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Evkeeza®: evinacumab for injection

  • 効能又は効果、用法及び用量、警告・禁忌を含む注意事項等
    については電子化された添付文書をご参照ください。

EVKEEZA is used with a low‑fat diet and other medicines to bring down cholesterol levels in adults and children aged 5 years and older with very high cholesterol caused by HoFH.

What is EVKEEZA® and how does it work?

ANGPTL3

Evinacumab, the active substance in EVKEEZA, attaches to a protein called ANGPTL3 and blocks its effects. ANGPTL3 is involved in controlling cholesterol levels and blocking its effect reduces the level of high LDL-cholesterol in the blood.

Bad Cholesterol

That’s how EVKEEZA can lower cholesterol levels and help manage HoFH.

What’s in EVKEEZA?

The medicinal ingredient is evinacumab and non-medicinal ingredients include: L-arginine hydrochloride, L-histidine, L-histidine monohydrochloride monohydrate, L-proline, polysorbate 80, and Water for Injection, USP.

Do not use EVKEEZA if:

  • You are allergic to evinacumab or any of the other ingredients in this medicine

What are the possible side effects?

Talk to your doctor or nurse if you experience any side effects during or after your infusion.

Possible side effects Uncommon but serious side effects
  • Abdominal pain
  • Back pain
  • Constipation
  • Decreased energy
  • Dizziness
  • Flu symptoms
  • Itchiness at the site of the injection
  • Nausea
  • Pain in legs or arms
  • Runny nose
  • Fatigue (for patients aged 5-11 years old)

Anaphylaxis (symptoms may include swelling of the lips, tongue, or throat that make it difficult to swallow or breathe, and may also include wheezing, feeling dizzy, or fainting)

If you experience these symptoms, stop taking EVKEEZA and get immediate medical help.

These are not all the possible side effects you may have when taking EVKEEZA. If you experience any side effects not listed here, tell your healthcare professional.

Learn about your EVKEEZA infusion

What is EVKEEZA used for?

EVKEEZA (evinacumab) is used to treat adults and children aged 5 years and older with very high cholesterol caused by a condition called homozygous familial hypercholesterolemia (HoFH). EVKEEZA is used with a low-fat diet and other medicines to bring down cholesterol levels.

Do not use EVKEEZA if:

  • You are allergic to evinacumab or any of the other ingredients in this medicine

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take EVKEEZA. Talk about any health conditions or problems you may have, including:

  • If you are pregnant, think you might be pregnant, or plan to become pregnant, ask your healthcare professional for advice before taking EVKEEZA. EVKEEZA may harm your unborn baby. Tell your healthcare professional if you become pregnant while using EVKEEZA. For people who are able to become pregnant:
    • Your healthcare professional may do a pregnancy test before you start treatment with EVKEEZA.
    • You should use an effective method of birth control during treatment and for at least 5 months after the last dose of EVKEEZA. Talk to your healthcare professional about birth control methods that you can use during this time.
  • If you are breastfeeding or plan to breastfeed, ask your healthcare professional for advice before you are given EVKEEZA. It is not known if EVKEEZA passes into your breast milk. You and your healthcare professional should decide if you will receive EVKEEZA or breastfeed.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

  • Studies to test how EVKEEZA interacts with other drugs have not been done.