Treprostinil Sodium, Injection

What are other names for this medicine?

Type of medicine: antihypertensive

Generic and brand names: treprostinil sodium, injection; Remodulin

What is this medicine used for?

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

This medicine may be used for 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
• kidney or liver disease
• lung 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?

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).

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

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

The catheter remains in your vein for a long time. 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: flushing, headache, lightheadedness, fainting, nausea, vomiting, diarrhea, seizures.

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, 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.

Serious (report these to your healthcare provider right away): Irregular or rapid heartbeat; rash, inflammation, or pain at the spot where the needle is inserted; chest pain; flushing; swelling or fever; increased trouble breathing; severe dizziness or lightheadedness.

Other: Headache, diarrhea, nausea, vomiting, itching, low blood pressure, 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:

• ACE inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• alpha blockers such as prazosin (Minipress) and doxazosin (Cardura)
• aspirin and other salicylates
• beta blockers such as atenolol (Tenormin), acebutolol (Sectral), betaxolol (Kerlone), carteolol, bisoprolol (Zebeta), pindolol, metoprolol (Lopressor, Toprol XL), timolol, sotalol (Betapace), nadolol (Corgard), propranolol (Inderal), labetalol (Normodyne, Trandate), and carvedilol (Coreg)
• calcium channel blockers such as diltiazem (Cardizem, Dilacor, Tiamate, Tiazac), nicardipine (Cardene), nifedipine (Procardia, Adalat), isradipine (DynaCirc), felodipine (Plendil), amlodipine (Norvasc), and verapamil (Calan, Isoptin, Verelan)
• medicine that reduces the chance of blood clots forming such as warfarin (Coumadin), heparin, dalteparin (Fragmin), enoxaparin sodium (Lovenox) , ticlopidine (Ticlid), dipyridamole (Persantine), and clopidogrel (Plavix)
• diuretics (water pills) such as hydrochlorothiazide (Microzide, Oretic), furosemide (Lasix), chlorothiazide (Diuril), bumetanide (Bumex), torsemide (Demadex), spironolactone (Aldactone), triamterene (Dyrenium), and amiloride (Midamor)
• natural remedies such as black currant, capsaicin, celery, clove oil, chaparral, fever few, garlic, ginger, ginkgo, and licorice
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin, Motrin IB, Advil, Nuprin), naproxen (Naprosyn, Anaprox, Aleve, Naprelan), ketoprofen, nabumetone (Relafen), indomethacin (Indocin), ketorolac (Toradol), sulindac (Clinoril), piroxicam (Feldene), diclofenac (Voltaren, Cataflam), and oxaprozin (Daypro)
• vasodilators such as hydralazine (Apresoline), nitroglycerin, minoxidil (Loniten), isoxsuprine (Vasodilan), nesiritide (Natrecor), and isosorbide (Isordil, Sorbitrate, Imdur, Monoket, ISMO)

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 14 days after you puncture the vial.

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.