Treprostinil (tre-PROS-ti-nil)

Treats breathing problems and other symptoms caused by exercise in people who have pulmonary arterial hypertension (PAH).

Brand Name(s):

When This Medicine Should Not Be Used:

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.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Check the liquid in the vial. If the liquid has changed color, is cloudy, or has particles in it, do not use it.
• 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.
• Missed dose: Call your doctor or pharmacist for instructions.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. You may keep the medicine for up to 30 days at room temperature after you open the vial and use your first dose. You will use a syringe to take medicine from the vial and insert the syringe into the pump.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

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

• Some medicines can affect how treprostinil works. Tell your doctor if you are using any of the following:
  • Aspirin, gemfibrozil, rifampin
  • Blood pressure medicine
  • Blood thinner (including warfarin)
  • Diuretic (water pill)
  • NSAID pain or arthritis medicine (including diclofenac, ibuprofen, naproxen)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, low blood pressure, or bleeding problems.
• This medicine can cause the following problems:
  • Increased risk of infection (including blood stream infection, sepsis) when given through a catheter
  • Low blood pressure
  • Increased risk of bleeding
• Do not suddenly stop receiving this medicine. Stopping the medicine suddenly may worsen the symptoms of your condition. Check with your doctor before stopping it completely.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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 trouble breathing, chest tightness, lightheadedness or fainting
• Severe redness, pain, rash, swelling, or a hard lump where the needle is placed
• Swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

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

• Anxiety or restlessness
• Headache
• Jaw pain
• Nausea, vomiting, diarrhea

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