EVKEEZA (evinacumab-dgnb) Injection

For the treatment of Homozygous FH

The First and Only FDA-Approved Therapy that Blocks a Specific Protein (ANGPTL3)

EVKEEZA is an injectable prescription medicine used along with other low-density lipoprotein (LDL) lowering medicines in people older than 12 years of age with a type of high cholesterol called Homozygous FH.

It is not known if EVKEEZA is safe and effective in people with other causes of high cholesterol. The effect of EVKEEZA on heart problems such as heart attacks, stroke, or death is not known. It is not known if EVKEEZA is safe and effective in children with Homozygous FH under 12 years of age.

Homozygous FH is a rare disorder where individuals are genetically unable to clear LDL-cholesterol, or LDL-C (bad cholesterol).

Please see Important Safety Information.

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Important Safety Information

Who should not use EVKEEZA^®?

Do not use EVKEEZA if you are allergic to evinacumab-dgnb or to any of the ingredients in EVKEEZA.

Before receiving EVKEEZA, tell your healthcare provider about all of your medical conditions, including if you:

Are pregnant or plan to become pregnant. EVKEEZA may harm your unborn baby. Tell your healthcare provider if you become pregnant while using EVKEEZA. People who are able to become pregnant:
- Your healthcare provider 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 with your healthcare provider about birth control methods that you can use during this time.
Are breastfeeding or plan to breastfeed. It is not known if EVKEEZA passes into your breast milk. You and your healthcare provider should decide if you will receive EVKEEZA or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of EVKEEZA?

EVKEEZA can cause serious side effects, including:
- Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Tell your healthcare provider right away if you get any of the following symptoms: swelling (mainly of the lips, tongue or throat which makes it difficult to swallow or breathe), breathing problems or wheezing, feeling dizzy or fainting, rash, hives, and itching.
The most common side effects of EVKEEZA include symptoms of the common cold, flu-like symptoms, dizziness, pain in legs or arms, nausea, and decreased energy.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of EVKEEZA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Indication

EVKEEZA is an injectable prescription medicine used along with other low-density lipoprotein (LDL) lowering medicines in people older than 12 years of age with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH).

It is not known if EVKEEZA is safe and effective in people with other causes of high cholesterol.
The effect of EVKEEZA on heart problems such as heart attacks, stroke, or death is not known.
It is not known if EVKEEZA is safe and effective in children with HoFH under 12 years of age.

Please see full Prescribing Information, including Patient Information.