Inhaled Treprostinil (Tyvaso®)

Tyvaso, (inhaled treprostinil) is an inhaled form of Remodulin®, which is a synthetic form of prostacyclin.

Like Remodulin, Tyvaso 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 for patients with PAH.

Since Tyvaso is delivered via an inhalation device, it eliminates the need for subcutaneous infusions or a central line catheter and the site pain and infection risks that are inherent to both Remodulin and Flolan.


Fda approval date
July 30, 2009

Recommended for
Tyvaso (inhaled treprostinil) is indicated to increase walk distance in patients with pulmonary arterial hypertension (WHO Group I) and NYHA Class III symptoms.

How administered

Tyvaso is administered using the Tyvaso Inhalation System.  The product is to be administered by oral inhalation, 4 times daily, approximately 4 hours apart during waking hours.  The effects on a persons ability to exercise will decrease over the course of the minimum recommended dosing interval of 4 hours but treatment timing can be adjusted for planned activities in order to accommodate individual schedules of activity.

At the beginning of each day, it will take approximately 5 minutes to prepare the inhalation unit for use for that day.  Tyvaso is supplied in ampules that are to be opened and placed into the medicine cup in the inhalation unit at the beginning of each day.  It is to be inhaled through the mouth, into the lungs 4 times a day, approximately 4 hours apart and should be taken exactly as your health care provider instructs you to.  Dosages may be adjusted up or down if your health care provider deems it necessary.  Each treatment takes approximately 2 to 3 minutes.


Risks/Side Effects
The most common side effects of Tyvaso include coughing, headache, nausea, diarrhea, reddening of your face and neck (flushing), throat irritation and pain and fainting or loss of consciousness.  The more serious side effects are the possibility of an increased risk of bleeding in people who take blood thinners (anticoagulants) or a lowering of blood pressure even further in people who already have low blood pressure.

Benefits

Since Tyvaso is delivered via an inhalation device, it eliminates the need for subcutaneous infusions or a central line catheter and the site pain and infection risks that are inherent to both Remodulin and Flolan.

Studies have shown that Tyvaso is a very effective treatment for pulmonary arterial hypertension.  It is much less invasive than the current subcutaneous or intravenous formulation of treprostinil (Remodulin) and since it is administered less frequently than Ventavis®, it makes it a  very desirable option for PAH patients.


Pathway
Treprostinil is a prostacyclin analogue. The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation.

Costs
The cost of treprostinil is $100,000 per year or more depending upon patient dose.

Manufactured by
Catalent Pharma Solutions

Distributed by
United Therapeutics Corp.

Visit the FDA Page for this drug/therapy

Visit the Official Drug Company Website

Info Source(s)
Full Prescribing Information




Page Reviewed/Edited: November 2010

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