Treprostinil inhalation solution

Generic Name: treprostinil (tre-PROST-i-nil)
Brand Name: Tyvaso

Treprostinil inhalation solution is used for:

Treating pulmonary arterial hypertension (PAH) (high blood pressure in the arteries of the lungs) in certain patients to increase walk distance. It may also be used for other conditions as determined by your doctor.

Treprostinil inhalation solution is a prostacyclin vasodilator. It works by relaxing blood vessels and increasing the supply of blood to the lungs in patients with high blood pressure in the lungs. This decreases how hard the heart must work to pump blood to the lungs. It also prevents the platelets in your blood from clotting to prevent unwanted blood clots.

Do NOT use treprostinil inhalation solution if:

  • you are allergic to any ingredient in treprostinil inhalation solution

Contact your doctor or health care provider right away if any of these apply to you.

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Before using treprostinil inhalation solution:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver or kidney problems, bleeding problems, a lung infection (eg, pneumonia) or breathing problems (eg, asthma or chronic obstructive pulmonary disease [COPD]), or low blood pressure

Some MEDICINES MAY INTERACT with treprostinil inhalation solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin) because the risk of side effects, such as bleeding, may occur
  • Blood pressure medicines (eg, lisinopril), diuretics (eg, furosemide), or vasodilators (eg, hydralazine) because the risk of side effects, such as dizziness, fainting, and very low blood pressure, may occur
  • Gemfibrozil because it may increase the risk of treprostinil inhalation solution's side effects
  • Rifampin because it may decrease treprostinil inhalation solution's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if treprostinil inhalation solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use treprostinil inhalation solution:

Use treprostinil inhalation solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with treprostinil inhalation solution. Talk to your pharmacist if you have questions about this information.
  • Treprostinil inhalation solution should only be used with the Tyvaso inhalation system. Follow the instructions for use and daily cleaning after the last treatment session of the day. Talk to your pharmacist if you have questions about this information.
  • Treprostinil inhalation solution is usually used in 4 treatment sessions each day approximately 4 hours apart during waking hours. Follow the dosing schedule given to you by your doctor carefully.
  • Treprostinil inhalation solution is inhaled through your mouth into your lungs.
  • Take your first treatment with treprostinil inhalation solution in the morning and take your last treatment session before bedtime unless your doctor tells you otherwise. Talk with your doctor if you need to time your dosing around any planned activities.
  • One ampule of treprostinil inhalation solution contains enough medicine for all 4 treatment sessions. Treprostinil inhalation solution should remain in the inhalation system for no more than 24 hours. Any remaining solution should be discarded at the end of the day.
  • Do not mix treprostinil inhalation solution with other medicines in the inhalation device.
  • Avoid skin or eye contact with treprostinil inhalation solution. If treprostinil inhalation solution comes in contact with skin or eyes, rinse immediately with water.
  • Use treprostinil inhalation solution on a regular schedule to get the most benefit from it.
  • If you miss a dose of treprostinil inhalation solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use treprostinil inhalation solution.

Important safety information:

  • Treprostinil inhalation solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use treprostinil inhalation solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Treprostinil inhalation solution may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Stopping treprostinil inhalation solution, even briefly, may lead to serious side effects. To avoid interruption in medicine treatment you should have access to a backup inhalation system.
  • Treprostinil inhalation solution may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
  • Treprostinil inhalation solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Tell your doctor or dentist that you take treprostinil inhalation solution before you receive any medical or dental care, emergency care, or surgery.
  • If your symptoms do not get better or if they get worse, check with your doctor.
  • Lab tests, including lung function, may be performed while you use treprostinil inhalation solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use treprostinil inhalation solution with caution in the ELDERLY; they may be more sensitive to its effects.
  • Treprostinil inhalation solution should be used with extreme caution in CHILDREN younger than 18 years old years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if treprostinil inhalation solution can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using treprostinil inhalation solution while you are pregnant. It is not known if treprostinil inhalation solution is found in breast milk. If you are or will be breast-feeding while you are using treprostinil inhalation solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of treprostinil inhalation solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; dizziness; headache; muscle, jaw, or bone pain; nausea; reddening of the face and neck (flushing); throat irritation or pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; coughing up blood; dark, tarry, or bloody stools; fainting; fever, chills, or persistent sore throat; increased cough; new or worsening shortness of breath; pale skin; severe or persistent tiredness, weakness, dizziness, headache, or nausea; swelling of the ankles or feet; unusual bruising or bleeding; vomit that looks like coffee grounds; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; dizziness; flushing; headache; nausea; vomiting.

Proper storage of treprostinil inhalation solution:

Store treprostinil inhalation solution in the unopened foil pouch at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Once the foil pack is opened, use the ampules within 7 days. Store away from heat, moisture, and light. Keep treprostinil inhalation solution out of the reach of children and away from pets.

General information:

  • If you have any questions about treprostinil inhalation solution, please talk with your doctor, pharmacist, or other health care provider.
  • Treprostinil inhalation solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take treprostinil inhalation solution or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about treprostinil inhalation solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to treprostinil inhalation solution. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using treprostinil inhalation solution.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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