Omontys Warnings and Precautions

Omontys is more likely to cause problems in people with certain conditions, such as heart disease, cancer, or uncontrolled high blood pressure. Other safety warnings with Omontys include precautions for people who have certain allergies or women who are pregnant or nursing. Also, this prescription medication may increase the risk for dangerous cardiovascular problems, such as blood clots, congestive heart failure, and strokes.

In February 2013, Omontys was pulled from the market (all of the product was recalled) to investigate reports of dangerous allergic reactions, including fatal anaphylactic reactions, which appear to be occurring more frequently than anticipated. This medication will not be available until further notice.
 

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to using Omontys® (peginesatide) if you have:
 
 
Also, let your healthcare provider know if you are:
 
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
 
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
 

Specific Precautions and Warnings With Omontys

Some warnings and precautions to be aware of prior to receiving this medicine include the following:
 
  • Omontys may increase the risk of serious cardiovascular problems, including heart attacks, strokes, congestive heart failure, and blood clots. This risk is higher if Omontys increases your hemoglobin (a measure of red blood cells) too quickly or too much. Your healthcare provider should measure your hemoglobin frequently and adjust your Omontys dosage to prevent this rapid or significant increase in hemoglobin levels.
However, this will not prevent all cardiovascular problems, and you and your healthcare provider must weigh the potential benefits and risks. Studies have not found a dosage, dosing strategy, or hemoglobin target level that does not increase the risks for cardiovascular problems.
  • Omontys is approved only for use in people with chronic kidney disease who are on dialysis. Studies have shown that this medicine increased the risk for serious side effects when used in people who were not on dialysis.
 
  • Omontys may accelerate the worsening of cancer and can shorten survival rates. This risk must be weighed against the potential benefits of using Omontys. This drug is not recommended for use in people with cancer, unless the anemia is clearly caused by chronic kidney disease and not by the cancer or chemotherapy treatment.
 
  • Omontys may cause high blood pressure (hypertension). This can be a problem, especially if you already have high blood pressure. Your healthcare provider should monitor your blood pressure closely while you are using Omontys.
 
  • In rare cases, people can form antibodies to Omontys, causing severe anemia. If your anemia worsens while you are receiving this medication, your healthcare provider should check to see if you are forming these antibodies. In this situation, you may need to stop using Omontys permanently.
 
  • Omontys can cause problems with the dialysis access site (including clotting). Certain measures, such as an adjustment in anticoagulant dosage, might be necessary to avoid or treat such problems.
 
 
  • Omontys is a pregnancy Category C medication. This means that it may not be safe for use during pregnancy. Talk to your healthcare provider about the risks and benefits of using the drug during pregnancy (see Omontys and Pregnancy).
 
  • It is not known if Omontys passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to receiving the drug (see Omontys and Breastfeeding).
 

Omontys Medication Information

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