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Leqvio 284mg/1.5ml Injection
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Indications & Clinical Uses
- Leqvio 284 mg/1.5 mL is a single-dose prefilled syringe containing inclisiran, a small interfering RNA (siRNA) that switches off production of the PCSK9 protein in the liver so more LDL receptors remain available to clear cholesterol from the blood.
- It is given as an adjunct to diet and exercise to lower LDL cholesterol in adults with primary hyperlipidaemia, including heterozygous familial hypercholesterolaemia, and in patients aged 12 years and over with heterozygous or homozygous familial hypercholesterolaemia; the US label also covers reducing cardiovascular risk in adults with, or at increased risk of, atherosclerotic cardiovascular disease.
- In the European Union it is authorised for adults with primary hypercholesterolaemia or mixed dyslipidaemia, alongside a statin or other lipid-lowering therapy, or alone when statins are not tolerated.
- A healthcare professional injects it under the skin of the abdomen, upper arm or thigh; patients do not inject it themselves.
Side Effects
- The Leqvio label carries NO boxed warning.
- The most common side effects are reactions where the injection is given, reported by about 8 in 100 people compared with 2 in 100 given placebo, and these are usually mild redness, pain or rash that settles without treatment.
- Joint pain affected about 5 in 100 people and bronchitis about 4 in 100.
- Discontinuation because of side effects was uncommon, at about 2.5 in 100 people.
- Serious hypersensitivity reactions, including anaphylaxis and angioedema with swelling of the face, lips, tongue or throat, have been reported and require emergency care.
- Because inclisiran works only in the liver and is cleared quickly from the blood, it does not cause the muscle problems associated with statins.
- Tell your healthcare provider if an injection-site reaction is severe, spreading or slow to settle.
Precautions & Warnings
- Leqvio is given by subcutaneous injection by a healthcare professional, with the first dose followed by a second at three months and then a dose every six months, so the schedule depends on keeping clinic appointments rather than daily dosing.
- If a dose is more than three months late, the schedule is restarted rather than simply resumed.
- It is contraindicated in anyone who has had a serious hypersensitivity reaction to inclisiran or the excipients.
- Injections are not given into areas of active skin disease or injury, into tattoos, scars or bruised skin, and the site is varied between doses.
- Leqvio does not replace diet, exercise or background statin therapy, which continue unless a statin cannot be tolerated.
- It should be stopped if pregnancy occurs, as lowering cholesterol may affect the developing baby; breastfeeding is discussed with your healthcare provider.
- Store the syringe at 20°C to 25°C and do not freeze.
Avoid Interactions
- Inclisiran is not handled by the liver's CYP450 enzymes and is neither a substrate, inhibitor nor inducer of them, so no formal interaction studies were needed and no medicine is known to raise or lower its effect in a way that requires a dose change.
- Population analysis showed no clinically important effect on atorvastatin or rosuvastatin levels, and Leqvio is designed to be used alongside statins, ezetimibe or other lipid-lowering treatments rather than instead of them.
- Because it is injected, food, grapefruit and alcohol do not alter its absorption, although heavy alcohol use works against the cholesterol and cardiovascular goals of treatment.
- Tell your healthcare provider about all prescription and over-the-counter medicines, herbal remedies and supplements you take, including any other PCSK9-directed antibody such as alirocumab or evolocumab, since routinely combining them is not established.
- The syringe must not be mixed or diluted with any other medicine.
References
Frequently Asked Questions
Leqvio (inclisiran) lowers LDL cholesterol in adults with primary hyperlipidaemia, including heterozygous familial hypercholesterolaemia, and in patients aged 12 and over with familial hypercholesterolaemia. It is added to diet and usually to a statin. The US label also covers reducing cardiovascular risk in atherosclerotic disease.
Leqvio (inclisiran) 284 mg is injected under the skin by a healthcare professional, with a second dose three months later and then one dose every six months. Injection sites are the abdomen, upper arm or thigh. You do not inject it yourself, so twice-yearly appointments are needed.
The most common Leqvio (inclisiran) side effects are injection-site reactions such as redness, pain or rash, reported by about 8 in 100 people, along with joint pain and bronchitis. Seek emergency care for swelling of the face, lips, tongue or throat, or difficulty breathing.
Leqvio (inclisiran) must not be used by anyone who has had a serious allergic reaction to inclisiran. Avoid injecting into skin that is diseased, injured, bruised, scarred or tattooed. It should be stopped in pregnancy, and it is not a replacement for diet, exercise or statin therapy.
If a Leqvio (inclisiran) dose is less than three months late, it is given as soon as possible and the original schedule continues. If more than three months have passed, the treatment schedule is restarted with a new starting dose followed by one at three months. Book the next appointment before leaving.
No, Leqvio (inclisiran) has no boxed warning. It works only in the liver and is not processed by CYP450 enzymes, so no dose changes are needed with other medicines. It is not linked to the muscle problems seen with statins, and cholesterol levels are still checked periodically.
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