Praluent Dosage/Direction for Use

Posology: Adults: 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.
HeFH in paediatric patients 8 years of age and older: See Table 4.

Click on icon to see table/diagram/image

Missed dose: If a dose is missed, the dose should be administered as soon as possible and thereafter, dosing should be resumed on the original schedule.
Special populations: Elderly: No dose adjustment is needed for elderly patients.
Hepatic impairment: No dose adjustment is needed for patients with mild or moderate hepatic impairment. No data are available in patients with severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is needed for patients with mild or moderate renal impairment. Limited data are available in patients with severe renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Body weight: No dose adjustment is needed in patients based on weight.
Paediatric population: The safety and efficacy of Praluent in children less than 8 years of age have not been established. No data are available.
Method of administration: Subcutaneous use.
Alirocumab is injected as a subcutaneous injection into the thigh, abdomen or upper arm.
Each pre-filled pen 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.
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 Instructions for use under Patient Counselling Information).
Paediatric patients 8 years of age and older: 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.
Adults: 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.