Yutrepia (Treprostinil sodium): Uses, Side Effects and Dosage

Important information you need to know before inhaling YUTREPIA inhalation powder:

• Do not swallow YUTREPIA capsules. YUTREPIA is for inhalation only.
• Use YUTREPIA as prescribed by your healthcare provider.
• YUTREPIA capsules come in 4 strengths: 26.5 mcg, 53 mcg, 79.5 mcg, and 106 mcg.
• If your prescribed dose is more than 106 mcg, you will need to inhale 2 YUTREPIA capsules. See Figure C: Dosing Chart to help you identify the 2 capsules needed for your prescribed dose. Only use the capsule combinations in the Dosing Chart when your prescribed dose is more than 106 mcg.
• The capsule must be inhaled within 5 minutes of opening the blister card or the full dose may not be administered. Read through this instruction sheet prior to the first use of this product.
• Always inhale each capsule 2 times to make sure you get your full dose of YUTREPIA.
• Do not wash the inhaler. Keep the inhaler dry.
• Wash and dry your hands before using YUTREPIA.
• If the contents of the capsule comes in contact with your skin or eyes, rinse the area immediately with water.
• YUTREPIA capsules should remain in the blister card(s) and each capsule should be removed only when ready to deliver a dose.

Storing YUTREPIA

• Store YUTREPIA carton in a clean, dry place at room temperature between 68°F to 77°F (20°C to 25°C).
• Leave YUTREPIA capsules in blister card to protect from moisture and light.
• Throw away the inhaler after 7 days of use or 56 capsules whichever comes first.
• Keep YUTREPIA and all medicines out of the reach of children.

The YUTREPIA carton contains (See Figure A):

• 1 dry powder inhaler (called “inhaler” in these instructions)
• 7 Foil blister cards of YUTREPIA capsules (called “capsules” in these instructions) containing 4 capsules each, in one of 4 available strengths
• 7 Cleaning brushes (1 for each day)
• 1 Desiccant tab within each blister strip to keep the capsule dry and prevent moisture. Throw away the blister strip and the desiccant tab after removing the capsule.

The capsule must be inhaled within 5 minutes of opening the blister card. Ensure all supplies are gathered and you are familiar with the use of the product prior to opening the card.

STEP 1. Gather your supplies.

1. a. Place your YUTREPIA carton on a clean, dry surface.
2. b. Remove the inhaler and foil blister cards from the carton (See Figure B).

STEP 2. Select the capsule(s) for your dose.

Use the Dosing Chart (See Figure C) to help you identify the capsule(s) needed for your prescribed dose.

• If your prescribed dose is more than 106 mcg, you will need to inhale 2 capsules per the Dosing Chart (see Figure C).
• Only load and inhale 1 capsule at a time.
• All capsules in a carton are the same strength. If your prescribed dose requires 2 capsules of different strengths, you will need to select your capsules from 2 separate cartons.

IMPORTANT: For doses requiring 2 capsules, only use the capsule combinations presented in the Dosing Chart (See Figure C). The order for inhaling 2 capsules does not matter, regardless of capsule strength.

STEP 3. Check the inhaler and blister card(s).

1. a.

   Look at the inhaler and blister card(s) to make sure they are not damaged (See Figure D).

   Do not use the inhaler or capsules if they are damaged.

2. b.

   Look at the expiration date on the blister cards to make sure it has not passed (See Figure E).

   Do not use the capsules if the expiration date has passed.

STEP 4. Open the inhaler.

1. a. Pull the cover straight off the inhaler (See Figure F).
2. b.

   Rotate the mouthpiece in the direction of the arrow (counter-clockwise) to open the inhaler and expose the capsule chamber (See Figure G).

   If the mouthpiece separates from the base of the inhaler, gently reattach the 2 pieces and continue to follow the instructions.

STEP 5. Remove the capsule from the blister strip.

1. a.

   Separate 1 blister strip by tearing at the pre-cut lines (See Figure H).

   Do not remove a capsule from the blister strip until you are ready to deliver your dose.

2. b.

   Peel the foil away from the blister strip, remove the capsule (See Figure I).

   Do not swallow the capsule.

   Do not push the capsule through the foil.

   Do not remove the desiccant tab.

   Capsule must be used within 5 minutes of opening the blister card.

STEP 6. Secure the capsule in the inhaler.

1. a. Hold the inhaler in an upright position.
2. b.

   Place the capsule in the capsule chamber in the base of the inhaler (See Figure J). Only load 1 capsule.

   Do not place a capsule in the mouthpiece.

   Do not swallow capsules.

STEP 7. Puncture the capsule.

1. a. Put one finger on top of the capsule to hold it down (See Figure K).
2. b.

   While still holding down the capsule, firmly press both puncture buttons all the way in with your other hand (See Figure L).

   Then let go of (release) the puncture buttons.

   This will puncture the capsule. You only need to press the puncture buttons 1 time.

3. c.

   Hold the base of the inhaler and

   rotate the mouthpiece to close it.

STEP 8. Position the inhaler.

1. a.

   Hold the inhaler upright and away from your mouth. (See Figure M).

   Do not hold the inhaler by the puncture buttons.

STEP 9. Breathe out (exhale).

1. a.

   Breathe out fully and away from the inhaler (See Figure N).

   Do not exhale into the mouthpiece.

STEP 10. Breathe in deeply (inhale)

1. a. Close your lips around the mouthpiece (See Figure O).
2. b. Tilt your head back slightly (See Figure O).
3. c.

   Take a comfortable deep breath in (inhale) until your lungs feel full (See Figure O).

   As you inhale, you will hear or feel a whirring noise as the capsule spins and releases medicine.

STEP 11. Hold breath, then breathe out (exhale).

1. a. Take the inhaler out of your mouth and hold your breath for 5 seconds or as long as you comfortably can (See Figure P).
2. b. Then breathe out normally.

IMPORTANT: If you cough when inhaling, repeat STEP 8 through11.

STEP 12. Inhale again.

1. a.

   To make sure the capsule is completely emptied of medicine, repeat STEP 8 through11 (See Figure Q).

   Always inhale each capsule 2 times to make sure you get your full dose.

STEP 13. Open the inhaler.

1. a. Rotate the mouthpiece in the direction of the arrow (counter-clockwise) to open the inhaler and expose the capsule chamber (See Figure R).
2. b. Remove the used (empty) capsule and throw away (dispose of) into household trash (See Figure S).
3. c. See box below if you need to use more than 1 capsule to complete your prescribed dose.
4. d. Continue to Step 14 if you have completed your prescribed dose.

STEP 14. Close the inhaler.

1. a. Hold the base of the inhaler and rotate the mouthpiece to close it (See Figure T).
2. b. Put the cover on the inhaler (See Figure U).
3. c. Store the inhaler in a clean, dry place at room temperature.

Clean the outside and inside of the inhaler after your last dose of the day.

1. a. Wipe the mouthpiece with a dry paper towel, tissue, or clean dry cloth (See Figure V).
2. b.

   Use the cleaning brush provided to clean the capsule chamber in order to remove visible powder buildup (See Figure W).

   NOTE: Throw away the brush after cleaning. Use only 1 brush each day.

Throw away (dispose of) the inhaler into household trash after 7 days of use.

1. a.

   The inhaler is reusable and will last for 7 days (1 week) or 56 capsules, whichever comes first.

   (See Figure X).