Methoxy polyethylene glycol-epoetin beta Solution for injection

What is this medicine?

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA (muh THOK see pol ee ETH i leen GLYE col - e POE e tin BAY ta) helps your body make more red blood cells. It is used to treat anemia caused by kidney failure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• cancer

• blood clotting disorders

• heart disease

• hemoglobin level of 12 g/dl or greater

• high blood pressure

• history of stroke or blood clots

• low levels of iron, folate, or vitamin B12

• seizures

• an unusual or allergic reaction to Methoxy polyethylene glycol-epoetin beta, mannitol, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a vein or under the skin. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

This medicine may interact with the following medications:

• darbepoetin alfa

• epoetin alfa

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your prescriber or health care professional for regular checks on your progress and for the needed blood tests and blood pressure measurements. It is especially important for the doctor to make sure your hemoglobin level is in the desired range, to limit the risk of potential side effects and to give you the best benefit. Keep all appointments for any recommended tests. Check your blood pressure as directed. Ask your doctor what your blood pressure should be and when you should contact him or her.

As your body makes more red blood cells, you may need to take iron, folic acid, or vitamin B supplements. Ask your doctor or health care provider which products are right for you. If you have kidney disease continue dietary restrictions, even though this medication can make you feel better. Talk with your doctor or health care professional about the foods you eat and the vitamins that you take.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• blood clots in your hemodialysis vascular access device

• feeling faint or lightheaded, falls

• high blood pressure

• seizures

• signs and symptoms of a blood clot such as breathing problems; chest pain; pain, swelling, warmth in the leg

• signs and symptoms of a stroke like changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm, or leg; trouble walking; dizziness; loss of balance or coordination

• swelling of the ankles, feet, hands

• unusual bleeding or bruising

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• headache

• irritation at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

If you are using this medicine at home, you will be instructed on how to store this medicine. Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). If a refrigerator is unavailable, the prefilled syringes may be stored at room temperature (up to 77 degrees F [25 degrees C]) for up to 30 days. Vials may be stored at room temperature for up to 7 days. Throw away any unused portion. Do not freeze or shake. Protect from light. Throw away unused medicine after the expiration date on the label.