Peginesatide (peg-in-ES-a-tide)

Treats anemia in patients who have chronic kidney disease (CKD) and are on dialysis. This medicine was withdrawn from the US market in February 2013 because it may cause serious allergic reactions.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin or into a vein.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Use a new needle and syringe each time you inject your medicine.
• You might not use all of the medicine in the vial or syringe. If the medicine in the vial or syringe has changed color, or if you see something floating in it, do not use it.
• Single-use vial or syringe: Do not save any leftover medicine from an open vial or syringe. Use each vial or syringe only 1 time.
• You may also need treatment for high blood pressure, which may include other medicines and a diet plan.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

If a dose is missed:

• Call your doctor or pharmacist for instructions.

How to Store and Dispose of This Medicine:

• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Keep the medicine in the carton until you are ready to use it. Protect the medicine from light.
• Single-use vial or syringe: If you cannot keep your single-use vials or syringes in the refrigerator, you may store them at or below room temperature for up to 30 days.
• Multiple-use vial: Store unused medicine in the refrigerator. The medicine is only good for 28 days after the vial is opened. Throw away any leftover medicine after 28 days.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. Throw away old medicine after the expiration date has passed.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have a history of cancer, stroke, heart or blood vessel disease, high blood pressure, seizures, or problems with blood clots.
• This medicine may increase your risk of heart attack, stroke, or blood clotting problems. Get emergency help right away if you have any symptoms of a heart attack or stroke. Some possible symptoms are chest pain or discomfort, uneven heartbeat, pain that spreads to you arm or jaw, unusual sweating, feeling faint, trouble breathing, slurred speech, or weakness on one side of your body.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• This medicine may cause high blood pressure. You may need to monitor your blood pressure at home. If you notice any changes to your recommended blood pressure, call your doctor right away.
• Make sure any doctor or dentist who treats you knows that you are using this medicine, especially if you are going to have any type of surgery.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain that may spread to your arms, jaw, back, or neck; nausea; unusual sweating
• Coughing up blood
• Lightheadedness, dizziness, or fainting
• Numbness or weakness in your arm or leg, or on one side of your body
• Pain in your lower leg (calf)
• Pain, redness, swelling, or bleeding where the injection was given
• Problems with your hemodialysis access
• Seizures
• Sudden or severe headache, problems with vision, speech, or walking
• Swelling in your hands, ankles, or feet
• Trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Back, joint, or muscle pain
• Diarrhea, nausea, or vomiting
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088