Treprostinil Injection for Treatment of Pulmonary Arterial Hypertension Launched in U.S.

Rare, Progressive Disease Primarily Affects Women

Sandoz’s treprostinil injection, the first fully substitutable, AP-rated generic for Remodulin® Injection, is now available in the U.S. for the treatment of adults with group 1 pulmonary arterial hypertension (PAH) to reduce symptoms associated with exercise.

PAH is a rare, progressive disease that leads to heart failure and a shortened life expectancy. In the U.S., about 52,000 patients have been diagnosed with the disease, and the numbers are expected to increase because of increased survival and diagnosis rates. 

In clinical trials, the most common adverse reactions associated with treprostinil included infusion-site pain and infusion-site reaction (e.g., redness of the skin, hardness of the skin, or rash). In some cases, infusion-site reactions were severe and led to the discontinuation of treatment. With both subcutaneous and intravenous (IV) infusion of treprostinil, rash and low blood pressure were also common, as were headache, diarrhea, jaw pain, edema, vasodilatation, and nausea. Adverse reactions associated with treprostinil IV included bloodstream infections, arm swelling, a tingling or prickling sensation, bruising, and pain.

Treprostinil was primarily studied in patients with New York Heart Association (NYHA) Functional Class II-IV symptoms. In patients with PAH who need to switch from epoprostenol sodium, treprostinil injection is approved to slow the worsening of symptoms. The risks and benefits of each drug should be carefully considered before switching.

Source: PR Newswire, March 25, 2019