The TYVASO Inhalation System should be handled with care.
Follow these important instructions to ensure proper use:
Introduction
Your doctor has prescribed TYVASO® (treprostinil) Inhalation Solution. Please see the accompanying Patient Package Insert for important safety information on TYVASO.
TYVASO is breathed in (inhaled) using the TYVASO Inhalation System, which consists of the inhalation device and its accessories.
These Instructions for Use (IFU) for the TYVASO Inhalation System provide important safety information. It is important that you read these instructions and the TYVASO Patient Package Insert (PPI) before setting up and using the TYVASO Inhalation System. If you have any questions, talk to your doctor or specialty pharmacy provider.
Before beginning treatment with TYVASO, you will receive either a Patient Starter Kit containing a 28-day supply of TYVASO or an Institutional Starter Kit containing a 4-day supply of medication. Both kits include two (2) complete inhalation devices (all accessories and supplies included). When you refill your prescription for TYVASO each month, you will receive a Refill Kit that contains a 28-day supply of TYVASO and new accessories. You will receive a replacement device every two (2) years.
Follow these important instructions before setting up your treatment:
Gather the following supplies before starting treatment. Use only the parts and accessories that are provided with your starter kit or in the monthly refill kit. Note: supplies are not shown to scale.
Setting Up Your TYVASO Inhalation System
Filling the Inhalation Device Chamber and Medicine Cup
Before using the TYVASO Inhalation System, you should:
ONLY USE DISTILLED WATER in the device. Distilled water is highly purified water that can be purchased at most grocery stores and pharmacies. It is necessary for the device to function properly. If you use another type of water (such as bottled or tap water), the device may not function properly.
1
Fill the white chamber inside the device with approximately 45 mL of distilled water (about 1.5 ounces), using the water level cup provided. Fill the cup until water level is between the two arrow markings.
There is a silver sensor on the inside wall of the chamber. The water level should be above the silver sensor and below the blue ring in the device chamber. DO NOT OVERFILL the chamber, or the medicine cup will not fit correctly. Check the water level after filling the chamber.
2
Obtain one (1) medicine cup and inspect it for any damage, holes, cracks, or dents. Do not use the medicine cup if it is damaged.
Insert the empty medicine cup into the chamber of the device, making sure that the cup's bottom tip is in the distilled water. The cup will sit on the blue ring.
3
Carefully cut open the top of the foil pouch, making sure not to cut the ampules. Each pouch contains four (4) ampules.
Remove one (1) ampule of TYVASO. Keep unused ampules in the foil pouch because the TYVASO medicine is sensitive to light.
One (1) ampule contains enough medicine for one (1) day of treatment no matter how many breaths your doctor has prescribed.
4
Gently hold the ampule in the upright (topup) position and twist off its top.
5
Point the ampule straight down toward the medicine cup's center to avoid spills.
Gently squeeze the medicine out of the ampule into the medicine cup. Squeeze until it is empty. Check to see that all of the medicine is in the medicine cup.
Assembling the Inhalation Device
The TYVASO Inhalation System is designed so the parts only fit together properly one way.
When the device is assembled correctly, the parts should fit together easily.
Do not force the parts together.
1
Visually check to make sure the blue plastic baffle plate and black ring are correctly placed in the dome assembly. They should appear as they do in the images below.
In the unlikely event that the baffle plate is loose or disconnected, use a new dome assembly. If you need to order a new dome assembly, contact your specialty pharmacy provider.
2
Align the raised circle on the side of the dome assembly with the circle on the side of the device. Push down and screw the dome assembly onto the device clockwise (right) until you hear a click, indicating the dome assembly is fully connected to the medicine cup. When the dome assembly is properly aligned, the filter shell port will point to the back of the device.
3
Insert the inhalation piece into the upper opening of the dome assembly and rotate toward the front of the device. Gently push down the inhalation piece to make sure it is securely inserted in the dome assembly.
4
Insert the mouthpiece into the inhalation piece.
5
Each day you will need to use a new filter membrane in each filter shell.
To install a new filter membrane:
Note: New filter shells come with fresh filter membranes already installed.
6
Insert one (1) of the filter shells into the filter shell port on the side of the dome assembly and insert the other filter shell into the port on the bottom of the inhalation piece. The two (2) filter shells are identical and can be used in either opening.
Make sure to insert the filter shells straight into their ports, rather than at an angle. If necessary, rotate the inhalation piece so you can insert the filter shell without the device getting in the way.
7
When the device is fully assembled, it should appear as it does in the photo below.
For convenience, rotate the inhalation piece so you can best see the indicator lights and display screen, which provide important prompts during your treatment.
Turning On the Inhalation Device
1
Connect your device to one (1) of the power source options by plugging one end of the power cord into the back of the inhalation device and the other end into the power source.
If using the AC wall plug, make sure to plug the output cable into the device before plugging adapter into the power source.
If using the rechargeable battery, make sure it is not also plugged into the AC wall plug.
2
To turn on the device, press and hold the ON/OFF button for approximately three (3) seconds. When you hear a short beep and the yellow status light is illuminated, release the ON/OFF button. Remember to press the center of the ON/OFF button when powering the device on or off.
When the power is on, the display screen will show the last number of breaths programmed and a yellow light will appear next to the screen.
Make sure the number matches the prescribed number of breaths for that treatment session. If it does not match, see the next page for instructions on setting the number of breaths in a treatment session.
Setting the Number of Breaths in a Treatment Session
You will inhale TYVASO during four (4) treatment sessions each day. During each treatment session, you will take a series of breaths through the mouthpiece of the TYVASO Inhalation System.
Your doctor will prescribe the number of breaths you should inhale in each treatment session.
You should record the number of breaths in your Treatment Tracker.
1
Make sure the device is powered off. To power off the device, press and hold the ON/OFF button for three (3) seconds. When you hear a short beep and the display screen turns off, release the ON/ OFF button.
To set the number of breaths, press and hold both the START/STOP and ON/OFF buttons at the same time until the display flashes and the device emits three (3) short beeps.
The flashing display indicates the inhalation device is in breath programming mode. You cannot begin a treatment while the display is flashing.
3
Once you have entered your prescribed number of breaths, remove your hands from the device and wait approximately 15 seconds.
After approximately 15 seconds, the display will stop flashing and the device will emit three (3) short beeps, indicating that it has saved the new number of breaths. The new number of breaths will appear on the display.
Make sure the number of breaths on the display matches the number of breaths in your prescription. If the numbers do not match, repeat steps 1-3.
Inhaling Your Medicine, TYVASO® (treprostinil) Inhalation Solution
You will inhale TYVASO during four (4) treatment sessions each day. During each treatment session, you will take a series of breaths through the mouthpiece of the TYVASO Inhalation System.
When breathing each TYVASO treatment, be sure to keep the device level, directing the flow of medicine into the throat and not toward the roof of the mouth.
Seal your lips around the mouthpiece to ensure that you can inhale the full amount of TYVASO after it is produced by the device.
Inhalation:
Each breath should last approximately three (3) seconds, breathing "normal full breaths." Do not hold your breath. Exhale normally and prepare for the next breath.
1
Hold the device upright as shown below. Make sure you can see the display screen and lights clearly and that your hands do not cover the display screen or lights while holding device. If the inhalation piece or mouthpiece block your view of the display screen or lights, move the inhalation piece so you can best see them.
2
Perform steps A-G to complete one (1) treatment session.
Follow the instructions exactly to make sure you receive the correct medication dose.
3
To pause the treatment between breaths, press the START/STOP button. The display screen will show "PA."
To resume treatment, press START/ STOP again. "PA" will disappear and the display screen will show the number of breaths remaining.
If the device is disconnected from its power source for any reason (for example, a power failure), reconnect the device to a power source. Follow the instructions on page 13 to turn on the device. The display will show how many breaths are left in that treatment session. Press the START/STOP button to continue your treatment session.
Storing the TYVASO Inhalation System Between Treatment Sessions
If you have more treatment sessions left in the day, perform the following steps.
If you have completed your last treatment session of the day, skip to Cleaning and Maintenance of the TYVASO Inhalation System (see page 24).
Be sure to pack all parts, including a backup power supply, in the carry case whenever transporting your device.
Do NOT remove the filter membranes from filter shells until after the last treatment session of the day.
5
Leave the dome assembly and medicine cup (with the medicine still in it) connected to the device.
6
Insert a plug into each of the open holes on the dome assembly to prevent the medicine from spilling out.
7
The inhalation device with the plugged dome assembly and all the accessories can be stored in the carrying case between treatment sessions.
Cleaning and Maintenance of the TYVASO Inhalation System
3
Open the filter shells by twisting in opposite directions.
6
Remove the dome assembly by turning it counter-clockwise (to the left). The medicine cup should stay attached to the dome assembly.
7
Remove the medicine cup by gently squeezing on the sides where it is attached to the dome assembly. Empty the medicine cup into a sink or waste basket, then discard the medicine cup.
Be careful not to spill the medicine when removing or discarding the medicine cup.
8
Empty the distilled water from the chamber and let the inhalation device air dry upside down. You can wipe the chamber with a soft cloth or paper towel to collect water.
9
Clean the accessories (pictured below) by hand in mild, soapy, warm water, then rinse them thoroughly with water. Allow accessories to air dry.
10
Once all the items are dry, the filter shells, inhalation piece, mouthpiece, dome assembly, and inhalation device can be stored in the carrying case until the next day's treatment sessions.
The rechargeable battery is supplied with its own instructions for use. Refer to these instructions for more information.
TYVASO Mass and Particle Specifications for 9 breaths
Ampule: A sealed, lightweight clear plastic vial containing a 1-day supply of TYVASO® (treprostinil) Inhalation Solution.
Control light for inhalation: A green LED on the top surface of the inhalation device that signals when you should inhale.
Baffle plate: A blue plastic piece that is inside the dome assembly. The baffle plate helps turn TYVASO into particles that are the correct size to inhale.
Black ring: A round seal that fits on the bottom of the dome assembly. The seal helps ensure that TYVASO does not mix with the distilled water in the device chamber.
Display screen: A small area on the inhalation device that displays number and letter prompts to guide you through your treatment sessions.
Distilled water: Water that is highly purified so that it contains only essential elements.
Dome assembly: The plastic accessory that contains the baffle plate and connects the mouthpiece, inhalation piece, and filter shells to the base of the inhalation device.
Inhalation piece: The plastic accessory that connects the mouthpiece with the dome assembly.
Inhalation device: The base of the TYVASO Inhalation System to which the accessories connect. The inhalation device contains the display screen and lights.
Inhale: How you will breathe in TYVASO with the TYVASO Inhalation System.
Medicine cup: The disposable plastic cone-shaped cup into which TYVASO is poured. The medicine cup fits inside the inhalation device chamber.
Mouthpiece: The plastic part that you will breathe through (using your mouth) to inhale TYVASO.
ON/OFF button: A manually activated control on the front of the device that switches between fully on and fully off power states.
Plugs: Plastic accessories that are inserted into the openings of the dome assembly between treatment sessions. Plugs help keep TYVASO from spilling if the inhalation device tips over.
Prompts: The audio and visual signals that help guide you through the treatment sessions.
Sensor: The silver object on the inside wall of the device chamber. The sensor must be covered with distilled water for the TYVASO Inhalation System to function properly.
Status light: A multicolored LED on the front of the inhalation device that indicates the device's operational status.
Start/Stop treatment button: A manually activated control on the front of the device that begins or pauses treatment.
Specialty pharmacy provider: A pharmacy that carries only specialized medicines and medical devices. Your specialty pharmacy provider is a good source of information about TYVASO and the TYVASO Inhalation System.
Treatment session: One (1) of four (4) daily sessions during which you will take TYVASO with a specific number of inhalations.
TYVASO: The prescription medicine that you will use with the TYVASO Inhalation System.
Water chamber: The white hollow portion in the center of the inhalation device into which distilled water and the medicine cup are placed.
Warranty Information
Your TYVASO Inhalation System is granted a full replacement or repair warranty good for two (2) years from your date of receipt of the TYVASO Inhalation System Starter Kit or five (5) years from the date of manufacture, whichever comes first. This warranty applies to the TYVASO Inhalation System device only. Accessory components are not covered under warranty.
Circumstances that may void your warranty include:
For all inquiries relating to service or warranty for your TYVASO Inhalation System, contact your specialty pharmacy provider. You should have the following information available:
Graphics in IFU are for representation only. Images may not be shown to scale
TYVASO®
INHALATION SYSTEM
Instructions for Use
TYVASO Inhalation Solution is for prescription use only.
TYVASO is a registered trademark of United Therapeutics Corporation.
Literature Issued 2016-07-30