"The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfiel"...
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Serious allergic reactions [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of OMONTYS cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice.
Patients with Chronic Kidney Disease
Adverse reactions were determined based on pooled data from two active controlled studies of 1066 dialysis patients treated with OMONTYS and 542 treated with epoetin, including 938 exposed for at least 6 months and 825 exposed for greater than one year to OMONTYS. The population for OMONTYS was 20 to 93 years of age, 58.5% male, and the percentages of Caucasian, Black (including African Americans), and Asian patients were 57.9%, 37.4%, and 3.1%, respectively. The median weight adjusted dose of OMONTYS was 0.07 mg/kg and 113 U/week/kg of epoetin.
Table 3 summarizes the most frequent adverse reactions ( ≥ 10%) in dialysis patients treated with OMONTYS.
Table 3 : Adverse Reactions Occurring in ≥ 10%
of Dialysis Patients treated with OMONTYS
|Adverse Reactions||Dialysis Patients Treated with OMONTYS
(N = 1066)
|Dialysis Patients Treated with Epoetin
(N = 542)
|Respiratory, Thoracic and Mediastinal Disorders|
|Injury, Poisoning and Procedural Complications|
|Arteriovenous Fistula Site Complication||16.1%||16.6%|
|Nervous System Disorders|
|Musculoskeletal and Connective Tissue Disorders|
|Pain in Extremity||10.9%||12.7%|
|General Disorders and Administration Site Conditions|
|Metabolism and Nutrition Disorders|
|Infections and Infestations|
|Upper Respiratory Tract Infection||11.00%||12.40%|
Seizures have occurred in patients participating in OMONTYS clinical studies. During the first several months following initiation of OMONTYS, blood pressure and the presence of premonitory neurologic symptoms should be monitored closely.
Advise patients to contact their healthcare practitioner for new-onset seizures, premonitory symptoms, or change in seizure frequency.
Allergic and infusion-related reactions have been reported in patients treated with OMONTYS.
Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Serious allergic reactions have been reported during postmarketing use of OMONTYS [see WARNINGS AND PRECAUTIONS].
Of the 2357 patients tested during clinical trials, 29 (1.2%) had detectable levels of peginesatide-specific binding antibodies. There was a higher incidence of peginesatide-specific binding antibodies in patients dosed subcutaneously (1.9%) as compared to those dosed intravenously (0.7%). Peginesatide neutralizing antibodies were detected in vitro using a cell-based functional assay in 21 of these patients (0.9%). In approximately half of all antibody-positive patients, the presence of antibodies was associated with declining hemoglobin levels, the requirement for increased doses of OMONTYS to maintain hemoglobin levels, and/or transfusion for anemia of CKD. No cases of pure red cell aplasia (PRCA) developed in patients receiving OMONTYS during clinical trials.
Read the Omontys (peginesatide) Side Effects Center for a complete guide to possible side effects »
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.
Last reviewed on RxList: 12/19/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Omontys Information
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