Treprostinil Oral Inhalation

Treprostinil oral inhalation is used to treat certain kinds of pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Treprostinil oral inhalation is also used to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD; high blood pressure in the lungs resulting from a lung disease that involves inflammation and scarring of the lungs). Treprostinil may improve the ability to exercise and slow the worsening of symptoms in patients with PAH and PH-ILD. Treprostinil is in a class of medications called vasodilators and platelet-aggregation inhibitors. It works by relaxing the blood vessels, including those in the lungs, and improving blood flow.

Treprostinil oral inhalation comes in ampules that contain a solution (liquid) to inhale by mouth using a special nebulizer (a device that turns medication into a mist that can be inhaled) and in cartridges that contain a dry powder to inhale by mouth using a special inhaler. It is usually inhaled four times a day, approximately every 4 hours, during waking hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use treprostinil exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor or nurse will show you how to use treprostinil inhalation solution with your nebulizer or treprostinil inhalation powder with the special inhaler. Your doctor will also tell you how many inhalations you will need for each dose. Carefully read the manufacturer's instructions for use that comes with the medication. These instructions describe how to prepare and inhale a dose of treprostinil oral inhalation and how to use the nebulizer or inhaler. Be sure that you understand these directions. Ask your healthcare provider if you have any questions about how to prepare or inhale this medication or how to use or store the nebulizer or inhaler.

Do not swallow treprostinil oral inhalation. If treprostinil solution or powder gets on your skin or in your eyes, rinse your skin or eyes with water right away.

The effects of the medication may not last more than 4 hours. You may need to adjust the timing of your doses to cover your planned activities.

Do not use the nebulizer or inhaler to inhale any other medications.

Treprostinil solution is used with a specific nebulizer. At the end of each day, dispose of any solution remaining in the nebulizer and carefully follow the manufacturer's instructions for cleaning the nebulizer components. Make sure you can get another nebulizer to use right away if your device does not work for any reason. Be sure to ask your healthcare provider what to do if your nebulizer stops working properly.

Treprostinil powder is used with a specific inhaler that can be used for 7 days. After each dose is inhaled, removed the used cartridge from the inhaler and discard the cartridge in a trash can. After 7 days of use, discard the inhaler in a trash can and replace with a new inhaler.

Treprostinil may control the symptoms of PAH and PH-ILD, but does not cure it. Continue to use treprostinil even if you feel well. Do not stop using treprostinil without talking to your doctor. If you suddenly stop using treprostinil, your symptoms may get worse. Your doctor will probably decrease your dose gradually.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient and a copy of the Instructions for Use for the inhaler device.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using treprostinil inhalation,

• tell your doctor and pharmacist if you are allergic to treprostinil (Orenitram, Remodulin, Tyvaso, Tyvaso DPI), any other medications, or any of the ingredients in treprostinil oral inhalation. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while you are using treprostinil inhalation. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had low blood pressure; bleeding problems; asthma, chronic obstructive pulmonary disease (COPD), or any other lung problems; or liver problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using treprostinil inhalation, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using treprostinil inhalation.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it and call your doctor.

Treprostinil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• cough
• throat irritation or pain
• headache
• nausea
• diarrhea
• flushing
• muscle, jaw, or bone pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• unusual bleeding or bruising
• dizziness or fainting
• wheezing, shortness of breath, trouble breathing, or chest tightness

Treprostinil inhalation may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Keep the ampules sealed in the foil pouch until you are ready to use them. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom). Dispose of unused treprostinil ampules if not used within 7 days after opening the foil pouch. Opened ampules of treprostinil that have been transferred to the delivery device may be stored in the delivery device for up to one day (24 hours); after that time, the solution should be discarded.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• headache
• flushing
• nausea
• vomiting
• diarrhea
• dizziness or fainting

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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• Tyvaso DPI^®