epoetin beta and methoxy polyethylene glycol

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Pronunciation: e POE e tin BAY ta meth OX ee pol ee ETH il een GLYE kol

Brand: Mircera

What is the most important information I should know about epoetin beta and methoxy polyethylene glycol?

You should not use this medicine if you have uncontrolled high blood pressure or if you have ever had pure red cell aplasia (PRCA).

Epoetin beta and methoxy polyethylene glycol can increase your risk of serious or fatal side effects, including heart attack, stroke, or blood clot.

Call your doctor or get emergency medical help if you have symptoms such as: chest pain, shortness of breath, sudden numbness or weakness, problems with vision or balance, pain or swelling in your legs, or feeling like you might pass out.

Never use more than your recommended dose of this medicine.

What is epoetin beta and methoxy polyethylene glycol?

Epoetin beta and methoxy polyethylene glycol is a man-made form of a protein that is normally produced by the kidneys to help your body produce red blood cells. This protein in your body may be reduced when you have kidney failure. When fewer red blood cells are produced, you can develop a condition called anemia.

Epoetin beta and methoxy polyethylene glycol is a combination medicine used to treat anemia (a lack of red blood cells in the body) in people with chronic kidney disease. This medicine is not for treating anemia caused by cancer chemotherapy.

Epoetin beta and methoxy polyethylene glycol may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using epoetin beta and methoxy polyethylene glycol?

You should not use epoetin beta and methoxy polyethylene glycol if you are allergic to it, or if you have:

  • uncontrolled hypertension (high blood pressure); or
  • if you have ever had a type of anemia called pure red cell aplasia (PRCA).

To make sure this medicine is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure;
  • a history of heart attack, stroke, or blood clot;
  • epilepsy or other seizure disorder;
  • past or present cancer; or
  • if you are receiving chemotherapy.

This medicine may shorten remission time or survival time in people with certain types of cancer.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether epoetin beta and methoxy polyethylene glycol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use epoetin beta and methoxy polyethylene glycol?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Never use more than your recommended dose.

Epoetin beta and methoxy polyethylene glycol 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 understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Your care provider will show you the best places on your body to inject epoetin beta and methoxy polyethylene glycol. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not shake the prefilled syringe or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Each single-use prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Call your doctor if you have signs that your body is not responding to this medicine (pale skin, feeling light-headed or short of breath, unusual tiredness, or lack of energy).

Your blood will need to be tested often. Your blood pressure will also need to be checked. Your next dose may be delayed based on the results of these tests.

If you need surgery, tell the surgeon ahead of time that you are using epoetin beta and methoxy polyethylene glycol. You may need to take medicine to prevent blood clots for a short time after your surgery.

Epoetin beta and methoxy polyethylene glycol is only part of a treatment program that may also include diet, regular dialysis treatments, and special medical care. Follow your doctor's instructions very closely.

Store in the refrigerator. Do not freeze. Keep the medicine in the original container until you are ready to give an injection.

You may also store the medicine for up to 30 days at cool room temperature. Protect from light.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Call your doctor for instructions if you miss more than one dose.

What happens if I overdose?

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

What should I avoid while using epoetin beta and methoxy polyethylene glycol?

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

What are the possible side effects of epoetin beta and methoxy polyethylene glycol?

Get emergency medical help if you have signs of an allergic reaction: hives, sweating; fast heartbeats; difficult breathing; dizziness, fainting; swelling of your face, lips, tongue, or throat.

This medicine can increase your risk of serious or fatal side effects. Call your doctor or get emergency medical help if you have:

  • dangerously high blood pressure --severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, irregular heartbeats;
  • symptoms of heart failure --shortness of breath (even with mild exertion), swelling, rapid weight gain;
  • heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • signs of a stroke --sudden numbness or weakness (especially on one side of the body), a cold or pale arm or leg, sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • signs of a blood clot in your leg --pain, swelling, warmth, or redness in one or both legs; or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Also call your doctor at once if you have a seizure (convulsions), or signs that you may have a seizure, such as:

  • sudden mood changes;
  • unusual tiredness;
  • sensitivity to light or noise; or
  • trouble concentrating.

Common side effects may include:

  • diarrhea; 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.

What other drugs will affect epoetin beta and methoxy polyethylene glycol?

Other drugs may interact with epoetin beta and methoxy polyethylene glycol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about epoetin beta and methoxy polyethylene glycol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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