Treprostinil Sodium, Injection

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KEY POINTS

• This medicine is given by infusion pump to treat pulmonary 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.
• Taking other blood pressure medicines along with this one may lower your blood pressure too much. 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; prostacyclin vasodilator

Generic and brand names: treprostinil sodium, injection; Remodulin

What is this medicine used for?

This medicine is used to treat pulmonary hypertension (high blood pressure in the lungs). It is infused through a special catheter and infusion pump.

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

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?

You will receive your first dose of this medicine in a hospital or clinic setting where you can be monitored closely.

This medicine is given as a continuous injection through a portable infusion pump. Before you use this medicine at home, you will be shown how to use the medicine, and how to care for your catheter and portable infusion pump.

Check the label on the medicine for directions about your specific dose. The dose of medicine you take may be increased gradually by your healthcare provider. Keep all appointments. 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.

Do not mix this medicine with any other medicine for injection. Wash your hands before and after using this medicine.

Do not run out of this medicine or suddenly stop the infusion. Your condition could get worse and cause shortness of breath, dizziness, or weakness. Talk to your healthcare provider about this.

You will need to learn and use sterile technique when you handle this medicine. Read and follow all directions given to you.

The catheter is placed in your vein. A small, portable pump that you carry with you is attached to the catheter by a tube. This delivers constant measured doses of the medicine. This allows you to follow a more normal life while receiving this medicine day and night. It is important that you learn how to take care of the catheter and keep it sterile. Check the area around the catheter for redness, pain, or discharge. You should also make sure that you understand how to use the pump.

You should have 2 working pumps at all times to make sure your treatment is not interrupted. Usually pumps are replaced every 6 months.

If you do not understand how you should prepare or use this medicine, ask your healthcare provider or pharmacist to explain.

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: trouble breathing, flushing, fast heartbeat, headache, lightheadedness, fainting, nausea, vomiting, diarrhea, seizures.

What should I watch out for?

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

This medicine may cause lightheadedness or dizziness. Do not drive or operate machinery unless you are fully alert.

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.

This medicine may increase your risk of bleeding. Do not take aspirin or other products that may increase the risk of bleeding unless your provider tells you to do so. Also, do not drink alcohol unless your healthcare provider approves.

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.): Irregular or fast heartbeat; rash, inflammation, or pain at the spot where the needle is inserted; chest pain; redness of face or neck; unexplained swelling or fever; cough; sore throat; increased trouble breathing; severe dizziness or lightheadedness; fainting; severe nausea, vomiting, or diarrhea; unusual bruising or bleeding.

Other: Headache, diarrhea, mild nausea, itching, jaw 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:

• Abiraterone (Zytiga)
• 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)
• Anagrelide (Agrylin)
• 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), 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)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Eplerenone (Inspra)
• Gemfibrozil (Lopid)
• HIV medicines such as lopinavir/ritonavir (Kaletra) and ritonavir (Norvir)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, prasugrel (Effient), rivaroxaban (Xarelto), vorapaxar (Zontivity), 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 celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Obinutuzumab (Gazyva)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pentoxifylline
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rifampin (Rifadin)
• Rifapentine (Priftin)
• 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)

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 vials of this medicine at room temperature. Keep the containers tightly closed. Protect from heat, high humidity, and bright light.

Use the medicine in each vial within 30 days after you puncture the vial.

Different brands of this medicine may have different storage instructions. Carefully follow the instructions in the medicine package for proper storage. Ask your healthcare provider or pharmacist if you have any questions.

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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.