Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- *new Pregnancy subsection entitled “Infertility” to provide information regarding contraception precautions and potential loss of fertility
- *updated to include information on concomitant use of antiepileptic medications
- Injection site reactions may occur during the administration of Etopophos. Closely monitor the infusion site for possible infiltration during drug administration. No specific treatment for extravasation reactions is known.
- Local soft tissue toxicity has been reported following extravasation of Etopophos.