Remodulin (injection)

Remodulin dilates (widens) the arteries and reduces the number of blood clotting platelets in your body. These effects lower blood pressure in the pulmonary artery that goes from the heart to the lungs.

Remodulin is used to treat pulmonary arterial hypertension (PAH). Remodulin improves your ability to exercise and can help prevent your condition from worsening.

Remodulin may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your medicine label and package. Inform all your healthcare providers about your medical conditions, allergies, and all medicines you are taking.

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

Tell your doctor if you have ever had:

• liver disease; or
• kidney disease.

Do not start or stop using Remodulin during pregnancy without your doctor's advice. It is important to properly control PAH during pregnancy because having this condition can harm both mother and baby. Tell your doctor right away if you become pregnant.

It may not be safe to breast-feed while using Remodulin. Ask your doctor about any risk.

Get emergency medical help if you notice any of these signs of an allergic reaction: hives; trouble breathing; swelling of your face, lips, tongue, or throat.

Using an intravenous catheter may increase your risk of a serious infection called sepsis. If you are using intravenous Remodulin, be alert for symptoms such as: fever, flu-like symptoms, mouth and throat sores, fast heart rate, or quick and shallow breathing. Contact your doctor immediately if you experience any of these symptoms.

Remodulin may lead to serious side effects. Contact your doctor right away if you have:

• pain, swelling, redness, bleeding, or a hard lump at your catheter site;
• swelling in your hands or feet;
• feeling light-headed, as if you might faint; or
• worsening PAH symptoms (tiredness, pale skin, chest pain, difficulty breathing).

Common side effects of Remodulin may include:

• pain, redness, bleeding, bruising, or swelling near the catheter;
• headache, jaw pain;
• diarrhea, nausea; or
• flushing (warmth, redness, or tingling).

This is not a complete list of side effects, and others may happen. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. You may need to use this medicine for many years.

You may receive your first dose in a hospital or clinic setting to quickly treat any serious side effects.

Remodulin is given around the clock using an infusion pump attached to a catheter placed under your skin (subcutaneous) or into a vein (intravenous). A healthcare provider can teach you how to properly use the infusion pump by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Remodulin if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

You may need to mix Remodulin with a liquid (diluent). When using injections by yourself, be sure you understand how to properly mix and store the medicine.

Prepare your injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Call your doctor if your symptoms do not improve, or if they get worse.

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

To make sure there is no interruption in your treatment, you may need to have a back-up infusion pump, replacement batteries, and extra infusion sets. Get your prescription refilled before you run out of medicine completely.

Store unopened vials (bottles) of treprostinil at room temperature away from moisture and heat. Throw away a vial after 30 days of use, even if there is still medicine left inside.

After mixing your medicine, you will need to use it within a certain number of hours or days. This will depend on the type of diluent used, and whether you store the mixture at room temperature or in a refrigerator. Carefully follow the mixing and storage instructions provided with your medicine. Ask your pharmacist if you have questions.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Because Remodulin is given all the time, you should never miss a dose if you use the medicine correctly. Call your doctor immediately if your Remodulin therapy is stopped for any reason.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe tingling or warmth under your skin, diarrhea, vomiting, or fainting.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Sometimes it is not safe to use certain medications together. Some drugs can change how much of another drug is in your blood, which may increase side effects or make the medications work less well.

Other drugs may affect Remodulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all the medications you are currently taking and any medication you begin or stop using.