Zemdri Approved to Treat cUTI
June 26, 2018 – The U.S. FDA has approved Zemdri™ (plazomicin), manufactured by Achaogen, to treat complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain bacteria. The product is approved for use in adult patients who have limited or no other treatment options.
Zemdri works against carbapenem-resistant (CRE) and extended-spectrum beta-lactamase (ESBL) producing bacteria species that belong to the family Enterobacteriaceae. The CDC has classified these types of bacteria, which often cause infection in hospital settings, as serious health threats. Recommended dosing with Zemdri is 15 mg/kg every 24 hours via intravenous (IV) infusion in patients whose creatinine clearance is at least 90 mL/min. A black box warning cautions there may be a risk of nephrotoxicity, ototoxicity, neuromuscular blockade, and fetal harm.
Achaogen has launched the product at an average wholesale price (AWP) of $378 per vial.
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.