Mircera

Generic name: Epoetin Beta And Methoxy Polyethylene Glycol
Drug class: Recombinant human erythropoietins

Usage of 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 (lack of red blood cells) and to reduce the need for blood cell transfusions.

Mircera is used to treat anemia caused by chronic kidney disease in adults, or in children at least 5 years old who are on hemodialysis.

This medicine is not for treating anemia caused by cancer chemotherapy. Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer.

Mircera should not be used to take the place of an emergency blood cell transfusion.

Mircera side effects

Get emergency medical help if you have signs of an allergic reaction to Mircera (hives, itching, sweating, wheezing, difficult breathing, dizziness, swelling in your face or throat, fainting) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

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:

high blood pressure;

headache;

vomiting and diarrhea;

stuffy nose, sinus pain; or

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.

Before taking Mircera

You should not use Mircera if you are allergic to epoetin beta or 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).

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Mircera.

To make sure Mircera is safe for you, tell your doctor if you have ever had:

heart disease, high blood pressure;

a seizure;

dialysis treatment; or

cancer.

Tell your doctor if you are pregnant or breastfeeding.

Relate drugs

How to use Mircera

Usual Adult Dose for Anemia Associated with Chronic Renal Failure:

Patients NOT on Dialysis: Not currently on erythropoiesis-stimulating agents (ESAs): Initial dose: 0.6 mcg/kg, intravenously (IV) or suBCutaneously (SC), once every 2 weeks Maintenance dose (when hemoglobin is stabilized): Administer once monthly, using twice the every 2 week dose; titrate as needed Conversion From Epoetin alfa (EA): EA dose under 8000 units/week: 60 mcg every 2 weeks OR 120 mcg monthly EA dose 8000 to 16,000 units/week: 100 mcg every 2 weeks OR 200 mcg monthly EA dose over 16,000 units/week: 180 mcg every 2 weeks OR 360 mcg monthly< Conversion From Darbepoetin alfa: Darbepoetin alfa dose under 40 mcg/week: 60 mcg every 2 weeks OR 120 mcg monthly Darbepoetin alfa dose 40 to 80 mcg /week: 100 mcg every 2 weeks OR 200 mcg monthly Darbepoetin alfa dose over 80 mcg /week: 180 mcg every 2 weeks OR 360 mcg monthly Comments: -Use is neither indicated or recommended for anemia from cancer chemotherapy. -Use is neither indicated or recommended as a substitute for red blood cell (RBC) transfusions when immediate correction of anemia is required. -Improvements in symptoms, physical function, or health related quality of life have not been shown. -Initiate therapy when hemoglobin is under 10 g/dL, the rate of hemoglobin decline is likely to require a RBC infusion, and reducing RBC transfusion related risks, including alloimmunization, is a goal. -If hemoglobin exceeds 10 g/dL, reduce or interrupt dose. -Use the lowest dose necessary to reduce the need for red blood cell transfusions.

Warnings

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

Mircera is not for treating anemia caused by cancer chemotherapy.

This medicine 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, trouble breathing, sudden numbness or weakness, a cold or pale arm or leg, confusion, or problems with speech or balance.

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.

Disclaimer

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