Praluent Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Alirocumab

Indications/Uses

Adults w/ primary hypercholesterolaemia (heterozygous familial & non-familial) or mixed dyslipidaemia & paed patients ≥8 yr w/ heterozygous familial hypercholesterolaemia (HeFH), as an adjunct to diet: in combination w/ a statin or statin w/ other lipid-lowering therapies in patients unable to reach LDL-C goals w/ max tolerated statin dose; or alone or in combination w/ other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Adults w/ established ASCVD to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: in combination w/ max tolerated statin dose w/ or w/o other lipid-lowering therapies; or alone or in combination w/ other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

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Dosage/Direction for Use

SC Adult Initially 75 mg once every 2 wk. Patients requiring larger LDL-C reduction (>60%) may be started on 150 mg once every 2 wk, or 300 mg once every 4 wk (mthly). Individualise dose based on patient characteristics eg, baseline LDL-C level, goal of therapy, & response. Assess lipid levels 4-8 wk after treatment initiation or titration, & adjust dose accordingly. Max dose: 150 mg once every 2 wk. Paed patient ≥8 yr w/ HeFH weighing ≥50 kg 300 mg once every 4 wk, or 150 mg once every 2 wk if additional LDL-C reduction is needed, <50 kg 150 mg once every 4 wk, or 75 mg once every 2 wk if additional LDL-C reduction is needed. Assess lipid levels 8 wk after treatment initiation or titration, & adjust dose accordingly.

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Overdosage

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Contraindications

Hypersensitivity.

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Special Precautions

Discontinue treatment if signs or symptoms of serious allergic reactions occur. Rotate inj site w/ each inj. Do not inj into areas of active skin disease or injury eg, sunburns, skin rashes, inflammation, or skin infections. Do not co-administer w/ other injectable medicinal products at the same inj site. Caution in patients w/ severe renal impairment (eGFR <30 mL/min/1.73 m²); severe hepatic impairment (Child-Pugh C). Not recommended during pregnancy unless deemed necessary. Not recommended in breastfeeding women during the period of colostrum production. Safety & efficacy in childn <8 yr have not been established.

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Use In Pregnancy & Lactation

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Adverse Reactions

Local inj site reactions, upper resp tract signs & symptoms, & pruritus.

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Drug Interactions

Statins & other lipid-modifying therapy (eg, ezetimibe, fenofibrate) are known to increase PCSK9 production leading to increased target-mediated clearance & reduced systemic exposure of alirocumab.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Praluent detailed prescribing information

Storage

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Description

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Action

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MIMS Class

Dyslipidaemic Agents

ATC Classification

C10AX14 - alirocumab ; Belongs to the class of other lipid modifying agents.

Regulatory Classification

P₁S₁S₃

Patient Counseling Information

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Presentation/Packing

Form

Praluent soln for inj 150 mg/mL

Packing/Price

1's

Form

Praluent soln for inj 300 mg/2 mL

Packing/Price

1's

Form

Praluent soln for inj 75 mg/mL

Packing/Price

1's

Praluent

alirocumab

Manufacturer:

Sanofi

Distributor:

DCH Auriga - Healthcare

Four Star