Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) as an adjunct to diet:
Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
Prior to initiating alirocumab secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.
The usual starting dose for alirocumab is 75 mg administered subcutaneously once every 2 weeks. Patients requiring larger LDL-C reduction (>60%) may be started on 150 mg once every 2 weeks, or 300 mg once every 4 weeks (monthly), administered subcutaneously.
The dose of alirocumab can be individualised based on patient characteristics such as baseline LDL-C level, goal of therapy, and response. Lipid levels can be assessed 4 to 8 weeks after treatment initiation or titration, and dose adjusted accordingly (up-titration or down-titration). If additional LDL-C reduction is needed in patients treated with 75 mg once every 2 weeks or 300 mg once every 4 weeks (monthly), the dosage may be adjusted to the maximum dosage of 150 mg once every 2 weeks.
| Body weight of patients | Recommended dose | Recommended dose if additional LDL-C reduction is needed* |
|---|---|---|
| Less than 50 kg | 150 mg once every 4 weeks | 75 mg once every 2 weeks |
| 50 kg or more | 300 mg once every 4 weeks | 150 mg once every 2 weeks |
* Lipid levels can be assessed 8 weeks after treatment initiation or titration and dose adjusted accordingly.
If a dose is missed, the dose should be administered as soon as possible and thereafter, dosing should be resumed on the original schedule.
No dose adjustment is needed for elderly patients.
No dose adjustment is needed for patients with mild or moderate hepatic impairment. No data are available in patients with severe hepatic impairment (see section 5.2).
No dose adjustment is needed for patients with mild or moderate renal impairment. Limited data are available in patients with severe renal impairment (see section 5.2).
No dose adjustment is needed in patients based on weight.
The safety and efficacy of Praluent in children less than 8 years of age have not been established. No data are available.
Subcutaneous use.
Alirocumab is injected as a subcutaneous injection into the thigh, abdomen or upper arm.
Each pre-filled pen or pre-filled syringe is for single use only.
To administer the 300 mg dose, either one 300 mg injection or two 150 mg injections should be given consecutively at two different injection sites.
It is recommended to rotate the injection site with each injection.
Alirocumab should not be injected into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections.
Alirocumab must not be co-administered with other injectable medicinal products at the same injection site.
The solution should be allowed to warm to room temperature prior to use (see section 6.6).
In adolescents 12 years of age and older, it is recommended that Praluent be administered by or under the supervision of an adult.
In children less than 12 years of age, Praluent must be given by a caregiver.
Adult patients may either self-inject alirocumab, or a caregiver may administer alirocumab, after guidance has been provided by a healthcare professional on proper subcutaneous injection technique.
There is no specific treatment for alirocumab overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
Praluent 75 mg solution for injection in pre-filled pen: 3 years.
Praluent 75 mg solution for injection in pre-filled syringe: 3 years.
Praluent 150 mg solution for injection in pre-filled pen: 2 years.
Praluent 150 mg solution for injection in pre-filled syringe: 2 years.
Praluent 300 mg solution for injection in pre-filled pen: 2 years.
Store in a refrigerator (2°C to 8°C). Do not freeze.
Praluent can be stored outside the refrigerator (below 25°C) protected from light for a single period not exceeding 30 days. After removal from the refrigerator, the medicinal product must be used within 30 days or discarded.
Keep the pen or syringe in the outer carton in order to protect from light.
1 ml or 2 ml solution in a siliconised Type 1 clear glass syringe, equipped with a stainless steel staked needle, a styrene-butadiene rubber needle shield, and an ethylene tetrafluoroethylene-coated bromobutyl rubber plunger stopper.
The syringe components are assembled into a single-use pre-filled pen with a blue cap and a light green activation button.
Pack size:
1, 2 or 6 pre-filled pens.
Or
The syringe components are assembled into a single-use pre-filled pen with a blue cap and without activation button.
Pack size:
1, 2, 3 pre-filled pens without activation button or multipack containing 6 (2 packs of 3) pre-filled pens without activation button.
The syringe components are assembled into a single-use pre-filled pen with a blue cap and a dark grey activation button.
Pack size:
1, 2 or 6 pre-filled pens.
Or
The syringe components are assembled into a single-use pre-filled pen with a blue cap and without activation button.
Pack size:
1, 2, 3 pre-filled pens without activation button or multipack containing 6 (2 packs of 3) pre-filled pens without activation button.
The syringe components are assembled into a single-use pre-filled pen with a blue cap and without activation button.
Pack size:
1 or 3 pre-filled pens without activation button.
The syringe is equipped with a light green polypropylene plunger rod.
Pack size:
1, 2 or 6 pre-filled syringes.
The syringe is equipped with a dark grey polypropylene plunger rod.
Pack size:
1, 2 or 6 pre-filled syringes.
Not all presentations and pack sizes may be marketed.
After use, the pre-filled pen/pre-filled syringe should be placed into a puncture resistant container. The container should not be recycled.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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