ANKTIVA (nogapendekin alfa inbakicept-pmln) combined with
ANKTIVA (nogapendekin alfa inbakicept-pmln) combined with BCG for bladder cancer can cause serious, sometimes fatal, adverse reactions, including cardiac arrest, severe urinary tract infections, and intense bladder issues.
Common, severe side effects often include increased creatinine, severe urinary urgency, frequency, and blood in the urine.
U.S. Food and Drug Administration (.gov)
Serious Side Effects and Safety Information
Fatal Cardiac
Arrest: A fatal case of cardiac arrest occurred in 1.1% of patients in clinical trials.
Severe Urinary Issues:
Significant side effects requiring treatment interruption or causing severe discomfort include:
Urinary tract infections (UTI).
Gross hematuria (blood in urine).
Severe dysuria (painful urination) and urgency.
Bladder irritation.
Musculoskeletal Pain:
Pain in muscles, bones, and joints occurred frequently and in some cases, was severe enough to cause discontinuation of treatment.
Other Adverse Reactions:
Increased blood creatinine (kidney function marker) and potassium levels were observed.
Risk of Disease Progression:
Delaying necessary bladder removal (cystectomy) if the cancer does not respond can lead to the spread of muscle-invasive or metastatic cancer, which can be fatal.
Embryo-Fetal Toxicity:
ANKTIVA may cause harm to a fetus; females of reproductive potential should use effective contraception during treatment and for 1 week after the last dose.
U.S. Food and Drug Administration (.gov)
Important Information:
In clinical studies, 16% of patients experienced serious side effects, and 7% discontinued treatment due to adverse reactions.
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