Interactions between Benlysta and Ipilimumab

Ipilimumab has a major potential interaction with Adrenal Insufficiency.

Immune-mediated endocrinopathies, including severe to life-threatening cases, have occurred with ipilimumab therapy. It is recommended to monitor for signs/symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Clinical chemistries (including adrenocorticotropic hormone [ACTH] level and thyroid function) should be evaluated at baseline and before each dose. Medical management should be started promptly, including specialty consultation as appropriate. Ipilimumab should be withheld or permanently discontinued depending on severity of endocrinopathies.

Ipilimumab has a major potential interaction with Allergies.

Ipilimumab can cause immune-mediated rash or dermatitis (including bullous and exfoliative dermatitis, Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], and drug rash with eosinophilia and systemic symptoms [DRESS]). Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes. Ipilimumab should be withheld for suspected SJS, TEN, or DRESS and permanently discontinued for confirmed SJS, TEN, or DRESS.

Ipilimumab has a major potential interaction with Autoimmune Disorders.

Ipilimumab can cause immune-mediated adverse reactions, which may be severe or fatal. Immune-mediated adverse reactions can occur in any organ system or tissue. Care should be exercised when using ipilimumab in patients with preexisting immune system disorders (e.g., ulcerative colitis, Crohn's disease, lupus). It is recommended to monitor for signs/symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Clinical chemistries (including liver enzymes, creatinine, adrenocorticotropic hormone [ACTH] level, and thyroid function) should be evaluated at baseline and before each dose. Medical management should be started promptly, including specialty consultation as appropriate. Ipilimumab should be withheld or permanently discontinued depending on severity.

Ipilimumab has a major potential interaction with Autonomic Neuropathy.

Ipilimumab can cause immune-mediated adverse reactions, which may be severe or fatal. Immune-mediated adverse reactions can occur in any organ system or tissue. Care should be exercised when using ipilimumab in patients with preexisting immune system disorders (e.g., ulcerative colitis, Crohn's disease, lupus). It is recommended to monitor for signs/symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Clinical chemistries (including liver enzymes, creatinine, adrenocorticotropic hormone [ACTH] level, and thyroid function) should be evaluated at baseline and before each dose. Medical management should be started promptly, including specialty consultation as appropriate. Ipilimumab should be withheld or permanently discontinued depending on severity.

Ipilimumab has a major potential interaction with Bone Marrow Transplantation.

Fatal or serious graft-versus-host disease (GVHD) can occur in patients who receive ipilimumab either before or after allogeneic hematopoietic stem cell transplantation (HSCT). These complications may occur despite intervening therapy between cytotoxic T-lymphocyte antigen 4 (CTLA-4) receptor blocking antibody and allogeneic HSCT. It is recommended to monitor patients closely for evidence of GVHD and intervene promptly. The benefit versus risks of treatment with ipilimumab after allogeneic HSCT should be considered.

The belimumab in Benlysta has a moderate potential interaction with Depression.

In clinical trials, depression and suicidality were reported in patients receiving belimumab. Before treatment with belimumab, the risk of depression and suicide should be assessed, considering the patient's medical history and current psychiatric status; patients should continue to be monitored during therapy. Patients receiving belimumab (and caregivers, if applicable) should be instructed to contact their health care provider if they experience new or worsening depression, suicidal thoughts or behaviors, or other mood changes. The risk and benefit of continued therapy should be considered for patients who develop such symptoms.

Ipilimumab has a major potential interaction with Dermatitis Herpetiformis.

Ipilimumab can cause immune-mediated rash or dermatitis (including bullous and exfoliative dermatitis, Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], and drug rash with eosinophilia and systemic symptoms [DRESS]). Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes. Ipilimumab should be withheld for suspected SJS, TEN, or DRESS and permanently discontinued for confirmed SJS, TEN, or DRESS.

Ipilimumab has a major potential interaction with Hyperthyroidism.

Immune-mediated endocrinopathies, including severe to life-threatening cases, have occurred with ipilimumab therapy. It is recommended to monitor for signs/symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Clinical chemistries (including adrenocorticotropic hormone [ACTH] level and thyroid function) should be evaluated at baseline and before each dose. Medical management should be started promptly, including specialty consultation as appropriate. Ipilimumab should be withheld or permanently discontinued depending on severity of endocrinopathies.

The belimumab in Benlysta has a moderate potential interaction with Immunodeficiency.

Cases of John Cunningham virus (JC virus)-associated progressive multifocal leukoencephalopathy (PML) resulting in neurological deficits (including fatal cases) have been reported in patients with systemic lupus erythematosus receiving immunosuppressants (including belimumab). Risk factors for PML include treatment with immunosuppressant therapies and impairment of immune function. The diagnosis of PML should be considered in any patient presenting with new-onset or deteriorating neurological signs/symptoms; a neurologist or other appropriate specialist should be consulted as clinically indicated. If PML is confirmed, belimumab should be discontinued.

The belimumab in Benlysta has a moderate potential interaction with Infection.

Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents (including belimumab). Overall, while the incidence of serious infections in controlled trials was similar between belimumab and placebo, fatal infection occurred more often with belimumab. The risk and benefit should be considered before starting treatment with belimumab in patients with severe or chronic infections. Interruption of therapy should be considered in patients who develop a new infection while receiving belimumab and these patients should be monitored closely.

Ipilimumab has a major potential interaction with Infectious Gastroenteritis.

Ipilimumab can cause immune-mediated colitis, which may be fatal. CMV infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis; repeating infectious workup should be considered in these patients to exclude alternative etiologies. Ipilimumab should be withheld or permanently discontinued depending on severity of colitis.

Ipilimumab has a major potential interaction with Inflammatory Bowel Disease.

Ipilimumab can cause immune-mediated colitis, which may be fatal. CMV infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis; repeating infectious workup should be considered in these patients to exclude alternative etiologies. Ipilimumab should be withheld or permanently discontinued depending on severity of colitis.

Ipilimumab has a major potential interaction with Liver Disease.

Ipilimumab can cause immune-mediated adverse reactions, which may be severe or fatal. Immune-mediated hepatitis has occurred with ipilimumab therapy. It is recommended to monitor for signs/symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Clinical chemistries (including liver enzymes) should be evaluated at baseline and before each dose. Ipilimumab should be withheld or permanently discontinued depending on severity of hepatitis.

Ipilimumab has a moderate potential interaction with Liver Disease.

Care should be exercised when using ipilimumab in patients with moderate (total bilirubin greater than 1.5 to 3 times the upper limit of normal [1.5 to 3 x ULN] and any AST) or severe (total bilirubin greater than 3 x ULN and any AST) liver dysfunction as ipilimumab has not been studied in these patients. Mild liver dysfunction (total bilirubin greater than 1 to 1.5 x ULN or AST greater than ULN) had no clinically significant effect on the clearance of ipilimumab.

Ipilimumab has a moderate potential interaction with Organ Transplant.

Solid organ transplant rejection has been reported during postmarketing experience with ipilimumab. Care should be exercised when using ipilimumab in patients who have received a solid organ transplant.

The belimumab in Benlysta has a moderate potential interaction with Psychiatric Disorders.

In clinical trials, depression and suicidality were reported in patients receiving belimumab. Before treatment with belimumab, the risk of depression and suicide should be assessed, considering the patient's medical history and current psychiatric status; patients should continue to be monitored during therapy. Patients receiving belimumab (and caregivers, if applicable) should be instructed to contact their health care provider if they experience new or worsening depression, suicidal thoughts or behaviors, or other mood changes. The risk and benefit of continued therapy should be considered for patients who develop such symptoms.

Ipilimumab has a moderate potential interaction with Pulmonary Impairment.

Ipilimumab can cause immune-mediated pneumonitis. Care should be exercised when using ipilimumab in patients with preexisting pulmonary impairment. Ipilimumab should be withheld or permanently discontinued depending on severity of pneumonitis.

Ipilimumab has a major potential interaction with Underactive Thyroid.

Immune-mediated endocrinopathies, including severe to life-threatening cases, have occurred with ipilimumab therapy. It is recommended to monitor for signs/symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Clinical chemistries (including adrenocorticotropic hormone [ACTH] level and thyroid function) should be evaluated at baseline and before each dose. Medical management should be started promptly, including specialty consultation as appropriate. Ipilimumab should be withheld or permanently discontinued depending on severity of endocrinopathies.

Ipilimumab has a major potential interaction with Visual Defect/Disturbance.

Ipilimumab can cause immune-mediated adverse reactions, which may be severe or fatal. It is recommended to monitor for signs/symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Ipilimumab should be permanently discontinued for a Grade 2, 3, or 4 ophthalmologic adverse reaction that does not improve to Grade 1 within 2 weeks while receiving topical therapy or if systemic therapy is required.