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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。

安全性情報

禁忌（次の患者には投与しないこと）

本剤の成分に対し過敏症の既往歴のある患者

効能又は効果

ホモ接合体家族性高コレステロール血症

効能又は効果に関連する注意

HMG-CoA 還元酵素阻害剤で効果不十分又は忍容性が不良な場合に本剤投与の要否を検討すること。

用法及び用量

通常、エビナクマブ（遺伝子組換え） として 15mg/kgを4週に 1回 、 60分以上かけて 点滴静注する

用法及び用量に関連する注意

HMG-CoA還元酵素阻害剤等による治療が適さない場合を除 き、他の脂質低下療法と併用すること。

重要な基本的注意

投与中は血中脂質値を定期的に検査し、本剤に対する反応が認められない場合には投与を中止すること。

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。

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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.