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.

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.

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 and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Mircera is injected under the skin or given as an infusion into a vein. When used in a child, the medicine should be given only into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your Mircera. Ask your doctor or pharmacist if you don't understand all instructions.

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

Your blood pressure will need to be checked often. You will also need frequent medical tests, and your next dose may be delayed based on the results.

Call your doctor if you have signs that your body is not responding to Mircera (pale skin, unusual tiredness, lack of energy, dizziness, fainting).

Your doctor may have you take an iron supplement. Take only the type and amount your doctor prescribes.

If you need surgery, tell your surgeon you currently use Mircera. You may need to take medicine to prevent blood clots for a short time after your surgery.

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

You may also store a prefilled syringe at cool room temperature up to 25°C (77°F), but you must use the syringe within 30 days or throw it away. Protect from light.

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

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

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.

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.

Call your doctor for instructions if you miss a dose.

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

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

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.

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.