Treprostinil (Remodulin®)

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
May 21, 2002

Recommended for
Remodulin is indicated for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise.

How 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)

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.

 

Picture 1-A

The Mini-Med Subcutaneous
Infusion Pump

Picture 2-A

The AutoCadd Legacy Pump



Risks/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.


Pathway
The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation.

Costs

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.


Manufactured by
Baxter Pharmaceutical Solutions LLC

Distributed by
United Therapeutics Corp.

Additional info
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.

Visit the FDA Page for this drug/therapy

Visit the Official Drug Company Website

Info Source(s)

Full Prescribing Information

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Page Reviewed/Edited: November 2010

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