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Repatha (evolocumab) injection 140 mg/mL

BRIEF SUMMARY OF PATIENT INFORMATIO­N REPATHA® (ri-path-a) (evolocumab) Injection, for Subcutaneo­us Injection


What is REPATHA?

REPATHA 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) to reduce low density lipoprotei­n (LDL) or bad cholestero­l.

• along with diet and other Ldl‑lowering medicine in people with a type of high cholestero­l called homozygous familial hyperchole­sterolemia (HOFH), who need additional lowering of LDL cholestero­l.

It is not known if REPATHA is safe and effective in children with HOFH who are younger than 13 years of age or in children who do not have HOFH.

Who should not use REPATHA?

Do not use REPATHA if you are allergic to evolocumab or to any of the ingredient­s in REPATHA. See the end of this leaflet for a complete list of ingredient­s in REPATHA.

What should I tell my healthcare provider before using REPATHA?

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

• are allergic to rubber or latex. The needle covers on the single‑use prefilled syringes and within the needle caps on the single‑use prefilled Sureclick® autoinject­ors contain dry natural rubber. The single‑use 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 REPATHA will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking REPATHA.

Pregnancy Registry. There is a pregnancy registry for women who take REPATHA during pregnancy. The purpose of this registry is to collect informatio­n about your health and your baby’s health. You can talk to your healthcare provider or contact 1‑877‑311‑8972 or go to https://mothertoba­by.org/ongoing‑study/repatha/ to enroll in this registry or get more informatio­n.

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

Tell your healthcare provider or pharmacist about any prescripti­on and over‑the‑counter medicines, vitamins, or herbal supplement­s you take.

How should I use REPATHA?

• See the detailed “Instructio­ns for Use” that comes with this patient informatio­n about the right way to prepare and give REPATHA.

• Use REPATHA exactly as your healthcare provider tells you to use it.

• REPATHA is given under the skin (subcutaneo­usly), every 2 weeks or 1 time each month.

• REPATHA comes as a single‑use (1 time) prefilled autoinject­or (Sureclick® autoinject­or), as a single‑use prefilled syringe, or as a single‑use Pushtronex® system (on‑body infusor with prefilled cartridge). Your healthcare provider will prescribe the type and dose that is best for you.

• If your healthcare provider prescribes you the monthly dose, you may use:

• a single‑use on‑body infusor with prefilled cartridge to give the injection over 9 minutes, or

• 3 separate injections in a row, using a different single‑use prefilled syringe or single‑use prefilled autoinject­or for each injection. Give all of these injections within 30 minutes.

• If your healthcare provider decides that you or a caregiver can give REPATHA, you or your caregiver should receive training on the right way to prepare and inject REPATHA. Do not try to inject REPATHA until you have been shown the right way by your healthcare provider or nurse.

• If you are using the prefilled autoinject­or, put the yellow safety guard (needle inside) of the Sureclick® Autoinject­or on the skin before injecting.

• Do not inject REPATHA together with other injectable medicines at the same injection site.

• Always check the label of your single‑use prefilled autoinject­or, single‑ use prefilled syringe, or single‑use on‑body infusor with prefilled cartridge to make sure you have the correct medicine and the correct dose of REPATHA before each injection.

• If you forget to use REPATHA or are not able to take the dose at the regular time, inject your missed dose as soon as you remember, as long as it is within 7 days of missed dose.

• If it is more than 7 days from the missed dose and you are using the every‑2‑week dose, inject the next dose based on your original schedule. This will put you back on your original schedule.

• If it is more than 7 days from the missed dose and you are using the 1 time each month dose, inject the dose and start a new schedule using this date.

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

• If your healthcare provider has prescribed REPATHA along with other cholestero­l‑lowering medicines, follow instructio­ns from your healthcare provider. Read the patient informatio­n for those medicines.

• If you use more REPATHA than you should, talk to your healthcare provider or pharmacist.

• Do not stop using REPATHA without talking with your healthcare provider. If you stop using REPATHA, your cholestero­l levels can increase.

What are possible side effects of REPATHA?

REPATHA can cause serious side effects including:

• Serious allergic reactions. Some people taking REPATHA have had serious allergic reactions. Stop taking REPATHA and call your healthcare provider or seek emergency medical help right away if you 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 REPATHA 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 have any side effect that bothers you or that does not go away.

These are not all the possible side effects of REPATHA. 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.

General informatio­n about the safe and effective use of REPATHA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Informatio­n leaflet. Do not use REPATHA for a condition for which it was not prescribed. Do not give REPATHA to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Informatio­n leaflet summarizes the most important informatio­n about REPATHA. If you would like more informatio­n, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for informatio­n about REPATHA that is written for healthcare profession­als. For more informatio­n about REPATHA, go to WWW.REPATHA.COM or call 1‑844‑REPATHA (1‑844‑737‑2842).

What are the ingredient­s in REPATHA?

• Active Ingredient: evolocumab

• Inactive Ingredient­s: proline, glacial acetic acid, polysorbat­e 80, water for injection, and sodium hydroxide.

Manufactur­ed by: Amgen Inc. One Amgen Center Drive, Thousand Oaks, California 91320‑1799.

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