Warnings & Recalls for Omontys
Omontys Black Box Warning
Patients who take ESA medications, such as Omontys, face an
increased risk for serious cardiovascular complications, such as heart attack, blood clots, and stroke. These conditions may be
fatal, and patients should take the lowest, effective dosage of Omontys to avoid developing any of these serious illnesses.
Omontys and Pregnancy
Omontys has been assigned as a
FDA pregnancy Category C medicine. Sufficient examinations have not been conducted to know if Omontys could harm the fetus if taken by a pregnant woman. It is
unknown if Omontys can be transferred through breast-milk and harm a nursing baby.
Before receiving Omontys, let your doctor know if you are
pregnant,
may become pregnant, or are
breastfeeding.
General Warnings
Omontys
should not be used by patients who have
uncontrolled high blood pressure or are
allergic to any ingredient in Omontys.
Before receiving Omontys, tell your doctor about any of the following conditions:
- heart problems, disease or failure
- high blood pressure
- if you have ever had a heart attack, stroke or any blood clotting disorder
- any blood diseases or disorders
- if you have cancer
- if you are epileptic or a seizure-causing disorder
Let your healthcare provider know about
all medicines and products you are using. Your doctor may require you to take a
different dosage. If you are undergoing
surgery, be sure to tell the surgeon in advance that you are taking Omontys.
Have your
blood checked often while using Omontys to be sure that the treatment is working safely and effectively.
Omontys Treatment and Use
Omontys | peginesatide is an erythropoiesis-stimulating agent (ESA) injection marketed by Affymax and Takeda Pharmaceuticals for treating low red blood cell amounts or anemia related to chronic kidney disease. Omontys is prescribed to patients over the age of 18 who are on dialysis.
How Does Omontys Work?
Omontys works by interacting with the bone marrow and increasing the production of red blood cells. This lowers the need for patients with anemia caused by chronic kidney disease to have blood transfusions.
How is Omontys Given?
Omontys is an injection which is administered intravenously (IV). Treatment usually is given with Omontys once each month by a doctor or nurse. If you have been asked to self-administer the injection, be sure to follow all packaged instructions and any advice given to you by your doctor. Dose varies in accordance to the patient’s medical condition, age, and weight.
Patients who are receiving Omontys should have their blood checked on a regular basis.