Remodulin injection

Treprostinil dilates (widens) the arteries and decreases the amount of blood clotting platelets in your body. These effects lower blood pressure in the pulmonary artery that leads from the heart to the lungs.

Treprostinil is used to treat pulmonary arterial hypertension (PAH). This medicine improves your ability to exercise and can help prevent your condition from getting worse.

Treprostinil may also be used for purposes not listed in this medication guide.

You should not use treprostinil if you are allergic to it.

To make sure treprostinil is safe for you, tell your doctor if you have:

• kidney disease;

• liver disease;

• if you are using epoprostenol (Flolan); or

• if you take medicine to treat high blood pressure (hypertension).

FDA pregnancy category B. Treprostinil is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether treprostinil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.

Treprostinil is injected under the skin (subcutaneous), or directly into a vein (intravenous). The medicine enters the body through a catheter placed under your skin or into a vein.

Treprostinil is given as a continuous (around-the-clock) injection using an infusion pump. Your healthcare provider will give you specific instructions on how to use an infusion pump. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

When given as an intravenous injection, treprostinil must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Do not use treprostinil if it has changed colors or has particles in it. Call your pharmacist for new medication.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

A central intravenous catheter may increase your risk of a serious infection called sepsis. If you use intravenous treprostinil, watch for symptoms such as: fever, flu symptoms, mouth and throat ulcers, rapid heart rate, or rapid and shallow breathing. Call your doctor right away if you have any of these conditions.

Use treprostinil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Make sure you have a backup infusion pump and infusion sets available so as not to interrupt your treatment if one infusion pump stops working. You will probably have to use this medicine for several months or years to control your condition and keep it from getting worse.

You should not reduce your dose or stop using treprostinil suddenly. Stopping suddenly may make your condition worse.

Call your doctor if you have new or worsening PAH symptoms such as feeling short of breath (even with mild exertion), tiredness, chest pain, and pale skin.

Store unopened vials (bottles) of treprostinil at room temperature away from moisture and heat. After the medicine has been placed into a syringe or pump, it should be given within 72 hours. If the medicine has been diluted (mixed with a liquid), you must use the medicine within 48 hours after mixing.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with treprostinil, especially medicine used to prevent blood clots, such as:

• dalteparin;

• enoxaparin;

• fondaparinux; or

• tinzaparin.

This list is not complete. Other drugs may interact with treprostinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Before using treprostinil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, kidney problems, bleeding problems.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.