Tyvaso DPI (Treprostinil): Uses, Side Effects and Dosage

Parts of the TYVASO DPI Inhaler

(see Figure A )

Your Starter Kit includes a Carrying Case

(see Figure B )

TYVASO DPI Blister Cards

(see Figure C )

This Instructions for Use contains information on how to inhale TYVASO DPI (treprostinil) Inhalation Powder. Read this Instructions for Use carefully before you start using your inhaler and each time you get a new inhaler. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Your healthcare provider should show you how to use your inhaler the right way before you use it for the first time.

Figure A

Figure C

Figure B

• Take TYVASO DPI exactly as prescribed by your healthcare provider.
• Take TYVASO DPI 4 times per day while you are awake, about 4 hours apart.
• If you miss a dose, take it as soon as possible at your usual dose.
• If your prescribed dose is higher than 80 mcg per treatment session, you will need to use more than 1 cartridge. If using more than 1 cartridge, the cartridges can be used in any order, regardless of cartridge strength.
• If you need to use more than 1 cartridge for your dose, remove the used cartridge from the inhaler before getting a new one. You can tell a cartridge has been used when the cartridge cup has moved from the front to the middle position in the cartridge base.
• Only TYVASO DPI cartridges should be used with the TYVASO DPI Inhaler.
• Each cartridge is for 1 time (single use) only. Use a new cartridge for each treatment session. After each treatment session, throw away the used cartridge right away.
• Do not open the cartridges. The inhaler opens the cartridge automatically during use.

• Warning: If any powder from the cartridge spills on your hands, throw away the cartridge right away into regular household trash and wash your hands.

  Then start with a new cartridge.

• Do not breathe in the TYVASO DPI treprostinil powder in any other way.
• Do not put cartridges in your mouth.
• Do not swallow cartridges.
• Use only 1 inhaler at a time. The same inhaler should be used even when needing to use more than 1 cartridge for your dose. Inhale 1 cartridge at a time.
• The inhaler lasts for 7 days. After 7 days of use, throw away your used inhaler and get a new one.
• Store the inhaler in a clean, dry place with the mouthpiece cover on until your next dose.

TYVASO DPI cartridges come in 5 strengths (see Figure D ).

Important: Always make sure you have the right number of TYVASO DPI cartridges for your dose before you start. Only use TYVASO DPI cartridges with the TYVASO DPI Inhaler.

Figure D

Store TYVASO DPI Inhalers, with the mouthpiece on, in a clean, dry place at room temperature between 68°F to 77°F (20°C to 25°C), such as a drawer or medicine cabinet (see Figure E ).

Inhalers may be stored in the refrigerator between 36°F to 46°F (2°C to 8°C), but should be left out at room temperature for 10 minutes before use.

Store unopened blister cards and strips in a clean, dry place at room temperature, such as a drawer or medicine cabinet. You can store in the carrying case when using outside your home or traveling (see Figure F ).

• Do not use after 8 weeks if stored at room temperature.

Unopened blister cards and strips may also be stored in the refrigerator (see Figure G ).

Figure F

Store opened blister strips in a clean, dry place at room temperature (see Figure H ), such as a drawer or medicine cabinet.

Opened blister strips must be used within 3 days.

• Do not put a blister strip back into the refrigerator after being opened or stored at room temperature.

• Do not leave or store cartridges in the inhaler.

  Keep out of the reach of children.

• Do not use after the Expiration Date has passed.

Figure E

ROOM TEMPERATURE

10 mins.

Select the TYVASO DPI cartridges for your dose (see Figure I ).

• Note: If using more than 1 cartridge, the cartridges can be used in any order, regardless of cartridge strength.

Figure J

Check the expiration date on the foil strip label (see Figure K ).

• Do not use the cartridges if the Expiration Date on the strip has passed.

If your prescribed TYVASO DPI dose is 16 mcg, use...

If your prescribed TYVASO DPI dose is 32 mcg, use...

If your prescribed TYVASO DPI dose is 48 mcg, use...

If your prescribed TYVASO DPI dose is 64 mcg, use...

If your prescribed TYVASO DPI dose is 80 mcg, use...

Figure K

If your prescribed TYVASO DPI dose is more than 80 mcg per treatment session, you will need to use more than 1 cartridge to get the right dose.

Example: If your prescribed TYVASO DPI dose is 96 mcg per treatment session, you can use...

Figure I

• Remove cartridge(s) from the strip by pushing on the white plastic to push the cartridge out (see Figure L ).

  Note: Pushing on the cup will not damage the cartridge.

• Make sure to remove the right number of cartridges for your dose.

• After you have removed a cartridge (or cartridges) from the strip, if any unused cartridges remain in the strip, store the strip at room temperature.

  Do not put a blister strip back into the refrigerator after being opened.

Figure L

ROOM TEMPERATURE

10 mins.

Place Inhaler on Flat Surface

Place the inhaler on a flat surface (see Figure M ).

Open Inhaler

Open the inhaler by lifting the mouthpiece to an upright (vertical) position (see Figure N ).

Important: If the cartridge came from a strip stored in the refrigerator (or if you stored the inhaler in the refrigerator), leave the cartridge and inhaler at room temperature for 10 minutes to remove condensation.

Place Cartridge in Inhaler

• Hold the cartridge with the cup facing down (see Figure O ).

• Line up the cartridge with the opening in the inhaler.

  The pointed end of the cartridge should line up with the pointed end in the inhaler (see Figure P ).

• Place the cartridge into the inhaler so that it lies flat.

Figure M

Figure N

Figure O

Figure P

Close Inhaler

Close the inhaler (this will open the cartridge). You should feel a snap when the inhaler is closed (see Figure Q ).

Important: Now that the cartridge is loaded, keep the inhaler level to avoid loss of the TYVASO DPI powder, until it is in your mouth (see Figure R ).

If any powder from the cartridge spills:

• Wash your hands right away if the powder comes into contact with your hands,
• Throw away the cartridge into household trash, and
• Repeat Steps 4, 5, and 6 to load a new cartridge

Figure Q

Figure R

DO NOT turn inhaler upside down.

DO NOT point the mouthpiece down.

DO NOT shake or drop the inhaler.

Remove the Mouthpiece Cover (see Figure T ).

Important: Keep the inhaler level during and after removal of the blue mouthpiece cover to prevent loss of TYVASO DPI powder.

Hold Inhaler Near Cheek

While keeping the inhaler level, carefully pick up the inhaler and bring it near your cheek, but not in front of your mouth (see Figure U ).

Exhale

Holding the inhaler away from your mouth, fully blow out (exhale) (see Figure V ).

Figure T

Figure U

Figure V

Position Inhaler in Mouth

• Keeping your head level, place the mouthpiece in your mouth and close your lips around the mouthpiece to form a seal.

• Tilt the inhaler slightly downward while keeping your head level (see Figure W ).

  • Note: This helps prevent the powder from being blocked by your tongue.

Inhale Deeply, Hold Breath, then Exhale

• With your mouth closed around the mouthpiece, inhale deeply through the inhaler (see Figure X ).
• Then remove the inhaler from your mouth and hold your breath for as long as you comfortably can (see Figure Y ).
• Then blow out (exhale) and continue to breathe normally (see Figure Z ).

Figure W

Figure X

Figure Y

Figure Z

Replace Mouthpiece Cover

Place the mouthpiece cover back onto the inhaler (see Figure AA ).

• Note: This keeps your fingers off the exposed mouthpiece.

Open Inhaler

Open the inhaler by lifting up the mouthpiece to an upright (vertical) position (see Figure AB ).

Remove Cartridge

• Remove the used cartridge from the blue base (see Figure AC ).

• The cup should now be in the middle of the used cartridge (see Figure AD ).

  • Warning: If any powder from the cartridge spills on your hands, wash your hands right away.

Figure AA

Figure AB

Figure AC

Figure AE

• Example: If your prescribed TYVASO DPI dose is 96 mcg per treatment session, you can use one 32 mcg cartridge and one 64 mcg cartridge (see Figure AF ):

Figure AF

Cleaning

After taking your dose, powder residue in the mouthpiece is normal; this will not affect your dose.

Use Time

Only use 1 inhaler at a time.

The same inhaler can be used to take 16 mcg, 32 mcg, 48 mcg, 64 mcg, or 80 mcg cartridges.

The outside of the inhaler can be wiped with a clean, dry cloth only, if needed.

Never wash the inhaler.

Always keep the inhaler dry.

Figure AI

Figure AH