Praluent

, nephrotic syndrome, hypothyroidism) should be excluded. The recommended alirocumab doses are 75 mg once every 2 weeks, 150 mg once every 2 weeks, 300 mg once every 4 weeks (monthly), administered subcutaneously. All doses may be used for initiation of treatment.

The dose of alirocumab can be individualised based on patient characteristics such as baseline LDL-C level, goal of therapy, and response to treatment. Lipid levels can be assessed 4 to 8 weeks after treatment initiation or titration, and dose adjusted accordingly (up-titration or down-titration).

1). HeFH in paediatric patients 8 years of age and older 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.

4 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. 2). Renal impairment No dose adjustment is needed for patients with mild or moderate renal impairment. 2). 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 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.

1%). Most common adverse reactions leading to treatment discontinuation in patients treated with alirocumab were local injection site reactions. The safety profile in ODYSSEY OUTCOMES was consistent with the overall safety profile described in the Phase 3 controlled trials.

No difference in the safety profile was observed between the two doses (75 mg and 150 mg) used in the Phase 3 program. Tabulated list of adverse reactions The following adverse reactions were reported in patients treated with alirocumab in pooled controlled studies and/or post-marketing use (see Table 1).

Frequencies for all adverse reactions identified from clinical trials have been calculated based on their incidence in pooled Phase 3 clinical trials. Adverse reactions are presented by system organ class. Frequency categories are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).

The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports. Consequently, the frequency of these adverse reactions is qualified as "not known". 1% in the control group (receiving placebo injections).

Most injection site reactions were transient and of mild intensity. 3% in the control group). 1% placebo). 0% of patients), mainly due to a difference in the incidence of pruritus. The observed cases of pruritus were typically mild and transient.

4). 8% placebo). No difference was seen in the incidence of pruritus. Special populations Elderly Although no safety issues were observed in patients over 75 years of age, data are limited in this age group. 2%) treated with alirocumab were ≥75 years of age.

2%) treated with alirocumab were ≥75 years of age. There were no significant differences observed in safety and efficacy with increasing age. Paediatric population The safety and efficacy of Praluent have been established in children and adolescents with heterozygous familial hypercholesterolaemia (HeFH).

Traceability 5 In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Allergic reactions General allergic reactions, including pruritus, as well as rare and sometimes serious allergic reactions such as hypersensitivity, nummular eczema, urticaria, and hypersensitivity vasculitis have been reported in clinical studies.

8). 3). 2). Alirocumab should be used with caution in patients with severe renal impairment. 2). Alirocumab should be used with caution in patients with severe hepatic impairment.

1.