Treprostinil, Oral (Pulmonary Hypertension)

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KEY POINTS

• This medicine is taken by mouth to treat high blood pressure in the blood vessels between the heart and lungs. Take it exactly as directed.
• This medicine may increase your risk of bleeding or cause other 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, oral; Orenitram

What is this medicine used for?

This medicine is taken by mouth to treat pulmonary hypertension (high blood pressure in the blood vessels between the heart and lungs) in adults.

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

Before taking 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
• Liver disease
• Low or high blood pressure
• Ulcers or diverticulosis

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take your dosage of this medicine exactly as your healthcare provider prescribes. Take the tablets at the same times every day. Do not take more than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Your condition could get worse and cause shortness of breath, dizziness, or weakness.

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

Take this medicine with food. These are extended-release tablets. Do not break, crush, or chew them. Swallow them whole.

What if I 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 2 doses, contact your healthcare provider. Your provider may need to adjust your dosage.

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: severe headache, nausea, vomiting, diarrhea, lightheadedness dizziness.

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 may lower 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.

This medicine may make you dizzy or lightheaded. Do not drive or operate machinery unless you are fully alert.

You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help. Also, drinking alcohol may make it worse. Do not drink alcohol unless your healthcare provider approves.

This medicine may increase your risk of bleeding. Be careful when shaving or brushing your teeth. Report any unusual bleeding or bruising to your healthcare provider.

You may see tablet shells in your bowel movement. This is normal and not a cause for concern.

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.): Severe headache, severe diarrhea, severe nausea or vomiting, severe dizziness, increased trouble breathing, unusual bruising or bleeding, unusual tiredness or weakness, severe muscle cramps, irregular heartbeat.

Other: Mild headache, flushing, mild nausea, mild diarrhea, jaw pain, stomach pain.

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), moexipril (Univasc), quinapril (Accupril), and ramipril (Altace)
• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), and terazosin
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• 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), nebivolol (Bystolic), pindolol, sotalol (Betapace, Sorine), and timolol
• Blood pressure medicines such as hydralazine, methyldopa, minoxidil, and reserpine
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as abiraterone (Zytiga) and obinutuzumab (Gazyva)
• Celecoxib (Celebrex)
• Clonidine (Catapres, Kapvay)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), chlorthalidone, eplerenone (Inspra), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Gemfibrozil (Lopid)
• Guanfacine (Intuniv, Tenex)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), edoxaban (Savaysa), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Natural remedies such as angelica, anise, arnica, asafoetida, capsicum, celery, chamomile, fenugreek, fish oil, 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)
• Other medicines that contain treprostinil (Remodulin, Tyvaso)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rifampin (Rifadin)
• Rifapentine (Priftin)
• Ritonavir (Norvir)
• SSRI antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), and sertraline (Zoloft)
• Vasodilators such as hydralazine, isosorbide (Dilatrate, Isordil, Monoket), isoxsuprine, minoxidil, nesiritide (Natrecor), and nitroglycerin (Minitran, Nitro-Dur, Nitrostat)

Do not drink alcohol while taking this medicine without your healthcare provider’s approval.

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 this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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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.