Dear Doctor:

We are pleased to present to you the article, “Ertapenem versus Cefotetan Prophylaxis in Elective Colorectal Surgery,” by K.M.F. Itani, S.E. Wilson, S.S. Awad, E.H. Jensen, T.S. Finn, and M.A. Abramson, as published in the December 21, 2006, issue of The New England Journal of Medicine.

INVANZ^® (ertapenem sodium) is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.

A second adequate and well-controlled study to confirm these findings has not been conducted; therefore, the clinical superiority of INVANZ over cefotetan has not been demonstrated.

INVANZ is also indicated for the treatment of patients with the following moderate to severe infections caused by susceptible isolates of the designated microorganisms:
Complicated intra-abdominal infections due to Escherichia coli, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus species, Bacteroides fragilis, B distasonis, B ovatus, B thetaiotaomicron, or B uniformis.
Complicated skin/skin structure infections, including diabetic foot infections without osteomyelitis, due to Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus agalactiae, Streptococcus pyogenes, E coli, Klebsiella pneumoniae, Proteus mirabilis, B fragilis, Peptostreptococcus species, Porphyromonas asaccharolytica, or Prevotella bivia. INVANZ has not been studied in diabetic foot infections with concomitant osteomyelitis.
Community-acquired pneumonia due to Streptococcus pneumoniae (penicillin-susceptible isolates only), including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase–negative isolates only), or Moraxella catarrhalis.
Complicated urinary tract infections, including pyelonephritis, due to E coli, including cases with concurrent bacteremia, or K pneumoniae.
Acute pelvic infections, including postpartum endomyometritis, septic abortion, and postsurgical gynecologic infections, due to S agalactiae, E coli, B fragilis, P asaccharolytica, Peptostreptococcus species, or P bivia.

Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to INVANZ. Therapy with INVANZ may be initiated empirically before results of these tests are known; once results become available, antimicrobial therapy should be adjusted accordingly.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of INVANZ and other antibacterial drugs, INVANZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

INVANZ is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams.

Due to the use of lidocaine HCl as a diluent, INVANZ administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type. (Refer to the prescribing information for lidocaine HCl.)

Carbapenems, including ertapenem, may reduce serum valproic acid concentrations to subtherapeutic levels, resulting in loss of seizure control. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations drop below the therapeutic range or a seizure occurs.

Clostridium difficile–associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including INVANZ, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. CDAD has been reported to occur over 2 months after administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C difficile may need to be discontinued.

Seizures and other central nervous system (CNS) adverse experiences have been reported in patients treated with INVANZ. During clinical investigations in adult patients, seizures, irrespective of drug relationship, occurred in 0.5% of patients during study therapy plus 14-day follow-up period. These experiences have occurred most commonly in patients with CNS disorders (eg, brain lesions or history of seizures) and/or compromised renal function. Close adherence to the recommended dosage regimen is urged, especially in patients with known factors that predispose to convulsive activity.

During clinical trials, the most common drug-related adverse experiences in adult patients treated with INVANZ, including those who were switched to therapy with an oral antimicrobial, were diarrhea (5.5%), infused vein complication (3.7%), nausea (3.1%), headache (2.2%), vaginitis in females (2.1%), phlebitis/thrombophlebitis (1.3%), and vomiting (1.1%).

In the attached study, the overall adverse experience profile was generally comparable to that observed in previous trials for ertapenem.

Before prescribing INVANZ, please read the Prescribing Information available on this Web site.

Sincerely,

Bram Greenberg, MD, FAAP
Executive Director, Medical Services