Tyvaso is a sterile inhalation solution that contains the active ingredient treprostinil, which acts as a prostacyclin mimetic. It is administered through oral inhalation using the Tyvaso Inhalation System. The solution is supplied in 2.9 mL ampules with each ampule containing 1.74 mg of treprostinil and key inactive ingredients such as sodium chloride, sodium citrate dihydrate, and sodium hydroxide.

How should I use this medication?

This medication is for inhalation using a nebulizer. Nebulizers make a liquid into an aerosol that you breathe in through your mouth or your mouth and nose and into your lungs. Only use with the Tyvaso Inhalation System. Do not mix this medication with other medications in the nebulizer. Take it as directed on the prescription label. Do not use it more often than directed. Keep taking it unless your care team tells you to stop.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store ampules in the unopened foil pouch at 20 to 25 degrees C (68 to 77 degrees F). Keep unopened ampules in the foil pouch. Once the foil pouch is open, use the ampules inside within 7 days. Protect from light. Do not open an ampule until you are ready to use it. Get rid of any unused medication after the expiration date.

Once the medication is put into the nebulizer, it should stay in the device for no more than 24 hours. Any unused medication in the device should be thrown away at the end of the day.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Wheezing or trouble breathing

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Cough
• Dizziness
• Facial flushing, redness
• Headache
• Irritation inside the nose or throat
• Nausea
• Sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Liver disease
• Low blood pressure
• Lung or breathing disease (asthma, COPD)
• Wheezing (trouble breathing with loud or whistling sounds)
• An unusual or allergic reaction to treprostinil, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

• Certain medications for high blood pressure or heart disease
• Gemfibrozil
• Rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.