Methoxy Polyethylene Glycol-Epoetin Beta (meth-OX-ee pol-ee-ETH-i-leen GLYE-kol e-POE-e-tin BAY-ta)

Treats anemia caused by kidney failure.

Brand Name(s):

Mircera

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. Do not inject into moles or areas that are tender, red, bruised, hard, or has scars, stretch marks, not intact, or that could be irritated by a belt or waistband.
• Do not shake. Do not use the medicine if it is cloudy, hazy, or has particles in it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Keep it in the original package until you are ready to use it. Protect it from light. Do not shake the medicine. If necessary, you may store it at room temperature for up to 30 days.
• 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:

• Tell your doctor if you are pregnant or breastfeeding, or if you have cancer, heart failure, heart or blood vessel disease, high blood pressure, or a history of seizures, stroke, or blood clots.
• This medicine may cause the following problems:
  • Increased risk of blood clots, heart failure, heart attack, or stroke
  • Increased risk of the cancer worsening or coming back
  • High blood pressure
  • Seizures
  • Serious skin reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis
• Tell any doctor or dentist who treats you that you are using this medicine. Your doctor may want you to take a blood thinner to prevent blood clots during or after surgery.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. You may also need to monitor your blood pressure at home.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Blistering, peeling, red skin rash
• Chest pain that may spread, trouble breathing, nausea, unusual sweating
• Lightheadedness, dizziness, or fainting
• Numbness or weakness on one side of your body, pain or swelling in your lower leg, sudden or severe headache, problems with vision, speech, or walking
• Seizures
• Swelling in your hands, ankles, or feet

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

• Back or muscle pain
• Diarrhea or vomiting
• Mild 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