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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
On-screen text: 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 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.
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)