Peginesatide Brand Name– Omontys
What is Peginesatide
Peginesatide is an erythropoiesis-stimulating agent (ESA) for the treatment of anemia in adult dialysis patients with chronic kidney disease (CKD).
In February 2013, the manufacturer instituted a voluntary recall of peginesatide after receiving post-marketing reports of serious hypersensitivity reactions including anaphylaxis and death and subsequently removed the product from the market. It is not indicated for use in patients with CKD not on dialysis, in patients receiving treatment for cancer whose anemia is not due to CKD, or as a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anemia.
Unlike epoetin alfa or darbepoetin alfa, which are recombinant forms of erythropoietin, peginesatide is a novel, synthetic peptide-based erythropoietin-receptor agonist with an amino acid sequence that is unrelated to erythropoietin.
As a class, ESAs have been shown to increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.
ESAs are not indicated for use in patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Clinicians are advised to use the lowest dose that will gradually increase the hemoglobin concentration to the lowest hemoglobin sufficient to avoid the need for RBC transfusions.
Peginesatide was FDA-approved in March 2012.
Indications
- anemia
For the treatment of anemia due to chronic kidney disease in patients on dialysis
Side Effects
- anaphylactoid reactions
- angioedema
- antibody formation
- arthralgia
- back pain
- bronchospasm
- cough
- diarrhea
- dyspnea
- fever
- headache
- heart failure
- hyperkalemia
- hypertension
- hypotension
- infection
- infusion-related reactions
- muscle cramps
- myocardial infarction
- nausea
- pruritus
- seizures
- stroke
- thromboembolism
- thrombosis
- vomiting
Monitoring Parameters
- ferritin
- hemoglobin/hematocrit
- serum electrolytes
- serum iron
- transferrin
Contraindications
- angina
- anticoagulant therapy
- breast-feeding
- cardiac disease
- children
- coronary artery bypass graft surgery (CABG)
- dialysis
- heart failure
- hemoglobin concentration greater than 11 g/dl
- hypertension
- infants
- mortality
- myocardial infarction
- neonates
- neoplastic disease
- pregnancy
- renal failure
- renal impairment
- seizures
- stroke
- thromboembolism
Peginesatide is contraindicated for use by patients with serious allergic reactions such as anaphylaxis to the drug.
Interactions
- Darbepoetin Alfa
Darbepoetin Alfa: (Severe) Patients receiving darbepoetin alfa should not receive peginesatide concurrently due to the adverse reactions that could result from therapeutic duplication.
