Warnings and Precautions
Increased mortality, myocardial infarction, stroke, and thromboembolism:
Increased mortality and/or increased risk of tumor progression or recurrence in patients with cancer:
- Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Use caution in patients with coexistent cardiovascular disease and stroke. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of >1 g/dL over 2 weeks may contribute to these risks
- In controlled clinical trials of ESAs in patients with cancer, increased risk for death and serious adverse cardiovascular reactions was observed. These adverse reactions included myocardial infarction and stroke
- In controlled clinical trials of ESAs, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and deep venous thrombosis (DVT) in patients undergoing orthopedic procedures
- In 2 trials of Omontys, patients with CKD not on dialysis experienced increased specific cardiovascular events
The safety and efficacy of Omontys have not been established for use in patients with anemia due to cancer chemotherapy. Omontys is not indicated in patients with cancer receiving chemotherapy.
Omontys is contraindicated in patients with uncontrolled hypertension. Appropriately control hypertension prior to initiation of and during treatment with Omontys. Reduce or withhold Omontys if blood pressure becomes difficult to control. Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions.
Lack or loss of response to Omontys:
For lack or loss of hemoglobin response to Omontys, initiate a search for causative factors. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for antibodies to peginesatide.
Patients receiving Omontys may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.
Evaluate transferrin saturation and serum ferritin prior to and during Omontys treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%.
The most common adverse reactions in clinical studies in patients with CKD on dialysis treated with Omontys were dyspnea, diarrhea, nausea, cough, and arteriovenous fistula site complication.