Getting started on MIMRYLO™ (rusfertide)

[OPENING CARD: MIMRYLO (rusfertide) for injection]
SCREEN TEXT: Administration with
MIMRYLO™ - rusfertide for injection
MIMRYLO™ (rusfertide) is a prescription medicine that is used to treat erythrocytosis in adults with
polycythemia vera.
Please see the Important Safety Information at the end of the video, the full Prescribing Information,
including the Patient Information at MIMRYLO.com/PI, and the full Instructions for Use at
MIMRYLO.com/IFU.
NURSE: If you’re watching this, you’ve probably considered or been prescribed MIMRYLO
(rusfertide) by your doctor. My name is Sophia, and this is your guide to self-injection with
MIMRYLO.
I’m going to guide you, step-by-step, through the entire process, and before long, you’ll be a
pro.
[SECTION CARD: Welcome]
NURSE: Joining me is Robert. I’m going to help guide him in performing his first injection with
MIMRYLO. Are you ready to get started?
PATIENT: Yup, I’m all set.
NURSE: First things first, we’re going to wash our hands well with soap and water. Keeping
everything safe and clean is super important.
Before we get started, it’s important to remember you always store your MIMRYLO at room
temperature.
PATIENT: Oh, so I don’t need to keep this in the refrigerator?
NURSE: Exactly. And NEVER freeze it.
Okay, now I want you to look at your MIMRYLO packaging and check to make sure that the
strength matches your prescribed dose. This is because MIMRYLO is available in more than
one strength, and you want to make sure you take what’s right for you.
PATIENT: It matches.
NURSE: Excellent. If it doesn’t, call your pharmacy or your doctor’s office. Now, check the
expiration date on the outside of the carton, right here.
Do not use MIMRYLO if the expiration date has passed. If the date has passed, call your
healthcare provider.

[SECTION CARD: Setting up the materials]
NURSE: Now, let’s take all the items out of the box.
Now, quick quiz: You’re looking through your supplies, what are you looking out for before we
start?
PATIENT: So I’m looking for anything missing, opened, or damaged. If it’s not perfect, I don’t
use it and I just call my pharmacy or my nurse case manager.
NURSE: Bingo.
PATIENT: In my drug kit, I have the prefilled diluent syringe and the medicine vial. I also
received the one-time use needle, and the vial adapter.
NURSE: Correct, we also have a sharps container for disposal. This is not included in the kit.

Now, if you’re starting a once-weekly self-injection like MIMRYLO, you’re going to want an FDA-
cleared sharps disposal container. FDA-cleared sharps disposal containers are generally

available through pharmacies, medical supply companies, healthcare providers, and online.
And there are other items not included in your kit that are good to have. These include alcohol
wipes, adhesive bandages, gauze, and cotton balls. You can also find these at your local
pharmacy.
Also, let’s establish quick ground rule for parts of our syringe and other materials that you
should not touch. I call them the “No-Go Zones.”
Only touch the body of your syringe. The tips, the rubber stoppers, and the open needles?
Those are No-Go Zones. If we don’t touch them, we keep everything sterile. Sound good?
PATIENT: Body only. No-Go Zones are off-limits. Got it.
[SECTION CARD: Prepping the medicine vial]
NURSE: Now that you've checked all of your materials, take the cap off of the medicine vial and
throw the cap away in your trash can.
Clean the gray rubber stopper on top of the medicine vial with a new alcohol wipe, then throw
the alcohol wipe away as well.
No-Go Zone time. Be sure to not touch the gray stopper on the top of the medicine vial after
cleaning. Now we’re going to attach the vial adapter. Peel back the cover while keeping the vial
adapter in its plastic packaging for now. And remember your No-Go Zone for the adapter as
well.
Place the medicine vial on a flat surface and hold it steady. Now, take the vial adapter still in the
packaging and place it over the medicine vial.
You’ll push the adapter straight down onto the top of the medicine vial until you hear a snap.

PATIENT: Oh, heard it!
NURSE: Good job. The snap means that the spike went through the stopper and now the
adapter is locked on and it’s fully attached. Once it’s attached we should never take it off.
Now we’re ready to attach the diluent syringe to the adapter.
You’re going to gently pull the adapter packaging away and toss it into the garbage. And
remember not to let the vial adapter tip touch your hands or any surface.
PATIENT: Got it. Another No-Go Zone.
NURSE: Yes, now we’re going to take off the syringe cap.
Hold the syringe by the body, and then remove the cap by turning to the left until it lifts away.
After that, you can just throw the cap away.
The No-Go Zones apply here too.
Now, to attach the liquid syringe to the vial adapter you’re going to place the medicine vial on a
flat surface, hold the vial adapter with one hand, and with the other hand, attach the liquid
syringe to the vial adapter by turning to the right until it is snug.
Make sure you don’t tighten it too much.
[SECTION CARD: Adding the liquid to the vial]
NURSE: Okay, now we need to mix the liquid with the medicine. We’re going to go slow and
steady so the process is clear. Are you ready?
PATIENT: I am.
NURSE: Keep the medicine vial on a flat surface with the syringe pointing down.
Inject all the liquid into the medicine vial by slowly pushing down on the syringe plunger rod until
it is empty. But don’t remove the syringe from the medicine vial just yet, we’ll need it for later.
PATIENT: Ok.
NURSE: We’re going to mix the liquid and the medicine, this is called reconstitution. First,
slowly and gently swirl in a circular motion until the powder is fully dissolved. Don’t shake it. This
may take about 2 minutes.
Okay, it’s been 2 minutes of swirling. Let’s check the vial.
PATIENT: Uhh, this looks dissolved.
NURSE: It does. Now, if you see powder medicine stuck to the inside of the medicine vial wall,
just keep gently swirling until it’s removed.

It’s possible that the mixed medicine may look foamy. Don’t worry, this is normal. And
remember not to shake the medicine vial.
PATIENT: Okay, what’s next?
NURSE: Set your vial and syringe on a clean flat surface and let it sit to allow the liquid to settle
and any excess foam to go away. This could take about 1 minute.
Sometimes, the syringe plunger rod may rise up by itself. Again, nothing to worry about, this is
normal.
Once the liquid has settled, it’s time to take another look.
It should be clear with very little foam, colorless, and free from visible particles or clumps.
PATIENT: It looks clear.
NURSE: This looks perfect. If the liquid looks colored or contains particles, don’t use it.
PATIENT: And call my doctor’s office.
NURSE: You got it. Now it’s important to remember, you must use the medicine within 4 hours
of mixing it.
PATIENT: Got it, I’ll make sure that I don’t forget about it.
[SECTION CARD: Drawing the solution into the syringe]
NURSE: Now we’re going to fill the syringe with the medicine we just prepared.
First, we make sure our syringe plunger rod is pressed all the way down to remove any air.
PATIENT: Pressing all the way down.
NURSE: While you’re holding the plunger down and holding the syringe by the body, turn the
syringe upside down so the medicine vial is now on top.
Slowly and gently, pull the plunger rod down to fill the syringe with all the mixed medicine.
Okay, the medicine vial is empty, so let’s get rid of it.
To do that, hold the syringe by the body, remember your No-Go Zones, and turn the vial adapter
to the left until it lifts away.
The empty vial goes into the sharps container, never the household trash.
PATIENT: Out you go.
NURSE: Remember not to touch the syringe tip or allow it to touch any surface. And don’t touch
or push the plunger rod until you are ready to inject.

[SECTION CARD: Attaching the needle to the syringe]
NURSE: There’s only a few more steps left, you got this. Ready to attach the needle to the
syringe?
PATIENT: Let’s do it.
NURSE: Alright. Pull the needle package apart, but remember your No-Go Zones.
PATIENT: Keeping my fingers clear of the open end of the needle.
NURSE: Mmhm, perfect. Now, hold the syringe by the body with one hand, and then attach and
turn the needle to the right with your other hand until it is snug.
PATIENT: Just like the adapter.
NURSE: Exactly!
Now we set the prepared syringe on a clean flat surface and get ready to inject.
PATIENT: Okay.
[SECTION CARD: Choosing and cleaning the injection site]
NURSE: Choosing your injection site is important. You’ll want to rotate between the abdomen
and the front of your thighs so you aren't injecting in the same place twice in a row. If you have
the help of a care partner, you can use the back of the arm as an injection site. But do not
attempt self-injection in this location.
Don’t select a site where the skin is tender, bruised, red, irritated, hard or broken. Now we’ll go
ahead and clean the surface of the skin with a new alcohol wipe.
Let the site air dry completely. No fanning or blowing, just a little bit of patience ensures a clean
start.
[SECTION CARD: Prepping the syringe]
NURSE: Take hold of the syringe by the body with the needle pointing up.
Now you’re going to pull the needle shield back. It’s the little plastic flap on the side. But make
sure you don’t take it off the syringe completely.
Then carefully take off the needle cap by firmly pulling the cap straight off. The needle cap can
be tossed in the garbage.
Here are a few safety tips to keep in mind when administering the medicine at home:

Don’t touch the plunger rod while taking off the needle cap. You don’t want to accidentally
remove any medicine before you use it.
Don’t inject if the needle looks damaged or bent.
Do not let the needle touch your hands or any surface.
And if your syringe is ever dropped without a needle cap on, do not use it.
The last step before injecting is to remove the air from the syringe. Hold the body of the syringe
with the needle tip pointing straight up. Tap it to move those bubbles to the top.
PATIENT: Tapping them up.
NURSE: Now, a slow, careful push on the plunger; just enough to clear a bit of air.
PATIENT: Squeezing them out.
NURSE: And it’s okay if a small air gap or bubbles are left in the syringe.
PATIENT: Got it.
NURSE: And with that, you’re ready to inject.
PATIENT: Here we go.
[SECTION CARD: Giving the injection]
NURSE: Use one hand to pinch the skin at the injection site. This allows you to insert the
needle into the fatty tissue just under the skin.
Now you’re going to insert the needle into the pinched skin anywhere from a 90- to a 45-degree
angle. When the needle is in, you can stop pinching.
With me?
PATIENT: I’m in.
NURSE: Okay, let’s slowly push the plunger rod to inject all of the medication. After the
medicine is injected, slowly pull the needle out of the skin at the same angle you inserted it.
PATIENT: I’m out!
NURSE: Awesome job!

[SECTION CARD: Disposal and observation of the injection site]
NURSE: Right after injecting the medicine, place the needle shield on a hard surface, and
carefully push the needle shield over the needle until it snaps into place and covers the needle.
PATIENT: So the needle stays on?
NURSE: It does. Do not try to remove the needle from the syringe. And don’t recap or touch the
needle. Okay, Robert, what are we going to do with the used syringe?
PATIENT: It goes right into the sharps container.
NURSE: That’s right! Never throw away needles in your household trash. Now that the needle is
disposed of safely, let’s check the injection site.
NURSE: If there is any bleeding at the injection site, gently press a cotton ball or a gauze pad
over the site and hold for about 10 seconds. You can cover it with an adhesive bandage if
needed.
Do not rub the injection site.
PATIENT: I’ll leave it alone.
NURSE: Yes, let it be. Now, it’s possible that you’ve been prescribed a larger dose of
MIMRYLO, which could require a second injection immediately or split across days. If so, follow
the schedule you and your doctor have discussed, and refer to your Dosing and Administration
Guide for a step-by-step reminder.
All that’s left to do is clean up any remaining materials, log your injection site in a journal or
calendar...
PATIENT: And relax!
NURSE: And you should relax, you did a great job. How do you feel?
PATIENT: Uh, I feel uh, I feel like I’ve got this, you know? Once we went over the steps, it’s not
overwhelming. I feel confident.
NURSE: I love that.
And I hope, after watching this, you will feel confident too. Thank you for watching and
congratulations on taking this important first step in your treatment.

Important Safety Information
What is MIMRYLO (rusfertide)?
MIMRYLO is a prescription medicine that is used to treat erythrocytosis (high red blood cell
count) in adults with polycythemia vera.
It is not known if MIMRYLO is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Before using MIMRYLO, tell your healthcare provider about all of your medical
conditions, including if you:
● are pregnant or plan to become pregnant. MIMRYLO may harm your unborn baby.
Females who are able to become pregnant:
— Your healthcare provider may do a pregnancy test before you start treatment with
MIMRYLO.
— Use effective birth control (contraception) during treatment and for at least 30 days
after the final dose of MIMRYLO.
— Tell your healthcare provider right away if you become pregnant or think that you
may be pregnant during treatment with MIMRYLO.
— Stop taking MIMRYLO if you become pregnant.
● are breastfeeding or plan to breastfeed. It is not known if MIMRYLO passes into your
breast milk. Do not breastfeed during treatment with MIMRYLO and for 30 days after the
final dose of MIMRYLO. Talk to your healthcare provider about the best way to feed your
baby during this time.
Tell your healthcare provider about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of MIMRYLO?
MIMRYLO may cause serious side effects, including:
● New or worsening increased blood platelets (thrombocytosis). MIMRYLO may
increase blood platelet counts. Your healthcare provider will do blood tests when you
start and during treatment with MIMRYLO to check your platelet counts.
● Injection site reactions. MIMRYLO may cause injection-site reactions such as redness,
itching, pain, swelling, bruising, hardening at the injection site, and irritation. If you get an
injection site reaction, apply ice packs, steroid cream, or take medicines as needed to
treat injection site pain and swelling.
Your healthcare provider may change your dose or stop treatment with MIMRYLO if you have
side effects.
The most common side effects of MIMRYLO are:
● injection site reactions

● low red blood cell count (anemia)

These are not all of the possible side effects of MIMRYLO. Call your doctor for medical advice
about side effects. You may report side effects to Takeda at 1-844-662-8532 or the FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Patient Information in the MIMRYLO (rusfertide) full Prescribing Information at
MIMRYLO.com.