Learn about the different options to take Repatha®

Repatha® is the first and only PCSK9 inhibitor that offers you an every 2 week and single monthly injection option. Talk to your doctor to determine which choice is right for you.

SureClick®Autoinjector

single-use prefilled autoinjector*

Every 2 Weeks

Read the full video transcript

Music up and under
AVO: This short video provides a high level overview of the Repatha® SureClick® autoinjector.
It is not intended for use as an instructional video. Prior to using the SureClick® autoinjector, read the entire patient Instructions for Use, which are provided in the product box.

SureClick® image [Fades up/and goes soft focus]
This video shows you how to inject Repatha with a single-use prefilled SureClick® Autoinjector; we will call it the Repatha SureClick® for the rest of this video.
LOGO: Repatha (evolocumab) injection 140 mg/mL [Fades up/out]
On-screen text: Using your single-use prefilled SureClick® Autoinjector [Fades up/out]
On-screen text: [Fades up/out] The following information is intended for use only by residents of the United States.

We’re going to briefly review each of the injection steps: prepare, get ready, inject, and finish. For complete injection and storage information, please see the Instructions for Use, available on this website.
On-screen text: Steps for injecting Repatha 1. Prepare 2. Get ready 3. Inject 4. Finish
On-screen text: For complete information, see the Instructions for Use.

Before we begin, it’s important that you do not inject yourself unless your healthcare provider has shown you how. If someone else is giving you the injection, he or she should also be trained first. If you’re still not sure how to use the Repatha SureClick®, contact your doctor, or call RepathaReady at 1-844-REPATHA.
Okay, let’s get started.
On-screen text: RepathaReady Personalized support services for patients & providers Questions? Call RepathaReady at 1-844-REPATHA

First, it’s important to store Repatha the right way. That means keeping it refrigerated in its original box. Don’t freeze or shake it. And remember to keep Repatha out of children’s reach like you would with any medicine.
On-screen text: Actor portrayal [Supers fade up/out after Step 1. Check (Prepare)]
On-screen text: Step 1. Prepare
On-screen text: Keep Repatha in the original carton in the refrigerator to protect it from light during storage. [Each fades up/out]
On-screen text: Do not freeze or shake it.
On-screen text: Keep Repatha out of children’s reach.

For a more comfortable injection, take one SureClick® out of the box from the refrigerator at least 30 minutes before injecting. Let it reach room temperature naturally. It may take longer to inject if Repatha is cold.
On-screen text: If removed from the refrigerator, Repatha can be kept in the original box at room temperature (68°F to 77°F) for up to 30 days.
On-screen text: Take 1 SureClick® out of the refrigerator at least 30 minutes before injecting. It may take longer to inject if Repatha is cold.

Clock reads 8:30 am
Leave any unused SureClicks in the box in the refrigerator.
On-screen text: Take one SureClick® out of the refrigerator at least 30 minutes before injecting. It may take longer to inject if Repatha is cold.

While you’re waiting, you can spend the time catching up on the things you want to do...
Wide shot of woman checking her mobile
On-screen text: Do not try to warm SureClick® by using a heat source such as hot water or microwave. Keep it out of direct sunlight.

…and giving your Repatha SureClick® the “once-over” before using it.
Close-up of woman checking SureClick®
On-screen text: Do not remove the orange cap yet.

Check the expiration date. You don’t want to use an expired SureClick®.

Look for any cracks. Check that the orange cap is in place, securely attached.
Woman checking for cracks and checking the orange cap
REVISED SUPER: The orange cap has a needle cover inside that contains dry natural rubber made from latex. Tell your healthcare provider if you are allergic to latex. [Super fades up/out]

Never use a SureClick® that’s cracked, missing the orange cap, or was dropped onto a hard surface.
Close-up of woman checking for cracks and checking the orange cap
On-screen text: Do not use a SureClick® if: [Each of the below supers fades up/out]

  • It is expired, cracked, or has been dropped onto a hard surface.
  • The orange cap is missing or not securely attached.

Next, look at the medicine in the SureClick® window. It should be clear and colorless. But it’s okay if the medicine is slightly yellow.
If you have any questions about using your Repatha SureClick®, call your doctor, pharmacy, or 1-844-REPATHA. Close-up of woman checking the medication window
On-screen text: Do not use if the medicine is cloudy or discolored or contains particles.
On-screen text: In all cases, use a new SureClick® and call 1-844-REPATHA. [Fades up/out]

Clock reads 9:00 am
Okay, your SureClick® looks good, and it’s been 30 minutes since you took it out of the refrigerator. Now, it’s time to get ready for your injection.

Wide shot of supplies already on the table
Make sure you’ve washed your hands. Next, choose a comfortable spot with plenty of light. Gather all of your injection supplies.
On-screen text: Injection supplies: New autoinjector, alcohol wipes, cotton ball or gauze pad, adhesive bandage, and a puncture-resistant sharps container [Holds on screen]

Close up of SureClick® and alcohol wipes
Place them on a clean, flat work surface.
On-screen text: Injection supplies: New autoinjector, alcohol wipes, cotton ball or gauze
pad, adhesive bandage, and a puncture-resistant sharps container
[Holds on screen]

Now, choose where you want to inject. You can use your thigh. Or, your stomach, except for the 2 inches around the belly button. If someone else is giving you the injection, he or she can also use the outer area of your upper arm.
Body icon fades in/stays with each area highlighted when mentioned
On-screen text: Thigh, Stomach, Upper Arm (only if someone else is giving you the injection)
Choose a different site each time you give yourself an injection. If you do need to use the same injection site, just make sure it’s not in the same spot on that site you used last time. And always avoid areas where the skin is bruised or hard.
On-screen text: Do not inject into areas where the skin is tender, bruised, red, or hard.

We’re going to show you how to inject in your thigh.
If you want to see how to inject in other areas, check out the Instructions for Use on this website. [Medium-wide shot of woman sitting at table, pulling up her skirt to expose more of her thigh as she cleans it with the alcohol wipe]
Alright. First, clean the injection site with an alcohol wipe. Let it dry. And don’t touch this area again until you’re ready to inject.
On-screen text: Would you rather use your stomach or upper arm for your injection site? Read the Instructions for Use or call RepathaReady at 1-844-REPATHA.

Next, pull the orange cap straight off, like this. If you see a drop of liquid at the end of the needle or yellow safety guard, that’s okay. Close-up of autoinjector
On-screen text: Step 2. Get ready
On-screen text: Do not twist or bend the orange cap or put it back on SureClick®.
Do not put your fingers into the yellow safety guard. [Fades up/out after Step 2. Get ready]

Next, stretch the skin on your thigh to create a firm surface.
Like this.
It’s important to keep a firm surface throughout the injection.
Close-up of woman stretching the skin on her thigh
On-screen text: Stretch your injection site to create a firm surface.

Hold the stretched or pinched skin. With the orange cap off, place the yellow end of the autoinjector on the skin at 90 degrees. Do not touch the gray start button yet. Be sure you can see the medication window. Push the SureClick® down firmly onto your skin until it stops moving. Medium shot of woman holding autoinjector straight up and down on her thigh
On-screen text: Step 3. Inject

When you’re ready to inject, press the gray start button. You will hear a click. That means your injection has started. [SFX: audio click; volume will be loud enough for viewers to hear]
Close-up of autoinjector in the unlocked position and woman’s hand pressing the start button; clock graphic on screen
On-screen text: Do not push the gray start button until you’re ready to inject.

Keep pushing the SureClick® down on your skin for about 15 seconds. That’s how long it could take for your injection to be done.
Close-up of woman holding autoinjector straight up and down on her thigh of time as medicine window starts to turn yellow
On-screen text: Keep pushing the SureClick® down on your skin for about 15 seconds.

If you’re not sure that your injection is finished, check the Repatha SureClick® window. It will turn yellow when the injection’s done. You may also hear a second click.
Close-up of yellow medicine window
On-screen text: Don’t see yellow in the window? Looks like the medicine is still injecting? Contact your healthcare provider or call RepathaReady at 1-844-REPATHA right away.

Lift the used SureClick® from your skin. The safety guard will automatically cover the needle. That’s it. You’re done injecting!
Medium-wide shot of woman lifting autoinjector off her thigh

Always put the used Repatha SureClick® and orange cap into a puncture-resistant container. You never want to put the used SureClick® into the trash or recycle bin.
Woman puts used autoinjector into sharps container on shelf
On-screen text: Step 4. Finish
On-screen text: Do not reuse or recycle a used SureClick® or sharps disposal
container. Do not throw them into the household trash. [Fades up after Step 4: Finish and holds on screen]

Once you’ve properly disposed of your SureClick®, check your injection site. If you have a little bleeding, press a cotton ball or gauze on the injection site. Just be careful not to rub it. You can put a bandage on it if you need to.
Medium-wide shot of woman holding cotton ball over injection site
On-screen text: Do not rub the injection site.

One last thing to keep in mind. If you need FDA-cleared disposal containers, you can get them from your local pharmacy. Puncture-resistant disposal containers with mail-back service are also available, free of charge, from RepathaReady. Just call 1-844-REPATHA.
Wherever you get your puncture-resistant disposal containers, be sure to keep them out of children’s reach.
Sharps container sits on cabinet shelf
On-screen text: For free disposal containers with mail-back service, call 1-844-REPATHA.
On-screen text: Keep disposal containers out of children’s reach. [Each fades up/out]

It’s also important to get rid of your full disposal container the right way. Local and state laws may require you to follow certain rules.
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
Do not recycle your used sharps disposal container.
For more information about proper needle disposal in your area, contact your local health department or your local trash removal service. Or, check out the FDA’s website listed on screen.
Woman replaces full sharps container with a new container
On-screen text: Visit www.fda.gov/safesharpsdisposal to learn how to get rid of full disposal containers.

You’re all done! Remember, if you have any questions about injecting, read the Instructions for Use. Or, contact your doctor, nurse, or pharmacist. Or, call the nurses at RepathaReady at 1-844-REPATHA.
On-screen text: Questions? Call RepathaReady at 1-844-REPATHA

Important Safety Information and Approved Use scrolls
What is Repatha?
Repatha is an injectable prescription medicine called a PCSK9 inhibitor. REPATHA is used

  • Along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart or blood vessel problems, who need additional lowering of LDL cholesterol.
  • Along with diet and other LDL lowering therapies in people with homozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL), who need additional lowering of LDL cholesterol.

The effect of Repatha on heart problems such as heart attacks, stroke, or death is not known.

It is not known if Repatha is safe and effective in children with homozygous familial hypercholesterolemia (HoFH) who are younger than 13 years of age or in children who do not have HoFH.

IMPORTANT SAFETY INFORMATION

Do not use Repatha if you are allergic to evolocumab or to any of the ingredients in Repatha.

Before you start using Repatha, tell your healthcare provider about all your medical conditions, including allergies, and if you are allergic to rubber or latex, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.

What are the possible side effects of Repatha?
Repatha may cause allergic reactions. 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, 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 are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information.

LOGO: Repatha (evolocumab) injection 140 mg/mL logo
LOGO: AMGEN CARDIOVASCULAR
On-screen text /CODELINE: ©2016 Amgen Inc., Thousand Oaks, CA 91320. All rights reserved. USA-145-106213(3)

Download the SureClick® Autoinjector Instructions for Use.

15 seconds

Self-injected with hand-held device

Audible click when you start and finish your dose

No need for syringes or vials

Hidden needle

Can inject into your stomach or thigh

*140 mg/mL
420 mg/3.5 mL
Injection under the skin

Dosing Time & Schedule

Every 2 Weeks

Watch Sureclick® demonstration video

Read the full video transcript

Music up and under
AVO: This short video provides a high level overview of the Repatha® SureClick® autoinjector.
It is not intended for use as an instructional video. Prior to using the SureClick® autoinjector, read the entire patient Instructions for Use, which are provided in the product box.

SureClick® image [Fades up/and goes soft focus]
This video shows you how to inject Repatha with a single-use prefilled SureClick® Autoinjector; we will call it the Repatha SureClick® for the rest of this video.
LOGO: Repatha (evolocumab) injection 140 mg/mL [Fades up/out]
On-screen text: Using your single-use prefilled SureClick® Autoinjector [Fades up/out]
On-screen text: [Fades up/out] The following information is intended for use only by residents of the United States.

We’re going to briefly review each of the injection steps: prepare, get ready, inject, and finish. For complete injection and storage information, please see the Instructions for Use, available on this website.
On-screen text: Steps for injecting Repatha 1. Prepare 2. Get ready 3. Inject 4. Finish
On-screen text: For complete information, see the Instructions for Use.

Before we begin, it’s important that you do not inject yourself unless your healthcare provider has shown you how. If someone else is giving you the injection, he or she should also be trained first. If you’re still not sure how to use the Repatha SureClick®, contact your doctor, or call RepathaReady at 1-844-REPATHA.
Okay, let’s get started.
On-screen text: RepathaReady Personalized support services for patients & providers Questions? Call RepathaReady at 1-844-REPATHA

First, it’s important to store Repatha the right way. That means keeping it refrigerated in its original box. Don’t freeze or shake it. And remember to keep Repatha out of children’s reach like you would with any medicine.
On-screen text: Actor portrayal [Supers fade up/out after Step 1. Check (Prepare)]
On-screen text: Step 1. Prepare
On-screen text: Keep Repatha in the original carton in the refrigerator to protect it from light during storage. [Each fades up/out]
On-screen text: Do not freeze or shake it.
On-screen text: Keep Repatha out of children’s reach.

For a more comfortable injection, take one SureClick® out of the box from the refrigerator at least 30 minutes before injecting. Let it reach room temperature naturally. It may take longer to inject if Repatha is cold.
On-screen text: If removed from the refrigerator, Repatha can be kept in the original box at room temperature (68°F to 77°F) for up to 30 days.
On-screen text: Take 1 SureClick® out of the refrigerator at least 30 minutes before injecting. It may take longer to inject if Repatha is cold.

Clock reads 8:30 am
Leave any unused SureClicks in the box in the refrigerator.
On-screen text: Take one SureClick® out of the refrigerator at least 30 minutes before injecting. It may take longer to inject if Repatha is cold.

While you’re waiting, you can spend the time catching up on the things you want to do...
Wide shot of woman checking her mobile
On-screen text: Do not try to warm SureClick® by using a heat source such as hot water or microwave. Keep it out of direct sunlight.

…and giving your Repatha SureClick® the “once-over” before using it.
Close-up of woman checking SureClick®
On-screen text: Do not remove the orange cap yet.

Check the expiration date. You don’t want to use an expired SureClick®.

Look for any cracks. Check that the orange cap is in place, securely attached.
Woman checking for cracks and checking the orange cap
REVISED SUPER: The orange cap has a needle cover inside that contains dry natural rubber made from latex. Tell your healthcare provider if you are allergic to latex. [Super fades up/out]

Never use a SureClick® that’s cracked, missing the orange cap, or was dropped onto a hard surface.
Close-up of woman checking for cracks and checking the orange cap
On-screen text: Do not use a SureClick® if: [Each of the below supers fades up/out]

  • It is expired, cracked, or has been dropped onto a hard surface.
  • The orange cap is missing or not securely attached.

Next, look at the medicine in the SureClick® window. It should be clear and colorless. But it’s okay if the medicine is slightly yellow.
If you have any questions about using your Repatha SureClick®, call your doctor, pharmacy, or 1-844-REPATHA. Close-up of woman checking the medication window
On-screen text: Do not use if the medicine is cloudy or discolored or contains particles.
On-screen text: In all cases, use a new SureClick® and call 1-844-REPATHA. [Fades up/out]

Clock reads 9:00 am
Okay, your SureClick® looks good, and it’s been 30 minutes since you took it out of the refrigerator. Now, it’s time to get ready for your injection.

Wide shot of supplies already on the table
Make sure you’ve washed your hands. Next, choose a comfortable spot with plenty of light. Gather all of your injection supplies.
On-screen text: Injection supplies: New autoinjector, alcohol wipes, cotton ball or gauze pad, adhesive bandage, and a puncture-resistant sharps container [Holds on screen]

Close up of SureClick® and alcohol wipes
Place them on a clean, flat work surface.
On-screen text: Injection supplies: New autoinjector, alcohol wipes, cotton ball or gauze
pad, adhesive bandage, and a puncture-resistant sharps container
[Holds on screen]

Now, choose where you want to inject. You can use your thigh. Or, your stomach, except for the 2 inches around the belly button. If someone else is giving you the injection, he or she can also use the outer area of your upper arm.
Body icon fades in/stays with each area highlighted when mentioned
On-screen text: Thigh, Stomach, Upper Arm (only if someone else is giving you the injection)
Choose a different site each time you give yourself an injection. If you do need to use the same injection site, just make sure it’s not in the same spot on that site you used last time. And always avoid areas where the skin is bruised or hard.
On-screen text: Do not inject into areas where the skin is tender, bruised, red, or hard.

We’re going to show you how to inject in your thigh.
If you want to see how to inject in other areas, check out the Instructions for Use on this website. [Medium-wide shot of woman sitting at table, pulling up her skirt to expose more of her thigh as she cleans it with the alcohol wipe]
Alright. First, clean the injection site with an alcohol wipe. Let it dry. And don’t touch this area again until you’re ready to inject.
On-screen text: Would you rather use your stomach or upper arm for your injection site? Read the Instructions for Use or call RepathaReady at 1-844-REPATHA.

Next, pull the orange cap straight off, like this. If you see a drop of liquid at the end of the needle or yellow safety guard, that’s okay. Close-up of autoinjector
On-screen text: Step 2. Get ready
On-screen text: Do not twist or bend the orange cap or put it back on SureClick®.
Do not put your fingers into the yellow safety guard. [Fades up/out after Step 2. Get ready]

Next, stretch the skin on your thigh to create a firm surface.
Like this.
It’s important to keep a firm surface throughout the injection.
Close-up of woman stretching the skin on her thigh
On-screen text: Stretch your injection site to create a firm surface.

Hold the stretched or pinched skin. With the orange cap off, place the yellow end of the autoinjector on the skin at 90 degrees. Do not touch the gray start button yet. Be sure you can see the medication window. Push the SureClick® down firmly onto your skin until it stops moving. Medium shot of woman holding autoinjector straight up and down on her thigh
On-screen text: Step 3. Inject

When you’re ready to inject, press the gray start button. You will hear a click. That means your injection has started. [SFX: audio click; volume will be loud enough for viewers to hear]
Close-up of autoinjector in the unlocked position and woman’s hand pressing the start button; clock graphic on screen
On-screen text: Do not push the gray start button until you’re ready to inject.

Keep pushing the SureClick® down on your skin for about 15 seconds. That’s how long it could take for your injection to be done.
Close-up of woman holding autoinjector straight up and down on her thigh of time as medicine window starts to turn yellow
On-screen text: Keep pushing the SureClick® down on your skin for about 15 seconds.

If you’re not sure that your injection is finished, check the Repatha SureClick® window. It will turn yellow when the injection’s done. You may also hear a second click.
Close-up of yellow medicine window
On-screen text: Don’t see yellow in the window? Looks like the medicine is still injecting? Contact your healthcare provider or call RepathaReady at 1-844-REPATHA right away.

Lift the used SureClick® from your skin. The safety guard will automatically cover the needle. That’s it. You’re done injecting!
Medium-wide shot of woman lifting autoinjector off her thigh

Always put the used Repatha SureClick® and orange cap into a puncture-resistant container. You never want to put the used SureClick® into the trash or recycle bin.
Woman puts used autoinjector into sharps container on shelf
On-screen text: Step 4. Finish
On-screen text: Do not reuse or recycle a used SureClick® or sharps disposal
container. Do not throw them into the household trash. [Fades up after Step 4: Finish and holds on screen]

Once you’ve properly disposed of your SureClick®, check your injection site. If you have a little bleeding, press a cotton ball or gauze on the injection site. Just be careful not to rub it. You can put a bandage on it if you need to.
Medium-wide shot of woman holding cotton ball over injection site
On-screen text: Do not rub the injection site.

One last thing to keep in mind. If you need FDA-cleared disposal containers, you can get them from your local pharmacy. Puncture-resistant disposal containers with mail-back service are also available, free of charge, from RepathaReady. Just call 1-844-REPATHA.
Wherever you get your puncture-resistant disposal containers, be sure to keep them out of children’s reach.
Sharps container sits on cabinet shelf
On-screen text: For free disposal containers with mail-back service, call 1-844-REPATHA.
On-screen text: Keep disposal containers out of children’s reach. [Each fades up/out]

It’s also important to get rid of your full disposal container the right way. Local and state laws may require you to follow certain rules.
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
Do not recycle your used sharps disposal container.
For more information about proper needle disposal in your area, contact your local health department or your local trash removal service. Or, check out the FDA’s website listed on screen.
Woman replaces full sharps container with a new container
On-screen text: Visit www.fda.gov/safesharpsdisposal to learn how to get rid of full disposal containers.

You’re all done! Remember, if you have any questions about injecting, read the Instructions for Use. Or, contact your doctor, nurse, or pharmacist. Or, call the nurses at RepathaReady at 1-844-REPATHA.
On-screen text: Questions? Call RepathaReady at 1-844-REPATHA

Important Safety Information and Approved Use scrolls
What is Repatha?
Repatha is an injectable prescription medicine called a PCSK9 inhibitor. REPATHA is used

  • Along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart or blood vessel problems, who need additional lowering of LDL cholesterol.
  • Along with diet and other LDL lowering therapies in people with homozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL), who need additional lowering of LDL cholesterol.

The effect of Repatha on heart problems such as heart attacks, stroke, or death is not known.

It is not known if Repatha is safe and effective in children with homozygous familial hypercholesterolemia (HoFH) who are younger than 13 years of age or in children who do not have HoFH.

IMPORTANT SAFETY INFORMATION

Do not use Repatha if you are allergic to evolocumab or to any of the ingredients in Repatha.

Before you start using Repatha, tell your healthcare provider about all your medical conditions, including allergies, and if you are allergic to rubber or latex, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.

What are the possible side effects of Repatha?
Repatha may cause allergic reactions. 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, 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 are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information.

LOGO: Repatha (evolocumab) injection 140 mg/mL logo
LOGO: AMGEN CARDIOVASCULAR
On-screen text /CODELINE: ©2016 Amgen Inc., Thousand Oaks, CA 91320. All rights reserved. USA-145-106213(3)

Download the SureClick® autoinjector Instructions for Use.

15 Seconds

Self-injected with hand-held device

See Additional Features

Audible click when you start and finish your dose

No need for syringes or vials

Hidden needle

Can inject into your stomach or thigh

Pushtronex System(On-body infusor with prefilled cartridge)

fits in the palm of your hand

single-use on-body infusor with a prefilled cartridge

Once a Month

Read the full video transcript

This short video provides a high level overview of the Repatha® Pushtronex system (on-body infusor with prefilled cartridge). It is not intended for use as an instructional video. Prior to using the Pushtronex system, read the entire patient Instructions for Use, which are provided in the product box.

A copy of the full Instructions for Use can be found at Repatha.com or within the product box.

On-screen text: Repatha® logo [fades up/out]

Before we begin, you should not use Repatha® Pushtronex unless your healthcare provider has shown you how. After referring to the Instructions for Use, if you’re still not sure how to use Pushtronex, contact your doctor or call RepathaReady at 1-844-REPATHA.

On-screen Text: RepathaReady
Personalized support services for patients & providers
Questions? Call RepathaReady at 1-844-REPATHA

You’ve been prescribed Repatha® to help lower bad (LDL-C) cholesterol more than was possible with statins alone. Using Repatha® Pushtronex to take your once-monthly dose of Repatha® can help you lower your high cholesterol levels. Take Repatha® as prescribed by your doctor.

Okay, let’s get started.

On-screen text: Indication
Repatha® is an injectable prescription medicine called a PCSK9 inhibitor. Repatha® is used along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart or blood vessel problems, who need additional lowering of LDL cholesterol.

Important Safety Information

Do not use Repatha® if you are allergic to evolocumab or to any of the ingredients in Repatha®.

First we will briefly review the steps needed to take your monthly dose of Repatha: preparing for the procedure, getting yourself ready for the injection, the injection itself, and what to do when it’s finished. For complete administration and storage information, please see the Instructions for Use available on the website or in the Repatha® packaging.

On-screen text: [text fade up/out after Step]
Steps for taking your monthly dose
1. Prepare
2. Get ready
3. Inject
4. Finish

For complete information, see the Instructions for Use.

www.Repatha.com

[fade up/out]

It’s important to store Repatha® the right way. That means keeping it refrigerated in its original box. Don’t freeze or shake it. Don’t store in extreme heat or cold. Once removed from the refrigerator, Repatha® can be kept in the original box at room temperature for up to 30 days. Keep it in the carton until you are ready to use. Remember to keep Repatha® out of the reach of a child, like you would with any medicine.

On-screen text: 1. Prepare [remains]

Repatha® should be stored in the refrigerator.

At a room temperature of 68°F to 77°F. [Fades up/out]

To prepare for administration, take the carton containing Repatha® out of the refrigerator. Check the carton for damage and the expiration date on the back. If it is damaged or the date has passed, use a new on-body infusor and prefilled cartridge. If the package is intact and unexpired, let it come to room temperature for at least 45 minutes before administration. You could take it out of the refrigerator the night before and take Repatha® the next morning.

In fact, you can keep Repatha® Pushtronex out of the refrigerator for up to 30 days if you leave it in the carton until you are ready to use. Do not try to warm the Pushtronex using hot water or a microwave, and keep it out of direct sunlight.

On-screen text: 1. Prepare [remains]

Keep at room temperature for at least 45 minutes and up to 30 days. [Fades up/out]

After at least 45 minutes and Repatha® has come to room temperature, open the carton and review the Instructions for Use. Then peel away the white paper cover. Next, remove the plastic cover from the clear tray.

On-screen text: 1. Prepare [remains]

Please refer to the Instructions for Use for a detailed guide of Repatha® Pushtronex.

Product shown for demonstration purposes. [Fades up/out]

Leave the on-body infusor and prefilled cartridge in the clear tray until you are ready to inject. Do not press down on the lid as it might close the door permanently. Be careful not to touch the start button until the on-body infusor is securely attached and you are ready to inject.

On-screen text: 1. Prepare [remains]

Callouts

Pushtronex SYSTEM (On-Body Infusor with prefilled cartridge)
Cartridge Door
Adhesive Backing
Start Button
Medicine Window
Prefilled Cartridge

Be careful not to touch the start button. [Fades up/out]

Once gathered, the supplies you’ll need to use should be placed on a clean, well-lit work surface along with the on-body infusor and prefilled cartridge.

On-screen text: 1. Prepare

Puncture-resistant sharps container
Adhesive bandage
Cotton ball or gauze pad
Alcohol wipes

[Holds on screen]

Next, you should wash your hands well with soap and water.

On-screen text: 1. Prepare [remains]

Choose a skin surface that is firm and flat, like the outside of your upper arm, your stomach area away from your navel, or your thigh. If you choose the upper arm, someone else will need to help you. Select a place that is less likely to have body hair. You can trim the hair if needed where you will adhere Repatha® Pushtronex to your skin.

On-screen text: 1. Prepare [remains]

Callouts
Outer Area of Upper Arm
(Only if someone else is giving you the injection)

Stomach

Thigh [Fades up/out]

Be careful not to inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with wrinkles, skin folds, scars, stretch marks, moles, and excessive hair. If you want to use the same area on your body for the injections, make sure to vary the location of the injection.

On-screen text: 1. Prepare [remains]

Do not inject into areas where the skin is tender, bruised, red, or hard. [Fades up/out]

Clean the site with an alcohol wipe and let it dry. Don’t touch this area again before you’re ready to apply the on-body infusor.

On-screen text: 1. Prepare [remains]

You can now get Repatha® Pushtronex ready by swinging the cartridge door to the right to open it. Be careful not to close the cartridge door or hit the blue start button. If you accidentally close the cartridge door, press on the left side of the door to release the door latch.

On-screen text: 2. Get Ready [Remains]

If you are still unable to open the door, call 1-844-REPATHA. [Fades up/out]

Inspect and clean the bottom of the dosing cartridge. The medicine in the cartridge should be clear and colorless to slightly yellow. It should not be used if it is cloudy or discolored or contains flakes or particles. If any part of the cartridge appears cracked, broken, has pieces missing, or is not securely attached, use a new Repatha® Pushtronex.

On-screen text: 2. Get Ready [Remains]

The medicine in the cartridge should be clear and colorless to slightly yellow. [Fades up/out]

Hold the cartridge with one hand and clean the bottom using an alcohol wipe. Do not remove or rotate the cartridge top or bottom. Do not touch the bottom of the cartridge after cleaning.

On-screen text: 2. Get Ready [Remains]

Do not remove or rotate the cartridge top or bottom. [Fades up/out]

When you’ve finished cleaning, load the cartridge bottom-first into the on-body infusor. Firmly push the cartridge straight down until it’s secure in the device.

On-screen text: 2. Get Ready [Remains]

Firmly push the cartridge straight down. [Fades up/out]

Once the cartridge is secure, close the door by swinging it to the left and squeeze firmly until it snaps into place. There should be no gap between the door and the body of the device. It’s important to now move to the next step without delay.

On-screen text: 2. Get Ready [Remains]

It’s now time to attach Repatha® Pushtronex for the injection. Turn Repatha® Pushtronex over and remove both green pull-tabs. This will expose the adhesive and turn the loaded Pushtronex on. You will hear beeping and see a flashing blue status light that lets you know it’s ready to place on your skin.

On-screen text: 3. Inject [Remains]

Here is some important information to take note of once you’ve removed the green pull-tabs and adhesive backing:

Avoid touching the skin adhesive with your fingers because it’s very sticky.

Do not touch the start button until you have placed the loaded Pushtronex on your skin.

Keep the needle cover area clean.

If the red status light flashes for more than 5 seconds, do not place the loaded Pushtronex on your body.

Do not pull the skin adhesive backing off of the on-body infusor or fold it over onto itself.

On-screen text: 3. Inject [Remains]

Do not touch the skin adhesive.

Do not touch the start button until you have placed the loaded Pushtronex on your skin.

Do not touch or contaminate the needle cover area.

Do not place the loaded Pushtronex on your body if the red status light flashes for more than 5 seconds.

Do not pull the skin adhesive backing off the loaded Pushtronex.

Do not fold the skin adhesive over onto itself.

[Holds onscreen]

Choose your Repatha® Pushtronex injection site. For this video we have chosen the stomach. Place Repatha® Pushtronex on your stomach. Stretch the skin to make sure it lays flat on your body so that the adhesive is completely attached. Secure the adhesive around the edges using your finger.

On-screen text: 3. Inject [Remains]

Important: Adjust your body posture to avoid skin folds and bulges. [Fades up/out]

Once it’s placed onto your skin, do not reposition the loaded Pushtronex. You will see a blue light.

On-screen text: 3. Inject [Remains]

Now you’re ready to begin your injection of Repatha®. Firmly press and release the start button. The flashing green light and a click is your signal that the injection has started. You will hear a gentle pumping sound that reassures you Repatha® Pushtronex is working. You may also feel a small pinch.

The process takes about 9 minutes, and during this time you can move and engage in moderate physical activities such as walking, reaching, or bending.

On-screen text: 3. Inject [Remains]

During the injection, you may engage in moderate physical activities.

Walking - Reaching - Bending [Each fades up/out]

When the device beeps several times and the status light turns from blinking to solid green, you’ll know it’s done.

On-screen text: 3. Inject

Injection is complete

Check to see that the medicine window is free of Repatha®, and the used plunger completely fills the medicine window. The green solid light is now off, letting you know all of the medicine has been injected. When finished, grab the edge of the adhesive to carefully peel the on-body infusor off of your skin.

On-screen text: 4. Finish [Remains]

Check the medicine window.

Green light should now be off.

If there is still Repatha® in the medicine window, call 1-844-REPATHA (1-844-737-2842) or visit www.REPATHA.com. [Each fades up/out]

The used Repatha® Pushtronex will also beep when removed from your skin. Don’t worry if you see a few drops of fluid on your skin after you remove the used Repatha® Pushtronex; this is perfectly normal.

Do not remove the used cartridge from the on-body infusor. Always put the entire used Repatha® Pushtronex into a puncture-resistant container right after you finish. You never want to put the used Repatha® Pushtronex into the trash or recycling bin. And you should never try to reuse Repatha® Pushtronex. Please refer to the Instructions for Use for full disposal information.

On-screen text: 4. Finish [Remains]

Do not remove the used cartridge from the on-body infusor.

Place Repatha® Pushtronex in a sharps disposal container after you finish.

Do not throw it into the household trash or recycling bin.

Do not reuse or recycle a used Repatha® Pushtronex or sharps disposal container. [Each fades up and holds onscreen]

Once you’ve properly disposed of the on-body infusor, check your injection site. If you have a little bleeding, press a cotton ball or gauze pad on the injection site. Just be careful not to rub it. You can put a bandage on it if needed.

On-screen text: 4. Finish [Remains]

Do not rub the injection site. [Fades up/out]

If the loaded Pushtronex status light continuously flashes red and you hear beeps, stop using the loaded Pushtronex. If Repatha® Pushtronex is attached to your body, carefully remove it. Call 1-844-REPATHA (1-844-737-2842) or visit REPATHA.com

On-screen text: Call 1-844-REPATHA (1-844-737-2842) or visit www.REPATHA.com

One last thing to keep in mind: if you need FDA-cleared disposal containers, you can get them from your local pharmacy. Puncture-resistant disposal containers with mail-back service are also available, free of charge, from Repatha®Ready. Just call 1-844-REPATHA. Wherever you get your puncture-resistant disposal containers, be sure to keep them out of children’s reach.

On-screen text: For free disposal containers with mail-back service, call 1-844-REPATHA. Keep disposal containers out of children’s reach. [Each fades up/out]

It’s also important to get rid of your full disposal container the right way. Local and state laws may require you to follow certain rules. For more information about proper needle disposal in your area, contact your local health department or your local trash removal service. You can also check out the FDA’s website listed on screen.

On-screen text: Visit www.fda.gov/safesharpsdisposal to learn how to get rid of full disposal containers.

You’re all done! Remember, before using Repatha® Pushtronex, and if you have any questions about injecting, read the Instructions for Use. You can also contact your doctor, nurse, pharmacist, or call the nurses at RepathaReady at 1-844-REPATHA.

On-screen text: Questions?

Call RepathaReady at 1-844-REPATHA

Important Safety Information and Approved Use

What is Repatha®?

Repatha® is an injectable prescription medicine called a PCSK9 inhibitor. Repatha® is used:

  • Along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart or blood vessel problems, who need additional lowering of LDL cholesterol.
  • Along with diet and other LDL lowering therapies in people with homozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL), who need additional lowering of LDL cholesterol.

IMPORTANT SAFETY INFORMATION

Do not use Repatha® if you are allergic to evolocumab or to any of the ingredients in Repatha®.

Before you start using Repatha®, tell your healthcare provider about all your medical conditions, including allergies, and if you are allergic to rubber or latex, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Please note, the single-use Pushtronex system (on-body infusor with prefilled cartridge) is not made with natural rubber latex.

Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.

What are the possible side effects of Repatha®?

Repatha® may cause allergic reactions. 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, 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 are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information.

LOGO: Repatha (evolocumab) injection 140 mg/mL logo
LOGO: AMGEN CARDIOVASCULAR
SUPER On-screen text /CODELINE: ©2016 Amgen Inc., Thousand Oaks, CA 91320. All rights reserved. USA‐145‐127275

Download the Pushtronex System Instructions for Use.

9 minutes

Hands-free device allows you to perform moderate physical activities during self-injection

Lights and sounds let you know it is working and when it is done

Attaches to body with adhesive

Hidden needle

Can inject into your stomach or thigh

Dosing Time & Schedule

Once a Month

Watch Pushtronex demonstration video

Read the full video transcript

This short video provides a high level overview of the Repatha® Pushtronex system (on-body infusor with prefilled cartridge). It is not intended for use as an instructional video. Prior to using the Pushtronex system, read the entire patient Instructions for Use, which are provided in the product box.

A copy of the full Instructions for Use can be found at Repatha.com or within the product box.

On-screen text: Repatha® logo [fades up/out]

Before we begin, you should not use Repatha® Pushtronex unless your healthcare provider has shown you how. After referring to the Instructions for Use, if you’re still not sure how to use Pushtronex, contact your doctor or call RepathaReady at 1-844-REPATHA.

On-screen Text: RepathaReady
Personalized support services for patients & providers
Questions? Call RepathaReady at 1-844-REPATHA

You’ve been prescribed Repatha® to help lower bad (LDL-C) cholesterol more than was possible with statins alone. Using Repatha® Pushtronex to take your once-monthly dose of Repatha® can help you lower your high cholesterol levels. Take Repatha® as prescribed by your doctor.

Okay, let’s get started.

On-screen text: Indication
Repatha® is an injectable prescription medicine called a PCSK9 inhibitor. Repatha® is used along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart or blood vessel problems, who need additional lowering of LDL cholesterol.

Important Safety Information

Do not use Repatha® if you are allergic to evolocumab or to any of the ingredients in Repatha®.

First we will briefly review the steps needed to take your monthly dose of Repatha: preparing for the procedure, getting yourself ready for the injection, the injection itself, and what to do when it’s finished. For complete administration and storage information, please see the Instructions for Use available on the website or in the Repatha® packaging.

On-screen text: [text fade up/out after Step]
Steps for taking your monthly dose
1. Prepare
2. Get ready
3. Inject
4. Finish

For complete information, see the Instructions for Use.

www.Repatha.com

[fade up/out]

It’s important to store Repatha® the right way. That means keeping it refrigerated in its original box. Don’t freeze or shake it. Don’t store in extreme heat or cold. Once removed from the refrigerator, Repatha® can be kept in the original box at room temperature for up to 30 days. Keep it in the carton until you are ready to use. Remember to keep Repatha® out of the reach of a child, like you would with any medicine.

On-screen text: 1. Prepare [remains]

Repatha® should be stored in the refrigerator.

At a room temperature of 68°F to 77°F. [Fades up/out]

To prepare for administration, take the carton containing Repatha® out of the refrigerator. Check the carton for damage and the expiration date on the back. If it is damaged or the date has passed, use a new on-body infusor and prefilled cartridge. If the package is intact and unexpired, let it come to room temperature for at least 45 minutes before administration. You could take it out of the refrigerator the night before and take Repatha® the next morning.

In fact, you can keep Repatha® Pushtronex out of the refrigerator for up to 30 days if you leave it in the carton until you are ready to use. Do not try to warm the Pushtronex using hot water or a microwave, and keep it out of direct sunlight.

On-screen text: 1. Prepare [remains]

Keep at room temperature for at least 45 minutes and up to 30 days. [Fades up/out]

After at least 45 minutes and Repatha® has come to room temperature, open the carton and review the Instructions for Use. Then peel away the white paper cover. Next, remove the plastic cover from the clear tray.

On-screen text: 1. Prepare [remains]

Please refer to the Instructions for Use for a detailed guide of Repatha® Pushtronex.

Product shown for demonstration purposes. [Fades up/out]

Leave the on-body infusor and prefilled cartridge in the clear tray until you are ready to inject. Do not press down on the lid as it might close the door permanently. Be careful not to touch the start button until the on-body infusor is securely attached and you are ready to inject.

On-screen text: 1. Prepare [remains]

Callouts

Pushtronex SYSTEM (On-Body Infusor with prefilled cartridge)
Cartridge Door
Adhesive Backing
Start Button
Medicine Window
Prefilled Cartridge

Be careful not to touch the start button. [Fades up/out]

Once gathered, the supplies you’ll need to use should be placed on a clean, well-lit work surface along with the on-body infusor and prefilled cartridge.

On-screen text: 1. Prepare

Puncture-resistant sharps container
Adhesive bandage
Cotton ball or gauze pad
Alcohol wipes

[Holds on screen]

Next, you should wash your hands well with soap and water.

On-screen text: 1. Prepare [remains]

Choose a skin surface that is firm and flat, like the outside of your upper arm, your stomach area away from your navel, or your thigh. If you choose the upper arm, someone else will need to help you. Select a place that is less likely to have body hair. You can trim the hair if needed where you will adhere Repatha® Pushtronex to your skin.

On-screen text: 1. Prepare [remains]

Callouts
Outer Area of Upper Arm
(Only if someone else is giving you the injection)

Stomach

Thigh [Fades up/out]

Be careful not to inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with wrinkles, skin folds, scars, stretch marks, moles, and excessive hair. If you want to use the same area on your body for the injections, make sure to vary the location of the injection.

On-screen text: 1. Prepare [remains]

Do not inject into areas where the skin is tender, bruised, red, or hard. [Fades up/out]

Clean the site with an alcohol wipe and let it dry. Don’t touch this area again before you’re ready to apply the on-body infusor.

On-screen text: 1. Prepare [remains]

You can now get Repatha® Pushtronex ready by swinging the cartridge door to the right to open it. Be careful not to close the cartridge door or hit the blue start button. If you accidentally close the cartridge door, press on the left side of the door to release the door latch.

On-screen text: 2. Get Ready [Remains]

If you are still unable to open the door, call 1-844-REPATHA. [Fades up/out]

Inspect and clean the bottom of the dosing cartridge. The medicine in the cartridge should be clear and colorless to slightly yellow. It should not be used if it is cloudy or discolored or contains flakes or particles. If any part of the cartridge appears cracked, broken, has pieces missing, or is not securely attached, use a new Repatha® Pushtronex.

On-screen text: 2. Get Ready [Remains]

The medicine in the cartridge should be clear and colorless to slightly yellow. [Fades up/out]

Hold the cartridge with one hand and clean the bottom using an alcohol wipe. Do not remove or rotate the cartridge top or bottom. Do not touch the bottom of the cartridge after cleaning.

On-screen text: 2. Get Ready [Remains]

Do not remove or rotate the cartridge top or bottom. [Fades up/out]

When you’ve finished cleaning, load the cartridge bottom-first into the on-body infusor. Firmly push the cartridge straight down until it’s secure in the device.

On-screen text: 2. Get Ready [Remains]

Firmly push the cartridge straight down. [Fades up/out]

Once the cartridge is secure, close the door by swinging it to the left and squeeze firmly until it snaps into place. There should be no gap between the door and the body of the device. It’s important to now move to the next step without delay.

On-screen text: 2. Get Ready [Remains]

It’s now time to attach Repatha® Pushtronex for the injection. Turn Repatha® Pushtronex over and remove both green pull-tabs. This will expose the adhesive and turn the loaded Pushtronex on. You will hear beeping and see a flashing blue status light that lets you know it’s ready to place on your skin.

On-screen text: 3. Inject [Remains]

Here is some important information to take note of once you’ve removed the green pull-tabs and adhesive backing:

Avoid touching the skin adhesive with your fingers because it’s very sticky.

Do not touch the start button until you have placed the loaded Pushtronex on your skin.

Keep the needle cover area clean.

If the red status light flashes for more than 5 seconds, do not place the loaded Pushtronex on your body.

Do not pull the skin adhesive backing off of the on-body infusor or fold it over onto itself.

On-screen text: 3. Inject [Remains]

Do not touch the skin adhesive.

Do not touch the start button until you have placed the loaded Pushtronex on your skin.

Do not touch or contaminate the needle cover area.

Do not place the loaded Pushtronex on your body if the red status light flashes for more than 5 seconds.

Do not pull the skin adhesive backing off the loaded Pushtronex.

Do not fold the skin adhesive over onto itself.

[Holds onscreen]

Choose your Repatha® Pushtronex injection site. For this video we have chosen the stomach. Place Repatha® Pushtronex on your stomach. Stretch the skin to make sure it lays flat on your body so that the adhesive is completely attached. Secure the adhesive around the edges using your finger.

On-screen text: 3. Inject [Remains]

Important: Adjust your body posture to avoid skin folds and bulges. [Fades up/out]

Once it’s placed onto your skin, do not reposition the loaded Pushtronex. You will see a blue light.

On-screen text: 3. Inject [Remains]

Now you’re ready to begin your injection of Repatha®. Firmly press and release the start button. The flashing green light and a click is your signal that the injection has started. You will hear a gentle pumping sound that reassures you Repatha® Pushtronex is working. You may also feel a small pinch.

The process takes about 9 minutes, and during this time you can move and engage in moderate physical activities such as walking, reaching, or bending.

On-screen text: 3. Inject [Remains]

During the injection, you may engage in moderate physical activities.

Walking - Reaching - Bending [Each fades up/out]

When the device beeps several times and the status light turns from blinking to solid green, you’ll know it’s done.

On-screen text: 3. Inject

Injection is complete

Check to see that the medicine window is free of Repatha®, and the used plunger completely fills the medicine window. The green solid light is now off, letting you know all of the medicine has been injected. When finished, grab the edge of the adhesive to carefully peel the on-body infusor off of your skin.

On-screen text: 4. Finish [Remains]

Check the medicine window.

Green light should now be off.

If there is still Repatha® in the medicine window, call 1-844-REPATHA (1-844-737-2842) or visit www.REPATHA.com. [Each fades up/out]

The used Repatha® Pushtronex will also beep when removed from your skin. Don’t worry if you see a few drops of fluid on your skin after you remove the used Repatha® Pushtronex; this is perfectly normal.

Do not remove the used cartridge from the on-body infusor. Always put the entire used Repatha® Pushtronex into a puncture-resistant container right after you finish. You never want to put the used Repatha® Pushtronex into the trash or recycling bin. And you should never try to reuse Repatha® Pushtronex. Please refer to the Instructions for Use for full disposal information.

On-screen text: 4. Finish [Remains]

Do not remove the used cartridge from the on-body infusor.

Place Repatha® Pushtronex in a sharps disposal container after you finish.

Do not throw it into the household trash or recycling bin.

Do not reuse or recycle a used Repatha® Pushtronex or sharps disposal container. [Each fades up and holds onscreen]

Once you’ve properly disposed of the on-body infusor, check your injection site. If you have a little bleeding, press a cotton ball or gauze pad on the injection site. Just be careful not to rub it. You can put a bandage on it if needed.

On-screen text: 4. Finish [Remains]

Do not rub the injection site. [Fades up/out]

If the loaded Pushtronex status light continuously flashes red and you hear beeps, stop using the loaded Pushtronex. If Repatha® Pushtronex is attached to your body, carefully remove it. Call 1-844-REPATHA (1-844-737-2842) or visit REPATHA.com

On-screen text: Call 1-844-REPATHA (1-844-737-2842) or visit www.REPATHA.com

One last thing to keep in mind: if you need FDA-cleared disposal containers, you can get them from your local pharmacy. Puncture-resistant disposal containers with mail-back service are also available, free of charge, from Repatha®Ready. Just call 1-844-REPATHA. Wherever you get your puncture-resistant disposal containers, be sure to keep them out of children’s reach.

On-screen text: For free disposal containers with mail-back service, call 1-844-REPATHA. Keep disposal containers out of children’s reach. [Each fades up/out]

It’s also important to get rid of your full disposal container the right way. Local and state laws may require you to follow certain rules. For more information about proper needle disposal in your area, contact your local health department or your local trash removal service. You can also check out the FDA’s website listed on screen.

On-screen text: Visit www.fda.gov/safesharpsdisposal to learn how to get rid of full disposal containers.

You’re all done! Remember, before using Repatha® Pushtronex, and if you have any questions about injecting, read the Instructions for Use. You can also contact your doctor, nurse, pharmacist, or call the nurses at RepathaReady at 1-844-REPATHA.

On-screen text: Questions?

Call RepathaReady at 1-844-REPATHA

Important Safety Information and Approved Use

What is Repatha®?

Repatha® is an injectable prescription medicine called a PCSK9 inhibitor. Repatha® is used:

  • Along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart or blood vessel problems, who need additional lowering of LDL cholesterol.
  • Along with diet and other LDL lowering therapies in people with homozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL), who need additional lowering of LDL cholesterol.

IMPORTANT SAFETY INFORMATION

Do not use Repatha® if you are allergic to evolocumab or to any of the ingredients in Repatha®.

Before you start using Repatha®, tell your healthcare provider about all your medical conditions, including allergies, and if you are allergic to rubber or latex, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Please note, the single-use Pushtronex system (on-body infusor with prefilled cartridge) is not made with natural rubber latex.

Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.

What are the possible side effects of Repatha®?

Repatha® may cause allergic reactions. 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, 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 are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information.

LOGO: Repatha (evolocumab) injection 140 mg/mL logo
LOGO: AMGEN CARDIOVASCULAR
SUPER On-screen text /CODELINE: ©2016 Amgen Inc., Thousand Oaks, CA 91320. All rights reserved. USA‐145‐127275

Download the Pushtronex system Instructions for Use.

9 Minutes

Hands-free device allows you to perform moderate physical activities during self-injection

See Additional Features

Lights and sounds let you know it is working and when it is done

Attaches to body with adhesive

Hidden needle

Can inject into your stomach or thigh

*140 mg/mL
420 mg/3.5 mL
Injection under the skin

Taking Repatha® with the
single-use prefilled syringe?Prior to injecting, download and review the Instructions for Use here.

Watch a demonstration video and learn how to use it.

icon

Storing and Traveling with Repatha®

Store Repatha® in the refrigerator (36°F to 46°F) until you’re ready to use it. Repatha® can also be kept at room temperature (68°F to 77°F) in its original box for up to 30 days. This makes it easier to take your medicine with you when you’re on the go.

icon

Get free needle-disposal containers mailed to your door

Recycle your used needles safely, conveniently, and at no cost to you with needle-disposal containers that can be exchanged when full.

Sign up for RepathaReady to get your kit shipped to your door.

icon

Need a little extra help while taking Repatha®?

Get nurse support 7 days a week, 9 AM–11 PM Eastern Time, with RepathaReady™ by calling 1-844-REPATHA (1-844-737-2842).

Questions about
paying for Repatha®?

Pay no more than $5* with the Repatha® Copay Card, and learn about other financial programs

*Eligibility Requirements for Repatha® Copay Card: Program is available to patients with commercial insurance and applies to deductible, coinsurance, and copay for Repatha®. This program is not open to patients receiving prescription reimbursement under any federal, state or government-funded healthcare program, such as Medicare, Medicare Advantage, Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), the Department of Defense (DoD) or TRICARE® or where prohibited by law.

Sign up with RepathaReady 
for information on
Repatha® and living
with high LDL

Learn more about Repatha®
and get useful cholesterol
management tips

Close

Important Safety Information and Approved Use

Do not use Repatha® if you are allergic to evolocumab or to any of the ingredients in Repatha®.

Before you start using Repatha®, tell your healthcare provider about all your medical conditions, including allergies, and if you are allergic to rubber or latex, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. The needle covers on the single-use prefilled syringes and the inside of 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.

Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.

What are the possible side effects of Repatha®?

Repatha® may cause allergic reactions. 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, 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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-10881-800-FDA-1088.

Approved Use

Repatha® is an injectable prescription medicine called a PCSK9 inhibitor. Repatha® is used:

  • along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart or blood vessel problems, who need additional lowering of LDL cholesterol.

The effect of Repatha® on heart problems, such as heart attacks, stroke, or death, has not been determined.

Please see full Prescribing Information on this website.

See MoreVer más

You are now leaving Repatha.com

This information is intended only for U.S. healthcare professionals. If you are a healthcare professional, click "I Agree" to continue.