therapy adjunct to diet
Treatment of 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 statin, or
-alone or combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Dosage
Adults
Initial dose 284mg, repeated at 3 months and then every 6 months.
Additional Dosage Information
Missed doses
If a dose is missed by less than 3 months, inclisiran should be administered and dosing continued according to the patient's original schedule.
If a 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. It is recommended that inclisiran is administered within 2 weeks after the last dose of a monoclonal antibody PCSK9 inhibitor to maintain LDL-C lowering.
Administration
For subcutaneous injection only.
Contraindications
Children under 18 years
Breastfeeding
Pregnancy
Precautions and Warnings
Haemodialysis
Severe hepatic impairment
Severe renal impairment
Haemodialysis patients: administer drug at least 72 hours before dialysis
Avoid injection into rash covered skin
Do not inject near site of skin infection
Pregnancy and Lactation
Pregnancy
Inclisiran is contraindicated during pregnancy.
The manufacturer does not recommend using inclisiran during pregnancy. At the time of writing there is limited published information regarding the use of inclisiran during pregnancy. Animal studies do not indicate direct or indirect harmful effects, however as a precautionary measure, use of inclisiran is preferably avoided as potential risks are unknown.
Lactation
Inclisiran is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues inclisiran or discontinues breastfeeding. Animal data reports levels of inclisiran in the breast milk, however presence in human breast milk and the effects on exposed infants are unknown.
Side Effects
Erythema at injection site
Injection site reactions
Local pain (injection site)
Rash at injection site
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: April 2021
Reference Sources
Summary of Product Characteristics: Leqvio 284mg solution for injection pre filled syringe. Novartis Europharm Limited. Revised December 2020.
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