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Remodulin®, (also known as UT-15) is a synthetic, stable form of prostacyclin for either subcutaneous infusion delivery or intravenous delivery. Additionally, there is an inhaled version of Remodulin known as Tyvaso®, which was approved by the FDA in July 2009.
Remodulin is a potent vasodilator that relaxes the blood vessels in the lungs and slows the process of scarring and cell growth within the lung’s blood vessels, which prevents further narrowing. It also assists in increasing cardiac output and oxygen saturation. It improves exercise tolerance and prolongs survival in patients with PAH. It is a second generation to Flolan®, although produced by a different drug company.
Remodulin has a much longer half-life in the human body than Flolan so it reduces the danger if infusion is interrupted. Additionally Remodulin is stable at room temperature for up to five years, unlike Flolan. The drug's dilation action lasts from 4-6 hours versus the short 2-3 minute action of Flolan.
Fda approval date
Remodulin can be administered in two ways. For under the skin delivery, called subcutaneous infusion, Remodulin is infused with a pager-sized MiniMed microinfusion device (see picture 1-A).
Subcutaneous Remodulin lowers the risk of infection and related hospitalizations associated with the Flolan central line catheter.
For intravenous delivery, Remodulin is delivered through a central line catheter, much like Flolan (see picture 2-A)
Remodulin does not require mixing; the fluid comes ready-to-use in glass vials. No refrigeration is needed. A small syringe is used to withdraw solution and the syringe itself becomes the cassette placed into the pump. Every three days, a new site on the belly is begun, using a spring-loaded device to insert a very thin plastic cannula approximately 1/2 inch into the belly.
The Mini-Med Subcutaneous
The AutoCadd Legacy Pump
The chief drawback to Remodulin is site pain, which can be quite severe. Often a pain medication must be prescribed for Remodulin patients. However, for those patients unable to tolerate the site pain, Remodulin can now be delivered intravenously.
Remodulin has the same side effects as Flolan, but often not as severe. Side effects can include jaw pain, headache, flushing, nausea, diarrhea, and vomiting.
The yearly cost of Remodulin is upwards of $100,000 per year, dependent on the patient and dosage. Many insurance companies consider it an ongoing treatment rather than a prescription, so it's classified differently where co-pays are concerned.
Full Prescribing Information
For Additional Information Visit:
- United Therapeutics Website
- Clinical Trial Information for Inhaled Remodulin®
- Slide Presentation to FDA: NDA 21-272Remodulin®™ (treprostinil sodium)
- Safety, Efficacy and Treatment Satisfaction Switching From Flolan to Remodulin
- Remodulin Therapy Assistance Program
Page Reviewed/Edited: November 2010
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- Oral Treprostinil New Drug Application Accepted by FDA for Review
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- BioTech CEOs offer cautionary tales
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- Subcutaneous treprostinil in pulmonary arterial hypertension: Practical considerations.
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- Standard PAH therapy improves long term survival in CTEPH patients.
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- PAH Drug Outperforms Expectations