Merck & Co. Inc. has received an approval from the US Food and Drug Administration for Invanz (ertapenem), a once-daily injectable antibiotic, for the treatment of moderate to severe complicated foot infection due to indicated pathogens in diabetic patients without osteomyelitis. The approval was based on the results of the sidestep study, the largest prospective, randomized and double-blind clinical trial ever conducted in diabetic patients with moderate to severe complicated foot infection. Foot infections commonly occur in patients with diabetes and are known to be difficult to treat.


"Currently there are limited data available for helping clinicians decide on the most appropriate treatment for foot infections in diabetic patients. The study supporting this new indication for Invanz provides physicians with another proven option in the treatment of diabetic foot infections," said Murray A. Abramson, medical director, clinical development, infectious diseases and oncology at Merck and Co.

According to a company release, Invanz is indicated for the treatment of moderate to severe complicated skin and skin structure infections including diabetic foot infections without osteomyelitis due to Staphylococcus aureus (methicillin susceptible isolates only), Streptococcus agalactiae, Streptococcus pyogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Bacteroides fragilis, Peptostreptococcus species, Porphyromonas asaccharolytica, or Prevotella bivia.

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

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 known hypersensitivity to local anaesthetics of the amide type. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams.

Invanz, a carbapenem related to the class of antibiotics known as beta-lactams, is generally given to adults as a 1-gram dose, once a day, by intravenous infusion or intramuscular injection. Dosage adjustment of Invanz is required in diabetic patients with reduced renal function (see prescribing information). Invanz is also indicated for the treatment of adults and paediatric patients over three months of age for the following moderate to severe infections caused by susceptible isolates of the designated pathogens.