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Omontys

"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"...

Omontys

Omontys Patient Information Including Side Effects

Brand Names: Omontys

Generic Name: peginesatide (Pronunciation: PEG in ES a tide)

What is peginesatide (Omontys)?

Peginesatide is a man-made form of a protein that helps your body produce red blood cells. The amount of this protein in your body may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.

Peginesatide is used to treat anemia (a lack of red blood cells in the body) in people with chronic kidney disease who are on dialysis.

Peginesatide is not for treating anemia caused by other conditions. Peginesatide is not for use in people who are not on dialysis.

Peginesatide may also be used for purposes not listed in this medication guide.

What are the possible side effects of peginesatide (Omontys)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Contact your doctor if you feel weak, lightheaded, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to this medication.

Peginesatide can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use peginesatide. Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • numbness, tingling, cold feeling, or pale appearance in your arms or legs;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • feeling light-headed, fainting; or
  • if your hemodialysis vein access stops working.

Call your doctor at once if you have any other serious side effect such as:

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • feeling light-headed, fainting;
  • pale skin, feeling short of breath, rapid heart rate, trouble concentrating;
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
  • fever;
  • seizure (convulsions); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • nausea, vomiting, diarrhea;
  • cough;
  • headache;
  • back pain, muscle spasm, pain in your arms or legs;
  • joint pain; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Omontys (peginesatide) Side Effects Center for a complete guide to possible side effects

What is the most important information I should know about peginesatide (Omontys)?

You should not use this medication if you are allergic to peginesatide, or if you have untreated or uncontrolled high blood pressure.

Before using peginesatide, tell your doctor if you have heart disease, congestive heart failure, high blood pressure, cancer, a seizure disorder, a blood cell or clotting disorder (such as sickle cell anemia or hemophilia), or a history of stroke, heart attack, or blood clot.

Your other medication doses may need to be changed after you start using peginesatide. Tell your doctor about all medications you use.

To be sure this medication is helping your condition, your iron and blood cells will need to be checked with frequent blood tests. Your blood pressure will also need to be checked often. Visit your doctor regularly.

Contact your doctor if you feel weak, lightheaded, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to this medication.

Peginesatide can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use peginesatide.

Seek emergency medical help if you have symptoms of heart or circulation problems, such as: chest pain, sudden numbness or weakness, severe headache, problems with vision or speech, sudden cough, coughing up blood, pain or warmth in your leg, cold or tingly feeling, feeling short of breath, rapid weight gain, or problems with your hemodialysis vein access.

Side Effects Centers
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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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