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Mircera

Generic Name: epoetin beta and methoxy polyethylene glycol (e POE e tin BAY ta meth OX ee pol ee ETH il een GLYE kol)
Brand Names: Mircera

What is Mircera?

Mircera injection contains epoetin beta and methoxy polyethylene glycol. Epoetin beta and methoxy polyethylene glycol is a man-made form of a protein normally produced by the kidneys that helps your body produce red blood cells. When your body does not make enough of this protein because of kidney failure, you can develop a condition called anemia (lack of red blood cells).

Mircera is used to treat anemia in people with chronic kidney disease. This medicine is not for treating anemia caused by cancer chemotherapy.

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

Important information

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

Mircera 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, nausea, sweating, sudden numbness or weakness, a cold or pale arm or leg, confusion, or problems with speech or balance.

Before taking this medicine

You should not use Mircera if you are allergic to epoetin beta and methoxy polyethylene glycol, 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 Mircera is safe for you, tell your doctor if you have ever had:

  • heart disease, high blood pressure;

  • a heart attack, stroke, or blood clot;

  • a seizure;

  • kidney disease (or if you are on dialysis); or

  • cancer.

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

It is not known whether Mircera 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 Mircera?

Use Mircera exactly as it was prescribed for you. This medicine is usually given once every 2 weeks or once per month. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Never use more than your recommended dose.

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

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 Mircera. 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 Mircera 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 Mircera prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a disposable needle and syringe only once. 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 Mircera. You may need to take medicine to prevent blood clots for a short time after your surgery.

Mircera 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 Mircera for up to 30 days at cool room temperature. Protect from light.

Mircera dosing information

Usual Adult Dose of Mircera for Anemia Associated with Chronic Renal Failure:

1) For Patients Not Currently Treated with an erythropoiesis-stimulating agent (ESA):

Initial dose: 0.6 mcg/kg body weight administered as a single IV or subcutaneous injection once every two weeks

Epoetin beta-methoxy polyethylene glycol should be dosed to achieve and maintain hemoglobin between 10 and 12 g/dL. Once the hemoglobin has been maintained within this range, epoetin beta-methoxy polyethylene glycol may be administered once monthly using a dose that is twice that of the every two week dose and subsequently titrated as necessary.

2) For Patients Currently Treated with an erythropoiesis-stimulating agent (ESA):

Epoetin beta-methoxy polyethylene glycol can be administered once every two weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. The dose of epoetin beta-methoxy polyethylene glycol, given as a single IV or subcutaneous injection, should be based on the total weekly ESA dose at the time of conversion.

If the previous weekly epoetin alfa dose was less than 8000 units per week or the previous weekly darbepoetin alfa dose was less than 40 mcg per week, then the epoetin beta-methoxy polyethylene glycol dose would be 120 mcg per month or 60 mcg every two weeks.

If the previous weekly epoetin alfa dose was from 8000 units to 16,000 units per week or the previous weekly darbepoetin alfa dose was from 40 mcg to 80 mcg per week, then the epoetin beta-methoxy polyethylene glycol dose would be 200 mcg per month or 100 mcg every two weeks.

If the previous weekly epoetin alfa dose was greater than 16,000 units per week or the previous weekly darbepoetin alfa dose was greater than 80 mcg per week, then the epoetin beta-methoxy polyethylene glycol dose would be 360 mcg per month or 180 mcg every two weeks.

Usual Geriatric Dose of Mircera for Anemia Associated with Chronic Renal Failure:

Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

Dosage Information (comprehensive)

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of Mircera.

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 Mircera?

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

Mircera side effects

Get emergency medical help if you have signs of an allergic reaction to Mircera: 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:

  • increased blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;

  • 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; or

  • signs of a stroke or blood clot - sudden numbness or weakness (especially on one side of the body), slurred speech, sudden confusion, problems with vision or balance, a cold or pale arm or leg.

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 Mircera 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.

Side Effects (complete list)

What other drugs will affect Mircera?

Other drugs may interact with epoetin beta and methoxy polyethylene glycol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Mircera.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Mircera only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2017 Cerner Multum, Inc. Version: 3.01.

Last reviewed: September 26, 2017
Date modified: November 06, 2017

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