Evinacumab

Evinacumab is a prescription medication used along with other low-density lipoprotein-C (LDL-C) lowering medicines for homozygous familial hypercholesterolemia (HoFH) in adults and children aged above 5 years of age.

• Evinacumab is available under the following different brand names: Evkeeza, evinacumab-dgnb.

Common side effects of Evinacumab include:

• Symptoms of the common cold
• Flu-like symptoms
• Dizziness
• Pain in legs or arms
• Nausea
• Decreased energy.

Serious side effects of Evinacumab include:

• Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis with symptoms like:
• 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

Rare side effects of Evinacumab include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, solution

• Single-dose vial
  • 345 mg/2.3 mL (150 mg/mL)
  • 1200 mg/8 mL (150 mg/mL)

Hypercholesterolemia

Adult dosage

• 15 mg/kg intravenously once monthly

Pediatric dosage

• Children below 5 years: Safety and efficacy not established.
• Children 5 years and above: 15 mg/kg intravenously once monthly

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Evinacumab has no noted severe interactions with any other drugs.
• Evinacumab has no noted serious interactions with any other drugs.
• Evinacumab has no noted moderate interactions with any other drugs.
• Evinacumab has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of serious hypersensitivity to the drug or any of its excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Evinacumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Evinacumab?”

Cautions

• Serious hypersensitivity reactions, including anaphylaxis, are reported; if a serious reaction occurs, discontinue the infusion, and treat according to the standard of care.
• May cause fetal harm based on animal reproduction studies.

Pregnancy and Lactation

• Based on animal studies, may cause fetal harm
• Consider pregnancy testing in females who may become pregnant before starting treatment.
• Available human data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• Evinacumab is a human IgG4 monoclonal antibody, and human IgG is known to cross the placental barrier; therefore, evinacumab may potentially transmit from the mother to the developing fetus.
• Advise pregnant females of potential fetal risk.
• If the patient becomes pregnant during treatment, report exposure by calling 1-833-385-3392
• Contraception
  • Females of reproductive potential should use effective contraception during treatment and for at least 5 months following the last dose.
• Lactation
  • Data are unavailable regarding the presence of human milk or animal milk, effects on breastfed infants, or effects on milk production.
  • Maternal IgG is known to be present in human milk; the effects of local gastrointestinal exposure and limited systemic exposure in breastfed infants are unknown.