Evolocumab

Generic name: Evolocumab
Brand names: Repatha
Drug class: PCSK9 inhibitors

Usage of Evolocumab

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.

Evolocumab side effects

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.

Before taking Evolocumab

Pregnancy:

If you are pregnant or plan to become pregnant it is not known if evolocumab will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking evolocumab.

Breastfeeding:

If you are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take evolocumab or breastfeed.

If you or your child are pregnant or breastfeed during evolocumab treatment, you are encouraged to call Amgen at 1-800-772-6436 (1-800-77-AMGEN) or visit https://wwwext.amgen.com/products/global-patient-safety/adverse-event-reporting to share information about the health of you and your baby or your child and your child's baby.

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How to use Evolocumab

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.

What other drugs will affect Evolocumab

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.

Disclaimer

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