Adult Dosing
Anemia due to chronic kidney disease in patients on dialysis
Patients not treated with an ESA (Erythropoiesis-Stimulating Agent)
- Start 0.04 mg/kg IV/SC once monthly, in dialysis patients with hemoglobin level <10 g/dL
Notes: - Monitor hemoglobin levels at least q2 wks until stable, then monitor at least monthly
- Increase the dose only once in 4 weeks
- Reduce the dose by 25% or more if hemoglobin rises >1 g/dL in 2 wks prior to the dose or >2 g/dL in 4 wks
- Decrease or interrupt the dose if hemoglobin level reaches or exceeds 11 g/dL
- Increase dose by 25% if hemoglobin has not increased by >1 g/dL after 4 wks
- Increasing the dose further is unlikely to improve response and may increase risks for patients with inadequate response after 12 wks of therapy. Use lowest dose to maintain hemoglobin level sufficient to reduce RBC transfusion need. Discontinue peginesatide if responsiveness does not improve
- If a dose is missed, administer as soon as possible and restart peginesatide at the prescribed once monthly dosing frequency
Conversion from epoetin alfa or darbepoetin alfa to peginesatide in CKD patients on dialysis
- Maintain same route of administration; estimate starting monthly dose of peginesatide based on weekly dose of epoetin alfa or darbepoetin alfa at the time of substitution
- Patients previously receiving epoetin alfa: Administer first dose of peginesatide one week after the last dose of epoetin alfa
- Patients previously receiving darbepoetin alfa: Administer first dose of peginesatide at the next scheduled dose in place of darbepoetin alfa
- Dialysis patients with CKD and cancer: Physicians must refer warnings and precautions
Estimated peginesatide starting doses for patients based on previous weekly ESA dose
| Previous Total Weekly Epoetin Alfa Dose (U/week) | Previous Weekly Darbepoetin Alfa Dose (mcg/week) | Peginesatide Dose Once Monthly (mg/month) |
| Less than 2,500 | Less than 12 | 2 |
| 2,500 to less than 4,300 | 12 to less than 18 | 3 |
| 4,300 to less than 6,500 | 18 to less than 25 | 4 |
| 6,500 to less than 8,900 | 25 to less than 35 | 5 |
| 8,900 to less than 13,000 | 35 to less than 45 | 6 |
| 13,000 to less than 19,000 | 45 to less than 60 | 8 |
| 19,000 to less than 33,000 | 60 to less than 95 | 10 |
| 33,000 to less than 68,000 | 95 to less than 175 | 15 |
| greater than or equal to 68,000 | greater than or equal to 175 | 20 |
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Therapy may be associated with an increased risk of death, serious cardiovascular events, and stroke when administered to target a hemoglobin level of greater than 11 g/dL [US Black Box Warning]
- In CKD patients, peginesatide increases the risk of death, myocardial infarction, stroke, CHF, thrombosis of hemodialysis vascular access, and other thromboembolic events when given to target for higher hemoglobin levels (13-14 g/dL)
- MI, stroke, CHF, and hemodialysis vascular access thrombosis, and even death may occur in patients with cancer. A rate of hemoglobin rise of >1 g/dL over 2 wks may be a contributing factor to these risks
- An increased risk of mortality in patients undergoing CABG and deep vein thrombosis (DVT) may exist in patients receiving this drug and undergoing surgical orthopedic procedures
- Therapy not recommended and not indicated for the treatment of anemia in patients with CKD who are not on dialysis
- Peginesatide is not indicated and recommended for reduction of RBC transfusions in patients receiving chemotherapy and whose anemia is not due to CKD
- Safety and efficacy of peginesatide have not been established in patients with anemia due to chemotherapy
- ESAs may be associated with reduced overall survival and/or increased risk of tumor progression or recurrence in patients with breast cancer, non-small cell lung cancer, advanced head and neck cancer, lymphoid malignancy, and cervical cancers
- Therapy is contraindicated in patients with uncontrolled hypertension. Carefully monitor and control hypertension prior to initiation of and throughout the course of therapy, particularly in patients with a history of CV disease or hypertension. Adjust dose or suspend therapy if required
- Serious allergic reactions including anaphylactic reactions, generalized pruritus, bronchospasm, angioedema, hypotension may occur; immediately and permanently stop drug use and administer proper treatment
- Lack of hemoglobin response or failure to maintain a hemoglobin response in patients receiving therapy within the recommended dosing range should prompt a search for causative factors
- Patients undergoing hemodialysis and receiving this drug may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis
- Evaluate the patient’s iron status, including transferrin saturation and serum ferritin prior to and during therapy
- Patients may require supplemental iron therapy for increasing or maintaining transferrin saturation to levels which will adequately support erythropoiesis stimulated by this drug
- Monitor hemoglobin levels every 2 weeks following therapy initiation and after each dose adjustment until the hemoglobin is stable and sufficient to minimize the need for RBC transfusion; then, monitor hemoglobin every month
Cautions: Use cautiously in
- Coexistent cardiovascular disease and stroke
- Seizure disorder
Supplemental Patient Information
- Advise patients to undergo regular blood pressure monitoring, adhere to prescribed anti-hypertensive regimen, and follow recommended dietary restrictions
- Advise patients to consult their physician for new-onset neurologic symptoms or change in seizure frequency
- Instruct patients to have regular laboratory tests for hemoglobin
Pregnancy Category:C
Breastfeeding: No data available regarding the use of peginesatide during breastfeeding. It is poorly excreted into breastmilk owing to its large molecular weight and is unlikely to adversely affect the breastfed infant. If peginesatide is required by the mother of an older infant, it is not a reason to discontinue breastfeeding; however, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 7 December 2011). Manufacturer advises caution.
