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Praluent
alirocumab
Adult Dosing .
Dosage forms: INJ (pen): 75 mg per mL, 150 mg per mL
primary hyperlipidemia
- [75-150 mg SC q2wk or 300 mg SC q4wk]
- Start: 75 mg SC q2wk or 300 mg SC q4wk; Info: may adjust dose to 150 mg SC q2wk after 4wk; see pkg insert for missed dose recommendations
heterozygous familial hypercholesterolemia
- [w/o LDL apheresis]
- Dose: 75-150 mg SC q2wk or 300 mg SC q4wk; Start: 75 mg SC q2wk or 300 mg SC q4wk; Info: may adjust dose to 150 mg SC q2wk after 4wk; see pkg insert for missed dose recommendations
- [w/ LDL apheresis]
- Dose: 150 mg SC q2wk; Info: see pkg insert for missed dose recommendations
homozygous familial hypercholesterolemia, adjunct tx
- [150 mg SC q2wk]
- Info: see pkg insert for missed dose recommendations
cardiovascular event risk reduction
- [75-150 mg SC q2wk or 300 mg SC q4wk]
- Start: 75 mg SC q2wk or 300 mg SC q4wk; Info: may adjust dose to 150 mg SC q2wk after 4wk; see pkg insert for missed dose recommendations
renal dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined
Peds Dosing .
- Dosage forms: INJ (pen): 75 mg per mL, 150 mg per mL
heterozygous familial hypercholesterolemia, adjunct tx
- [8 yo and older, <50 kg]
- Dose: 150 mg SC q4wk; Info: may adjust dose to 75 mg SC q2wk after 4wk; see pkg insert for missed dose recommendations
- [8 yo and older, >50 kg]
- Dose: 300 mg SC q4wk; Info: may adjust dose to 150 mg SC q2wk after 4wk; see pkg insert for missed dose recommendations
renal dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
Drug Interactions .
Overview
alirocumab
PCSK9 inhibitor
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn, severe
- nummular eczema
- hypersensitivity vasculitis
- angioedema
Common Reactions
- injection site rxn
- hypersensitivity rxn
- influenza
- diarrhea
- myalgia
- muscle spasms
- ALT or AST incr.
- contusion
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy, esp. in 2nd and 3rd trimesters; no human data available, though likely to cross placenta in 2nd and 3rd trimesters based on human data w/ other monoclonal antibodies; risk of humoral immunosuppression based on animal data at 13x and 81x MRHD
Pregnancy Reporting
report any suspected fetal exposure to Regeneron pregnancy safety study at 1-844-734-6643
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available, though risk of infant harm not expected based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: unknown; CYP450: none
Excretion: unknown; Half-life: 17-20 days
Subclass: Dyslipidemia: PCSK9 Inhibitors
Mechanism of Action
inhibits proprotein convertase subtilisin kexin type 9 (PCSK9) binding to LDL receptors, decreasing LDL receptor degradation and increasing LDL clearance (monoclonal antibody)
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Regeneron
DEA/FDA: Rx
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
subcutaneous solution:
- 75 mg/mL (1 carton, 2 pens): $482.00
- 150 mg/mL (1 carton, 2 pens): $482.00
subcutaneous solution:
- 75 mg/mL (1 syringe): $581.00
- 150 mg/mL (2 syringe): $1,152.00
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