Erythropoiesis-stimulating agents (ESAs) increase the risk of death, MI, stroke, venous thromboembolism, thrombosis of vascular access.
Chronic kidney disease:
In controlled trials, patients experienced greater risks of death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target a hemoglobin level of greater than 11 g/dL.
ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
Due to increased risk of DVT, DVT prophylaxis is recommended.
Breast cancer, endometrial cancer, or other estrogen- or progestin-dependent neoplasms (current or a history of), hepatic tumors (benign or malignant) or hepatic disease, cholestatic jaundice of pregnancy or jaundice with prior OCP use, pregnancy, undiagnosed abnormal genital bleeding; coadministration with hepatitis C drug combinations containing ombitasivir/partiaprevier/ritonavir with or without dasabuvir.
Use is also contraindicated in women at high risk of arterial or venous thrombotic diseases (specifics vary by product labeling), for example, women with cerebrovascular disease, coronary artery disease, diabetes mellitus with vascular disease, DVT, thrombophlebitis, thromboembolic disorders, or thrombophilic conditions, hypertension (severe or uncontrolled; specified as systolic ≥160 mm Hg or diastolic ≥100 mm Hg in some product labeling), valvular heart disease with thrombogenic complications, headaches with focal neurological symptoms, major surgery with prolonged immobilization, women >35 years of age who smoke ≥15 cigarettes per day.