Hi and thanks for watching the 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. Within each main step, there will be some intermediate steps to take. We'll walk you through each of these. If you're taking the Nemluvio pen out of the refrigerator, it takes 30 to 45 minutes for the pen to reach room temperature. 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 a 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. Wash your hands with soap to avoid contamination or infection.
Inside the carton, you will find the Nemluvio pen, Instructions For Use, and patient information leaflet. Remove the pen from the carton and gather your supplies. Set aside a clean, flat and well-lit surface to put them on. You 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. If your health care 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 want to make sure that the expiration date on the Nemluvio pen has not passed. Also, please ensure that the Nemluvio pen has not been stored at room temperature for more than 90 days prior to injection; the powder is white and has not dissolved; 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 at this number.
Now you're ready to activate the Nemluvio pen to start the dissolving process. Pull the pen upright and turn the activation knob to the right until it stops. This starts the process of mixing the water with a 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 five minutes.
Here are some things to look for after the five minutes is up. If the medicine has not dissolved completely, shake the Nemluvio pen again for 30 seconds and then wait five 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. Do not use the pen of the dissolved medicine is cloudy or contains any particles. If conditions are not met, please call the number shown on the screen.
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 the Instructions For Use. If you're going to be self injecting, you can choose the abdomen (at least 2 inches or 5 centimeters) away from your navel, or the upper thigh. Caregivers can inject in the same areas as just mentioned, or the outer upper arm. There are some areas you should not inject. Do not inject near the waistline, or within 2 inches or 5 centimeters 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 health care practitioner to administer a second dose using a second pen, select a different injection site, at least one inch or 2.5 centimeters 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. 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. If the gray cap cannot be removed, refer back to step five of the Instructions For Use on how to activate the Nemluvio pen. Or call the number shown on the screen.
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. Once the orange rod and gray rod have stopped moving, you will not hear a click at the end of the injection. This means that the injection has been completed and that you can lift the pen away from the 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. Discard the used pen and the gray cap in a dedicated sharps disposal container or other appropriate heavy duty container. For more information about safe sharps disposal, including details for the state you live in, go to the FDA's website at fda.gov/safe sharps disposal. You're all done. Thanks for watching.