When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to treprostinil.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. A nurse or other trained health professional will teach you or a caregiver how to give this medicine. The medicine is given as an infusion through a catheter that is placed directly under your skin or into a vein. Do not use more medicine than your doctor tells you to.
• Your doctor or nurse will teach you how to prepare the medicine and how to use the pump for the infusion. Treprostinil must be given continuously by a portable pump. The instructions for the pump may vary depending on the particular make and model. You will be given detailed instructions on how to use and care for your pump and accessories. Make sure you understand all of the instructions before giving yourself an infusion.
• If you are receiving your medicine under your skin, you will be shown the body areas where this infusion can be given. Use a different body area each time you start an infusion. Keep track of where you give each infusion to make sure you rotate body areas.
• Ask your doctor who to call if you have any problems with the infusion pump. You may be given a second infusion pump to have in case the first pump stops working. Make sure you have access to this pump as a backup at all times.
• Use a new needle and syringe each time you inject your medicine.
• You will need to continue using this medicine for a long period of time, possibly for many years. Talk with your doctor if you have any concerns about this.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using aspirin (Ecotrin®), gemfibrozil (Lopid®), rifampin (Rifadin®, Rimactane®), a blood thinner such as warfarin (Coumadin®), or medicine for arthritis or pain (diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Motrin®, Naprosyn®, or Voltaren®).
• Tell your doctor if you use a diuretic ("water pill") such as furosemide, hydrochlorothiazide (HCTZ), indapamide, metolazone, spironolactone, torsemide, triamterene, Aldactone®, Demadex®, Lasix®, Lozol®, Maxzide®, or Zaroxolyn®.
• Make sure your doctor knows if you are also using medicine to lower blood pressure. Some blood pressure medicines are atenolol, lisinopril, metoprolol, quinapril, Accupril®, Cozaar®, Diovan®, Lotrel®, Norvasc®, Toprol®, or Zestril®.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease.
• Be sure to report any signs of an infection or reaction at the catheter site to your doctor right away. Also, if you develop a sudden fever, contact your doctor as soon as possible.
• Do not suddenly stop using this medicine. Stopping the medicine suddenly may bring on symptoms of your condition and can be dangerous. Check with your doctor before stopping it completely.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Extreme warmth or redness in the face, neck, arms, or upper chest.
• Increased troubled breathing.
• Lightheadedness or fainting.
• Severe nausea, vomiting, or diarrhea.
• Severe redness, pain, rash, swelling, or a hard lump where the needle is placed.
• Swelling in your hands, ankles, or feet.

If you notice these less serious side effects, talk with your doctor:

• Anxiety or restlessness.
• Headache.
• Jaw pain.
• Mild nausea or diarrhea.
• Mild skin itching.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088