Treprostinil Solution

Generic Name: Treprostinil Injection Solution (TREH-prost-in-ill)
Brand Name: Remodulin

Treprostinil Solution is used for:

Treating high blood pressure in the circulatory system of the lungs. It may also be used to treat other conditions as determined by your doctor.

Treprostinil Solution is a prostaglandin. It works by relaxing blood vessels and increasing the supply of blood to the lungs in patients with high blood pressure in the lungs. This decreases how hard the heart must work to pump blood to the lungs.

Do NOT use Treprostinil Solution if:

you are allergic to any ingredient in Treprostinil Solution

Contact your doctor or health care provider right away if any of these apply to you.

Before using Treprostinil Solution:

Some medical conditions may interact with Treprostinil Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, plan to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have liver or kidney problems, bleeding problems, swelling, or high sodium levels in the blood

Some MEDICINES MAY INTERACT with Treprostinil Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Diuretics ("water pills") (eg, furosemide), vasodilators (eg, hydralazine), blood pressure medicines (eg, lisinopril) because the actions and side effects of these medicines, such as low blood pressure, may be increased
Blood thinners (eg, warfarin) because the actions and side effects of Treprostinil Solution, such as increased bleeding, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Treprostinil Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Treprostinil Solution:

Use Treprostinil Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Treprostinil Solution is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Treprostinil Solution at home, carefully follow the injection procedures taught to you by your health care provider. Ask any questions that you may have about Treprostinil Solution or giving infusions.
Treprostinil Solution is usually administered as an infusion by direct injection into the skin. It may be necessary for you to take Treprostinil Solution for a prolonged period of time, possibly years. Additional treatment may require injecting medicine through the vein.
Treprostinil Solution is for injection beneath the skin or through the vein only.
If Treprostinil Solution contains particles, is discolored, or if the vial is cracked or damaged in any way, do not use it.
If your dose is interrupted, contact your doctor or pharmacist immediately to establish a new dosing schedule.

Ask your health care provider any questions you may have about how to use Treprostinil Solution.

Important safety information:

Treprostinil Solution may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Treprostinil Solution. Using Treprostinil Solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
Stopping Treprostinil Solution, even briefly, may lead to serious side effects. To avoid interruption in medicine treatment you should have access to a backup infusion pump and infusion sets should your equipment fail.
Depending on your condition, you may be given other medicines to help prevent blood clots. Take all prescribed medicines exactly as directed.
Treprostinil Solution may reduce the number of blood cells that are needed for clotting. To prevent bleeding, avoid situations where bruising or injury may occur. Report any unusual bleeding or bruising, blood in stools, or dark tarry stools to your doctor.
Use Treprostinil Solution with caution in the ELDERLY because they may be more sensitive to its effects.
Treprostinil Solution is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Treprostinil Solution during pregnancy. It is unknown if Treprostinil Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Treprostinil Solution, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Treprostinil Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; flushing or redness of the skin; jaw pain; joint or muscle aches; nausea; pale skin; lightheadedness; redness, swelling, or pain at the injection site; sweating; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; changes in the appearance of the skin (eg, unusual paleness, blue/gray color); chest pain; dark, tarry stools; enlarged abdomen; fast, slow, or irregular heartbeat; fever; itching; mental or mood changes; shortness of breath; stomach pain; swelling of the legs; unexplained weight gain; unusual bruising or bleeding; unusual fatigue or weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http: / / www.aapcc.org / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately. Symptoms may include fainting; nausea; severe dizziness; vomiting.

Proper storage of Treprostinil Solution:

Store as directed on the prescription label. Keep Treprostinil Solution out of the reach of children and away from pets.

General information:

If you have any questions about Treprostinil Solution, please talk with your doctor, pharmacist, or other health care provider.
Treprostinil Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Treprostinil Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: August 6, 2008

Database Edition 08.3.1.002