Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Symptoms of bladder irritability, related to the inflammatory response induced, are reported in approximately 60% of patients receiving TICE ® BCG.
The symptoms typically begin 4 to 6 hours after instillation and last 24 to 72 hours.
The irritative side effects are usually seen following the third instillation, and tend to increase in severity after each administration.
The irritative bladder adverse effects can usually be managed symptomatically with products such as pyridium, propantheline bromide, oxybutynin chloride, and acetaminophen.
The mechanism of action of the irritative side effects has not been firmly established, but is most consistent with an immunological mechanism.
3 There is no evidence that dose reduction or antituberculous drug therapy can prevent or lessen the irritative toxicity of TICE BCG.
"Flu-like" symptoms (malaise, fever, and chills) which may accompany the localized, irritative toxicities often reflect hypersensitivity reactions which can be treated symptomatically.
Antihistamines have also been used.
5 Adverse reactions to TICE BCG tend to be progressive in frequency and severity with subsequent instillation.
Delay or postponement of subsequent treatment may or may not reduce the severity of a reaction during subsequent instillation.
WARNINGS BCG LIVE (TICE ® BCG) is not a vaccine for the prevention of cancer.
BCG Vaccine, not BCG LIVE (TICE BCG), should be used for the prevention of tuberculosis.
For vaccination use, refer to BCG Vaccine prescribing information.
Handling Precautions TICE BCG is an infectious agent.
Physicians using this product should be familiar with the literature on the prevention and treatment of BCG-related complications, and should be prepared in such emergencies to contact an infectious disease specialist with experience in treating the infectious complications of intravesical BCG.
Like all medications, Tice Bcg can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: