TREPROSTINIL - INJECTION

PHONETIC PRONUNCIATION: (treh-PRAW-steh-nil)

COMMON BRAND NAME(S): Remodulin

GENERIC NAME(S): treprostinil sodium

Uses

USES: This medication is used to treat a type of high blood pressure in the lungs (pulmonary arterial hypertension). Treprostinil helps to improve symptoms such as shortness of breath and tiredness. It works by relaxing and widening the blood vessels (arteries) in the lungs and other parts of the body so that blood can flow more easily. This medication belongs to a class of drugs known as vasodilators.

How to use TREPROSTINIL - INJECTION

HOW TO USE: When you first start using this medication, it must be given by a health care professional in a hospital or clinic. This medication is given as a continuous injection, usually under the skin using an infusion pump. If you cannot receive the drug under the skin, it may be mixed with an IV solution and given into a vein using an infusion pump. Your health care professional will prepare and mix the solution for you according to the manufacturer's instructions. If your doctor directs you to continue using this medication at home, follow all instructions from your health care professional about how to properly use this medication and the infusion pump. Learn how to properly care for your injection site and how to avoid infection. Also learn how to store and discard needles and medical supplies safely. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid, and contact your health care professional right away. If you have any questions about the use of this medication, consult your health care professional. Do not suddenly decrease the dose or suddenly stop using this medication because doing either may lead to serious (rarely fatal) worsening of your condition. If you must stop this medication, gradually reduce the dose as directed by your doctor. Consult your doctor right away if your infusion is interrupted or if you develop worsening trouble breathing, dizziness, or weakness. To avoid interruptions in drug treatment, you should have a backup infusion pump and infusion sets available in case your equipment fails. Consult your health care professional for more information. The dosage is based on your medical condition, weight, and response to treatment. Your doctor may direct you to use other medications in addition to treprostinil to treat your condition and to prevent problems. Use all prescribed medications exactly as directed. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

SIDE EFFECTS: Nausea, vomiting, diarrhea, headache, dizziness, jaw pain, flushing, loss of appetite, weakness, abdominal pain, and redness/swelling/pain at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: new/worsening swelling of the arms/legs, mental/mood changes (such as restlessness, nervousness), unusual bleeding/bruising. To avoid infection, follow your health care professional's instructions for proper handling of this medication. Tell your doctor right away if you develop any signs of infection (such as fever, chills). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: 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. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. 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.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Treprostinil may lower your blood pressure. Your doctor may also direct you to take other medications that may also lower your blood pressure (including "water pills"/diuretics such as furosemide, ACE inhibitors such as captopril, calcium channel blockers such as nifedipine, other vasodilators such as nitrates). Your doctor may also prescribe "blood thinners" (such as warfarin) to prevent blood clots. Treprostinil may increase your risk of bleeding if you take "blood thinners." Your doctor or pharmacist will monitor you for these possible drug interactions. Tell your doctor or pharmacist right away if you develop symptoms such as easy or unusual bleeding/bruising, severe dizziness, or fainting.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting.

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Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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