Label Changes for:
Vumon (teniposide) Injection
Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2011
- ....metabolic acidosis added
- ...Physicians should be aware of the possible occurrence of a hypersensitivity reaction variably manifested by chills, fever, urticaria, tachycardia, bronchospasm, dyspnea, hypertension or hypotension, rash
- section added
Central Nervous System
- ...neurotoxicity added
- ...Sepsis, sometimes fatal, may be a consequence of severe myelosuppression.
Other Adverse Reactions
- ... headache, confusion, asthenia
- ....for effects on male fertility and incorporate rash as a possible symptom of an anaphylactic-type reaction, as well as sepsis as a consequence of myelosuppression.