treprostinil inhalation

treprostinil inhalation

Pronunciation: tre PROS ti nil

Brand: Tyvaso, Tyvaso Refill Kit, Tyvaso Starter Kit

What is the most important information I should know about treprostinil inhalation?

Before using this medication, tell your doctor if you have a breathing disorder such as asthma or COPD (chronic obstructive pulmonary disease), an infection in your lungs (including pneumonia), low blood pressure, liver or kidney disease, or a bleeding or blood clotting disorder.

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Treprostinil inhalation should be used only with a Tyvaso inhalation system. The inhalation system comes with patient instructions for safe and effective use. Do not use the medication at home if you do not fully understand how to use the inhalation system and properly clean it daily. Ask your doctor or pharmacist if you have any questions.

The effects of treprostinil inhalation will lessen over time between doses. Talk with your doctor if you need to time your dosing around any planned activities.

It is important to use treprostinil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Make sure you have a backup inhalation system available so as not to interrupt your treatment if one system stops working.

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Call your doctor if your symptoms do not improve or if they get worse.

What is treprostinil inhalation?

Treprostinil works by dilating (widening) blood vessels in your lungs and by keeps the platelets in your blood from coagulating (clotting) to prevent unwanted blood clots. These effects lower blood pressure in the pulmonary artery that leads from your heart to your lungs.

Treprostinil is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

Treprostinil may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using treprostinil inhalation?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication:

  • a breathing disorder such as asthma or COPD (chronic obstructive pulmonary disease);
  • an infection in your lungs, including pneumonia;
  • low blood pressure;
  • liver disease;
  • kidney disease; or
  • a bleeding or blood clotting disorder.

FDA pregnancy category B. It is not known whether this medication is harmful to an unborn baby. Use an effective form of birth control while you are using treprostinil inhalation. Tell your doctor if you become pregnant during treatment.

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It is not known whether treprostinil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is treprostinil inhalation given?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

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Treprostinil inhalation should be used only with a Tyvaso inhalation system. The inhalation system comes with patient instructions for safe and effective use. Do not use the medication at home if you do not fully understand how to use the inhalation system and properly clean it daily. Ask your doctor or pharmacist if you have any questions.

The inhalation form of treprostinil is usually given 4 times per day at evenly spaced intervals during waking hours. Each time you use the medication, you will inhale up to 9 breaths of the medication. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results from this medication. Most people start treatment with 1 to 3 breaths per treatment session, slowly increasing the number to 9 breaths per session.

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Do not use more than 9 breaths per treatment session.

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Wash your hands before preparing your treprostinil doses in the inhalation system.

One ampule of treprostinil inhalation contains enough medicine for all 4 of a day's doses.

Before your first dose of each day, twist off the top of one ampule and squeeze out the entire contents into the medicine cup of the inhalation system. At the end of the day after the last dose has been given, empty and rinse out the medicine cup, even if there is still unused treprostinil left in it.

To keep the medicine in the cup from spilling, store the inhalation system upright and tightly capped with the plugs when not in use.

The effects of treprostinil inhalation will lessen over time between doses. Talk with your doctor if you need to time your dosing around any planned activities.

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Call your doctor if your symptoms do not improve or if they get worse.

It is important to use treprostinil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Make sure you have a backup inhalation system available so as not to interrupt your treatment if one system stops working.

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Store treprostinil ampules in their foil pouch at room temperature away from moisture, heat, and light. Once you have opened a foil pouch, the ampules in it should be used within 7 days.

Any treprostinil placed into the medicine cup of the inhalation system must be used within 24 hours. Throw away any unused medicine at the end of the day after your last dose.

What happens if I miss a dose?

Call your doctor for instructions.

What happens if I overdose?

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Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include flushing (warmth, redness or tingling), headache, nausea, vomiting, diarrhea, feeling light-headed, or fainting.

What should I avoid while using treprostinil inhalation?

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Avoid getting treprostinil in your eyes or on your skin. If this does happen, rinse with water.

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Do not swallow treprostinil inhalation. The medication should be inhaled using only the Tyvaso inhalation system.

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Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

What are the possible side effects of treprostinil inhalation?

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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Call your doctor at once if you have any of these serious side effects:

  • new or worsening PAH symptoms such as feeling short of breath (even with mild exertion), tiredness, chest pain, and pale skin;
  • feeling like you might pass out;
  • fever, chills, cough with yellow or green mucus, stabbing chest pain, wheezing;
  • unusual bleeding such as nosebleeds, bleeding gums, or any bleeding that will not stop;
  • pale skin, weakness, easy bruising;
  • unexpected vaginal bleeding;
  • blood in your urine or stools, black or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds; or
  • swelling of your ankles or feet.

Less serious side effects may include:

  • cough, sore throat;
  • pain or irritation in your throat after use;
  • dizziness;
  • nausea, diarrhea;
  • headache or jaw pain; or
  • flushing (warmth, redness or tingling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect treprostinil inhalation?

Before using treprostinil, tell your doctor if you are using any of the following drugs:

  • gemfibrozil (Lopid);
  • delavirdine (Rescriptor);
  • nicardipine (Cardene);
  • pioglitazone (Actos, ActoPlus Met, Duetact);
  • tolbutamide (Orinase);
  • an antibiotic such as rifampin (Rifater, Rifadin, Rifamate) or rifapentine (Priftin);
  • antifungal medication such as fluconazole (Diflucan), or ketoconazole (Nizoral);
  • blood pressure medication;
  • a blood thinner such as warfarin (Coumadin).
  • a diuretic (water pill);
  • medication to treat congestive heart failure, such as hydralazine (Apresoline, BiDil), nesiritide (Natrecor), nitroglycerin, or nitroprusside (Nitropress);
  • an NSAID (non-steroidal anti-inflammatory drug) such as flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), indomethacin (Indocin), mefenamic acid (Ponstel), or piroxicam (Feldene);
  • seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin) fosphenytoin (Cerebyx), phenobarbital (Solfoton), primidone (Mysoline), or secobarbital (Seconal);or
  • sulfa drugs such as sulfisoxazole (Bactrim, Cotrim, Gantanol, Gantrisin, Septra), and others.

This list is not complete and there may be other drugs that can interact with treprostinil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about treprostinil inhalation.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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