Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Marketing Authorisation Holder: sanofi-aventis groupe, 54, rue La Boétie, F – 75008 Paris, France
Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, 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 Praluent secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g. nephrotic syndrome, hypothyroidism) should be excluded.
The usual starting dose for Praluent 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 Praluent 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.
If a dose is missed, the patient should administer the injection as soon as possible and thereafter resume treatment 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 and adolescents less than 18 years of age have not been established. Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made. Alirocumab has not been studied in paediatric patients less than 8 years of age.
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 patient 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.
Precautions to be taken before handling or administering the medicinal product The solution should be allowed to warm to room temperature prior to use (see section 6.6).
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 solution in a siliconised Type 1 clear glass syringe, equipped with a stainless steel staked needle, a styrene-butadiene rubber soft needle shield, and an ethylene tetrafluoroethylene-coated bromobutyl rubber plunger stopper.
Pre-filled pen 75 mg: The syringe components are assembled into a single-use pre-filled pen with 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 or 6 pre-filled pens without activation button.
Pre-filled pen 150 mg: The syringe components are assembled into a single-use pre-filled pen with 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 or 6 pre-filled pens without activation button.
300 mg solution for injection in pre-filled pen: 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.
75 mg solution for injection in pre-filled syringe: The syringe is equipped with a light green polypropylene plunger rod.
Pack size: 1, 2 or 6 pre-filled syringes.
150 mg solution for injection in pre-filled syringe: 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.
The solution should be clear, colourless to pale yellow. If the solution is discoloured or contains visible particulate matter, the solution should not be used.
After use, place the pre-filled pen/pre-filled syringe into a puncture resistant container and discard as required by local regulations. Do not recycle the container. Always keep the container out of the sight and reach of children. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
