Intravenous Remodulin®

What it is:

Remodulin®, (also known as UT-15) is a synthetic, stable form of prostacyclin. It is produced by United Therapeutics, Inc and received FDA approval in 2002, for subcutaneous infusion delivery; and in 2005 for intravenous delivery. Additionally, the inhaled version of Remodulin® is currently in clinical trials (2006).

It 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.

How it is Administered:

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).

Maintenance and Routines:

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.

Side Effects:

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.

Cost:

The yearly cost of Remodulin® is upwards of $75,000 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.

Summary:

Remodulin® appears to be as effective as Flolan for treating PAH.

IMPORTANT NOTE:  An oral version of Remodulin is currently in work. This new medication may or may not make it to the U.S. or world market. According to a Dec 2008 press release, "the company announced that an oral version of its lung-disease drug Remodulin failed to achieve its primary endpoint in a pivotal phase III study." United Therapeutics will have to conduct more trials and plans to resubmit in late 2010. An inhaled version of the same drug was approved by the FDA July 30, 2009.  Visit the Inhaled Tyvaso treatment page.
 

Recent items from the PHCentral Newsroom:

• Improved Long-Term Outcome With Remodulin Reported in European Respiratory Journal
  (Doctor's Guide) -- United Therapeutics Corporation announced the publication of two studies: Long-term outcome in pulmonary arterial hypertension patients with subcutaneous treprostinil and Rapid Switch from intravenous epoprostenol to intravenous treprostinil in patients with pulmonary arterial hypertension.
   
• United Therapeutic hypertension drug trial disappoints
  (Business Journal (BizJournal)) -- United Therapeutics Corp suffered a scientific blow with news that the oral version of its pulmonary hypertension drug has failed to produce anticipated results in the latest phase of clinical trials.
   

For Additional Information Visit:

• United Therapeutics Website
• Clinical Trial Information for Inhaled Remodulin®
• Slide Presentation to FDA: NDA 21-272Remodulin®™ (treprostinilsodium)
• FDA Drug Search: For information about this drug and any other drug approved by the U.S. FDA – patient info sheets, label info, approval history etc.
• Safety, Efficacy and Treatment Satisfaction Switching From Flolan to Remodulin
• Remodulin Therapy Assistance Program

August 2009 - Page reviewed and updated