Treprostinil Sodium, Inhalation

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KEY POINTS

• This medicine is inhaled through the mouth to treat pulmonary arterial hypertension. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antihypertensive

Generic and brand names: treprostinil sodium, inhalation; Tyvaso

What is this medicine used for?

This medicine is inhaled through the mouth to treat pulmonary arterial hypertension (high blood pressure in the arteries of the lungs).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Bleeding or blood clotting problems
• Heart disease or heart failure
• Kidney or liver disease
• Low blood pressure
• Lung disease such as asthma or COPD

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Do not stop taking this medicine without your healthcare provider's approval. You will probably need this medicine for a long time (maybe years).

Check with your healthcare provider before using this medicine in children under age 18.

This medicine should only be inhaled using the Tyvaso Inhalation system, a special lung drug delivery device. Follow the instructions in the medicine package for using the Tyvaso Inhalation System and for daily cleaning of the device after your last treatment of the day. Ask your provider if you should have a backup device so that you will not miss doses.

This medicine is inhaled 4 times per day, about 4 hours apart. Do not mix this medicine with any other medicine for inhalation. Wash your hands before and after using this medicine.

If you do not understand how to use this medicine and delivery device, ask your healthcare provider or pharmacist to demonstrate.

Do not get the medicine into your eyes or onto your skin. If it does, rinse your skin or eyes right away with water.

What if I miss a dose?

Do not miss a dose. If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: flushing, headache, dizziness, fainting, nausea, vomiting, diarrhea.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine lowers blood pressure. Taking other blood pressure medicines along with this one may lower your blood pressure too much. Be sure you tell your healthcare provider about all other medicines you take.

Saunas, hot baths, or sunbathing may cause blood vessels to dilate and lower your blood pressure too far. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Increased trouble breathing; severe dizziness or lightheadedness; fainting; unusual bruising or bleeding.

Other: Headache, cough, dizziness, flushing, nausea, throat irritation and pain, itching, diarrhea.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Alpha blockers such as doxazosin (Cardura) and prazosin (Minipress)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), sertraline (Zoloft), and vilazodone (Viibryd)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aspirin and other salicylates
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), betaxolol, bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, sotalol (Betapace, Sorine), and timolol
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Clonidine (Catapres, Kapvay)
• Conivaptan (Vaprisol)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), chlorthalidone, furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Gemfibrozil (Lopid)
• HIV medicines such as lopinavir/ritonavir (Kaletra) and ritonavir (Norvir)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), argatroban, bivalirudin (Angiomax), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, prasugrel (Effient), rivaroxaban (Xarelto), and warfarin (Coumadin)
• Natural remedies such as angelica, anise, arnica, asafoetida, capsicum, celery, chamomile, fenugreek, ginger, ginkgo, ginseng, horse chestnut, horseradish, licorice, papain, passionflower, red clover, turmeric, and willow
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rifampin (Rifadin)
• Rifapentine (Priftin)
• Secobarbital (Seconal)
• Tetrabenazine (Xenazine)
• Vasodilators such as hydralazine, isosorbide (Dilatrate, Isordil, Monoket), isoxsuprine, minoxidil, nesiritide (Natrecor), and nitroglycerin (Minitran, Nitro-Dur, Nitrostat)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store unopened foil pouches of this medicine at room temperature. Once you open the foil pack, use the ampules within 7 days. Protect from heat, high humidity, and bright light.

Use one ampule of the medicine each day. Discard any medicine left in the device at the end of the day.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.