Drug Guide
Alirocumab
Classification
Therapeutic: Lipid-lowering agent
Pharmacological: PCSK9 inhibitor
FDA Approved Indications
- Homozygous familial hypercholesterolemia ( HoFH) as an adjunct to diet, maximally tolerated statin therapy, and other lipid-lowering therapies
- homozygous familial hypercholesterolemia (HoFH) in pediatric patients aged 13 years and older
- Heterozygous familial hypercholesterolemia (HeFH) as an adjunct to diet and maximally tolerated statins in adults
Mechanism of Action
Alirocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), thereby increasing the number of LDL receptors on hepatocyte surfaces and promoting LDL cholesterol clearance from the bloodstream.
Dosage and Administration
Adult: Initial dose: 75 mg subcutaneously every 2 weeks. Dose may be increased to 150 mg every 2 weeks based on LDL-C response.
Pediatric: In children aged 13 years and older with homozygous familial hypercholesterolemia, the dosing is similar to adults, administered via subcutaneous injection every 2 weeks.
Geriatric: No specific adjustment recommended, but caution in renal/hepatic impairment.
Renal Impairment: No specific dosage adjustment necessary.
Hepatic Impairment: No specific adjustment recommended.
Pharmacokinetics
Absorption: Subcutaneous absorption is slow with peak concentrations in approximately 3–7 days.
Distribution: Limited data; likely distributed in extravascular tissues.
Metabolism: Metabolized via catabolic pathways, similar to other IgG antibodies.
Excretion: Primarily through catabolism to amino acids; no specific excretion pathway identified.
Half Life: Approximately 17–20 days.
Contraindications
- Hypersensitivity to alirocumab or excipients.
Precautions
- Risk of hypersensitivity reactions including anaphylaxis; use caution in patients with a history of allergic reactions.
- Monitor lipid levels and clinical response.
Adverse Reactions - Common
- Injection site reactions (Common)
- Nasopharyngitis (Common)
- Influenza (Common)
- Upper respiratory tract infection (Common)
Adverse Reactions - Serious
- Allergic reactions including hypersensitivity and anaphylaxis (Rare)
Drug-Drug Interactions
- No significant interactions identified with other lipid-lowering agents; concurrent use with statins and ezetimibe is common.
Drug-Food Interactions
- No known food interactions.
Drug-Herb Interactions
- Limited data, but consult with healthcare provider about herbal supplement use.
Nursing Implications
Assessment: Monitor lipid panel, liver function tests, and for signs of hypersensitivity reactions.
Diagnoses:
- Risk for decreased cardiac tissue perfusion related to hyperlipidemia.
- Impaired skin integrity related to injection site reactions.
Implementation: Administer subcutaneously as ordered, observe for adverse reactions, educate patient on injection technique.
Evaluation: Assess reduction in LDL-C levels, monitor for adverse reactions, ensure patient adherence.
Patient/Family Teaching
- Inject medication as instructed.
- Report any signs of allergic reactions or side effects.
- Maintain lipid-lowering diet and lifestyle modifications.
- Attend regular follow-up appointments for lipid monitoring.
Special Considerations
Black Box Warnings:
- No black box warnings at this time.
Genetic Factors: Patients with homozygous familial hypercholesterolemia may have differing responses; genetics may influence efficacy.
Lab Test Interference: No known interference with laboratory tests.
Overdose Management
Signs/Symptoms: No specific overdose data; symptoms unlikely to occur due to nature of medication.
Treatment: Supportive care; discontinue medication and monitor patient.
Storage and Handling
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.
Stability: Stable when stored properly; see manufacturer's instructions for expiration.