Giapreza Approved to Treat Low Blood Pressure
December 21, 2017 – The U.S. FDA has approved Giapreza™ (angiotensin II) injection for IV infusion, manufactured by La Jolla Pharmaceuticals, to increase blood pressure in adults experiencing septic or other distributive shock. Distributive shock can be fatal, and occurs when abnormal distribution of blood through small blood vessels leads to insufficient blood reaching the tissues and organs of the body. Septic shock, the most common form of distributive shock, occurs when organs are injured or damaged in response to infection by bacteria, viruses, fungi, or parasites.
Recommended dosing for Giapreza is based on weight and blood pressure response. Giapreza is administered through a central venous line at a recommended starting dose of 20 nanograms/kg/minute. The dosage should be titrated up every five minutes in increments of 15ng/kg/min to reach and maintain the target blood pressure. Dosing should not exceed 80ng/kg/min in the first three hours of treatment, and maintenance dosing should not be above 40ng/kg/min. When the patient has sufficiently improved, dosage should be titrated down based on blood pressure.
Pricing for Giapreza has not yet been announced. Launch is expected in March of 2018.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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 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.