Hi, and thanks for watching this self-administration injection training session.

Meet Samantha.

She’s here to show you and your caregiver how to self-administer NEMLUVIO.

Your healthcare provider should have taken you through these steps already.

We know the idea of injections can feel intimidating—especially when you’re administering a medicine to yourself, or a loved one.

But with our instructions, you’ll soon find it easier to inject NEMLUVIO.

There are three main steps to these instructions, and we’ll take you through them one by one, shortly.

Here are the basics:

Step 1. Let’s prepare the injection—which includes allowing NEMLUVIO to reach room temperature, washing your hands, gathering the supplies you’ll need, checking and activating the NEMLUVIO pen to start the dissolving process.

Just a heads up—it takes 30-45 minutes for the pen to reach room temperature. If you are taking NEMLUVIO out of the refrigerator, please keep this in mind when you’re planning to inject.

The supplies you’ll need include the NEMLUVIO pen, alcohol wipes, gauze pads or cotton balls, and a sharps disposal container, where applicable, or an appropriate heavy-duty container to dispose of the pen safely.

Inside the carton, you will find the NEMLUVIO pen, instructions for use, and patient information leaflet.

Step 2 is the injection—which involves selecting one of the recommended injection sites on your body, cleaning the injection site, preparing the NEMLUVIO pen for injection, injecting and removing the pen after injection.

And step 3 is disposing of the pen safely. If you don’t have a dedicated sharps disposal container, we’ll show you how to use a heavy-duty household container instead.

Ready? You’ve got this!

Before we begin, a few important safety guidelines to remember.

The NEMLUVIO pen requires specific steps before injecting. So be sure to watch and understand these instructions before using the pen.

Do not inject yourself or someone else until you’ve been trained on how to inject NEMLUVIO by your healthcare professional.

NEMLUVIO is supplied as a single-dose pen. It contains the medicine—that’s 30 milligrams of white powder—in one chamber, and water for dissolving the medicine in another chamber.

Before you can inject NEMLUVIO, you‘ll need to ensure that white powder and water for dissolving in the NEMLUVIO pen are properly mixed.

Also, you’ll want to take the time to familiarize yourself with the instructions for use supplied with the NEMLUVIO pen. If you haven’t been through the instructions for use already, pause the video to familiarize yourself with the contents. We’ll be right here when you’re done.

Now that you’ve read and understood the instructions for use, it’s time to take a closer look at the components of the NEMLUVIO pen.

Here’s how the pen looks before use:

Starting at the top, here's the gray cap. The inspection window just below. And the medicine—that’s the white powder—just below that.

Underneath, although you can’t see it, is a separate chamber with water for dissolving the medicine.

And right at the bottom is the activation knob—this will already be in the ‘Locked’ position, as shown by the lock icon.

After use, you’ll see these parts:

Under the gray cap is the needle cover, and the orange needle guard.

In the inspection window, you’ll see a gray rod, and an orange rod.

And the activation knob at the bottom which, after use, will be in the ‘Unlocked’ position.

Now we can start step 1—preparing the NEMLUVIO pen.

Within each main step, there’ll be some intermediate steps to take. We’ll walk you through each of these.

Ok! First, if you're taking the NEMLUVIO pen out of the refrigerator, make sure you wait until it reaches room temperature.

Bringing the pen to room temperature takes 30 to 45 minutes, so it’s a good idea to set a reminder alarm if you go and do something else.

If you have removed the NEMLUVIO pen from the refrigerator:

Do not try to speed up the process by warming up the pen with a heat source—like a microwave, or even direct sunlight.

Do not shake the NEMLUVIO pen prior to being instructed to mix the water with the white powder.

Also, do not directly expose the pen to any liquids—which means no putting it in warm water either!

This might damage NEMLUVIO.

Making sure the pen is at room temperature, wash your hands with soap to avoid contamination or infection, and dry them properly.

Now, remove the pen from the carton, and gather your supplies. Set aside a clean, flat and well-lit surface to put them on.

You’ll need the NEMLUVIO pen, alcohol wipes. Gauze pads or cotton balls, and a sharps disposal container, where applicable, or other appropriate heavy-duty container to dispose of the pen safely.

Inside the carton, you will find the NEMLUVIO pen, instructions for use, and patient information leaflet. If you don’t have a dedicated sharps disposal container, make sure that you have an appropriate heavy-duty household container available (more details in Step 3 of this video).

If your healthcare provider has advised you to take more than one dose, you’ll use one pen immediately after the other.

Next, you need to check the NEMLUVIO pen for a few things.

You’ll want to make sure that:

1. The expiration date on the NEMLUVIO pen has not passed.

2. The NEMLUVIO pen has not been stored at room temperature for more than 90 days prior to injection.

3. The powder is white and has not dissolved.

4. You have not dropped the pen, and that the pen is not damaged or cracked.

Do not use the pen unless all of these four conditions are met.

If any condition is not met, call the NEMLUVIO information line in the US on 866-735-4137 during working hours.

In case any of these four conditions are not met, discard the pen and request a replacement pen if you don't already have one available. To dispose of the pen safely, see Step 3 of this video.

Have all the four conditions been met? Great! Now you’re ready to activate the NEMLUVIO pen to start the dissolving process.

Hold the pen upright and turn the activation knob to the right until it stops. This starts the process of mixing the water with the white powder.

Now watch the inspection window until the gray rod stops moving.

Do not shake the NEMLUVIO pen before the gray rod has completely stopped.

When the gray rod has completely stopped, shake the NEMLUVIO pen up and down for 30 seconds to dissolve the medicine.

Now, wait for the bubbles to decrease, and the white powder to dissolve – this means the liquid should look clear and colorless to slightly yellow. This will take about 5 minutes.

Here are some things to look for after the 5 minutes is up.

If the medicine has not dissolved completely, shake the NEMLUVIO pen again for 30 seconds, and then wait 5 additional minutes.

If you see a small foam layer or a few small air bubbles remaining in the dissolved medicine, it’s okay—this is normal.

Check the medicine in the inspection window.

Make sure the dissolved medicine is clear and colorless, or slightly yellow. It should not contain any particles.

Do not use the pen if the dissolved medicine is cloudy, or contains any particles.

Instead, discard the pen and use a new one. To dispose of the pen safely, see Step 3 of this video.

After the medicine has dissolved, it must be used within 4 hours. During this time, the pen should be kept at room temperature— that’s up to 77 degrees Fahrenheit, or 25 degrees Celsius. If you have not used it within 4 hours, safely dispose of it.

All prepped? Great!

Now, let’s walk through the injection process.

First, let’s choose an injection site using this chart—it’s also included in your instructions for use.

If you’re going to be self-injecting, you can choose the abdomen, at least 2 inches (or 5 cm) away from your navel.

Or, the upper thigh.

If you’re a caregiver administering the injection, you can place it in the patient’s abdomen, or at least 2 inches (or 5 cm) away from the navel.

The upper thigh.

Or the outer, upper arm.

There are some areas you should not inject:

Do not inject near the waistline, or within 2 inches (or 5cm) around the navel.

Do not inject into tender, bruised, red skin or areas with scars or stretch marks.

Do not inject twice into the same site during the same injection session.

If you’ve been trained by your healthcare practitioner to administer a second dose using a second pen, select a different injection site—at least one inch (or 2.5cm) away from the first injection site.

Picked a spot?

It’s time to clean the injection site.

Always use a new alcohol wipe to clean the injection site and avoid contamination and infection.

Then let the skin air dry.

After cleaning:

Do not touch the injection site.

Do not fan or blow air on the cleaned injection site.

And do not reuse the alcohol wipe.

Once your skin is dry, you are going to twist the gray cap off the pen.

No pulling! This could damage the pen.

To do this right:

Hold the pen upright.

Twist the gray cap until the orange needle guard pops up (but don’t touch the orange needle guard).

Then gently pull the cap off the orange needle guard.

If you can’t remove the gray cap, make sure the activation knob at the bottom of the pen is turned completely to the right until it stops, and is in the ‘Unlocked’ position.

You’re almost ready to place the NEMLUVIO pen onto the injection site. But before you do, it’s important to understand what steps are coming up so you don’t race ahead.

To summarize—but don’t do this just yet!—you’re going to:

Hold the pen firmly as shown in IFU Figure N.

Place the pen on the injection site at a 90 degree angle, and hold firmly for 15 seconds.

And make sure you can see the inspection window during the injection.

Once the injection is complete, you’re going to lift the pen straight up.

Have some gauze handy to place on top of the injection site, but don’t rub the injection site.

Ready to do this?

Here we go!

Place the pen on the injection site at a 90 degree angle, so that the orange needle guard is flat against the skin.

And make sure you can see the inspection window during the injection.

Gently push the pen down until the orange needle guard is completely pushed in.

Hear that click? That’s when you know the injection has started.

Do not lift the pen yet!

Just keep pushing down and count to 15.

In the inspection window, you’ll see the orange rod moving to cover the gray rod. Now wait until they’ve both stopped moving.

Do not lift the pen until they’ve stopped.

In some cases, the orange rod may not fully cover the gray rod at the end of the injection, and that’s normal.

But if the orange rod is not visible at all, please call the NEMLUVIO information line in the US on 866-735-4137.

Then, discard the pen and use a new one. To dispose of the pen safely, see Step 3 of this video.

Once the orange rod and gray rod have stopped moving, it means the injection has been completed, and you can lift the pen straight up from your skin.

The orange needle guard will lock into place to safely cover the needle.

If you see any bleeding, just press a cotton ball or gauze over it.

Do not rub the injection site.

The injection is done!

Lastly, you’re going to safely dispose of the pen and cap straight after use.

Be sure to avoid contact with the needle while you dispose of the pen.

Discard the used pen and the gray cap in a dedicated sharps disposal container or other appropriate heavy-duty container.

Here are some things you shouldn’t do.

Do not:

• Recap the pen after use
• Dispose of the pen and cap in your household trash
• Dispose of your used sharps disposal container in your household trash, unless your local regulations permit this, or
• Recycle your used sharps disposal container

If you don’t have a sharps disposal container, you can use an appropriate heavy-duty household container instead that is:

• Made of heavy-duty plastic
• Closed with a tight-fitting, puncture resistant lid, to ensure the sharps won’t come out
• Upright and stable during use
• Leak-resistant, and
• Properly labeled to warn of hazardous waste inside the container

When your disposal container is almost full, you’ll need to follow your local regulations to dispose of it.

There may be state or local laws regulating the disposal of used pens.

For more information about safe sharps disposal, including details for the state you live in, go to the FDA’s website at fda.gov/SafeSharpsDisposal

You’re all done!

And remember, you can come back to watch this video—and read the step-by-step NEMLUVIO instructions for use and patient information leaflet—anytime.

Thanks for watching.