Failure to clear catheter-related bacterial infections, suggesting compromised immune response from leukocyte suppression
“The bacterial infections likely originated from indwelling catheters but the failure to clear the infections suggest a compromised immune response, consistent with trilaciclib-mediated leukocyte and thrombocyte suppression during treatment.”
✓ VerifiedFDA pharmacology/toxicology review, p. 9Source ↗
Biodistribution & persistence
Highest in thyroid, kidney, harderian, adrenal and lacrimal glands, spleen and liver; eye uveal tract and meninges in pigmented rats
“Highest radioactivity, representing drug or metabolite tissue distribution, was seen in thyroid, kidney, harderian gland, adrenal gland, lacrimal glands, spleen, and liver in non-pigmented rats with additional distribution in eye/eye uveal tract and meninges in pigmented rats.”
✓ VerifiedFDA pharmacology/toxicology review, p. 35Source ↗
Modality-specific risk
Major human metabolite M8 not covered in animals (<1% in rat plasma, absent in dog plasma)
“Negligible levels of M8 (<1%) were detected in rat plasma and none were detected in dog plasma, so animals were not exposed to M8 at expected clinical exposure levels in toxicology studies.”
✓ VerifiedFDA pharmacology/toxicology review, p. 10Source ↗