Selected Important Safety Information
- INVANZ® (ertapenem sodium) 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.
- Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. Serious anaphylactic reactions require immediate emergency treatment as clinically indicated.
- Seizures and other central nervous system (CNS) adverse experiences have been reported during treatment with INVANZ. 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
- Co-administration of carbapenems, including INVANZ, to patients receiving valproic acid or divalproex sodium results in a reduction of valproic acid concentrations, which may drop below the therapeutic range and increase the risk of breakthrough seizures. Increasing the dose of sodium may not be sufficient. The concomitant use of ertapenem and valproic acid/divalproex sodium is generally not recommended. Antibacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. If administration of INVANZ is necessary, supplemental anticonvulsant therapy should be considered.
- 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.
- Caution should be taken when administering INVANZ intramuscularly to avoid inadvertent injection into a blood vessel.
- As with other antibiotics, prolonged use of INVANZ® (ertapenem sodium) 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. Prescribing INVANZ in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
- 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%).
- In adult patients treated for complicated intra-abdominal infections, death occurred in 4.7% (15/316) of patients receiving INVANZ and 2.6% (8/307) of patients receiving comparator drug. These deaths occurred in patients with significant comorbidity and/or severe baseline infections. Deaths were considered unrelated to study drugs by investigators.
- In clinical studies with adults, seizure was reported during study therapy plus 14-day follow-up period in 0.5% of patients treated with INVANZ, 0.3% of patients treated with piperacillin/tazobactam, and 0% of patients treated with ceftriaxone.
- In a clinical trial in adults for the prophylaxis of surgical site infection following elective colorectal surgery in which 476 patients received a 1 g dose of INVANZ 1 hour prior to surgery and were then followed for safety 14 days post surgery, the overall adverse experience profile was generally comparable to that observed for INVANZ in previous clinical trials.
- The overall adverse experience profile in pediatric patients is comparable to that in adult patients.
- The most common drug-related adverse experiences in pediatric patients treated with INVANZ, including those who were switched to therapy with an oral antimicrobial, were diarrhea (6.5%), infusion-site pain (5.5%), infusion-site erythema (2.6%), and vomiting (2.1%).
- Probenecid interferes with the active tubular secretion of INVANZ® (ertapenem sodium), resulting in increased plasma concentrations of INVANZ. Co-administration of probenecid with INVANZ is not recommended.
- The potential for drug-drug interactions via the cytochrome P450 pathway is limited.
- Safety and effectiveness of INVANZ in pediatric patients aged 3 months to 17 years are supported by evidence from adequate and well-controlled studies in adults, pharmacokinetic data in pediatric patients, and additional data from comparator-controlled studies in pediatric patients aged 3 months to 17 years of age.
- INVANZ is not recommended in infants younger than 3 months, as no data are available.
- INVANZ is not recommended in the treatment of meningitis in the pediatric population due to lack of sufficient cerebrospinal fluid penetration.
- No overall differences in safety or effectiveness were observed between geriatric patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Since INVANZ is substantially excreted by the kidney and elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Before prescribing INVANZ, please read the Prescribing Information.
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