Avycaz Receives New Indication
February 1, 2018 – The U.S. FDA has approved a new indication for Avycaz® (ceftazidime/avibactam), a combination antibacterial agent manufactured by Allergan. The new indication is for treatment of adults who have hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia caused by strains of bacteria susceptible to the drug.
Avycaz was originally approved in 2015, and is also indicated to treat adults who have complicated intra-abdominal infections (cIAI), when used in combination with metronidazole, as well as adults with complicated urinary tract infections (cUTI) including pyelonephritis. The product contains ceftazidime, a cephalosporin, and avibactam, a beta-lactamase inhibitor.
Recommended dosing with Avycaz is based on the indication and the patient’s renal health. It is administered via intravenous infusion over the course of two hours. Treatment can last for anywhere from five to fourteen days. Avycaz is available in single-dose vials of powder for reconstitution. Each vial contains ceftazidime 2gm and avibactam 0.5gm.
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.