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peginesatide (Discontinued)Brand and Other Names:Omontys

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & 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
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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

Safety and efficacy not established

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Adverse 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

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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%)

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Pregnancy & 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.

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Pharmacology

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

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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

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