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Treprostinil extended release tablets

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

Treprostinil extended release tablets are used for:

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

Treprostinil extended release tablets are a prostaglandin. It works by relaxing blood vessels, which increases blood flow to the lungs.

Do NOT use treprostinil extended release tablets if:

  • you are allergic to any ingredient in treprostinil extended release tablets
  • you have severe liver problems

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

Before using treprostinil extended release tablets:

Some medical conditions may interact with treprostinil extended release tablets. 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 or high blood pressure, or stomach or bowel problems (eg, ulcers, diverticulosis)
  • if you have had a stroke
  • if you are taking another medicine that contains treprostinil

Some MEDICINES MAY INTERACT with treprostinil extended release tablets. 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 extended release tablets
  • Gemfibrozil because it may increase the risk of treprostinil extended release tablets's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if treprostinil extended release tablets 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 extended release tablets:

Use treprostinil extended release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with treprostinil extended release tablets. Talk to your pharmacist if you have questions about this information.
  • Take treprostinil extended release tablets by mouth with food.
  • Swallow treprostinil extended release tablets whole. Do not break, crush, split, or chew before swallowing. Do not take a tablet that is damaged or broken.
  • Take treprostinil extended release tablets on a regular schedule to get the most benefit from it. Taking treprostinil extended release tablets at the same times each day will help you to remember to take it.
  • Continue to take treprostinil extended release tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of treprostinil extended release tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss 2 or more doses, contact your doctor.

Ask your health care provider any questions you may have about how to use treprostinil extended release tablets.

Important safety information:

  • Do not drink alcohol while you are using treprostinil extended release tablets.
  • Do not change your dose or suddenly stop taking treprostinil extended release tablets. You may experience worsening of PAH symptoms (eg, shortness of breath, dizziness, weakness). Discuss any questions or concerns with your doctor.
  • Treprostinil extended release tablets 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.
  • You may notice parts of the tablet shell in your stool. This is normal and not a cause for concern.
  • Tell your doctor or dentist that you take treprostinil extended release tablets before you receive any medical or dental care, emergency care, or surgery.
  • Treprostinil extended release tablets should be used with extreme caution in CHILDREN; safety and effectiveness in 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 extended release tablets while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking treprostinil extended release tablets.

Possible side effects of treprostinil extended release tablets:

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; flushing; headache; jaw pain; mild stomach pain; nausea; pain in the hands or feet.

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); chest pain; fainting; fast, slow, or irregular heartbeat; new or worsening shortness of breath; unusual dizziness 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 ( http://www.aapcc.org), or emergency room immediately.

Proper storage of treprostinil extended release tablets:

Store treprostinil extended release tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep treprostinil extended release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about treprostinil extended release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Treprostinil extended release tablets are 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 extended release tablets 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 extended release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to treprostinil extended release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using treprostinil extended release tablets.

Review Date: November 3, 2016

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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