Keytruda's mechanism of action involves blocking the PD-1 protein on T cells, preventing its interaction with PD-L1 on cancer cells. This inhibition "takes the brakes off" the immune system, allowing T cells to recognize and attack cancer cells more effectively. By enhancing the body's natura...
12.1MechanismofAction 5WARNINGSANDPRECAUTIONS 12.3Pharmacokinetics 5.1Immune-MediatedPneumonitis 13NONCLINICALTOXICOLOGY 5.2Immune-MediatedColitis 13.1Carcinogenesis,Mutagenesis,ImpairmentofFertility 5.3Immune-MediatedHepatitis13.2AnimalToxicologyand/orPharmacology 5.4Immune-MediatedEndocrinopathies14CLINICALSTUDIES 5.5Immune-Me...
Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYT...
Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential ...
Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below. “The results that support this approval from the KEYNOTE-407 trial demonstrate the potential of KEYTRUDA in combination ...
have experienced disease progression while on programmed death receptor-1 (PD-1) or PD-L1 inhibitor therapy (other than when used as second-line or subsequent therapy for metastatic or unresectable melanoma in combination with ipilimumab following progression on single agent anti-PD-1 immunotherapy)....
. Based on the severity of the adverse reaction, Keytruda should be withheld or permanently discontinued and corticosteroids administered if appropriate. Keytruda can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, Keytruda can cause fet...
providing further validation of the potential benefit of the combination therapy,” saidRob Janssen, M.D., Chief Medical Officer. “These data underscore the value of stimulating the innate immune response through TLR9 and build on clinical evidence around the proposed mechanism of action for SD-10...
KEYTRUDA. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action,...
Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related react...