Evolocumab

1
Evolocumab
Brands

DEA Class; Rx

Common Brand Names; Repatha

  • Lipid-Lowering Agents, PCSK9 Inhibitors

Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor
For use in heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, and reduction of myocardial infarction, stroke, or hospitalization for unstable angina in adults with established cardiovascular disease
Reports of serious hypersensitivity reactions including hypersensitivity vasculitis

Indicated for the treatment of primary hypercholesterolemia, including heterozygous familial hypercholesterolemia, as an adjunct to diet, alone or in combination with other LDL-C-lowering therapies to reduce LDL-C.

For use adjunct to other LDL-C lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) who require further reduction of LDL-C.
For myocardial infarction prophylaxis, stroke prophylaxis, and to reduce the risk of coronary revascularization in patients with established cardiovascular disease.
 

History of serious hypersensitivity to evolocumab or any excipients

  • Nasopharyngitis (4-10.5%)
  • Upper respiratory tract infection (2.1-9.3%)
  • Influenza (1.2-7.5%)
  • Back pain (2.3-6.2%)
  • Injection site reactions (3.2-5.7%)
  • Allergic reaction (5.1%)
  • Cough (1.2-4.5%)
  • Urinary tract infection (1.3-4.5%)
  • Sinusitis (4.2%)
  • Headache (4%)
  • Myalgia (4%)
  • Dizziness (3.7%)
  • Musculoskeletal pain (3.3%)
  • Hypertension (3.2%)
  • Diarrhea (3%)
  • Gastroenteritis (3%)
  • Arthralgia (1.8%)
  • Nausea (1.8%)
  • Fatigue (1.6%)
  • Muscle spasms (1.3%)
  • Contusion (1%)
  • Oropharyngeal pain (7%)
  • Allergic reactions: Angioedema

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No available data on use in pregnant women

Unknown if distributed in human breast milk

Adults

420 mg/dose subcutaneously once monthly for most indications or every 2 weeks for homozygous familial hypercholesterolemia (HoFH).

Geriatric

420 mg/dose subcutaneously once monthly for most indications or every 2 weeks for homozygous familial hypercholesterolemia (HoFH).

Adolescents

420 mg/dose subcutaneously once monthly for heterozygous familial hypercholesterolemia (HeFH) or every 2 weeks for homozygous familial hypercholesterolemia (HoFH).

Children

10 to 12 years: 420 mg/dose subcutaneously once monthly for heterozygous familial hypercholesterolemia (HeFH) or every 2 weeks for homozygous familial hypercholesterolemia (HoFH).
1 to 9 years: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Evolocumab

solution for SC injection

  • 140mg/mL single-use prefilled syringe OR single-use SureClick autoinjector
  • 420mg/3.5mL single-use Pushtronex system (on-body infusor with prefilled cartridge)
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