Tyvaso DPI: Package Insert and Label Information (Page 3 of 4)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Instructions for Use).

Train patients in the administration process for Tyvaso DPI, including dosing, Tyvaso DPI Inhaler setup, operation, cleaning, and maintenance, according to the instructions for use [see Dosage and Administration (2.1, 2.2)].

Advise patients that after 7 days of use, the inhaler must be discarded and replaced with a new inhaler [see Dosage and Administration (2.1)].

Instruct patients to use Tyvaso DPI only with the Tyvaso DPI Inhaler [see Dosage and Administration (2.1)].

If a scheduled treatment session is missed, resume therapy as soon as possible [see Dosage and Administration (2.2)].

© Copyright 2022 United Therapeutics Corp. All rights reserved.
Tyvaso DPI™ and Tyvaso® are trademarks of United Therapeutics Corporation.

Tyvaso DPI manufactured by:

MannKind Corporation
Danbury, CT 06810

Tyvaso DPI manufactured for and distributed by:

United Therapeutics Corp.
Research Triangle Park, NC 27709

Instructions
for Use

TYVASO [ tī-vā’-sō ] DPI™
(treprostinil) Inhalation Powder For oral inhalation only

Table of Contents
page(s)
Read Before Starting 1
Important Information 2
Storing TYVASO DPI Inhalers and Cartridges 3
Preparing to Inhale TYVASO DPI 4-7
Inhaling TYVASO DPI 8-9
Removing the Used Cartridge 10
Disposing of TYVASO DPI Cartridge 11
Inhaling Multiple Cartridges of TYVASO DPI 12
Caring for Your TYVASO DPI Inhaler 13
Disposing of Your TYVASO DPI Inhaler 13

Read Before Starting

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
(click image for full-size original)
Figure A
The TYVASO DPI inhaler and blister strips can be stored in the carrying case when using outside of your home or traveling.Figure CFigure C
Figure BFigure B

Important Information

Important information you need to know before inhaling TYVASO DPI Inhalation Powder using the TYVASO DPI Inhaler
  • 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 64 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 4 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
(click image for full-size original)
Figure D
If you are having problems with your TYVASO DPI Inhaler, have any side effects, or if your TYVASO DPI Inhaler breaks and you need a new one, please call 1-877-UNITHER (1-877-864-8437).

Storing TYVASO DPI Inhalers and Cartridges

Storing TYVASO DPI InhalersStoring Unopened Blister Cards and StripsStoring Opened Blister Strips
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 5 weeks if stored at room temperature.
Figure G).
Figure FFigure 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 HFigure H
Figure EFigure E Important: If refrigerated, cartridges and inhaler should be left out at room temperature for 10 minutes before use.Figure GFigure G
ImageROOM TEMPERATURE Image10 mins.

Preparing to Inhale TYVASO DPI

Step 1 : Select the TYVASO DPI cartridges for your dose (see Figure I)Step 2 : Tear off 1 strip Step 3 : Check the expiration date on the strip
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.
Tear along the perforation to remove 1 strip from the blister card (see Figure J).
Figure J
(click image for full-size original)
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…ImageIf your prescribed TYVASO DPI dose is 32 mcg, use…ImageIf your prescribed TYVASO DPI dose is 48 mcg, use…ImageIf your prescribed TYVASO DPI dose is 64 mcg, use…ImageFigure KFigure K
If your prescribed TYVASO DPI dose is more than 64 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 80 mcg per treatment session, you can use…
Figure IFigure I
Step 4 : Remove cartridge(s) from stripStep 5 : Check supplies before continuing
  • 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.
ImageCheck that you have the right cartridge(s) for your dose.
ImageOnly use one inhaler for multiple cartridges. Your inhaler lasts for 7 days.

Figure L

Figure L
Important: If refrigerated, cartridges and inhaler should be left out at room temperature for 10 minutes before use.ImageROOM TEMPERATURE Image10 mins.
Step 6: Load a cartridge
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 MFigure M
Figure NFigure N Figure OFigure O Figure PFigure 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).Not keeping the inhaler level could cause a loss of TYVASO DPI powder (see Figure S)
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 QFigure Q Figure RFigure R Image DO NOT turn inhaler upside down.Image DO NOT point the mouthpiece down.Image DO NOT shake or drop the inhaler.
This can cause a loss of TYVASO DPI powder.
Figure S

Inhaling TYVASO DPI

Before inhaling TYVASO DPI, fully review all parts of Step 7 before you take your dose.

Step 7: Inhale Your Dose
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 TFigure T
Figure U
(click image for full-size original)
Figure U
Figure VFigure 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 WFigure W Figure XFigure X Figure YFigure Y Figure ZFigure Z

Removing the Used Cartridge

Step 8 : Remove the used cartridge
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 AAFigure AA Figure ABFigure AB Figure ACFigure AC Figure AD
The cup moves to the middle of the cartridge when it has been used.
Figure AD

Disposing of TYVASO DPI Cartridges

Step 9 : Throw away used cartridge
Throw away the used cartridge in your regular household trash (see Figure AE).
Figure AEFigure AE

Inhaling Multiple Cartridges of TYVASO DPI

Step 10 : Inhaling multiple cartridges (skip if not needed)
If your dose requires you to inhale multiple cartridges, repeat steps 6 through 9 for each cartridge.Warning: Be careful not to mix NEW cartridges with used cartridges (see Figure AG).
Example: If your prescribed TYVASO DPI dose is 80 mcg per treatment session, you can use one 32 mcg cartridge and one 48 mcg cartridge (see Figure AF):
Figure AG
The cup moves to the middle of the cartridge when it has been used.
Figure AF
(click image for full-size original)
Figure AF
Figure AG
Caring for Your TYVASO DPI InhalerDisposing of Your TYVASO DPI Inhaler
Inhaler Care Instructions Throw away used inhaler after 7 days of use
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, or 64 mcg cartridges.After 7 days of use, throw away the used inhaler in your regular household trash (see Figure AH and Figure AI).
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.Replace the inhaler after 7 days (see Figure AH and Figure AI). Keep track of 7 days from when you start using the inhaler with a calendar.

Figure AI

Figure AI

Figure AH

Figure AH

For further questions and information, or to report a problem with your device or any side effects with your TYVASO DPI, please call 1-877-UNITHER (1-877-864-8437).

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Issued: May 2022

TYVASO DPI™ is a trademark of United Therapeutics Corporation.

Patents: www.tyvasodpi.com/patent

Distributed by:
United Therapeutics Corporation
Research Triangle Park, NC 27709
USA

Manufactured by:
MannKind Corporation
Danbury, CT 06810
USA

05/2022
30-1311-006-01

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