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

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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. try to in­ject REPATHA un­til you have been shown the right way by your health­care provider or nurse.

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

• Al­ways check the la­bel of your sin­gle-use pre­filled au­toin­jec­tor, sin­gleuse 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:

• al­ler­gic re­ac­tions. REPATHA may cause al­ler­gic re­ac­tions that can be se­ri­ous. Call your health­care provider or go to the near­est hos­pi­tal emer­gency room right away if you have any symp­toms of an al­ler­gic re­ac­tion in­clud­ing a se­vere rash, red­ness, se­vere itch­ing, a swollen face, or trou­ble breath­ing.

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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