Evinacumab-dgnb (Intravenous)

Evinacumab-dgnb injection is used along with other medicines to treat homozygous familial hypercholesterolemia (HoFH). This medicine works as an ANGPTL3 (angiopoietin-like protein 3) inhibitor.

This medicine must be given only by your doctor or under their direct supervision.

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly to lower your cholesterol level and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to prevent getting pregnant during treatment and for at least 5 months after your last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you or your child have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, trouble breathing, or unusual tiredness or weakness.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. Here are important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done on how evinacumab-dgnb injection affects children younger than 5 years old. Its safety and effectiveness in this age group have not been established.

Geriatric

Studies so far have not found any specific problems related to age that would limit the usefulness of evinacumab-dgnb injection in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together even if there could be an interaction. In these situations, your doctor might need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at the same time as food or specific types of food because interactions may happen. Using alcohol or tobacco with certain medicines can also lead to interactions. Discuss with your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

• Chest tightness
• cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• trouble breathing
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Chills
• diarrhea
• fever
• general feeling of discomfort or illness
• headache
• itching at the injection site
• joint pain
• loss of appetite
• muscle aches, pains, or weakness
• nausea
• shivering
• sore throat
• stuffy or runny nose
• sweating
• trouble sleeping
• vomiting

Less common

• Body aches or pain
• constipation
• ear congestion
• lack or loss of strength
• loss of voice
• pain in the arms or legs
• sneezing
• stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Evkeeza

Available Dosage Forms:

• Solution

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: Evinacumab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to remain in place for at least 60 minutes. It is usually given once a month (every 4 weeks).

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Missed Dose

Call your doctor or pharmacist for instructions.

• How does Evkeeza work (its mechanism of action)?