Imfinzi Disease Interactions

Durvalumab can cause immune-mediated adrenal insufficiency. Adrenal function should be monitored in patients with adrenal insufficiency or with borderline adrenal function and in patients with prolonged periods of stress due to major surgery, intensive care, etc. It is recommended to monitor patients for clinical signs and symptoms of adrenal insufficiency and to institute appropriate measures as necessary. Monitor as clinically indicated prior to and periodically during treatment and withhold, reduce dose, or discontinue therapy with durvalumab as necessary.

Immune-mediated colitis has been reported with the use of durvalumab. Monitor patients for signs and symptoms of diarrhea or colitis. It is recommended to administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents followed by corticosteroid taper for severe or life-threatening colitis. It is recommended to interrupt or to permanently discontinue durvalumab for life-threatening or for recurrent colitis. Care should be taken when using durvalumab in patients with inflammatory bowel disease.

Durvalumab can cause type 1 diabetes mellitus. Monitor for hyperglycemia or other signs and symptoms of diabetes. Withhold treatment in cases of severe hyperglycemia until metabolic control is achieved. Permanently discontinue durvalumab for life-threatening hyperglycemia. If appropriate interrupt treatment according to manufacturer recommendations. Care should be exercised when using durvalumab in diabetic patients.

Durvalumab may alter the normal immune response and increase susceptibility to infections. Monitor patients for signs and symptoms of infection and withhold durvalumab treatment for Grade 3 or higher infections, particularly in patients with urinary tract infections. Resume once clinically stable.

Durvalumab can cause immune-mediated hepatitis. Caution is recommended when using durvalumab in patients with moderate or severe hepatic impairment as this agent has not been studied in these patients. Monitor patients for signs and symptoms of hepatitis during and after treatment discontinuation. Periodic hepatic function test should be performed according to medical practices. Administer corticosteroids as appropriate according to manufacturer recommendations. It is recommended to interrupt or permanently discontinue treatment with durvalumab for severe or life-threatening transaminase or total bilirubin elevation. Care should be taken when using durvalumab in patients with liver disease.

Durvalumab can cause immune-mediated nephritis. Monitor patients for abnormal renal function tests prior to and periodically during treatment. It is recommended to administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents followed by corticosteroid taper for life-threatening increased serum creatinine. Withhold or permanently discontinue durvalumab based on severity. If appropriate modify the dose according to manufacturer recommendations. Care should be taken when using durvalumab in patients with renal dysfunction.

Durvalumab can cause immune-mediated thyroid disorders. Monitor thyroid function prior to and periodically during treatment. Administer hormone-replacement therapy for hypothyroidism or initiate medical management for control of hyperthyroidism. Continue durvalumab for hypothyroidism and interrupt for hyperthyroidism based on the manufacturer recommendation. Care should be taken when using this agent in patients with thyroid disease.

Durvalumab can cause immune-mediated pneumonitis. Monitor patients for signs and symptoms of pneumonitis. Evaluate patients with suspected pneumonitis with radiographic imaging. It is recommended to administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents for moderate pneumonitis or 1 to 4 mg per kg per day or equivalent corticosteroid for more severe pneumonitis, followed by a taper. It is recommended to interrupt or permanently discontinue durvalumab based on the severity of symptoms. Care should be exercised when using this agent in patients with suspected pneumonitis.

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a programmed death receptor-1/ligand-1 (PD-1/PD-L1) blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. It is recommended to follow patients closely for evidence of transplant-related complications and intervene promptly. The benefit versus risks of treatment with a PD-1/PD-L1 blocking antibody before or after an allogeneic HSCT should be considered.

Myasthenic syndrome/myasthenia gravis (including exacerbation) has been reported with the use of programmed death receptor-1/ligand-1 (PD-1/PD-L1) blocking antibodies. Care should be exercised when using PD-1/PD-L1 blocking antibodies in patients with myasthenia gravis.

Solid organ transplant rejection has been reported with the use of programmed death receptor-1/ligand-1 (PD-1/PD-L1) blocking antibodies. Care should be exercised when using PD-1/PD-L1 blocking antibodies in patients who have received a solid organ transplant.