ELECTIVE COLORECTAL SURGERY PROPHYLAXIS in ADULTS
INVANZ is indicated in adults for the prophylaxis of surgical site infection (SSI) following elective colorectal surgery
The PREVENT trial is the largest double-blind study of antimicrobial prophylaxis for elective colorectal surgery.
Prophylaxis of Surgical Site Infection (SSI) Following Elective Colorectal Surgery
Ertapenem was evaluated in adults for prophylaxis of SSI following elective colorectal surgery in a multicenter, randomized, double-blind clinical trial. This study compared a single intravenous dose of ertapenem (1 g) vs cefotetan (2 g) administered over 30 minutes, 1 hour before elective colorectal surgery.
- 1,002 adult patients scheduled for elective surgery of the colon or rectum were randomized (INVANZ n=500, cefotetan n=502).
- All patients received 1 of 2 standard bowel preparations (sodium phosphate or polyethylene glycol) before surgery.1
- Patients received a single dose of study antibiotic in a 30-minute infusion.
901 patients in the MITT population
The modified intent-to-treat (MITT) population included all patients who were randomized and treated, and who underwent elective colorectal surgery with adequate bowel preparation. Prophylactic success rates were accessed at 4 weeks posttreatment.
685 clinically evaluable patients
The clinically evaluable population consisted of patients who received a complete dose of study therapy no more than 2 hours before surgical incision and no more than 6 hours before surgical closure. All evaluable patients were evaluated in the office, 4 weeks posttreatment.
- For the primary analysis, patients with documented surgical site infection, in addition to those with postoperative anastomotic leak or unexplained antibiotic use, were considered to have failed prophylaxis.
- Patients requiring emergency colorectal surgery, a second planned surgery requiring antibiotic prophylaxis, revision of a previous surgery, and those undergoing laparoscopic-assisted surgery or an isolated rectal procedure were ineligible.1
Selected important safety information
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.)
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING THERAPY WITH BETA-LACTAMS. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE, OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION.
Seizures and other central nervous system (CNS) adverse experiences have been reported in patients treated with INVANZ.
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.
During clinical investigations in adult patients treated with INVANZ (1 g once a day), 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.
As with other antibiotics, prolonged use of INVANZ may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient’s condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
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%).
Before prescribing INVANZ, please read the Prescribing Information available on this Web site.
