Treprostinil solution

Generic Name: treprostinil (tre-PROST-i-nil)
Brand Name: Remodulin

Treprostinil solution is used for:

Treating high blood pressure in the blood vessels of the lungs (pulmonary arterial hypertension [PAH]).

Treprostinil solution is a prostaglandin. It works by relaxing blood vessels, which increases blood flow 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.

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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, planning 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, low blood pressure, fluid retention (eg, unusual swelling of the arms, hands, legs, or feet), 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:

  • Blood pressure medicines (eg, lisinopril), diuretics (eg, furosemide), or vasodilators (eg, hydralazine) because the risk of their side effects, such as dizziness, fainting, and very low blood pressure, may be increased
  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased by treprostinil solution
  • Gemfibrozil because it may increase the risk of treprostinil solution's side effects
  • Rifampin because it may decrease treprostinil solution's effectiveness

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 given at your doctor's office, hospital, or clinic. If you will be using treprostinil solution at home, a health care provider will teach you how to use it. Be sure you understand how to use treprostinil solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • 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.
  • Do not use treprostinil solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • 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. This effect may be worse if you take it with alcohol or certain medicines. Use treprostinil solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not suddenly stop using treprostinil solution. You may experience a recurrence of PAH symptoms (eg, shortness of breath, dizziness, weakness). To avoid interruption in treatment, you should have access to a backup infusion pump and infusion sets should your equipment fail. Discuss any questions or concerns with your doctor.
  • If your symptoms do not get better or if they get worse, check with your doctor.
  • Treprostinil solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Tell your doctor or dentist that you take treprostinil solution before you receive any medical or dental care, emergency care, or surgery.
  • Treprostinil solution should be used with extreme caution in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using treprostinil solution while you are pregnant. It is not known if treprostinil solution is found in breast milk. If you are or will be breast-feeding while you are using treprostinil solution, check with your doctor. Discuss any possible 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; flushing or redness of the skin; headache; jaw pain; light-headedness; mild pain or redness at the injection site; nausea; tiredness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; burning, numbness, or tingling; chest pain; dark, tarry, or bloody stools; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes (eg, anxiety, restlessness); new or worsening shortness of breath; pain, swelling, redness, heat, tenderness, or hard skin at the injection site; pale skin; severe or persistent dizziness; swelling of the hands, arms, ankles, or feet; unexplained weight gain; unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; flushing; loss of consciousness; nausea; seizure; severe dizziness, diarrhea, or headache; vomiting.

Proper storage of treprostinil solution:

Treprostinil solution is usually handled and stored by a health care provider. If you are using treprostinil solution at home, store treprostinil solution as directed by your pharmacist or health care provider. 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take treprostinil solution or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about treprostinil solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to treprostinil solution. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using treprostinil solution.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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