Label Changes for:

Vumon (teniposide) Injection

October 2011

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

 

 

WARNINGS

  • ....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
Male Fertility
  • section added

 

ADVERSE REACTIONS

Central Nervous System
  • ...neurotoxicity added
Hematological Toxicity
  • ...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.

 

Hide
(web5)