Evkeeza (evinacumab)

$10,127.44$32,182.40

Evkeeza (evinacumab) is an injectable medicine used together with other low-density lipoprotein (LDL)-lowering medicines in people aged 12 years and older with a type of high cholesterol called Homozygous Familial Hypercholesterolemia (HoFH).

SKU: N/A Categories: ,

What is Evkeeza (evinacumab) for?

Evkeeza (evinacumab) is an ANGPTL3 (angiopoietin-like 3) inhibitor used together with other low-density lipoprotein (LDL)-lowering medicines in people aged 12 years and older with a type of high cholesterol called Homozygous Familial Hypercholesterolemia (HoFH).[1]

It is not known if Evkeeza (evinacumab) is safe and effective in people with other causes of high cholesterol.[1]

This medicine is available in vial form for intravenous infusion, containing either 345 mg/2.3 mL (150 mg/mL) or 1,200 mg/8 mL (150 mg/mL) evinacumab.[1]

How does Evkeeza (evinacumab) work?

HoFH is a rare, life-threatening disease, in which people have a mutation in their low-density lipoprotein (LDL) receptor. As a result, they have extremely high blood levels of LDL cholesterol (LDL-C), known as “bad cholesterol”. People with HoFH have increased risk of developing cardiovascular disease, including heart attack and heart disease, at a young age.[2,3]

Evinacumab is a monoclonal antibody, a type of protein, that can bind to the angiopoietin-like protein 3 (ANGPTL3). ANGPTL3 inhibits the function of enzymes in the body that break down fats. By inhibiting ANGPTL3, evinacumab helps speed up the breakdown of fats that lead to high cholesterol levels.[2,3]

Where has Evkeeza (evinacumab) been approved?

Evkeeza (evinacumab) was approved for the treatment of people with HoFH by:

  • The Food and Drug Administration (FDA), USA on February 11, 2021.[3]
  • The European Medicines Agency (EMA) on April 21, 2021.[4]

Evkeeza (evinacumab) was approved under Priority Review and was previously granted Orphan Drug designation, which provides incentives to assist and encourage drug development for rare diseases and Breakthrough Therapy designation.[3]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Evkeeza (evinacumab) taken?

The standard dosage is:[1]

  • 15 mg/kg body weight administered by intravenous (IV) infusion (drip) once monthly (every 4 weeks)

The diluted solution is given via IV infusion over 60 minutes through an IV line.[1]

This medicine should not be mixed with other medications or given together with other medications concomitantly via the same infusion line.[1]

LDL-C should be assessed when clinically possible. The LDL-lowering effect of Evkeeza (evinacumab) may be measured as early as 2 weeks after start of treatment.[1]

Complete information about Evkeeza (evinacumab) infusion preparation, dosage and administration can be found in the official prescribing information listed in our references section.[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Evkeeza (evinacumab)?

Common adverse reactions

The most common side effects ( ≥5% of patients) listed in the prescribing information include:[1]

  • Symptoms of the common cold (nasopharyngitis)
  • Flu-like symptoms
  • Dizziness
  • Pain in legs or arms
  • Nausea
  • Decreased energy

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:[1]

  • Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis

Use in a specific population

Evkeeza (evinacumab) can be fatal for a fetus, it is advised to avoid pregnancies. It is not known if Evkeeza (evinacumab) passes into your breast milk. Discuss with your treating doctor if you will receive this medicine or breastfeed.[1]

It is not known if Evkeeza (evinacumab) is safe and effective in children with HoFH under 12 years of age.[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.[1]

Single-dose vial

1 vial of 345 mg/2.3 mL (150 mg/mL), 1 vial of 1,200 mg/8 mL (150 mg/mL)