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Evolocumab

Class
Hypolipidemic agents
Subclass
Anti-PCSK9 monoclonal antibodies
Substance name
Evolocumab
Brand names
Repatha®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Treatment
Heterozygous familial hypercholesterolemia
140 mg SC q2 weeks
Alternative
420 mg SC q1 month
Homozygous familial hypercholesterolemia
420 mg SC q2-4 weeks
Primary hyperlipidemia
140 mg SC q2 weeks
Alternative
420 mg SC q1 month
Adjunctive treatment
Adjunctive treatment for homozygous familial hypercholesterolemia
420 mg SC q1 month
Titrate to 420 mg q2 weeks if the LDL-C response in 12 weeks is inadequate. Consider starting with 420 mg q2 weeks in patients undergoing LDL apheresis.
Prevention
Prevention of cardiovascular events in patients with CVD
140 mg SC q2 weeks
Alternative
420 mg SC q1 month
Indications for use
Labeled indications
Adults
Treatment of heterozygous familial hypercholesterolemia
Treatment of homozygous familial hypercholesterolemia
Treatment of primary hyperlipidemia
Adjunctive treatment for homozygous familial hypercholesterolemia
Prevention of CVD in patients with diabetes mellitus type 2
Prevention of cardiovascular events in patients with CVD
Prevention of stroke in patients with CVD
Children
Treatment of heterozygous familial hypercholesterolemia
Treatment of homozygous familial hypercholesterolemia
Safety risks
Contraindications
Hypersensitivity to evolocumab or its components
Warnings and precautions
Drug hypersensitivity reaction
Maintain a high level of suspicion, as evolocumab has been associated with an increased risk of hypersensitivity reactions, including vasculitis, angioedema, and other reactions requiring hospitalization.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
Use acceptable. No dose adjustment required.
Hepatic impairment
Child-Pugh A (mild)
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B1
Insufficient evidence. Monoclonal antibodies cross the placenta, with transport increasing as pregnancy progresses and peaks during the third trimester.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
Nasopharyngitis
Common 1-10%
Diabetes mellitus, gastroenteritis, hypertension, influenza virus infection, arthralgia, nausea, back pain, cough, diarrhea, dizziness, fatigue, injection site reactions, muscle spasms, musculoskeletal pain, myalgia, headache, skin rash, contusion, sinusitis, urinary tract infections, upper respiratory tract infections
Uncommon < 1%
Serum anti-evolocumab antibodies, skin erythema, urticaria
Unknown frequency
Angioedema
Interactions
Drug(s)
Check Interactions
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