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Pronunciation: PEG-in-ES-a-tide AS-e-tate
Class: Erythropoiesis-stimulating agent
- Injection, solution 1 mg per 0.5 mL
- Injection, solution 2 mg per 0.5 mL
- Injection, solution 3 mg per 0.5 mL
- Injection, solution 4 mg per 0.5 mL
- Injection, solution 5 mg per 0.5 mL
- Injection, solution 6 mg per 0.5 mL
- Injection, solution 10 mg/mL
Stimulates red blood cell production.
T max is 48 h (subcutaneous). Bioavailability is approximately 46% (subcutaneous).
The mean Vd is 34.9 ± 13.8 mL/kg (IV).
Urinary excretion is the predominant route of elimination. Mean half-life is 25 ± 7.6 (IV) and 53 ± 17.7 h (subcutaneous) in healthy patients and 47.9 ± 16.5 h (IV) in dialysis patients. Mean systemic Cl is 0.5 ± 0.2 mL/h•kg (IV) in dialysis patients.
The pharmacokinetics are not altered based on population pharmacokinetic analyses.Gender
The pharmacokinetics are not altered based on population pharmacokinetic analyses.Race
The pharmacokinetics are not altered based on population pharmacokinetic analyses.
Indications and Usage
For the treatment of anemia due to chronic kidney disease in adult patients on dialysis.
Dosage and AdministrationAdults
Subcutaneous/IV 0.04 mg/kg once monthly. Do not increase the dose more frequently than once every 4 wk. If the Hgb rises rapidly (eg, more than 1 g/dL in the 2 wk prior to the dose or more than 2 g/dL in 4 wk), reduce the dose by 25% or more as needed to reduce rapid responses. If the Hgb level approaches or exceeds 11 g/dL, reduce or interrupt the dose. After a dose has been withheld and once the Hgb begins to decrease, restart at a dose approximately 25% below the previously administered dose. For patients who do not respond adequately, if the Hgb has not increased by more than 1 g/dL after 4 wk of therapy, increase the dose by 25%.Conversion
In patients previously receiving epoetin alfa or darbepoetin alfa, estimate the starting monthly dose of peginesatide for patients on the basis of the weekly dose of epoetin alfa or darbepoetin alfa at the time of substitution. Maintain the route of administration (IV or subcutaneous). For patients previously receiving epoetin alfa, the first dose of peginesatide should be administered 1 wk after the last epoetin alfa dose was administered. For patients previously receiving darbepoetin alfa, the first dose of peginesatide should be administered at the next scheduled dose in place of darbepoetin alfa.
- For subcutaneous or IV administration only. Not for intradermal, IM, or intra-arterial administration.
- Use the lowest dose that will maintain a Hgb level sufficient to reduce the need for RBC transfusions.
- When adjusting therapy, consider Hgb rate of rise, rate of decline, erythropoiesis-stimulating agent responsiveness, and Hgb variability. A single Hgb excursion may not require a dosing change.
- For patients who do not respond adequately over a 12-wk escalation period, increasing the dose further is unlikely to improve response and may increase risks. Evaluate other causes of anemia. Discontinue if responsiveness does not improve.
- If a dose is missed, administer the missed dose as soon as possible and restart at the prescribed once-monthly dosing frequency.
- Do not dilute peginesatide and do not administer in conjunction with other drug solutions.
Store at 36° to 46°F. Protect from light. Retain in carton until time of use. Storage over the recommended temperature, when necessary, is permissible only for temperatures up to 77°F and for no more than 30 days. Discard unused portion. After first use, the multiple-use vials should be stored at 36° to 46°F and then discarded after 28 days.
None well documented.
Hypotension (14%); hypertension (13%); procedural hypotension (11%).
Headache (15%); seizure.
Diarrhea (18%); nausea (17%); vomiting (15%).
Muscle spasms (15%); arthralgia, back pain, pain in extremity (11%).
Dyspnea (18%); cough (16%); upper respiratory tract infection (11%).
Arteriovenous fistula site complication (16%); pyrexia (12%); hyperkalemia (11%); allergic reactions.
In controlled trials, patients experienced greater risks of death, serious adverse CV reactions, and stroke when administered erythropoiesis-stimulating agents to target an Hgb level greater than 11 g/dL. No trial has identified an Hgb target level, erythropoiesis-stimulating agent dose, or dosing strategy that does not increase these risks. Use the lowest dose sufficient to reduce the need for RBC transfusions.
Evaluate transferrin saturation and serum ferritin prior to and during treatment. Following initiation of therapy and after each dose adjustment, monitor Hgb every 2 wk until the Hgb is stable and sufficient to minimize the need for RBC transfusion. Thereafter, Hgb should be monitored at least monthly, provided that Hgb levels remain stable. Monitor BP and for the presence of premonitory neurologic symptoms.
Category C . Peginesatide was teratogenic and caused embryofetal lethality when administered to pregnant animals at doses and/or exposures that resulted in polycythemia.
Safety and efficacy not established.
Allergic reactions have been reported.
Patients may require adjustments in their dialysis prescriptions after initiation of treatment and may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.
Special Risk Patients
Use caution in patients with coexistent CV disease and stroke.
Peginesatide is not indicated and is not recommended for reduction of RBC transfusions in patients receiving treatment for cancer and whose anemia is not due to chronic kidney disease. Results from clinical trials of erythropoiesis-stimulating agents in patients with anemia due to cancer therapy showed decreased locoregional control, progression-free survival, and/or overall survival.
Appropriately control hypertension prior to initiation of and during treatment. Reduce or withhold dose if BP becomes difficult to control.
Lack or loss of response
For lack or loss of Hgb response, initiate a search for causative factors (eg, bleeding, infection, inflammation, iron deficiency). If typical causes of lack or loss of Hgb response are excluded, evaluate for the presence of antibodies to peginesatide. In the absence of antibodies, follow dosing recommendations for management of patients with an insufficient Hgb response to peginesatide.
The majority of patients with chronic kidney disease will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%.
Elevated Hgb levels, hypertension.
- Instruct patients to read the Medication Guide before starting therapy and at regular intervals during treatment.
- Inform patients of the increased risks of mortality, serious CV reactions, thromboembolic reactions, stroke, and tumor progression.
- Inform patients to undergo regular BP and Hgb monitoring, adhere to prescribed antihypertensive regimen, and follow dietary restrictions.
- Inform patients to contact their health care provider for new-onset neurologic symptoms or change in seizure frequency.
- Instruct patients who self-administer peginesatide of the importance of following instructions for use; the dangers of reusing needles, syringes, or unused portions of single-dose vials or prefilled syringes; and proper disposal of syringes, needles, unused vials, and the full container.
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