LEQVIOTM NSS - Bahrain
LEQVIOTM NSS - Bahrain
Regulatory Affairs
LEQVIOTM (inclisiran)
284 mg/1.5 mL Solution for injection
National Succinct Statement (NSS)
Version 1.3
CDS Effective date: 12-Dec-2023
Safety Label Change (SLC) 2023-PSB/GLC-1398-s
Tracking number:
Document status: Final
Property of Novartis Confidential
May not be used, divulged, published or otherwise disclosed
without the consent of Novartis
► This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via www.report.novartis.com
LeqvioTM
Important note: Before prescribing, consult full prescribing information:
This link will contain the most updated product information approved by the reference country
Presentation:
Solution for injection: Each pre-filled syringe contains 1.5 mL of solution containing 284 mg inclisiran (equivalent to 300 mg inclisiran sodium).
Indications:
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:
Posology
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
Elderly (age ≥65 years)
No dose adjustment is necessary in elderly patients.
Hepatic impairment
No dose adjustments are necessary for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. No data are available in patients with severe hepatic impairment (Child-Pugh class C). Inclisiran should be used with caution in patients with severe hepatic impairment.
Renal impairment
No dose adjustments are necessary for patients with mild, moderate or severe renal impairment or patients with end-stage renal disease. There is limited experience with inclisiran in patients with severe renal impairment. Inclisiran should be used with caution in these patients.
Paediatric population
The safety and efficacy of inclisiran in children aged less than 18 years have not yet been established. No data are available.
Method of administration Subcutaneous use.
Inclisiran is for subcutaneous injection into the abdomen; alternative injection sites include 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.
Each 284 mg dose is administered using a single pre-filled syringe. Each pre-filled syringe is for single use only.
Inclisiran is intended for administration by a healthcare professional.
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Warnings and 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.
Pregnancy, lactation, females and males of reproductive potential
Pregnancy: No available human data. Animal reproduction studies have not shown risk of increased fetal abnormalities. As a precautionary measure, it is preferable to avoid the use of inclisiran during pregnancy.
Lactation: Not known if transferred into human milk. No data on the effects on the breastfed child or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Leqvio and any potential adverse effects on the breastfed child from Leqvio.
Infertility: No human data. No effects on animal fertility.
Adverse drug reactions:
Common (≥1 to <10%): Adverse events at the injection site (includes injection site reaction, injection site pain, injection site erythema, and injection site rash).
Interactions: Not a substrate, inhibitor or inducer of CYP450 enzymes or common drug transporters.
Not expected to have clinically significant interactions with other medications.
Drug-drug interaction assessments demonstrated a lack of clinically meaningful interactions with either atorvastatin, rosuvastatin or other statins.