Terms of use agreement

This website may contain information about United Therapeutics Corporation, its subsidiaries and affiliates (collectively, "Company"), and/or one or more product marketed by Company. Access to and use of this website is subject to the following terms and conditions and all applicable laws. By accessing and using the website, you agree to be bound by and to comply with this Terms of Use Agreement without limitation or qualification and you acknowledge that it supersedes any other agreement between you and Company regarding this subject matter. If you do not agree with these Terms of Use, please exit and do not use the website. These terms of use may be revised by Company from time to time and you should therefore review them on your next visit to the website. Your continued use of the website following any such posting will be deemed as consent to the new notice, term or condition.

  1. You may browse this website. You may download and print material from this website, provided that you retain all copyright and trademark notices contained in such materials. You may use such downloaded and printed materials for your own personal, non-commercial use. You may not use in any manner such materials for public or commercial purposes without Company’s express written consent.
  2. All product names, logos and service marks displayed on this website that are identified by “™” or “®” or that appear in type form different from that of the surrounding text are trademarks owned by or licensed to Company or our affiliates (collectively, “Trademarks”), unless otherwise identified as being owned by another entity. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right, either express or implied, under any patent or Trademark of Company or any third party. No use of any Trademark may be made without the prior written authorization of Company, except to identify the product or services of the company.
  3. Company’s products are available only by prescription from licensed health care professionals. Company does not provide medical advice or services.
  4. You should assume that all content of the website is protected by copyright law unless otherwise noted and may not be used except as provided herein, or with the express written permission of Company. Except as expressly provided above, nothing contained herein shall be construed as conferring any license or right under any Company copyright.
  5. You are prohibited from posting or transmitting to the website any unlawful, threatening, libelous, defamatory, obscene, inflammatory, pornographic or profane material or any material that could constitute or encourage conduct that would be considered a criminal offense, give rise to civil liability or would otherwise violate the law. Company will fully cooperate with any law enforcement authorities or court order requesting or directing Company to disclose the identity of anyone posting any such information or materials.

Disclaimer

COMPANY MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND OR NATURE WITH RESPECT TO ANY OF THE INFORMATION CONTAINED ON THIS WEBSITE. COMPANY DISCLAIMS ALL REPRESENTATIONS AND/OR WARRANTIES, EXPRESS OR IMPLIED, CREATED BY LAW, CONTRACT OR OTHERWISE, INCLUDING WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE OR NONINFRINGEMENT.

In no event shall Company be liable for any damages of any kind or nature, including without limitation, direct, indirect, special, consequential or incidental damages arising from or in connection with the existence or use of the website and/or the information.

Important Safety Information for Remodulin

Warnings and Precautions

  • Chronic intravenous (IV) infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion is the preferred mode of administration.
+

Important Safety Information for Remodulin

Warnings and Precautions

  • Chronic intravenous (IV) infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion is the preferred mode of administration.
  • Avoid abrupt withdrawal or sudden large reductions in dosage of Remodulin, which may result in worsening of PAH symptoms.
  • Titrate slowly in patients with hepatic or renal insufficiency because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal function.
  • Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn. Co-administration of Remodulin with a CYP2C8 inhibitor increases exposure to treprostinil, or with an inducer, decreases exposure to treprostinil.

Drug Interactions/Specific Populations

  • Remodulin is a potent pulmonary and systemic vasodilator. Concomitant administration of Remodulin with blood pressure lowering agents, such as diuretics, antihypertensive agents, or other vasodilators, may increase the risk of symptomatic hypotension.
  • Since Remodulin inhibits platelet aggregation, there may be an increased risk of bleeding, particularly among patients receiving anticoagulants.
  • Safety and effectiveness of Remodulin in pediatric patients have not been established. It is unknown if geriatric patients respond differently than younger patients. Caution should be used when selecting a dose for geriatric patients.
  • There are no adequate and well-controlled studies with Remodulin in pregnant women. It is not known whether treprostinil is excreted in human milk.

Adverse Reactions

  • Adverse Reactions: In clinical studies of SC Remodulin infusion, the most common adverse events reported were infusion site pain and infusion site reaction (redness and swelling). These symptoms were often severe and sometimes required treatment with narcotics or discontinuation of Remodulin. The IV infusion of Remodulin has been associated with a risk of blood stream infections, arm swelling, paresthesias, hematoma, and pain. Other common adverse events (≥3% more than placebo) seen with either SC or IV Remodulin were headache, diarrhea, nausea, jaw pain, vasodilatation, and edema.

Indication

Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious blood stream infections, continuous intravenous infusion should be reserved for patients who are intolerant of the subcutaneous route or in whom these risks are considered warranted.

In patients with PAH requiring transition from Flolan® (epoprostenol sodium), Remodulin is indicated to diminish the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.