Omontys 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.

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

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

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

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

Before using Omontys, 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 Omontys. Tell your doctor about all medications you use.

To be sure Omontys 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.

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

Use Omontys exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Omontys is injected under the skin or into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Omontys is usually given once per month. Follow your doctor's dosing instructions very carefully.

Your doctor may occasionally change your dose to make sure you get the best results.

Each prefilled syringe or single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Do not use Omontys if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

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.

If you need surgery, tell the surgeon ahead of time that you are using Omontys.

Omontys is only part of a complete program of treatment that may also include diet and taking blood pressure medication. Follow your diet and medication routines very closely.

Omontys doses are based on weight. Tell your doctor if you have any changes in your weight.

Store Omontys in its original container in a refrigerator, do not freeze. Protect from light. If needed, the medicine can be stored at room temperature for up to 30 days. Do not use the multi-use vial (bottle with more than one dose in it) for longer than 28 days after you first put a needle into the vial. Throw the vial away, even if there is still some medicine left in it after 28 days.

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

To make sure you can safely use Omontys, tell your doctor if you have any of these other conditions:

• heart disease, congestive heart failure, or high blood pressure (hypertension);

• a history of stroke, heart attack, or blood clot;

• a blood cell or clotting disorder, such as sickle cell anemia or hemophilia;

• cancer; or

• epilepsy or another seizure disorder.

FDA pregnancy category C. It is not known whether Omontys will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether peginesatide passes into breast milk or if it could harm a nursing baby. Do not use Omontys without telling your doctor if you are breast-feeding a baby.

Use the missed dose as soon as you remember. Then restart your once-a-month dosing schedule and use your next dose 30 days later. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any of these signs of an allergic reaction to Omontys: 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.

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

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 Omontys 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.

There may be other drugs that can interact with Omontys. Your other medication doses may need to be changed after you start using Omontys.

Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.