b'IMFINZI (durvalumab) injection, for intravenous use 2Immune-Mediated Pneumonitis Intestinal perforation and large intestine perforation were reportedpatientsreceivingIMFINZIincombinationwithtremelimumab-IMFINZI can cause immune-mediated pneumonitis. The incidencein0.1%ofpatientsreceivingIMFINZIincombinationwithactl, including Grade 3 (0.5%) adverse reactions. Events resulted ofpneumonitisishigherinpatientswhohavereceivedpriortremelimumab-actl. in permanent discontinuation in 1 patient. Systemic corticosteroids thoracic radiation. Immune-Mediated Hepatitis were required in 6 patients with immune-mediated hypophysitis; IMFINZI as a Single Agent IMFINZI can cause immune-mediated hepatitis. of these, 2 of the 8 patients received high-dose corticosteroid In Patients Who Did Not Receive Recent Prior Radiation IMFINZI as a Single Agent treatment (at least 40 mg prednisone or equivalent per day). Four In patients who received IMFINZI on clinical trials in which radiationImmune-mediated hepatitis occurred in 2.8% (52/1889) of patientspatients also required endocrine therapy.therapywasgenerallynotadministeredimmediatelypriortoreceiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) andThyroid Disordersinitiation of IMFINZI, the incidence of immune-mediated pneumonitisGrade 3 (1.4%) adverse reactions. Events resolved in 21 of theIMFINZI can cause immune-mediated thyroid disorders. Thyroiditis was 2.4% (34/1414), including fatal ( 0.1%), and Grade 3-4 (0.4%)52 patients and resulted in permanent discontinuation of IMFINZI incan present with or without endocrinopathy. Hypothyroidism can adverse reactions. Events resolved in 19 of the 34 patients and6 patients. Systemic corticosteroids were required in all patients withfollowhyperthyroidism.Initiatehormonereplacementtherapy resultedinpermanentdiscontinuationin5patients.Systemicimmune-mediated hepatitis, while 2 patients (2/52) required useforhypothyroidismorinstitutemedicalmanagementof corticosteroids were required in 19 patients (19/34) with pneumonitisof mycophenolate with high-dose steroids. hyperthyroidism as clinically indicated. Withhold or discontinue who did not receive chemoradiation prior to initiation of IMFINZI. IMFINZI with Tremelimumab-actl IMFINZI based on the severity [see Dosage and Administration (2.2) In Patients Who Received Recent Prior Radiation Immune-mediated hepatitis occurred in 7.5% (29/388) of patientsin the full Prescribing Information].The incidence of pneumonitis (including radiation pneumonitis)receiving IMFINZI in combination with tremelimumab-actl, includingThyroiditisin patients with unresectable Stage III NSCLC following definitivefatal (0.8%), Grade 4 (0.3%), and Grade 3 (4.1%) adverse reactions.IMFINZI as a Single Agentchemoradiation within 42 days prior to initiation of IMFINZI inEvents resolved in 12 of the 29 patients and resulted in permanentImmune-mediated thyroiditis occurred in 0.5% (9/1889) of patients PACIFIC was 18.3% (87/475) in patients receiving IMFINZI anddiscontinuationin9patients.Systemiccorticosteroidswerereceiving IMFINZI, including Grade 3 ( 0.1%) adverse reactions. 12.8% (30/234) in patients receiving placebo. Of the patients whorequired in all 29 patients and all 29 patients required high-doseEvents resolved in 4 of the 9 patients and resulted in permanent received IMFINZI (475) 1.1% were fatal and 2.7% were Grade 3corticosteroid treatment (at least 40 mg prednisone or equivalentdiscontinuationin1patient.Systemiccorticosteroidswere adverse reactions. Events resolved in 50 of the 87 patients andper day). Eight patients (8/29) required other immunosuppressants. required in 3 patients (3/9) with immune-mediated thyroiditis, resulted in permanent discontinuation in 27 patients. IMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy while 8 patients (8/9) required endocrine therapy.Systemiccorticosteroidswererequiredin64patients(64/87)Immune-mediated hepatitis occurred in 3.9% (23/596) of patientsIMFINZI with Tremelimumab-actlwithpneumonitiswhohadreceivedchemoradiationpriortoreceiving IMFINZI in combination with tremelimumab-actl, includingImmune-mediated thyroiditis occurred in 1.5% (6/388) of patients initiation of IMFINZI, while 2 patients required use of infliximabfatal (0.3%), Grade 4 (0.5%), and Grade 3 (2.0%) adverse reactions.receiving IMFINZI in combination with tremelimumab-actl. Events with high-dose steroids. Events resolved in 12 of the 23 patients and resulted in permanentresolved in 2 of the 6 patients. Systemic corticosteroids were Thefrequencyandseverityofimmune-mediatedpneumonitisdiscontinuationin10patients.Systemiccorticosteroidswererequired in 2 patients (2/6) with immune-mediated thyroiditis; of in patients who did not receive definitive chemoradiation prior torequiredinallpatientswithimmune-mediatedhepatitis,whilethese, 1 patient required high-dose corticosteroid treatment (at IMFINZI were similar whether IMFINZI was given as a single agent in2 patients (2/23) required use of other immunosuppressants. least 40 mg prednisone or equivalent per day). All patients required patients with various cancers in a pooled data set or in patients withImmune-Mediated Endocrinopathies other therapy including hormone replacement therapy, thiamazole, ES-SCLC or BTC when given in combination with chemotherapy. Adrenal Insufficiency carbimazole, propylthiouracil, perchlorate, calcium channel blocker, IMFINZI with Tremelimumab-actl IMFINZI can cause primary or secondary adrenal insufficiency.or beta-blocker.Immune-mediated pneumonitis occurred in 1.3% (5/388) of patientsFor Grade 2 or higher adrenal insufficiency, initiate symptomaticIMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapyreceiving IMFINZI in combination with tremelimumab-actl, includingtreatment, including hormone replacement as clinically indicated.Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients fatal (0.3%) and Grade 3 (0.2%) adverse reactions. Events resolvedWithhold or permanently discontinue IMFINZI based on the severityreceiving IMFINZI in combination with tremelimumab-actl. Events in 3 of the 5 patients and resulted in permanent discontinuation in[seeDosageandAdministration(2.2)inthefullPrescribingresolved in 2 of the 7 patients and one resulted in permanent 1 patient. Systemic corticosteroids were required in all patients; ofInformation]. discontinuation.Systemiccorticosteroidswererequiredin these, 4 patients required high-dose corticosteroid treatment (atIMFINZI as a Single Agent 2 patients (2/7) with immune-mediated thyroiditis, while all patients least 40 mg prednisone or equivalent per day). One patient (1/5)Immune-mediatedadrenalinsufficiencyoccurredin0.5%required endocrine therapy.required other immunosuppressants. (9/1889) of patients receiving IMFINZI, including Grade 3 ( 0.1%)HyperthyroidismIMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy adverse reactions. Events resolved in 1 of the 9 patients and didIMFINZI as a Single AgentImmune-mediatedpneumonitisoccurredin3.5%(21/596)ofnot lead to permanent discontinuation of IMFINZI in any patients.Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patientsreceivingIMFINZIincombinationwithtremelimumab- Systemiccorticosteroidswererequiredinallpatientswithpatients receiving IMFINZI. Events resolved in 30 of the 39 patients actlandplatinum-basedchemotherapy,includingfatal(0.5%),adrenal insufficiency; of these, the majority remained on systemicand did not lead to permanent discontinuation of IMFINZI in any and Grade 3 (1%) adverse reactions. Events resolved in 11 of thecorticosteroids. patients.Systemiccorticosteroidswererequiredin9patients 21patientsandresultedinpermanentdiscontinuationinIMFINZI with Tremelimumab-actl (9/39) with immune-mediated hyperthyroidism, while 35 patients 7 patients. Systemic corticosteroids were required in all patientsImmune-mediated adrenal insufficiency occurred in 1.5% (6/388)(35/39) required endocrine therapy.with immune-mediated pneumonitis, while 1 patient (1/21) requiredof patients receiving IMFINZI in combination with tremelimumab- IMFINZI with Tremelimumab-actlother immunosuppressants. actl, including Grade 3 (0.3%) adverse reactions. Events resolvedImmune-mediated hyperthyroidism occurred in 4.6% (18/388) of Immune-Mediated Colitis in 2 of the 6 patients. Systemic corticosteroids were required in allpatients receiving IMFINZI in combination with tremelimumab-actl, IMFINZI can cause immune-mediated colitis that is frequently asso- 6 patients, and of these, 1 patient required high-dose corticosteroidincluding Grade 3 (0.3%) adverse reactions. Events resolved in ciated with diarrhea. Cytomegalovirus (CMV) infection/reactivationtreatment (at least 40 mg prednisone or equivalent per day). 15 of the 18 patients. Two patients (2/18) required high-dose hasbeenreportedinpatientswithcorticosteroid-refractoryIMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy corticosteroid treatment (at least 40 mg prednisone or equivalent immune-mediated colitis. In cases of corticosteroid-refractory colitis,Immune-mediated adrenal insufficiency occurred in 2.2% (13/596)per day). Seventeen patients required other therapy (thiamazole, consider repeating infectious workup to exclude alternative etiologies. of patients receiving IMFINZI in combination with tremelimumab- carbimazole, propylthiouracil, perchlorate, calcium channel blocker, IMFINZI as a Single Agent actl, including Grade 3 (0.8%) adverse reactions. Events resolvedor beta-blocker).Immune-mediated colitis occurred in 2% (37/1889) of patientsin 2 of the 13 patients and resulted in permanent discontinuation inIMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapyreceiving IMFINZI, including Grade 4 ( 0.1%) and Grade 3 (0.4%)1 patient. Systemic corticosteroids were required in all patients withImmune-mediated hyperthyroidism occurred in 5% (30/596) of adverse reactions. Events resolved in 27 of the 37 patients andadrenal insufficiency. One patient also required endocrine therapy. patients receiving IMFINZI in combination with tremelimumab-actl, resultedinpermanentdiscontinuationin8patients.SystemicHypophysitis including Grade 3 (0.2%) adverse reactions. Events resolved in corticosteroids were required in all patients with immune-mediatedIMFINZI can cause immune-mediated hypophysitis. Hypophysitis21 of the 30 patients. Systemic corticosteroids were required in colitis, while 2 patients (2/37) required other immunosuppressantscan present with acute symptoms associated with mass effect5 patients (5/30) with immune-mediated hyperthyroidism, while (e.g., infliximab, mycophenolate). such as headache, photophobia, or visual field cuts. Hypophysitis28 patients (28/30) required endocrine therapy.IMFINZI with Tremelimumab-actl cancausehypopituitarism.InitiatesymptomatictreatmentHypothyroidismImmune-mediated colitis or diarrhea occurred in 6% (23/388) ofincluding hormone replacement as clinically indicated. WithholdIMFINZI as a Single Agentpatients receiving IMFINZI in combination with tremelimumab-actl,or permanently discontinue IMFINZI depending on severity [seeImmune-mediated hypothyroidism occurred in 8.3% (156/1889) including Grade 3 (3.6%) adverse reactions. Events resolved inDosage and Administration (2.2) in the full Prescribing Information]. of patients receiving IMFINZI, including Grade 3 (0.1%) adverse 22 of the 23 patients and resulted in permanent discontinuation inIMFINZI as a Single Agent reactions. Events resolved in 31 of the 156 patients and did not 5patients.Allpatientsreceivedsystemiccorticosteroids,andGrade 3 hypophysitis/hypopituitarism occurred in 0.1% (1/1889)lead to permanent discontinuation of IMFINZI in any patients. 20 of the 23 patients received high-dose corticosteroid treatmentofpatientswhoreceivedIMFINZI.TreatmentwithsystemicSystemic corticosteroids were required in 11 patients (11/156) (at least 40 mg prednisone or equivalent per day). Three patientscorticosteroids was administered in this patient. The event did notand the majority of patients (152/156) required long-term thyroid also received other immunosuppressants. lead to permanent discontinuation of IMFINZI. hormone replacement.Intestinal perforation has been observed in other studies of IMFINZIIMFINZI with Tremelimumab-actl IMFINZI with Tremelimumab-actlin combination with tremelimumab-actl. Immune-mediatedhypophysitis/hypopituitarismoccurredinImmune-mediated hypothyroidism occurred in 11% (42/388) of IMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy 1% (4/388) of patients receiving IMFINZI in combination withpatients receiving IMFINZI in combination with tremelimumab-actl. Immune-mediated colitis occurred in 6.5% (39/596) of patientstremelimumab-actl.Eventsresolvedin2ofthe4patients.Events resolved in 5 of the 42 patients. One patient received receiving IMFINZI in combination with tremelimumab-actl includingSystemic corticosteroids were required in 3 patients, and of these,high-dose corticosteroid treatment (at least 40 mg prednisone or fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Events resolved1patientreceivedhigh-dosecorticosteroidtreatment(atleastequivalent per day). All patients required other therapy (thiamazole, in 33 of 39 patients and resulted in permanent discontinuation in40mgprednisoneorequivalentperday).Twopatientsalsocarbimazole, propylthiouracil, perchlorate, calcium channel blocker, 11 patients. Systemic corticosteroids were required in all patientsrequired endocrine therapy. or beta-blocker).with immune-mediated colitis, while 4 patients (4/39) requiredIMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy IMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapyother corticosteroids. Immune-mediatedhypophysitisoccurredin1.3%(8/596)ofImmune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with tremelimumab-actl, US-76417_US-77669_US-77951 Imfinzi-Imjudo US Medicine - The Compendium.indd 4 12/6/23 3:45 PM'