Evinacumab-dgnb

What is Evinacumab-dgnb?

• Evinacumab-dgnb (Evkeeza) is an ANGPTL3 (angiopoietin-like 3) inhibitor indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies.

What are the uses of this medicine?

This medicine is 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).

How does this medicine work?

• Evinacumab-dgnb is a recombinant human monoclonal antibody that binds to and inhibits ANGPTL3.
• ANGPTL3 is a member of the angiopoietin-like protein family that is expressed primarily in the liver and plays a role in the regulation of lipid metabolism by inhibiting lipoprotein lipase (LPL) and endothelial lipase (EL).
• Evinacumab-dgnb inhibition of ANGPTL3 leads to reduction in LDL-C, HDL-C, and triglycerides (TG).
• Evinacumab-dgnb reduces LDL-C independent of the presence of LDL receptor (LDLR) by promoting very low-density lipoprotein (VLDL) processing and clearance upstream of LDL formation.
• Evinacumab-dgnb blockade of ANGPTL3 lowers TG and HDL-C by rescuing LPL and EL activities, respectively.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a history of serious hypersensitivity reaction to evinacumab-dgnb or to any of the excipients in Evkeeza. Serious hypersensitivity reactions, including anaphylaxis, have occurred.

Limitations of Use:

• The safety and effectiveness of Evkeeza have not been established in patients with other causes of hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).
• 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.

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

Recommended Dosage

• The recommended dose of Evkeeza is 15 mg/kg administered by intravenous (IV) infusion over 60 minutes once monthly (every 4 weeks).
• Assess LDL-C when clinically appropriate. The LDL-lowering effect of Evkeeza may be measured as early as 2 weeks after initiation.

Administration

• Your healthcare provider will give you Evkeeza into your veins through an intravenous (IV) line over 60 minutes.
• Evkeeza should be given every month (4 weeks).
• If you miss any infusion appointments, call your healthcare provider as soon as possible to reschedule.
• Your healthcare provider may slow down your infusion rate, temporarily stop, or permanently stop treatment with Evkeeza if you have certain side effects. See "WHAT ARE THE POSSIBLE SIDE EFFECTS OF Evkeeza?"
• Your healthcare provider may prescribe other cholesterol-lowering medicines, to use with Evkeeza. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 345 mg/2.3 mL (150 mg/mL) and 1,200 mg/8 mL (150 mg/mL) solution in single-dose vials.

This medicine is available in fallowing brand namesː

• Evkeeza

What side effects can this medication cause?

The most common side effects of this medicine include:

• symptoms of the common cold
• flu like symptoms
• dizziness
• pain in legs or arms
• nausea
• decreased energy

Evkeeza can cause serious side effects, including: Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis which may include:

• 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
• itching

What special precautions should I follow?

• This medicine may cause serious hypersensitivity reactions. If a serious hypersensitivity reaction occurs, discontinue Evkeeza, treat according to standard-of-care and monitor until signs and symptoms resolve.
• Evkeeza may cause fetal harm based on animal studies. Advise patients who may become pregnant of the risk to a fetus. Consider obtaining a pregnancy test prior to initiating treatment with Evkeeza. Advise patients who may become pregnant to use contraception during treatment and for at least 5 months following the last dose.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Evkeeza may cause fetal harm when administered to pregnant patients.
• Available human data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Evkeeza as an adjunct to other LDL-C-lowering therapies for the treatment of HoFH have been established in pediatric patients aged 12 years and older.
• The safety and effectiveness of Evkeeza have not been established in pediatric patients with HoFH who are younger than 12 years old.

What should I know about storage and disposal of this medication?

• Store in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F). Store the vial in the original carton to protect from light. Do not freeze. Do not shake.
• Evkeeza does not contain a preservative.
• If not used immediately, store the diluted solution refrigerated at 2 °C to 8 °C (36 °F to 46 °F) for no more than 24 hours from the time of preparation OR at room temperature up to 25 °C (77 °F) for no more than 6 hours from the time of infusion preparation to the end of the infusion.

• Dailymed label info on Evinacumab-dgnb
• FDA Evinacumab-dgnb

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