Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

TREPROSTINIL - INJ

(treh-PRAW-steh-nil)

COMMON BRAND NAME(S): Remodulin

Uses

This medication is used to treat a type of high blood pressure in the lungs (pulmonary arterial hypertension). It works by causing the blood vessels (arteries) in the lungs to relax and expand, thus decreasing the pressure.

How To Use

Inject this medication directly into the skin (subcutaneous, SQ) continuously, using an infusion pump, or use as directed by your doctor. This medication should be started in a hospital/clinic. Do not suddenly decrease the dose or stop using this medication, unless directed to do so by your doctor. Stopping this drug, even briefly, may lead to serious side effects (see Side Effects section). To avoid interruptions in drug treatment, you should have access to a backup infusion pump and infusion sets should your equipment fail. Consult your doctor or pharmacist for more information. Depending on your condition, you may be given other medications to help prevent blood clots (embolism). Take all prescribed medication exactly as directed. Learn all preparation and usage instructions, including how to prepare and administer this drug and how to care for the injection site and avoid infection. Learn how to store and discard needles and medical supplies safely. If any of the information about the use of this medication is unclear, consult your doctor or pharmacist. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Side Effects

Nausea, headache, dizziness, jaw pain, diarrhea, flushing, joint/muscle aches, sweating, or redness/swelling/pain at the injection site may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: swelling of face/legs, stomach pain. Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, unusual fatigue or weakness, fast/slow/irregular heartbeat, mental/mood changes, changes in the appearance of the skin (e.g., unusual paleness or blue/grey color), enlarged abdomen, unexplained weight gain. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. Do not suddenly stop using this medication or decrease the dose unless directed to do so by your doctor. Serious effects such as trouble breathing, dizziness, or weakness may occur, which rarely may lead to death, if this medication is suddenly stopped or interrupted even briefly. Contact your doctor or pharmacist immediately if your dose is interrupted or if you develop these side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history, especially of: liver problems, bleeding problems, any allergies. This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or operating machinery. Limit alcoholic beverages as they may intensify the dizziness effect of this medication. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Tell your doctor of all prescription and nonprescription medication you may use, especially: "water pills" (e.g., furosemide, torsemide), "blood thinners" (e.g., warfarin, heparins), blood pressure medication (e.g., captopril, lisinopril, nifedipine), vasodilators (e.g., hydralazine, nitrates), digoxin. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: severe dizziness, fainting.

Notes

Do not share this medication with others. Laboratory and/or medical tests (e.g., blood pressure, heart rate, heart function) will be performed to monitor your progress and response to this medication.

Missed Dose

This drug is to be given continuously into the skin. If your dose is interrupted, contact your doctor or pharmacist immediately to establish new dosing.

Storage

Store unopened vials at room temperature between 59 and 77 degrees F (15 to 25 degrees C) away from light and moisture. Brief storage at 59 to 86 degrees F (15-30 degrees C) is permitted. Do not freeze. Consult your pharmacist for details regarding the stability of the drug after the vial has been opened.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).