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VIDEOS

Help, Support and Understanding

The following videos offer helpful information about treatment with TYVASO and how to get the most out of your TYVASO journey.

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Introduction To The TYVASO Inhalation System

Find out everything you need to know to get started with the TYVASO TD-300, a portable device that allows for dosing at home or on the go.

INTRODUCTION TO THE TYVASO INHALATION SYSTEM

[VIDEO DURATION 22:26]

UNITED THERAPEUTICS (UT) EMPLOYEE:

Welcome to “Getting Started on TYVASO”—brought to you by United Therapeutics Corporation.

Hello there! I’m Michelle. I am an employee of United Therapeutics.

United Therapeutics partners with Specialty Pharmacy nurses who provide home visits to make sure you have the information and support you need while starting TYVASO. Specialty Pharmacy nurses can also teach you how to use the TYVASO device and answer questions you may have when taking TYVASO. Remember to always talk to your doctor about questions concerning your health and your treatment regimen.

In this video, you will see what a Specialty Pharmacy nurse-patient interaction might look like. I’m going to play the role of the Specialty Pharmacy nurse. Before we do that, I would like to introduce Donna. Donna is a PAH patient. Together, we will give you an overview of the TYVASO Inhalation System, using the TD-300 device, and Donna will tell you a little bit about her experience with TYVASO and share how TYVASO may fit into your daily life.

PATIENT:

Hello! My name is Donna and I have pulmonary arterial hypertension, or better known as “PAH.” It hasn’t been easy, but I do not let PAH run my life. I love my great nephew, I take him to the park, I play with him, and I have a puppy dog that I am just in love over. And I like to cook. I’m not afraid to try new things!

I was first introduced to TYVASO by my doctor. TYVASO fit into my lifestyle so easily and I liked being able to adjust my treatment around my schedule. Also, the TYVASO device is portable, so I could take it with me out and about.

UT EMPLOYEE:

Thanks, Donna. Now, let’s get started with the TD-300 device overview.

You are probably watching this video because your doctor has prescribed TYVASO for the treatment of your pulmonary arterial hypertension.

TYVASO is approved for the treatment of PAH (WHO Group I). TYVASO can improve the ability to exercise in people who also take bosentan (an ERA) or sildenafil (a PDE-5 inhibitor).

I would like to remind you to tell your doctor about all of your medical conditions before you start TYVASO. These conditions can include lung disease or infection, liver or kidney problems, low blood pressure, and bleeding problems. It is important to share this information since these conditions may affect your treatment with TYVASO. Also, be sure to tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. It is not known if TYVASO will harm your unborn baby or if it passes into breast milk.

Also, be sure to read the full Instructions for Use manual prior to starting on TYVASO.

You may be wondering what comes next. Donna, do you remember starting on TYVASO. How was that process for you?

PATIENT:

While I was waiting to begin my treatment, Michelle contacted me to make an appointment to go over how to use TYVASO. I appreciated that she gave me 2 location options, my doctor’s office or my home. I chose to be in the comfort of my house because I wanted my husband to be present for the training in case I forgot something.

Just prior to my appointment, I received a box containing all the materials I needed to get started. It included my TYVASO Inhalation System (I call it my TYVASO device) and Instructions for Use manual. I remember having mixed emotions. I was nervous, but I couldn’t wait to begin my treatment!

UT EMPLOYEE:

Yes, and it’s important to remember: even if you are excited to begin your treatment, do not start taking TYVASO until you have been trained by your Specialty Pharmacy nurse. This training usually takes about an hour and will give you the information you need to get started.

You can think of your Specialty Pharmacy nurse as part of your healthcare team during this initiation period. This process can be overwhelming at first, so that’s why they are here, to help you along the way. Expect your specialty pharmacy nurse to stay in touch, follow up with you regularly, and be available to answer any additional questions you might have.

PATIENT:

I can speak to this. I had a great experience. Michelle was warm. She made me feel comfortable with the device and my treatment. And her support didn’t stop after the first day of the treatment. She came back several times to be sure I was using the device properly and was available to answer questions and provide guidance even after I started my treatment with TYVASO. I am grateful for the assistance and encouragement I received from Michelle and my team at my doctor’s office. They helped start my TYVASO treatment journey off on the right track.

[DEVICE OVERVIEW 04:50]

UT EMPLOYEE:

Now, we will take a closer look at the TYVASO device.

Donna and I went over what to expect as you get ready to start your treatment with TYVASO. Now we want to share some features of the TYVASO device.

The Instructions for Use manual provides much more information. It’s an important resource to keep handy when taking TYVASO.

PATIENT:

A feature that I found useful is the ability to check my battery’s status. I do this by setting the switch to Run and holding the blue button to turn the device on. The battery icon appears at the bottom of the screen, which can be seen here.

The device has 4 different icons that make it easy to track my battery.

Every morning, I check for "Battery full" so the charge will last all day.

UT EMPLOYEE:

That’s a helpful tip to ensure your device has enough power, especially if you are taking it on the go.

But just to be safe, you should always take the charger with you when you go out. If the battery is too low to deliver a full treatment, “Charge battery” will appear on screen. When this happens, be sure to charge your battery.

Now, let’s look at some other features. For example, you can use just 1 button to power the device on and off, and to start and pause a treatment.

PATIENT:

Having 1 multi-functional button really does make things easy! The device also has other helpful features. When I turn the device on, I see an introductory screen, then the time since my last treatment, and then the current breaths programmed for each dose. This helps me track when I took my last treatment.

You may be wondering about how to dose TYVASO. The starting dose is usually 3 breaths per session.

My doctor started me on 3 breaths and increased my dose based on how I tolerated TYVASO, until I reached a target dose of 9 breaths per session.

Your doctor will determine the number of breaths that are right for you. A typical treatment session should take 2 to 3 minutes and, remember, you do this 4 times daily.

UT EMPLOYEE:

Remember to contact your doctor or Specialty Pharmacy nurse if you have questions about dosing or trouble increasing your dose.

This video is not designed to tell you everything about the TYVASO Inhalation System. It’s important to refer to your Instructions for Use Manual for detailed information on how to use the TYVASO device. Your Specialty Pharmacy nurse is also a great resource for additional questions you might have.

[ASSEMBLING YOUR DEVICE 07:30]

Let’s talk about how to assemble your device once daily.

PATIENT:

I remember the first time I tried to assemble my TYVASO Inhalation System. I was worried about getting it right. With practice and a couple of calls to Michelle, the process became second nature.

It’s important to be careful and not to force the parts together. At first, I was nervous about putting the parts together incorrectly. One thing that helped me make the process easier was remembering that the clear and cloudy pieces fit together. I also like to keep the Instructions for Use manual handy in case I get stuck.

UT EMPLOYEE:

Here is a quick demonstration of the assembly process.

Begin by filling the water level cup with fresh, distilled water up to the arrow markers. Pour it into the water chamber.

Then place 1 new, empty medicine cup into the chamber of the device. Make sure that the cup’s bottom tip is in the distilled water.

Now you will add the medicine. Carefully cut open the top of the foil pouch, being careful not to cut the ampules. Remove 1 ampule of TYVASO, and be sure to store the remaining ampules in the foil pouch to protect them from light. One ampule contains enough medicine for 1 day of treatment. Even if your doctor increases your dose, you still only use 1 ampule of medication each day.

PATIENT:

That’s really helpful for someone who likes to stay busy! I assemble my device first thing in the morning and then I am ready for my 4 treatment sessions that I do throughout the day.

UT EMPLOYEE:

Hold the ampule upright and twist off its top. Point the ampule straight down toward the medicine cup’s center. Gently empty the medicine out of the ampule into the medicine cup.

After the medicine is in the medicine cup, assemble your device. First, check that the black ring is securely placed in the dome assembly.

Then, attach the dome assembly onto the device by pushing down and screwing it onto the device in a clockwise direction.

PATIENT:

I like to think of this step as screwing on a water bottle top. But in this case, I hear clicks or a crunching sound, letting me know the dome assembly is screwed on tight and is connected to the medicine cup.

UT EMPLOYEE:

Continue the assembly by installing a new filter membrane in each of the filter shells.

Next, insert 1 filter shell into the filter shell port on the back of the device and the second filter shell onto the port on the bottom of the inhalation piece.

Insert the inhalation piece on the attached filter shell into the upper opening of the dome assembly and rotate it toward the front of the device.

Last but not least, carefully insert the mouthpiece onto the inhalation piece.

When the device is fully assembled, it should appear like this.

See, it’s pretty easy when you do it a few times.

If you would like a more detailed description of how to prepare your TYVASO System for daily treatment, take a look at pages 26 to 39 in your Instructions for Use manual.

[INHALING TYVASO 11:15]

Once you have assembled your device, you are ready to start your treatment.

As you get used to the breathing technique, you can use the device cues to help you along the way.

PATIENT:

I like that the device gives both visual and audio cues. The device signals me with beeps or green flashing lights when it’s time to exhale to prepare for inhaling the medication.

In addition, I can follow the device screen to remind me of my next step. It displays the number of breaths left, with an Exhale or an Inhale icon.

UT EMPLOYEE:

You will inhale TYVASO during 4 treatment sessions each day during waking hours. During each session, you will take the number of breaths prescribed by your doctor.

It is very important to keep the device level when inhaling TYVASO. This will help deliver the medication into your lungs at the proper angle. Be careful not to tilt the device, as this can dispense the medication improperly. Remember, proper technique is crucial to proper dosing! Improper technique may contribute to cough and throat irritation.

PATIENT:

When I first started my treatment with TYVASO, I had to adjust to inhaling my medication 4 times a day. The doses are spaced about 4 hours apart. I've found that each treatment session takes me about 2 to 3 minutes. Now, I can usually fit a session into most of the activities I plan in my day.

UT EMPLOYEE:

Now, let’s review a session of 3 breaths.

Remember to keep your device upright and level to the floor. This will direct the flow of medicine into your lungs and not toward the roof of your mouth.

After you turn the device on, wait until it emits 2 short beeps. When you hear a long beep, exhale in preparation to inhale.

When you hear 1 short beep and see the indicator lights flash green, place your lips securely around the mouthpiece and inhale for 3 seconds.

PATIENT:

When I first started using TYVASO, I felt like I needed to hold my breath while inhaling. Michelle corrected my breathing, which helped me relax during the inhalation process. I also found that drinking some liquids before treatment helps to coat my throat.

UT EMPLOYEE:

You nailed it, Donna! I’m always reminded my patients, do not hold your breath while you inhale.

You should take a normal full breath for about 3 seconds; then take your mouth off the mouthpiece and exhale normally.

Go at your own pace. If you need to slow down, use the blue button to pause your treatment until you are ready for your next breath.

After you complete a breath, you will notice that the screen will decrease the number of breaths left by 1.

Donna will show you this inhalation sequence. You should repeat it for your number of breaths prescribed.

After displaying your last treatment session, the green Done screen will appear and you will hear a beep, letting you know your treatment is done.

Once you have finished a session, record the number of breaths you inhaled in your Treatment Tracker.

You can also see pages 42 to 45 in your Instructions for Use manual for a full recap of your inhalation process. Feel free to reach out to your Specialty Pharmacy nurse if you have other questions about your treatments or using the TYVASO device.

[TAKING TYVASO ON THE GO 15:05]

PATIENT:

I try to keep busy so it’s important for me to be able to take TYVASO on the go.

UT EMPLOYEE:

Did you know that the TYVASO Inhalation System is portable? You can pack the device in its carrying case and take it with you.

Let’s go through this process step by step. Start by removing both the mouthpiece and inhalation piece.

When removing accessories, always make sure to hold the device by its base to avoid spilling the medicine.

Also, you do not need to remove the filter membranes from the filter shells until after your last treatment session of the day.

In addition to leaving the filter membranes in the filter shells, leave the dome assembly and medicine cup attached to the device. Do NOT open the dome assembly. The water and medication should remain in the device.

Next, place a plug into each of the 2 open holes on the dome assembly. This helps to prevent medicine from spilling out.

Keep in mind that if the plugs are not in place, the medicine may spill. If it happens, be sure to start your next treatment with a new ampule of medication, as well as new filter membranes.

Once the plugs are in, place the inhalation device and all of its components in the carrying case. Make sure to keep the carrying case upright while you insert the device and components so that the water and medicine do not spill.

UT EMPLOYEE:

I recommend taking your device with you wherever you go. Sometimes, even with careful planning, you may be delayed in coming home in time for your next treatment.

PATIENT:

I definitely agree! I like having my TYVASO System easily accessible to take my treatment while I am out and about.

When I know I won’t be home for a while and need to use the device on the go, I make sure the internal battery is fully charged. It’s a great feeling not having to worry about finding a wall outlet. I do that enough with my cell phone!

However, I always take the AC wall plug with me just in case I need to recharge the device while I'm away from home.

UT EMPLOYEE:

If you need a refresher on how to pack your portable device, refer to pages 48 to 51 in your Instructions for Use manual.

[CLEANING YOUR DEVICE 17:20]

Follow these steps to clean your TYVASO Inhalation System.

Once you have completed your last treatment session of the day, remove the mouthpiece and inhalation piece with the attached filter shell.

Next, remove both filter shells. Open them and discard the used filter membranes.

Once you have removed the dome assembly, remove the medicine cup, empty any leftover medicine, and discard the empty cup.

Be careful not to spill any medicine on your hands. If a spill happens, wash your hands immediately. Medicine contact with your skin can cause irritation.

After you have removed all the accessories from your device, empty it and let it air dry by turning it upside down on a clean dry surface. Then, clean your accessories.

PATIENT:

You may be wondering how I wash and dry my accessories. Initially, I thought that I could wash them in the dishwasher. However, Michelle advised against this. Instead, hand washing them with soapy, warm water followed by a thorough rinse does the trick.

In terms of drying, I use a drying rack and leave my accessories out on the counter to dry overnight.

UT EMPLOYEE:

A drying rack is a great idea! Donna, you mentioned you had a great end-of-the-day tip to get ready for the next day.

PATIENT:

I like to be proactive and I have found that charging my device at night once it’s dry is one less thing to worry about so I’m ready to go with my first dose in the morning.

UT EMPLOYEE:

Once a week, use a clean, dry cloth to wipe the inside of the inhalation device chamber.

Once a month, you will receive a set of new accessories as part of your TYVASO Refill Kit. This is when you should discard your old accessories.

Make sure you read the TYVASO Instructions for Use manual. And if questions or issues arise, contact your doctor or Specialty Pharmacy nurse.

A number of additional resources are available to you. You can sign up for the TYVASO Support Program at TYVASO.com. Once you sign up, you will receive e-mails with information and tips that can help you along your treatment journey.

PATIENT:
Head over to TYVASO.com to learn more about the support programs and resources available to patients who are on TYVASO. Thanks for watching!

VOICEOVER:

What is TYVASO?

TYVASO (treprostinil) is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH; WHO Group I), which is high blood pressure in the arteries of your lungs. TYVASO can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO. It is not known if TYVASO is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

Before you take TYVASO, tell your healthcare provider about all your medical conditions, including if you have lung disease or infection, liver or kidney problems, low blood pressure, or bleeding problems. If you are pregnant, plan to become pregnant, or breast-feeding, tell your doctor. It is not known if TYVASO will harm your unborn baby or if it passes into breast milk.

Tell your healthcare provider about all the medicines you take, as TYVASO and other medicines may affect each other. Especially medicines used to treat high blood pressure or heart disease, or that decrease blood clotting (anticoagulants), water pills (diuretics), gemfibrozil (Lopid) or rifampin (Rimactane, Rifadin, Rifamate, Rifater).

TYVASO can cause serious side effects, including low blood pressure (symptomatic hypotension) and bleeding problems, especially in people who take blood thinners (anticoagulants).

The most common side effects of TYVASO are cough, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), fainting or loss of consciousness, dizziness, and diarrhea. These are not all the possible side effects of TYVASO. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

The risk information provided here is not comprehensive. To learn more about TYVASO, talk with your healthcare provider. Please see Full Prescribing Information, Patient Product Information, and the TD-100 and TD-300 TYVASO Inhalation System Instructions for Use manuals at www.TYVASO.com or call 1-877-UNITHER (1-877-864-8437).

How To Use TYVASO

Learn how to assemble, use, and clean your TD-300 device, and discover user-friendly enhancements that facilitate ease of use.

HOW TO USE TYVASO

[VIDEO DURATION 07:23]

VOICEOVER:

Welcome to the TYVASO Inhalation System!

Today, we are going to walk you through how to prepare your device once daily, and use it for daily treatments.

For detailed instructions, please refer to the TYVASO Inhalation System Instructions for Use Manual.

Before assembling the TYVASO Inhalation System, wash your hands, and rest the device on a stable, flat surface.

Prepare a proper environment before setting up your treatment.

Gather the provided supplies and inspect each part prior to use, not using any parts that appear damaged or dirty.

Be sure to unplug the device and only use fresh, distilled water when filling the device.

Fill the water level cup with approximately 45 mL of distilled water up to the arrow markers and pour into the water chamber.

Make sure the water level is between the upper, silver sensor and the blue ring.

Place one new medicine cup into the chamber of the device, making sure that the cup’s bottom tip is in the distilled water.

Make sure you place only one medicine cup, as placing multiple cups will prevent the flow of medicine.

Remove 1 ampule of TYVASO from the foil pouch. One ampule contains enough medicine for one day of treatment, no matter how many breaths your doctor has prescribed.

Open only one foil pouch at a time, as ampules must be used within 7 days of opening the pouch. Throw away any unused ampules after 7 days.

Hold the ampule in the upright position and twist off its top.

If any medicine from the ampule spills on your hands, wash your hands right away. Medicine contact with the skin can cause irritation.

Point the ampule straight down towards the medicine cup and gently squeeze the medicine out until it is empty.

Do not force any parts together, as the TYVASO Inhalation System is designed so the parts only fit together properly and easily one way.

Check to make sure the black ring is securely placed in the dome assembly.

If the black ring is loose or missing, do not use the dome assembly.

Align the raised circles on the side of the dome assembly and the device. Push down and screw the dome assembly onto the device clockwise until you hear clicks and the filter shell port is tight and pointed to the back of the device.

The dome assembly “clicks” only the first time it connects to the medicine cup. If you then realign the dome assembly, you will not hear another click.

Each day you will need to use a new filter membrane in each filter shell.

To install a new membrane in each shell, open the shell by unscrewing the two halves, place a new membrane in one of the shell halves, and then close the shell by screwing the two halves together until you can twist no further.

Insert one shell straight into the filter shell port on one side of the dome assembly and the second shell straight into the port on the bottom of the inhalation piece.

The shells are the same and can be used in either port. Turn the shells around to fit into the ports, as needed. Make sure to insert filter shells straight into the ports, not at an angle.

Insert the inhalation piece into the upper opening of the dome assembly and turn it towards the front of the device, gently pushing down to make sure it is securely inserted in the dome assembly.

Carefully insert the mouthpiece into the inhalation piece.

Slightly turn the inhalation piece so you can see the display screen, which provides important prompts during your treatment. Your once-daily preparation is now complete, and you are ready to use the device.

Do not use device if you see liquid leaking from bottom.

Press and hold the On/Off button until the screen turns on and the device beeps once.

The screen will display the splash screen, then the time since your last treatment, then the current breaths programmed for each dose. Make sure the number on the screen above “Breaths left” matches the prescribed number of breaths for that treatment session.

If the number of breaths displayed does not match the number of breaths in your prescription, see page 22 “Setting your prescribed dose” in your Instructions for Use Manual.

If the device’s internal battery is too low to deliver a full treatment, the screen will display an instruction to plug in the power to charge the device battery. If the battery is fully depleted, the screen will not turn on.

You can conduct a treatment session with the power plugged in. The power status light above the port will light green when properly plugged in.

You will take a series of breaths of TYVASO during 4 treatment sessions each day, evenly spaced during your waking hours.

Before inhaling your medicine, ensure the Run/Program switch is in the “Run” position, and make sure the number displayed on screen matches your prescribed numbers of breaths for that treatment session.

Stand or sit in an upright position and hold the device upright and level when breathing TYVASO, to direct the flow of medicine into the throat and not toward the roof of the mouth. Avoid covering the bottom of the device so that the audio speaker is not blocked, and make sure you can see the display screen and lights clearly.

Press the blue button to start treatment. After starting, you can press and immediately release the blue button as needed to pause and resume treatment.

Look at the display screen for cues. Wait until you hear two short beeps. When you hear one long beep, exhale to prepare to inhale.

When you hear one short beep and the indicator lights flash green, seal your lips securely around the mouthpiece to ensure that you can inhale the full amount of TYVASO, and inhale for three seconds. Do not hold your breath. When the lights stop flashing, remove your lips from the mouthpiece and exhale normally.

The screen will decrease the number of breaths left by one. Repeat the previous two steps for the number of prescribed breaths.

If medicine does not appear to be flowing properly, the system might be set up incorrectly. See the Troubleshooting section starting on page 65 in your Instructions for Use Manual.

After displaying the last breath sequence, the green Done light will appear, you will hear a beep, and your treatment will be done.

Be sure to record the number of breaths you inhaled on your Treatment Tracker.

Press and hold the blue button until the screen turns off.

You have successfully used the TYVASO Inhalation System! For additional instructions, including how to clean and store the device, please refer to the TYVASO Inhalation System Instructions for Use Manual.

How TYVASO Works

Listen to a doctor and patient discuss how TYVASO is inhaled directly to the lungs and quickly delivers medicine where it’s needed.

HOW TYVASO WORKS

[VIDEO DURATION 06:48]

DOCTOR:

OK, Amy. Let’s discuss what’s going on with you, and what might help.

PATIENT/AMY:

Thanks, Doctor. I’ll take all the help I can get.

DOCTOR:

As you know, you have a condition called pulmonary arterial hypertension, PAH for short, which means you have high blood pressure in the lungs.

Now, it’s been a few years. There are 4 functional classes of PAH, and the symptoms increase with each class.

PATIENT/AMY:

Yes, it has been harder to walk to the mailbox, and climbing stairs has been more difficult.

DOCTOR:

Well, based on your increased symptoms and the tests we did, you are currently in Functional Class 3.

PATIENT/AMY:

Hmmm… so what are my options?

DOCTOR:

For people like you who are already taking an oral medication, such as an ERA, which blocks excess endothelin, or a PDE5i, which increases blood flow to the arteries, I suggest adding another medicine that works differently—TYVASO, an inhaled prosta­cyclin analogue.

PATIENT/AMY:

What is that and how does it work?

DOCTOR:

Prostacyclin is a natural substance found in the body. It works on one of three pathways that help keep your blood vessels open. If any of these pathways are imbalanced, the arteries in your lungs can narrow, which may be the cause of your PAH symptoms.

Because your body doesn’t make enough prostacyclin, TYVASO may help. It mimics some of the natural effects of prostacyclin helping to keep the blood vessels in the lungs open and working properly.

PATIENT/AMY:

And how would I take TYVASO?

DOCTOR:

You take it by using a device to inhale it into your lungs to help open up the blood vessels and allow more blood to flow into your lungs.

VOICEOVER:

What is TYVASO?

TYVASO (treprostinil) is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH; WHO Group I), which is high blood pressure in the arteries of your lungs. TYVASO can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO. It is not known if TYVASO is safe and effective in children under 18 years of age.

DOCTOR:

Everyone is different. But, in a 12-week clini­cal trial, patients who added TYVASO to either bosentan or sildenafil walked an average of 71 feet or about 21-and-a-half meters more than before adding TYVASO.

In the clinical trial, some of the most common side effects were cough, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), fainting or loss of consciousness, dizziness, and diarrhea.

Shall we get you started on TYVASO?

PATIENT/AMY:

Sounds good, Doctor...tell me how!

DOCTOR:

Well, first I’ll send in a referral to a Specialty Pharmacy that will work with your insurance company.

Once approved, you’ll get a call from the Specialty Pharmacy to arrange for TYVASO to be delivered to your home.

They will also make an appointment for a nurse to teach you how to use the TYVASO inhalation device.

[Phone rings]

PATIENT/AMY:

Hello.

SPECIALTY PHARMACY WORKER:

Hi, this is the Specialty Pharmacy calling. Your TYVASO kit should arrive any day now. We can have a nurse come by and train you on Thursday.

PATIENT/AMY:

That works great for me!

VOICEOVER:

Remember to wait for your SPS nurse to walk you through the process before starting TYVASO.

[Doorbell rings]

SPECIALTY PHARMACY NURSE:

Hi Amy, I’m Beth, your Specialty Pharmacy nurse.

PATIENT/AMY:

Hi Beth. Come in.

SPECIALTY PHARMACY NURSE:

Thank you.

PATIENT/AMY:

I'm a bit nervous.

SPECIALTY PHARMACY NURSE:

Most people are at first, but you'll soon get the hang of it.

PATIENT/AMY:

You think so?

SPECIALTY PHARMACY NURSE:

Of course...and keep in mind, I'll be coming back a few times as you get started. And you'll receive follow up calls.

PATIENT/AMY:

That’s a relief!

SPECIALTY PHARMACY NURSE:

Yes, don't worry. We're here to help.

PATIENT/AMY:

I've been taking TYVASO for about a month, and it fits right into my daily schedule.

DELIVERY MAN/CARLOS:

Hello!

PATIENT:

Oh, hi Carlos!

DELIVERY MAN/CARLOS:

How are you doing?

PATIENT/AMY:

I'm doing well.

VOICEOVER:

What is TYVASO?

TYVASO (treprostinil) is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH; WHO Group I), which is high blood pressure in the arteries of your lungs. TYVASO can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO. It is not known if TYVASO is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

Before you take TYVASO, tell your healthcare provider about all your medical conditions, including if you have lung disease or infection, liver or kidney problems, low blood pressure, or bleeding problems. If you are pregnant, plan to become pregnant, or breast-feeding, tell your doctor. It is not known if TYVASO will harm your unborn baby or if it passes into breast milk.

Tell your healthcare provider about all the medicines you take, as TYVASO and other medicines may affect each other. Especially medicines used to treat high blood pressure or heart disease, or that decrease blood clotting (anticoagulants), water pills (diuretics), gemfibrozil (Lopid) or rifampin (Rimactane, Rifadin, Rifamate, Rifater).

TYVASO can cause serious side effects, including low blood pressure (symptomatic hypotension) and bleeding problems, especially in people who take blood thinners (anticoagulants).

The most common side effects of TYVASO are cough, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), fainting or loss of consciousness, dizziness, and diarrhea. These are not all the possible side effects of TYVASO. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

The risk information provided here is not comprehensive. To learn more about TYVASO, talk with your healthcare provider. Please see Full Prescribing Information, Patient Product Information, and the TD-100 and TD-300 TYVASO Inhalation System Instructions for Use manuals at www.TYVASO.com or call 1-877-UNITHER (1-877-864-8437).

A Day With TYVASO

See how TYVASO treatments can fit into your day – at home, work, or on the go.

A DAY WITH TYVASO

[VIDEO DURATION 06:55]

VO=voiceover.

VO PATIENT/SALLY:

Hmmm, I love my mornings. It's so great to have a little 'me time'.

I usually start my day by making some tea and reviewing the day’s schedule for the bakery. Waiting for my tea to steep gives me the perfect time to take my TYVASO treatment.

VO:

What is TYVASO?

TYVASO (treprostinil) is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH; WHO Group I), which is high blood pressure in the arteries of your lungs. TYVASO can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO. It is not known if TYVASO is safe and effective in children under 18 years of age.

VO PATIENT/SALLY:

First I wipe down the counter and thoroughly wash my hands.

All ready...everything I need to prepare for all four sessions today. I've already fully charged the device.

I’ve got the distilled water and the medicine cup. I just need one ampule of TYVASO.

This will last me all day, even on my trip to New York for the Baking Expo!

Once the medicine is in, there are a few more simple steps to take.

Everything should fit easily and securely into the device.

After just a few tries, I was very comfortable assembling my TYVASO system.

Okay, time for my treatment session, the first of 4 today. I've programmed in the number of breaths my doctor prescribed.

The display screen makes it really easy to set or adjust the dose.

Once the device is activated, I wait to hear two short beeps.

When I hear the 3rd beep, and see the word "Exhale" on the screen, I breathe out completely.

Following the next short beep, the lights flash green and the word "Inhale" appears on the screen. This signals me to put my lips around the mouthpiece and take a normal full breath.

I must remember to turn the volume down when I take my treatment at the bakery today.

I like how the display screen counts down the number of breaths I need to take, until it reaches zero.

And it only takes me 2-3 minutes to finish a treatment session.

After each session, I use the TYVASO treatment tracker to record my breaths.

I've got a busy day. Being able to quickly pack up my device keeps me on schedule.

See you later, Einstein.

SALLY TO STAFF:

Okay, so everyone knows the plan for while I’m away. Ed, that big order from the new store on Maple, let’s be sure to make it perfect.

ED:

Absolutely.

VO PATIENT/SALLY:

My doctor started my treatment plan at three breaths per session. I like that I can work TYVASO treatments into my plans.

I thought it might be awkward to have to go through security with my device, but it’s really quite manageable.

The battery lasts all day, so I can do my therapy on the go, without having to find an outlet.

Mmmm, delicious…keeping my strength up for the competition.

Last dose of the day. All done. Now to clean up, so I’m ready for the morning.

I let everything air dry completely and then plug it in, so it's charged and ready to go in the morning.

I know it's properly plugged in because the status light above the port shows green. It’s great that the battery lasts all day – no need to charge in between treatment sessions.

With the TYVASO device I can travel without missing a treatment.

I’m ready to ace the bread bake-off tomorrow. Watch out celebrity chefs!

VOICEOVER:

What is TYVASO?

TYVASO (treprostinil) is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH; WHO Group I), which is high blood pressure in the arteries of your lungs. TYVASO can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO. It is not known if TYVASO is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

Before you take TYVASO, tell your healthcare provider about all your medical conditions, including if you have lung disease or infection, liver or kidney problems, low blood pressure, or bleeding problems. If you are pregnant, plan to become pregnant, or breast-feeding, tell your doctor. It is not known if TYVASO will harm your unborn baby or if it passes into breast milk.

Tell your healthcare provider about all the medicines you take, as TYVASO and other medicines may affect each other. Especially medicines used to treat high blood pressure or heart disease, or that decrease blood clotting (anticoagulants), water pills (diuretics), gemfibrozil (Lopid) or rifampin (Rimactane, Rifadin, Rifamate, Rifater).

TYVASO can cause serious side effects, including low blood pressure (symptomatic hypotension) and bleeding problems, especially in people who take blood thinners (anticoagulants).

The most common side effects of TYVASO are cough, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), fainting or loss of consciousness, dizziness, and diarrhea. These are not all the possible side effects of TYVASO. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

The risk information provided here is not comprehensive. To learn more about TYVASO, talk with your healthcare provider. Please see Full Prescribing Information, Patient Product Information, and the TD-100 and TD-300 TYVASO Inhalation System Instructions for Use manuals at www.TYVASO.com or call 1-877-UNITHER (1-877-864-8437).

FAQS Answered By A TYVASO Patient

Get answers firsthand from a fellow PAH patient and TYVASO user.

FAQS ANSWERED BY A TYVASO PATIENT

[VIDEO DURATION 09:27]

VO=voiceover.

LA=live action.

VO:

Frequently asked questions about TYVASO.

LA/MARLA:

Hello, my name is Marla, and I’ve been on TYVASO therapy for a few years now.

Knowing firsthand what it's like living with PAH, I just want to share the perspective of someone who’s walked the same path.

VO:

As you know, PAH is high blood pressure in the arteries of the lungs. It’s caused by excess cells and platelets building up in the artery lining and decreasing blood flow from the heart to the lungs.

And it causes symptoms that make daily activities harder.

LA/MARLA:

Some people can be helped by adding TYVASO, and I’m one of them.

Let me share with you some frequently asked questions I often get about TYVASO.

The first question I get is: “What is TYVASO?”

VO/MARLA:

TYVASO is a prostacyclin analogue therapy that’s inhaled directly into the lungs. It’s for people already on a background oral therapy with an ERA or a PDE-5 inhibitor who need to improve their ability to exercise.

People living with PAH have too little prostacyclin in their bodies.

TYVASO mimics the effects of natural prosta­cyclin in the body, helping to keep the pulmonary arteries open and working properly.

VO:

What is TYVASO?

TYVASO (treprostinil) is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH; WHO Group I), which is high blood pressure in the arteries of your lungs. TYVASO can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO. It is not known if TYVASO is safe and effective in children under 18 years of age.

LA/MARLA:

People ask me: “How do I inhale TYVASO?”

TYVASO comes with a portable handheld device that delivers the medicine directly to your lungs.

VO/MARLA:

Once daily, you will set up the device. Your Specialty Pharmacy Services nurse will show you how, and they'll stay in touch with you during the first few weeks of treatment.

You’ll inhale TYVASO 4 times a day, so it helps to link treatments to daily activities.

During each session, you will take a series of breaths through the mouthpiece.

My doctor started me with 3 breaths and increased my dose based on how I tolerated TYVASO, until I reached a target dose of 9 breaths per treatment session.

Your doctor will determine the amount of breaths that are right for you. A typical session should take 2-3 minutes. And, remember, you'll do this 4 times a day.

LA/MARLA:

Once you get used to it, you’ll find it fits into your daily routine.

People also want to know: “What side effects are associated with TYVASO?”

VO/MARLA:

Some people do experience side effects. If you do have side effects, your doc­tor or Specialty Pharmacy Services nurse are there to help.

The most common side effects seen with TYVASO are coughing, headache, throat irritation and pain, nausea, reddening of your face and neck (flushing), fainting or loss of consciousness, dizziness, and diarrhea.

TYVASO increases the risk of bleeding, partic­ularly if you take blood thinners.

Or, if you have low blood pressure, TYVASO may lower your blood pressure further.

These are not all of the possible side effects with TYVASO.

If you have any side effects that bother you or don’t go away, speak to your doctor so you can get help.

He or she may want you to bring your device to your office visit, or have a Specialty Phar­macy Services nurse visit you to check that you are using the device correctly.

You’ll also find helpful suggestions on the TYVASO website.

LA/MARLA:

Of course, the main question for all of us is: “I just want to see an improvement; will TYVASO help me?”

VO/MARLA:

Well, in a clinical trial, patients who added TYVASO to their background oral therapy (bosentan or sildenafil) increased their exercise ability by an average of 71 feet or about 21-and-a-half meters.

Some people find they’re able to walk a bit further, do a little more.

LA/MARLA:

That’s how it’s helped me.

VO/MARLA:

What support will I receive once I have been prescribed TYVASO?

Once your healthcare provider has put you on TYVASO, you will be contact­ed by a Specialty Pharmacy.

The Specialty Pharmacy will let you know when to expect your TYVASO shipment to arrive and make an appointment for a Specialty Pharmacy Services nurse to come to your house to show you how to use it.

The nurse will set up a schedule of visits and follow-up phone calls to make sure you are comfortable using TYVASO.

Also, check the TYVASO website for other programs sponsored by United Therapeutics that you may find useful.

LA/MARLA:

Another important question is: “How often do you take it?”

Of course you want to know how TYVASO will fit into your life.

VO/MARLA:

TYVASO is taken 4 times a day.

An easy way to remember is to link these sessions to other things you do every day.

Your doctor will prescribe the number of breaths that you will take during each of your 4 treatment sessions.

If you are at home for the day, you only have to set up your unit once in the morning. But if you are traveling or on the go, it is easy to disassemble and reassemble.

LA/MARLA:

Last question: “How do I care for the Inhalation System?”

VO/MARLA:

At the end of each day, you'll need to go through a process of taking apart the unit and washing the various accessories.

Once you get used to it, this usually takes about 5 minutes.

Once a week, use a lint-free cloth to wipe out the inside of the inhalation device chamber.

And once a month, you’ll get a set of new ac­cessories, along with your TYVASO Refill Kit.

LA/MARLA:

If you’re like me, you’ll soon get into a routine.

And, remember, if you have any questions, call your doctor or Specialty Pharmacy and they will be happy to help you!

I hope TYVASO will help you…as it’s helped me!

VO:

What is TYVASO?

TYVASO (treprostinil) is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH; WHO Group I), which is high blood pressure in the arteries of your lungs. TYVASO can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO. It is not known if TYVASO is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

Before you take TYVASO, tell your healthcare provider about all your medical conditions, including if you have lung disease or infection, liver or kidney problems, low blood pressure, or bleeding problems. If you are pregnant, plan to become pregnant, or breast-feeding, tell your doctor. It is not known if TYVASO will harm your unborn baby or if it passes into breast milk.

Tell your healthcare provider about all the medicines you take, as TYVASO and other medicines may affect each other. Especially medicines used to treat high blood pressure or heart disease, or that decrease blood clotting (anticoagulants), water pills (diuretics), gemfibrozil (Lopid) or rifampin (Rimactane, Rifadin, Rifamate, Rifater).

TYVASO can cause serious side effects, including low blood pressure (symptomatic hypotension) and bleeding problems, especially in people who take blood thinners (anticoagulants).

The most common side effects of TYVASO are cough, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), fainting or loss of consciousness, dizziness, and diarrhea. These are not all the possible side effects of TYVASO. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

The risk information provided here is not comprehensive. To learn more about TYVASO, talk with your healthcare provider. Please see Full Prescribing Information, Patient Product Information, and the TD-100 and TD-300 TYVASO Inhalation System Instructions for Use manuals at www.TYVASO.com or call 1-877-UNITHER (1-877-864-8437).