Tyvaso DPI (Inhalation)

Treprostinil inhalation is used to treat the symptoms of pulmonary arterial hypertension (PAH) and pulmonary hypertension with interstitial lung disease (PH-ILD) to help improve your ability to exercise. PAH is high blood pressure in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle has to work harder to pump enough blood through the lungs. Treprostinil works by blocking a hormone (a naturally occurring substance) that is found in high amounts in the blood and lungs of people with pulmonary arterial hypertension.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

It is very important that your doctor check your blood pressure regularly while you are taking this medicine. You may also need to monitor your blood pressure at home. If you notice any changes to your recommended blood pressure, call your doctor right away.

This medicine may increase the risk of bleeding. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may make you dizzy, lightheaded, or faint. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Standing up slowly from a sitting or lying position can help.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Your doctor may adjust the doses of all the medicines you are taking or monitor you carefully for side effects.

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine compared to the benefits it may provide. The following points should be considered for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how treprostinil inhalation affects children. Safety and effectiveness have not been confirmed.

Geriatric

To date, studies have not shown specific problems in older adults that would limit the use of treprostinil inhalation. However, older patients are more likely to have age-related liver, kidney, or heart issues that may require caution and a dosage adjustment when using treprostinil inhalation.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the possible benefits against the potential risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of an interaction. In these situations, your doctor may need to change the dose, or take other precautions. It is particularly important that your healthcare professional knows if you are taking any of the following medicines while using this medicine. The interactions listed below are based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Abrocitinib
• Defibrotide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Aceclofenac
• Acemetacin
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bemiparin
• Betrixaban
• Bivalirudin
• Bromfenac
• Bufexamac
• Caplacizumab-yhdp
• Celecoxib
• Certoparin
• Choline Salicylate
• Citalopram
• Clonixin
• Clopidogrel
• Curcumin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyridamole
• Dipyrone
• Droxicam
• Duloxetine
• Edoxaban
• Enoxaparin
• Eptifibatide
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Heparin
• Ibrutinib
• Ibuprofen
• Indomethacin
• Inotersen
• Ketoprofen
• Ketorolac
• Lepirudin
• Levomilnacipran
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Melphalan
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Parnaparin
• Paroxetine
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piracetam
• Piroxicam
• Pixantrone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Selumetinib
• Sertraline
• Sodium Salicylate
• Sulindac
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticagrelor
• Tinzaparin
• Tolfenamic Acid
• Tolmetin
• Trazodone
• Turmeric
• Valdecoxib
• Vilazodone
• Vortioxetine
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtimes, as certain foods may cause interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The interactions listed below are based on their potential significance and may not be all-inclusive.

Other Medical Problems

Other medical conditions may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Bleeding problems or
• Breathing problems (e.g., COPD, asthma) or
• Hypotension (low blood pressure)—Use with caution. May worsen these conditions.

• Liver disease—Use with caution. Effects may be stronger because the body may remove the medicine more slowly.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all side effects may happen, but if they do, they might need medical attention.

Check with your doctor right away if any of the following side effects happen:

More common

• Cough
• fainting
• feeling of warmth
• redness of the face, neck, arms, and sometimes, upper chest
• sore throat
• trouble breathing

Incidence not known

• Bloody nose
• chest pain or tightness
• chills
• coughing or spitting up blood
• difficulty or trouble breathing
• fever
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• sneezing
• unusual bleeding or bruising

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred vision
• confusion
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• headache
• nausea
• sweating
• unusual tiredness or weakness
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain
• constipation
• indigestion
• loss of appetite
• muscle, jaw, or bone pain
• stomach cramps, discomfort, or pain
• swollen mouth and tongue
• unpleasant taste
• urge to have a bowel movement

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Tyvaso
• Tyvaso DPI

Available Dosage Forms:

• Powder
• Solution

Therapeutic Class: Vasodilator

Pharmacologic Class: Prostaglandin

Treprostinil inhalation should be taken when you wake up and also before any physical activity, but not more than every 4 hours. Do not change your dose without talking to your doctor.

This medicine is for use in your lungs. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away with water.

Tyvaso® oral inhalation solution is breathed into your lungs with Tyvaso® Inhalation System. This system consists of the Tyvaso® Inhalation System device and its accessories. Carefully follow your doctor's instructions for using the medicine and operating and cleaning the equipment. Do not put other medicines into this equipment.

Do not drink this medicine. Do not allow the inhalation solution to come into contact with your skin or eyes. If it does, rinse it off with water right away.

To avoid missing a dose or any possible problems with the drug delivery device you are using, you should have a back-up with Tyvaso® Inhalation System device.

Tyvaso DPI™ inhalation powder should only be inhaled using the Tyvaso DPI™ Inhaler. This medicine comes with patient instructions. Read these instructions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

To use the Tyvaso DPI™ Inhaler:

• Remove the mouthpiece cover and look at the mouthpiece to make sure it is clean.
• Hold the inhaler away from your mouth, breathe out fully. Keep your head level, put the mouthpiece fully into your mouth and close your lips around it. Tilt the inhaler slightly downward to prevent your tongue from blocking the powder.
• Breathe in through your mouth quickly and deeply as you can until you have taken a full deep breath. Hold your breath for as long as you can. Then breathe out and continue to breathe normally.
• Put the mouthpiece cover back after each inhalation and lift up the mouthpiece in an upright position to open the inhaler.
• Do not rinse the inhaler. Always keep it dry.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For pulmonary arterial hypertension and pulmonary hypertension with interstitial lung disease: For inhalation dosage form (powder): Adults—At first, 16 micrograms (mcg) per treatment session at least 4 hours apart, 4 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 64 mcg per treatment session, 4 times a day. Children—Use and dose must be determined by your doctor. For inhalation dosage form (solution): Adults—At first, 18 micrograms (mcg) or three breaths, per treatment session at least 4 hours apart, 4 times a day. Each treatment session will take 2 to 3 minutes. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 12 breaths per treatment session, 4 times a day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Protect the medicine from direct light. Keep your medicine in the unopened foil pouch until you are ready to use it. Once the foil pack is opened, the ampules should be used within 7 days.

Store the unopened blister strips in the refrigerator. You may also store at room temperature for 5 weeks.

Store the opened blister strips in the refrigerator. You may remove the medicine from the refrigerator and store at room temperature for 3 days. Do not return it in the refrigerator.

Store theTyvaso DPI™ Inhaler at room temperature. You may also store it in the refrigerator but should allow the medicine at room temperature for 10 minutes before use. Throw away used inhaler after 7 days.