Drug Interaction:
No formal drug/drug interaction studies have been performed.
Peginesatide does not bind to serum albumin or lipoproteins as demonstrated
in in vitro protein binding studies in rat, monkey and human sera.
In vitro studies conducted with human hepatocytes or microsomes have shown
no potential for peginesatide to induce or inhibit CYP450 enzymes.
Indication:
OMONTYS (peginesatide) Injection, for intravenous or subcutaneous use
Initial U.S. Approval: 2012
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL
INFARCTION, STROKE, VENOUS THROMBOEMBOLISM,
THROMBOSIS OF VASCULAR ACCESS AND TUMOR
PROGRESSION OR RECURRENCE
See full prescribing information for complete boxed warning.
Chronic Kidney Disease:
In controlled trials, patients experienced greater risks for death, serious
adverse cardiovascular reactions, and stroke when administered
erythropoiesis-stimulating agents (ESAs) to target a hemoglobin
level of greater than 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 OMONTYS dose sufficient to reduce the need for
red blood cell (RBC) transfusions
RECENT MAJOR CHANGES
Contraindications (4) 12/2012
Warnings and Precautions,
Serious Allergic Reactions (5.4) 12/2012
Drug Name- Omontys
Active Ingredient - Peginesatide
To treat anemia, a condition in which the body does not have enough
red blood cells , in adult patients who have chronic kidney disease(CKD)
Indication-
To treat anemia, a condition in which the body does not have enough
red blood cells , in adult patients who have chronic kidney disease(CKD)
Approved by FDA on 27-3-2012 (Ref- FDA Approved List- 2012)
Adverse Reaction:
The most common adverse events ( 10%) are dyspnea, diarrhea, nausea, cough,
and arteriovenous fistula site complication
Contra-Indications:
CONTRAINDICATIONS
Uncontrolled hypertension
Serious allergic reactions to OMONTYS
WARNINGS AND PRECAUTIONS
Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism:
Using ESAs to target a hemoglobin level of greater than 11 g/dL increases
the risk of serious adverse cardiovascular reactions and has not been
shown to provide additional benefits
Use caution in patients with coexistent cardiovascular disease and stroke
Hypertension: Control hypertension prior to initiating and during treatment
with OMONTYS
Dosages/ Overdosage Etc:
Indication-
To treat anemia, a condition in which the body does not have enough
red blood cells , in adult patients who have chronic kidney disease(CKD)
INDICATIONS AND USAGE
OMONTYS is an erythropoiesis-stimulating agent (ESA) indicated for
the treatment of anemia due to chronic kidney disease (CKD) in adult
patients on dialysis
Limitations of Use
OMONTYS is not indicated and is not recommended for use:
In patients with CKD not on dialysis
In patients receiving treatment for cancer and whose anemia is not
due to CKD
As a substitute for RBC transfusions in patients who require immediate
correction of anemia .
OMONTYS has not been shown to improve symptoms, physical functioning
or health-related quality of life
DOSAGE AND ADMINISTRATION
Initial treatment: 0.04 mg/kg body weight administered once monthly
Conversion from another ESA: dose once monthly based on the total
weekly epoetin or darbepoetin alfa dose at the time of conversion
DOSAGE FORMS AND STRENGTHS
Single use vials (preservative-free)
Strengths
2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, and 6 mg/0.5 mL
Single use pre-filled syringes (preservative-free)
1 mg/0.5 mL, 2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL,
and 6 mg/0.5 mL
Multiple use vials
10 mg/mL and 20 mg/2 mL
(with preservative)
Patient Information:
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide).
Prior to treatment, inform patients of the risks and benefits of OMONTYS.
Inform patients:
To read the Medication Guide and to review and discuss any questions
or concerns with their healthcare provider before starting OMONTYS and
at regular intervals while receiving OMONTYS.
Of the increased risks of mortality, serious cardiovascular reactions,
thromboembolic reactions, stroke, and tumor progression
To undergo regular blood pressure monitoring, adhere to prescribed
anti-hypertensive regimen and follow recommended dietary restrictions.
To seek medical care immediately if they experience any symptoms of an
allergic reaction with use of OMONTYS
To contact their healthcare provider for new-onset neurologic symptoms or
change in seizure frequency.
Of the need to have regular laboratory tests for hemoglobin.
Administer OMONTYS under the direct supervision of a healthcare provider or,
in situations where a patient has been trained to administer OMONTYS at home,
provide instruction on the proper use of OMONTYS, including instructions to:
Carefully review the Medication Guide and the Instructions for Use
Avoid the reuse of needles, syringes, or unused portions of the OMONTYS
single use vials or single use pre-filled syringes and properly dispose of these items
Always keep a puncture-proof disposal container available for the disposal
of used syringes and needles.
Pharmacology/ Pharmacokinetics:
1. Mechanism of Action
Peginesatide binds to and activates the human erythropoietin receptor and stimulates
erythropoiesis in human red cell precursors in vitro.
2. Pharmacokinetics
Following single intravenous and subcutaneous injections at doses ranging from 0.03 to
0.1 mg/kg to dialysis patients, maximal plasma concentration (Cmax) and area under
the plasma concentration versus time curve (AUC) increase with dose.
Following subcutaneous administration, the maximum concentrations of
peginesatide are reached in approximately 48 hours.
The bioavailability of peginesatide following subcutaneous administration is
approximately 46%.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women.
Peginesatide was teratogenic and caused embryofetal lethality when
administered to pregnant animals at doses and/or exposures that resulted
in polycythemia.
OMONTYS should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.
2. Nursing Mothers
It is not known whether peginesatide is excreted in human milk. Because many
are excreted into human milk, caution should be exercised when OMONTYS
is administered to a nursing woman.
3. Pediatric Use
The safety and efficacy of OMONTYS in pediatric patients have not been established.
4. Geriatric Use
Of the total number of dialysis patients in Phase 3 clinical studies of OMONTYS,
32.5% were age 65 and over, while 13% were age 75 and over.
No overall differences in safety or effectiveness were observed between these
subjects and younger subjects.
Manufacturer Details