Label Changes for:
Invanz (ertapenem) for Injection
March 2012
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2012
ADVERSE REACTIONS
Postmarketing Experience
- muscular weakness, gait disturbance, and coordination abnormal
May 2010
ADVERSE REACTIONS
Post-Marketing Experience
- Skin and Subcutaneous Tissue Disorders: Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome)
October 2009
WARNINGS
Seizure Potential
- Case reports in the literature have shown that co-administration of carbapenems, including ertapenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction. The concomitant use of ertapenem and valproic acid/divalproex sodium is generally not recommended.
PRECAUTIONS
Information for Patients
- Patients should be counseled to inform their physician if they are taking valproic acid or divalproex sodium. Valproic acid concentrations in the blood may drop below the therapeutic range upon coadministration with Invanz. If treatment with Invanz is necessary and continued, alternative or supplemental anti-convulsant medication to prevent and/or treat seizures may be needed.
