Interactions between Copiktra and Durvalumab

Durvalumab has a moderate potential interaction with Adrenal Insufficiency.

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.

Durvalumab has a moderate potential interaction with Autoimmune Disorders.

Programmed death receptor-1/ligand-1 (PD-1/PD-L1) blocking antibodies can cause immune-mediated adverse reactions, which may be severe or fatal. Immune-mediated adverse reactions can occur in any organ system or tissue at any time after starting therapy. This may be considered when using PD-1/PD-L1 blocking antibodies in patients with immune system disorders (e.g., ulcerative colitis, Crohn's disease, lupus) or with conditions affecting the nervous system (e.g., myasthenia gravis, Guillain-Barre syndrome). It is recommended to monitor patients closely for signs/symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions.

Durvalumab has a moderate potential interaction with Bone Marrow Transplantation.

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.

Durvalumab has a moderate potential interaction with Diabetes Mellitus.

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 has a moderate potential interaction with Diarrhea.

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.

The duvelisib in Copiktra has a major potential interaction with Infection.

Any infection should be treated prior to initiation of treatment with duvelisib. Serious, including fatal infections have occurred in patients receiving treatment with this drug. The most common serious infections were pneumonia (including fatal pneumocystis jirovecii pneumonia, PJP), sepsis, and lower respiratory infections. Advise patients to report any new or worsening signs and symptoms of infection. In some cases, treatment might need to be suspended while the infection is treated. Prophylaxis for PJP should be provided during treatment, and in some cases also prophylactic antivirals should be considered in patients with history of CMV infection to avoid CMV reactivation.

Durvalumab has a moderate potential interaction with Infection.

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 has a moderate potential interaction with Inflammatory Bowel Disease.

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.

The duvelisib in Copiktra has a moderate potential interaction with Liver Disease.

Bilirubin and ALT and/or AST elevation has been reported in patients receiving duvelisib. Monitor hepatic function in all patients during treatment with duvelisib. Caution and close monitoring is advised in patients with hepatic impairment.

Durvalumab has a moderate potential interaction with Liver Disease.

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.

The duvelisib in Copiktra has a moderate potential interaction with Neutropenia.

Caution and close monitoring is advised when starting treatment in patients with neutropenia. Grade 3 or 4 neutropenia has been reported in 42% of patients receiving treatment. Monitor neutrophil counts at least every 2 weeks for the first 2 months of duvelisib therapy, and at least weekly in patients with neutrophil counts < 1.0 Gi/L (Grade 3-4). Withhold treatment with duvelisib in patients presenting with neutrophil counts < 0.5 Gi/L (Grade 4). Monitor until ANC is > 0.5 Gi/L, and then resume duvelisib at same dose for the first occurrence or a reduced dose for subsequent occurrence.

The duvelisib in Copiktra has a major potential interaction with Noninfectious Colitis.

Serious, including fatal diarrhea or colitis has been reported in 18% of patients receiving treatment with duvelisib. Patients with history of colitis should be monitored closely for any signs or symptoms. Advise patients to report any new or worsening diarrhea. Patients presenting with abdominal pain, stool with mucus or blood, change in bowel habits, peritoneal signs, or with diarrhea that is noninfectious should be followed closely and supportive therapy should be initiated based on severity (antidiarrheal agents, to enteric acting or systemic steroids if needed). A diagnostic work- up to determine etiology, including colonoscopy, should be performed. Monitor at least weekly. Upon resolution of the diarrhea or colitis, treatment can be restarted at a reduced dose. Treatment should be discontinued for recurrent Grade 3 diarrhea or recurrent colitis of any grade.

Durvalumab has a moderate potential interaction with Organ Transplant.

Solid organ transplant rejection and other transplant (including corneal graft) rejection have been reported with the use of programmed death receptor-1/ligand-1 (PD-1/PD-L1) blocking antibodies. This may be considered when using PD-1/PD-L1 blocking antibodies in patients who have received a solid organ or other transplant.

Durvalumab has a moderate potential interaction with Pleuropulmonary Infection.

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.

Durvalumab has a moderate potential interaction with Renal Dysfunction.

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 has a moderate potential interaction with Thyroid Disease.

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.