Evkeeza
Generic name: evinacumab-dgnb
Dosage form: injection, for intravenous use
Drug class: Miscellaneous antihyperlipidemic agents
Medically reviewed by A Ras MD.
What is Evkeeza?
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.
Description
Evinacumab-dgnb is an angiopoietin-like protein 3 (ANGPTL3) inhibitor monoclonal antibody (IgG4 isotype) produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. Evinacumab-dgnb has an approximate molecular weight of 146 kDa.
EVKEEZA (evinacumab-dgnb) injection is a sterile, preservative-free solution for intravenous use. The solution is clear to slightly opalescent, colorless to pale-yellow, and free from visible particles.
Each vial contains 345 mg/2.3 mL or 1,200 mg/8 mL. Each mL contains 150 mg of evinacumab-dgnb, and L-arginine hydrochloride (14.8 mg), L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.1 mg), L-proline (30 mg), polysorbate 80 (1 mg) and Water for Injection, USP. The pH is 6.
Mechanism of Action
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, respective
Who should not use Evkeeza?
Do not use Evkeeza if you are allergic to evinacumab-dgnb or to any of the ingredients in Evkeeza. See the end of this guide for a complete list of ingredients in Evkeeza.
What should I tell my healthcare provider before using 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 of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use Evkeeza?
- 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 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 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
- itching
The most common side effects of Evkeeza include:
- symptoms of the common cold
- flu like symptoms
- dizziness
- pain in legs or arms
- nausea
- decreased energy
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of 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.
General information about the safe and effective use of Evkeeza
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information about Evkeeza, talk with your healthcare provider. You can ask your healthcare provider for information about Evkeeza that is written for health professionals.
What are the ingredients in Evkeeza?
Active ingredient: evinacumab-dgnb
Inactive ingredients: L-arginine hydrochloride, L-histidine, L-histidine monohydrochloride monohydrate, L-proline, polysorbate 80, and Water for Injection, USP.
Label
PRINCIPAL DISPLAY PANEL – 345 MG/2.3 ML VIAL CARTON
- NDC 61755-013-01
Rx only - Evkeeza™
(evinacumab-dgnb)
Injection - 345 mg/2.3 mL (150 mg/mL)
- For Intravenous Infusion after Dilution
Single-Dose Vial – Discard Unused Portion - Must dilute before use.
- Do not use vial if seal is broken or missing.
- Do not use after expiration.
- Store in the original carton
to protect from light.
PRINCIPAL DISPLAY PANEL – 1200 MG/8 ML VIAL CARTON
- NDC 61755-010-01
Rx only - Evkeeza™
(evinacumab-dgnb)
Injection - 1200 mg/8 mL (150 mg/mL)
- For Intravenous Infusion after Dilution
Single-Dose Vial – Discard Unused Portion - Must dilute before use.
- Do not use vial if seal is broken or missing.
- Do not use after expiration.
- Store in the original carton
to protect from light.
SRC: NLM .