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Generic Name: peginesatide (PEG-in-ES-a-tide)
Brand Name: Omontys

Clinical studies have shown erythropoietin-stimulating agents (ESAs), such as Omontys, to increase the risk of serious side effects (eg, blood clots, stroke, heart attack, heart failure) and death in some cases. ESAs have also been shown to shorten the overall survival and/or increase the risk of tumor growth or recurrence in patients with certain types of cancer. Talk with your doctor about the risks and benefits of using Omontys. Do not use more than the recommended dose without checking with your doctor.

Omontys is used for:

Treating anemia in patients with chronic kidney disease who are on dialysis. It may also be used for other conditions as determined by your doctor.

Omontys is a synthetic ESA. It works by stimulating the bone marrow to produce more red blood cells.

Do NOT use Omontys if:

  • you are allergic to any ingredient in Omontys
  • you have uncontrolled high blood pressure
  • you have chronic kidney disease and you are not on dialysis
  • you have cancer and your anemia is not caused by chronic kidney disease

Contact your doctor or health care provider right away if any of these apply to you.

Before using Omontys:

Some medical conditions may interact with Omontys. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of cancer, seizures, blood problems (eg, sickle cell anemia, porphyria, hemolytic anemia, thalassemia), bleeding or clotting problems, stroke, a heart attack or other heart problems (eg, congestive heart failure, ischemic heart disease), or high blood pressure
  • if you have an infection or recent injury; an inflammatory condition (eg, bowel disease, rheumatoid arthritis); or low blood iron, folic acid, or vitamin B12 levels
  • if you have recently had surgery or are scheduled to have surgery
  • if you have recently received another ESA (eg, darbepoetin alfa, epoetin alfa)

Some MEDICINES MAY INTERACT with Omontys. However, no specific interactions with Omontys are known at this time. Tell your health care provider if you are taking any other medicines.

Ask your health care provider if Omontys may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Omontys:

Use Omontys as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Omontys comes with an extra patient information sheet called a Medication Guide. It also comes with an extra patient leaflet with detailed instructions for use. Read them carefully. Read them again each time you get Omontys refilled. Ask your doctor, nurse, or pharmacist any questions that you may have about this information.
  • Omontys is usually given every month as an injection at your doctor's office, hospital, or clinic. If you will be using Omontys at home, a health care provider will teach you how to use it. Be sure you understand how to use Omontys. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • If drawing up a dose into a syringe, be sure to follow the procedure demonstrated to you to prevent contamination of the vial, syringe, or medicine. Never touch the rubber stopper of the vial or the needle of the syringe with your fingers. Always carefully check that you have drawn up the correct dose before administration.
  • Do not dilute Omontys. Do not mix it with other solutions unless your doctor directs you otherwise.
  • If you are using a single-dose vial, throw away any medicine left in the vial after you have used your dose. Ask your doctor, pharmacist, or other health care provider if you have questions about whether you are using a single-dose vial.
  • If you are using a multiple-use vial, throw away any unused medicine no later than 28 days from the first day that you put a needle into the vial.
  • Omontys should be colorless to slightly yellow. Do not use Omontys if it contains lumps, flakes, or particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Do not inject Omontys into an area on your body that is tender, red, bruised, hard, or that has scars or stretch marks.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you inject more than the prescribed dose of Omontys, contact your doctor right away.
  • Continue to use Omontys even if you feel well. Do not miss any doses.
  • If you miss a dose of Omontys, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Omontys.

Important safety information:

  • It may take several weeks for Omontys to work. Do not stop taking Omontys without checking with your doctor.
  • Do NOT use more than the recommended dose without checking with your doctor.
  • It is important to keep your blood pressure under control while you use Omontys. Do not stop taking any of your blood pressure medicines without checking with your doctor. Closely follow your doctor's instructions for diet and blood pressure monitoring.
  • Tell your doctor immediately if symptoms of anemia persist or recur, such as unusual tiredness, lack of energy, dizziness, fainting, or pale skin color.
  • Tell your doctor or dentist that you take Omontys before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including blood pressure, iron and hemoglobin levels may be performed while you use Omontys. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Omontys should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Omontys while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Omontys, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Omontys:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; diarrhea; headache; joint pain; muscle spasms; nausea; symptoms of upper respiratory tract infection (eg, cough, runny or stuffy nose, sneezing, mild sore throat); vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); calf or leg pain, redness, tenderness, or swelling; chest, jaw, or arm pain; confusion; cool or pale arm or leg; coughing up blood; dizziness or light-headedness; fainting; fever; irregular heartbeat; muscle pain, weakness, or cramping; new or worsening pale skin color, tiredness, or weakness; seizures; severe or persistent headache; shortness of breath; sudden numbness or weakness of the face, arm, or leg, especially on one side of the body; sudden, severe nausea or vomiting; sudden trouble walking, or loss of balance or coordination; sudden, unexplained weight gain; swelling of the hands, ankles, legs, or feet; trouble speaking or understanding others' speech; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe headache.

Proper storage of Omontys:

Omontys is usually handled and stored by a health care provider. If you are using Omontys at home, store Omontys as directed by your pharmacist or health care provider. Keep Omontys, as well as syringes and needles, out of the reach of children and away from pets.

General information:

  • If you have any questions about Omontys, please talk with your doctor, pharmacist, or other health care provider.
  • Omontys is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Omontys or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Omontys. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Omontys. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Omontys.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.