Dosing and uses of Omontys (peginesatide)
Adult dosage forms and strengths
injectable solution, single-use viaL
- 2mg/0.5mL
- 3mg/0.5mL
- 4mg/0.5mL
- 5mg/0.5mL
- 6mg/0.5mL
injectable solution, single-use prefilled syringe
- 1mg/0.5mL
- 2mg/0.5mL
- 3mg/0.5mL
- 4mg/0.5mL
- 5mg/0.5mL
- 6mg/0.5mL
injectable solution, multiple-use viaL
- 10mg/mL
- 20mg/2mL
Chronic Kidney Disease-Associated Anemia
February 2013: All lots recalled due to reports of serious hypersensitivity reactions and deaths
Pegylated erythropoiesis-stimulating agent indicated for treatment of anemia associated with chronic kidney disease
Individualize dose and use lowest dose sufficient to reduce the need for RBC transfusions
Initiate ESA treatment when the hemoglobin level is <10 g/dL
First dose (not currently receiving another ESA): 0.04-0.08 mg/kg as a single IV or SC injection once monthly; adjust dose as needed with subsequent doses
Dosage conversion from epoetin alfa (units/week)
For patients previously receiving epoetin alfa, the first dose of peginesatide should be administered 1 week after the last epoetin alfa dose was administered
Previous epoetin dose <2,500: 2 mg/month
Previous epoetin dose 2,500 to <4,300: 3 mg/month
Previous epoetin dose 4,300 to <6,500: 4 mg/month
Previous epoetin dose 6,500 to <8,900: 5 mg/month
Previous epoetin dose 8,900 to <13,000: 6 mg/month
Previous epoetin dose 13,000 to <19,000: 8 mg/month
Previous epoetin dose 19,000 to <33,000: 10 mg/month
Previous epoetin dose 33,000 to <68,000: 15 mg/month
Previous epoetin dose 68,000 or greater: 20 mg/month
Dosage conversion from darbepoetin alfa (mcg/week)
For patients previously receiving darbepoetin alfa, the first dose of peginesatide should be administered at the next scheduled dose in place of darbepoetin alfa
Previous darbepoetin dose <12: 2 mg/month
Previous darbepoetin dose 12 to <18: 3 mg/month
Previous darbepoetin dose 18 to <25: 4 mg/month
Previous darbepoetin dose 25 to <35: 5 mg/month
Previous darbepoetin dose 35 to <45: 6 mg/month
Previous darbepoetin dose 45 to <60: 8 mg/month
Previous darbepoetin dose 60 to <95: 10 mg/month
Previous darbepoetin dose 95 to <175: 15 mg/month
Previous darbepoetin dose 175 or greater: 20 mg/month
Dosage Adjustments & Monitoring
Monitor hemoglobin levels at least every 2 weeks until stable, then monitor at least monthly
When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability; a single hemoglobin change may not require a dosing change
Do not increase the dose more frequently than once every 4 weeks
If hemoglobin rises rapidly (eg, >1 g/dL in the 2 weeks prior to the dose, or >2 g/dL in 4 weeks), reduce peginesatide dose by 25% or more as needed to reduce rapid responses
If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt dose
After a dose has been withheld and once the hemoglobin begins to decrease, peginesatide may be restarted at a dose ~25% below the previously administered dose
For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%
For patients who do not respond adequately over a 12-week escalation period, increasing the peginesatide dose further is unlikely to improve response and may increase risks
Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions; evaluate other causes of anemia
Discontinue peginesatide if responsiveness does not improve
If a peginesatide dose is missed, administer the missed dose as soon as possible and restart peginesatide at the prescribed once monthly dosing frequency
Pediatric dosage forms and strengths
Safety and efficacy not established
Omontys (peginesatide) adverse (side) effects
>10%
Diarrhea (18.4%)
Dyspnea (18.4%)
Nausea (17.4%)
Arteriovenous fistula site complication (16.1%)
Cough (15.9%)
Headache (15.4%)
Muscle spasms (15.3%)
Vomiting (15.3%)
Hypotension (14.2%)
Hypertension (13.2%)
Pyrexia (12.2%)
Hyperkalemia (11.4%)
Upper respiratory tract infection (11%)
Procedural hypotension (10.9%)
Extremity/back pain (10.9%)
Arthralgia (10.7%)
Frequency not defined
Seizures, new-onset or change in frequency
Warnings
Black box warnings
Controlled trials in patients with chronic kidney disease observed a greater risks for death, serious adverse cardiovascular reactions, and stroke when ESAs were administered to a target hemoglobin level >11 g/dL
No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks
Use the lowest dose sufficient to reduce the need for red blood cell (RBC) transfusions
Contraindications
Serious allergic reactions, including anaphylaxis
Uncontrolled hypertension
Cautions
NOT indicated for patients with chronic kidney disease (CKD) who are not on dialysis
Increased mortality and/or risk of tumor progression/recurrence in patients with cancer receiving ESAs or in patients whose anemia is not caused by CKd
NOT a substitute for RBC transfusions in patients requiring immediate correction of anemia
Evaluate iron status before and during treatment and maintain iron repletion; correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding) Increased risk for mortality, MI, stroke, and thromboembolism with hemoglobin levels >11 g/dL (see Black box warnings)
Appropriately control hypertension prior to initiation
Search for causative factors (eg, iron deficiency, infection, inflammation, bleeding) if a lack or loss of response occurs; in absence of antibodies to peginesatide, follow dosing recommendations for management of patients with an insufficient hemoglobin response
Adjust dialysis prescriptions (eg, iron supplements) as needed after initiation
Evaluate transferrin saturation and serum ferritin prior to and during treatment; administer supplemental iron therapy when serum ferritin is <100 mcg/L or when serum transferrin saturation is <20%
The majority of patients with CKD will require supplemental iron during the course of ESA therapy
Following initiation of therapy and after each dose adjustment, monitor hemoglobin every 2 weeks until stable and sufficient to minimize the need for RBC transfusion; thereafter, monitor at least monthly
Immunogenicity: Detectable peginesatide-specific binding antibodies in 1.2%; higher incidence of peginesatide-specific binding antibodies with SC dose (1.9%) compared with IV (0.7%)
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether distributed in breast milk; caution advised
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Omontys (peginesatide)
Mechanism of action
Pegylated erythropoietin stimulating agent
Binds to and activates human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in vitro
Increases reticulocyte count, followed by increases in hemoglobin
Rate of hemoglobin increase varies among patients and is dependent upon the dose administered
Absorption
Bioavailability: 46% (SC)
Peak Plasma Time: 48 hr (SC)
Distribution
Protein Bound: Does not bind to serum albumin or lipoproteins
Vd: 34.9 mL/kg (IV)
Metabolism
In vitro studies showed no potential to induce or inhibit CYP450 enzymes
Elimination
Half-life: 47.9 hr (IV)
Total body clearance: 0.5 mL/hr•kg
Administration
IV/SC Preparation
Use the single use vial or prefilled syringe only 1 time; discard unused portion of peginesatide single-use vials
Do not use if tamper-evident seal on carton is broken or missing
Do not dilute and do not administer in conjunction with other drug solutions
Visually inspect for particulate matter and coloration prior to administration; do not use any vials or prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellow
IV/SC Administration
Administer by either SC or IV injection
Storage
Protect from light
Refrigerate unused vials or prefilled syringes in their cartons until time of use at 36-46 °F (2-8 °C)
Store unused portions of peginesatide in multiple use vials at 36-46 °F (2-8 °C), and then discard 28 days after first use
