About Ertapenem for Injection

Ertapenem for Injection is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria:

• Complicated intra-abdominal infections.
• Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis.
• Community-acquired pneumonia.
• Complicated urinary tract infections including pyelonephritis.
• Acute pelvic infections including postpartum endomyometritis, septic abortion and post- surgical gynecologic infections.

Ertapenem for Injection is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.

IMPORTANT SAFETY INFORMATION

Ertapenem for Injection is contraindicated in people with a known hypersensitivity to product components or anaphylactic reactions to β-lactams. Due to the use of lidocaine HCl as a diluent, Ertapenem for Injection administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type.

Serious hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams.

Seizures and other central nervous system adverse experiences have been reported during treatment.

Co-administration of Ertapenem for Injection with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures.

Clostridium difficile-associated diarrhea (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs.

Caution should be taken when administering Ertapenem for Injection intramuscularly to avoid inadvertent injection into a blood vessel.

The most common adverse reactions (≥ 5%) in adult patients treated with Ertapenem for Injection, including those who were switched to therapy with an oral antimicrobial, were diarrhea, nausea, headache and infused vein complication.

In the prophylaxis indication the overall adverse experience profile was generally comparable to that observed for ertapenem in other clinical trials.

For pediatrics, adverse reactions in this population were comparable to adults. The most common adverse reactions (≥ 5%) in pediatric patients treated with Ertapenem for Injection, including those who were switched to therapy with an oral antimicrobial, were diarrhea, vomiting and infusion site pain.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch.

Co-administration with probenecid inhibits the renal excretion of ertapenem and is therefore not recommended.

The concomitant use of ertapenem and valproic acid/divalproex sodium is generally not recommended. Anti-bacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium.

Renal impairment: Dose adjustment is necessary, if creatinine clearance is ≤ 30 mL/min/1.73 m².

This Important Safety Information does not include all the information needed to use Ertapenem for Injection, USP safely and effectively. Please see the full prescribing information for Ertapenem for Injection, USP at https://tinyurl.com/ww9wssl.

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