Mircera injection contains epoetin beta and methoxy polyethylene glycol. Epoetin beta 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.
Mircera is used to treat anemia (a lack of red blood cells in the body) in people with chronic kidney disease.
Mircera is not for treating anemia caused by cancer chemotherapy or as a substitute for blood transfusions in patients who require immediate correction of anemia.
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, 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 Mircera.
Before taking this medicine
You should not use Mircera if you are allergic to epoetin beta and methoxy polyethylene glycol, or if you have:
To make sure Mircera is safe for you, tell your doctor if you have:
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heart disease, high blood pressure;
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a history of heart attack, stroke, or blood clot;
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epilepsy or other seizure disorder;
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past or present cancer; or
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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 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. 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.
Mircera 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 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 Mircera 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 still have signs of anemia (pale skin, feeling light-headed or short of breath). This could mean your body is not responding to Mircera.
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 Mircera 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.
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 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.
Mircera can increase your risk of serious or fatal side effects. Call your doctor or get emergency medical help if you have:
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dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, irregular heartbeats;
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symptoms of heart failure--shortness of breath (even with mild exertion), swelling, rapid weight gain;
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heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
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signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
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signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
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signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.
Also call your doctor at once if you have a seizure (convulsions), or signs that you may have a seizure, such as:
Common Mircera side effects may include:
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.
See also: Side effects (in more detail)
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 each of your health care providers about all medicines you use now and any medicine you start or stop using.
