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Full Prescribing

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TYVASO is a medication you inhale directly to your lungs. TYVASO is inhaled during 4 short treatment sessions each day.

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TYVASO is delivered through a portable inhalation system.




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.

TYVASO Can Go Wherever Your Day Takes You

The portable TYVASO device allows for dosing at home or on the go.

  • Set up device once a day

  • Each treatment session takes about 2 to 3 minutes

  • Plan for treatment sessions approximately every 4 waking hours

  • Clean device once a night

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Tyvaso fits into your routine.
Tyvaso fits into your routine.

Getting Started and Reaching Your Target Dose

Most people start with 3 breaths, 4x daily and increase the number of breaths every week to a target dose of 9 breaths, 4x daily.

It took patients in the clinical study an average of 3 weeks to reach their target dose.It took patients in the clinical study an average of 3 weeks to reach their target dose.

Reaching your target dose is important so you’ll feel the most benefit from the medicine.

Your doctor will work with you to increase the breaths per treatment session until you reach your target dose, to help you feel better sooner. Click the link below to learn more about managing potential side effects.

TYVASO Treatment Tracker

Your personal diary for keeping track of your treatment sessions. See how TYVASO fits into your daily life.

You May Have Side Effects

Talk to your healthcare provider and click below to learn more about potential side effects.

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