Drugs & Vitamins

Remodulin Active Ingredients: Treprostinil injection Representative Names: Remodulin What is treprostinil injection? What should I tell my health care provider before I take this medicine? How should this medicine be used? What if I miss a dose? What drug(s) may interact with Treprostinil? What side effects may I notice from receiving Treprostinil? What should I watch for while taking Treprostinil? Where can I keep my medicine? What is treprostinil injection? (Back to top) TREPROSTINIL (Remodulin™) is used to treat a serious heart and lung disorder called pulmonary arterial hypertension. While treprostinil will not cure this disorder, it is designed to improve symptoms, such as shortness of breath. You must administer this medication to yourself through a specialized pump. Your health care provider will give you specific instructions on how to do this. Generic treprostinil injection is not yet available. What should I tell my health care provider before I take this medicine? (Back to top) They need to know if you have any of these conditions: •bleeding or blood clotting disorders •low blood pressure •infection •kidney or liver disease •an unusual reaction to treprostinil, epoprostenol, other medicines, foods, dyes, or preservatives •pregnant or trying to get pregnant •breast-feeding How should this medicine be used? (Back to top) Treprostinil is given as a continuous infusion at home. Treprostinil can be given as an infusion under your skin (subcutaneously) or into a vein (intravenously) via a catheter attached to a portable infusion pump. Your prescriber or health care professional will give you a detailed explanation on how to use treprostinil. You will need to know how to prepare treprostinil for injection, how to use the infusion pump, and how to take care of your catheter site to avoid infections. Be sure you understand all the instructions. Using treprostinil is a lot of work and you may need to use this drug for a long time, even years. You must be very motivated to use treprostinil correctly. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. What if I miss a dose? (Back to top) Treprostinil is given as a constant infusion, which means that a pump will always be injecting the drug. It is recommended that you have a second pump and start a new infusion at a different site when your first pump is close to running out of treprostinil. Your health care provider will give you specific instructions on how to do this. It is important that you do not stop the infusion for any reason without contacting your prescriber or health care professional. Stopping treprostinil may make your condition much worse. What drug(s) may interact with Treprostinil? (Back to top) •ephedrine or pseudoephedrine •blood thinners such as warfarin (your prescriber or health care professional, however, is likely to want you to take blood thinners while you are using treprostinil; this can be done safely) •herbal stimulants or weight loss products, like ephedra, ma huang •medicines for colds and breathing difficulties •medicines for high blood pressure •medicines for chest pain •monoamine oxidase inhibitors (Azilect®, Eldepryl®, Emsam®, Marplan®, Nardil®, Parnate®, Zelapar™) •water pills (diuretics) Your prescriber or health care professional may want you to take certain medications, such as digoxin or blood thinners, while you are using treprostinil. Your health care professional will monitor your therapy and this can be done safely. Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines. What side effects may I notice from receiving Treprostinil? (Back to top) Side effects that you should report to your prescriber or health care professional as soon as possible: •chest pain •difficulty breathing or increased shortness of breath •dizziness or fainting •fever or chills •skin rash, swelling or redness at the infusion site •slow, fast or irregular heart beat •worsening of tiredness or weakness Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): •diarrhea •flushing •headache •itching •jaw pain •nausea or vomiting What should I watch for while taking Treprostinil? (Back to top) Visit your prescriber or health care professional for checks on your progress. You will need to be seen regularly. Report any unusual or severe side effects immediately. If you are having trouble inserting your catheter or using the pump, be sure to contact your health care provider immediately. Inspect the area around your catheter frequently. Alert your prescriber or health care professional if there is any unusual redness, pain or discharge. Despite receiving treprostinil, your condition may worsen and you may need your dose adjusted. Call your prescriber or health care professional if you experience any worsening of your condition. Where can I keep my medicine? (Back to top) Keep out of the reach of children in a container that small children cannot open. Store unopened vials of treprostinil between 59 and 77 degrees F (15—25 degrees C). Throw away any unopened and unused medication after the expiration date printed on the package. A vial of treprostinil should be used no more than 30 days after the initial puncture into the vial. During use of the subcutaneous pump (under the skin), a single reservoir (syringe) of treprostinil can be used for up to 72 hours at 98.6 degrees F (37 degrees C). After 72 hours, any remaining treprostinil in the syringe should be thrown away. During use of the intravenous pump (into the vein), diluted treprostinil in the reservoir can be used for up to 48 hours at 98.6 degrees F (37 degrees C). After 48 hours, any remaining treprostinil in the pump should be thrown away. Last Updated:08/31/2006 CLINICAL PHARMACOLOGY© GOLD STANDARD MULTIMEDIA INC, ALL RIGHTS RESERVED

Note: The above 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 the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.