Evolocumab is an FDA approved medicine designed to treat high LDL (low-density lipoprotein) cholesterol levels. 

It is a monoclonal antibody that binds to PCSK9 protein which decreases LDL cholesterol levels. Having a lower LDL cholesterol level reduces your risk of strokes and heart disease.

Evolocumib is given as an injection under the skin, that you can have at home, either every 2 weeks or once a month.

What is evolocumab used for?

Evolocumab is an injectable prescription medicine used:

• in adults with cardiovascular disease to reduce the risk of heart attack, stroke, and certain types of heart surgery.
• along with diet alone or together with other cholesterol-lowering medicines in adults with high blood cholesterol levels called primary hyperlipidemia (including a type of high cholesterol called heterozygous familial hypercholesterolemia [HeFH]) to reduce low density lipoprotein (LDL) or bad cholesterol.
• along with diet and other LDL-lowering medicines in children aged 10 years and older with HeFH to reduce LDL cholesterol.
• along with other LDL-lowering medicines in adults and children aged 10 years and older with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH), to reduce LDL cholesterol.

It is not known if evolocumab is safe and effective in children with HeFH or HoFH who are younger than 10 years of age or in children with other types of hyperlipidemia.

You should only give yourself or someone else the injection if you have received full training from your healthcare provider on how to administer it.

Evolocumab can be given as a subcutaneous injection (injection under the skin) using:

• single-dose prefilled autoinjector
• single-dose prefilled syringe
• or single-dose on-body infusor with prefilled cartridge.

It takes up to 15 seconds to administer evolocumab using the single-dose prefilled autoinjector or single-dose prefilled syringe.  If you are using the single-dose on-body infusor with a prefilled cartridge it will take 5 minutes to administer.

Full patient instructions with diagrams are available at Patient Counseling Information.

Evolocumab is given as an injection under the skin (subcutaneously).

In adults with established CVD or with primary hyperlipidemia:

• the usual dose is either 140 mg every 2 weeks
• or 420 mg once a month.
• If you are changing your dose regimen, you should have the first dose of the new regimen, on the date that your next scheduled dose was to be given. 

In pediatric patients aged 10 years and older with HeFH:

• the usual dose is either 140 mg every 2 weeks
• or 420 mg once a month.
• If you are changing your dose regimen, you should have the first dose of the new regimen, on the date that your next scheduled dose was to be given.

In adults and pediatric patients aged 10 years and older with HoFH:

• the usual recommended dose is 420 mg once monthly given subcutaneously
• the dose can be increased to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks. 
• Patients on lipid apheresis may initiate treatment with 420 mg every 2 weeks to correspond with their apheresis schedule. Evolocumab should be given after the apheresis session is complete.

Evolocumab comes as a single-dose (1 time) prefilled autoinjector (SureClick® autoinjector), as a single-dose prefilled syringe or as a single-dose Pushtronex® system (on-body infusor with prefilled cartridge). Your healthcare provider will prescribe the type and dose that is best for you or your child.

• If your healthcare provider prescribes you or your child the 420 mg dose, you or your child may use:
  • a single-dose on-body infusor with prefilled cartridge to give the injection over 5 minutes, or
  • 3 separate injections in a row, using a different single-dose prefilled syringe or single-dose prefilled autoinjector for each injection. Give all of these injections within 30 minutes.
• If your healthcare provider decides that you or your child or a caregiver can give evolocumab, you or your child or your caregiver should receive training on the right way to prepare and inject evolocumab. Do not try to inject evolocumab until you or your child have been shown the right way by your healthcare provider or nurse.
  • If you or your child are using the prefilled autoinjector, put the yellow safety guard (needle inside) of the SureClick® autoinjector on the skin before injecting.
• You or your child can inject into the thigh, upper arm, or stomach (abdomen), except for a two-inch area around the belly button.
• Do not choose an area where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.
• Always check the label of your single-dose prefilled autoinjector, single-dose prefilled syringe, or single-dose on-body infusor with prefilled cartridge to make sure you have the correct medicine and the correct dose of evolocumab before each injection.
• If you or your child forget to use evolocumab or are not able to take the dose at the regular time, inject your or your child's missed dose as soon as you remember, as long as it is within 7 days of the missed dose.
  • If it is more than 7 days from the missed dose and you or your child are using the every-2-week dose, inject the next dose based on the original schedule. This will put you or your child back on the original schedule.
  • If it is more than 7 days from the missed dose and you or your child are using the 1 time each-month dose, inject the dose and start a new schedule using this date.

If you or your child are not sure when to take evolocumab after a missed dose, ask your healthcare provider or pharmacist.

If your healthcare provider has prescribed evolocumab along with other cholesterol-lowering medicines for you or your child, follow instructions from your healthcare provider. Read the patient information for those medicines.

If you or your child use more evolocumab than you should, talk to your healthcare provider or pharmacist.

Do not stop using evolocumab without talking with your healthcare provider. If you or your child stop using evolocumab, the cholesterol levels can increase.

Do not use evolocumab if you or your child are allergic to it or to any of the ingredients in evolocumab. See the end of this page for a complete list of ingredients in evolocumab.

What should I tell my doctor before taking evolocumab ?

Before you or your child start using evolocumab, tell your healthcare provider about all your medical conditions, including if you or your child:

• are allergic to rubber or latex. The needle covers on the single-dose prefilled syringes and within the needle caps on the single-dose prefilled SureClick® autoinjectors contain dry natural rubber. The single-dose Pushtronex system (on-body infusor with prefilled cartridge) is not made with natural rubber latex.
• are pregnant or plan to become pregnant. It is not known if evolocumab will harm your unborn baby. See below for more information about evolocumab and pregnancy. Tell your healthcare provider if you become pregnant while taking evolocumab.
• are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take evolocumab or breastfeed. See below for more information on evolocumab and breastfeeding.

Do not inject evolocumab into skin that is bruised, sore, scarred, or hardened. 

 Evolocumab can cause serious side effects including:

• Serious Allergic Reactions. Some people taking evolocumab have had serious allergic reactions. Stop taking evolocumab and call your healthcare provider or seek emergency medical help right away if you or your child have any of these symptoms:
  • trouble breathing or swallowing
  • raised bumps (hives)
  • rash, or itching
  • swelling of the face, lips, tongue, throat or arms

The most common side effects of evolocumab include: 

• runny nose,
• sore throat,
• symptoms of the common cold,
• flu or flu-like symptoms,
• back pain,
• high blood sugar levels (diabetes) and
• redness, pain, or bruising at the injection site.

Tell your healthcare provider if you or your child have any side effect that bothers you or that does not go away.

These are not all the possible side effects of evolocumab. Ask your healthcare provider or pharmacist for more information.

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

Other drugs may interact with evolocumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.