Uptravi Approved for Pulmonary Arterial Hypertension
December 21, 2015 – The U.S. Food and Drug Administration (FDA) approved Uptravi (selexipag), an oral prostacyclin receptor agonist to delay the progression of pulmonary arterial hypertension (PAH) and reduce the risk of hospitalization. Uptravi is manufactured by Actelion.
Pulmonary hypertension is a chronic, progressive disease that is caused by abnormally high blood pressure in the arteries of the lungs. It can cause symptoms such as shortness of breath, tiredness, fainting and swollen ankles and legs. Pulmonary hypertension is a debilitating disease that often leads to death or need for lung transplantation.
The recommended starting dose of Uptravi is 200mcg two times a day which should then be increased by 200mcg two times a day at weekly intervals to the highest tolerated dose up to 1600mcg two times a day. Actelion plans on launching Uptravi in early January 2016. It will be available through a limited network of specialty pharmacies.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.