Evolocumab

Evolocumab is a prescription medication used to reduce the risk of myocardial infarction, stroke, coronary revascularization, and to treat primary hyperlipidemia and homozygous familial hypercholesterolemia.

• Evolocumab is available under the following different brand names: Repatha.  

Adult and pediatric dosage

Solution for SC injection

• 140mg/mL single-use prefilled syringe or single-use SureClick autoinjector
• 420mg/3.5mL single-use Pushtronex system (on-body infuser with prefilled cartridge)

Prevention of Cardiovascular Events

Adult dosage

• 140 mg SC every 2 weeks or 420 mg SC once per month, based on patient preference for dosing frequency and injection volume.

Primary Hyperlipidemia

Adult dosage

• 140 mg SC every 2 weeks or 420 mg SC once monthly

Homozygous Familial Hypercholesterolemia

Adult dosage

• 420 mg SC one monthly
• May increase to 420 mg every 2 weeks if a clinically meaningful response not achieved in 12 weeks

Pediatric dosage

• Children younger than 10 years of age: Safely and efficacy not established
• Children 10-17 years of age:
• Initial: 420 mg SC once monthly
• May increase to 420 mg every 2 weeks if a clinically meaningful response not achieved in 12 weeks

Heterozygous Familial Hypercholesterolemia

Pediatric dosage

• Children younger than 10 years of age: Safely and efficacy not established
• Children 10-17 years of age:
• 140 mg SC every 2 weeks or 420 mg SC once monthly

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Evolocumab include:

• runny or stuffy nose, 
• upper respiratory tract infection, 
• influenza, 
• back pain, 
• injection site reactions (redness, pain and bruising), 
• allergic reactions (rash and hives), 
• cough, 
• urinary tract infection, 
• sinus infection, 
• headache, 
• muscle pain, 
• dizziness, 
• high blood pressure, 
• diarrhea, and
• stomach upset

Serious side effects of Evolocumab include:

• rash, 
• hives, 
• swelling of the face, lips, tongue, or throat, 
• difficulty breathing, and
• swelling under the skin

Rare side effects of Evolocumab include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result 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.

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.

No Clinically significant drug interactions are known for Evolocumab.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• History of serious hypersensitivity to Evolocumab or any excipients 

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Hypersensitivity
  • Hypersensitivity reactions (eg, angioedema) reported, including some that led to discontinuation of therapy
  • If signs or symptoms of serious allergic reactions occur, discontinue treatment, treat accordingly and monitor until signs and symptoms resolve
  • Needle cover of glass single-dose prefilled syringe and single-dose prefilled autoinjector contain dry natural rubber (latex derivative) which may cause an allergic reaction in individuals sensitive to latex

Pregnancy and Lactation

• No available data on use in pregnant women
• Monoclonal antibodies in humans indicate that they are unlikely to cross the placenta in the first trimester; however, they are likely to cross the placenta in increasing amounts in the second and third trimesters
• There is a pregnancy safety study for REPATHA; if administered during pregnancy, healthcare providers should report exposure by contacting Amgen at 1-800-77-AMGEN (1-800-772-6436) or https://wwwext.amgen.com/products/global-patient-safety/adverse-event-reporting
• Unknown if distributed in human breast milk
• The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant
• Human IgG is present in human milk, but published data suggest that breastmilk IgG antibodies do not enter the neonatal and infant circulation in substantial amounts