Mircera

Mircera is used in the treatment of anemia (low red blood cells) in a patient with chronic kidney disease.

Methoxy polyethylene glycol-epoetin beta is a synthetic form of erythropoietin (a protein normally made by the kidneys) which stimulates bone marrow to produce red blood cells.

In chronic kidney diseases or failure, the kidney is unable to make enough erythropoietin and so results in severe anemia. It is available in the form of solution only with your doctor’s prescription.

Before using Mircera, you must know all about the risks and complications associated with it.

Allergy

Inform your doctor if you are allergic to any food, preservatives, dyes, or had an allergic reaction when you used this drug before.

Children

There are no adequate studies done which prove Methoxy polyethylene glycol-epoetin beta’s harmful effects in children. However, safety and efficacy have not been established.

Elderly

This medicine does not cause any different side effects or problem than it does in younger adults. However, it should be used with caution in a patient who has kidney or liver diseases.

Pregnancy

It is a category C drug. It is not safe in pregnancy. It may cause harm and abnormalities in an unborn baby.

Breast Feeding

Methoxy polyethylene glycol-epoetin beta is not known if it can pass into breast milk or not. If you are using it while nursing, discuss the potential risks with your doctor.

Drug Interactions

Methoxy polyethylene glycol-epoetin beta may interact with other drugs. Your doctor should be informed of any other medicines which you are taking. He/she may want to change the dosage or drug.

Other Medical Problem

Several other conditions may reduce its effectiveness.

Make sure you inform your doctor of conditions such as:

• Heart disease (heart attack, congestive heart failure, heart bypass surgery)
• Hypertension (high blood pressure)
• Stroke
• Blood clot
• Epilepsy or other seizure disorder
• Past or present cancer
• Bone marrow diseases
• If you are receiving chemotherapy.

Proper usage of Mircera requires strict adherence to your doctor’s orders. Read the medication guide carefully. Ask your pharmacist if you have any queries.

A doctor or a trained health professional will inject this medicine through a needle into your vein or skin. Your doctor will teach you how to use this injection at home.

If you are using it at home, always use a new syringe. Do not use more medicine or more often than recommended by your doctor. Do not use leftover medicine or solution which has changed color or have visible particles in it. Used syringes should be thrown away in a hard container.

You should follow your special diet and take medicines regularly even if you feel better. It will control your kidney disease and high blood pressure. Take iron and vitamin supplements if your doctor tells you so.

Dosage

It is different for different patients. Dosage mentioned below is an average dose. You must follow your doctor’s command.

For anemia from chronic kidney failure

• Adults: The initial dose is 0.6 microgram (mcg) per kilogram (kg) of body weight injected into a vein or under the skin once every 2 weeks.
• Missed dose: Do not miss the dose. If you forget your dose, ask your pharmacist or doctor for instructions.

Storage

Store it at room temperature. Keep it away from children.

Before using Mircera, there are some precautions you must take. Your doctor should check your daily progress at regular visits. He/she may want a blood or urine test to check for unwanted effects.

Monitor your blood pressure at home. Inform your doctor if you notice any changes in it.

Tell your doctor or dentist that you take Methoxy polyethylene glycol-epoetin beta before you receive any medical or dental care, emergency care, or surgery.

It may worsen cancers. Discuss it with your doctor if you have any concerns regarding this.

It may cause seizures especially in first few months of treatment. Discuss it with your doctor if you have any concerns regarding this.

Methoxy polyethylene glycol-epoetin beta can cause anaphylactic reactions.

Inform your doctor immediately if you start having:

• rash, itching
• fainting
• palpitation
• trouble breathing
• swelling of hand, face and mouth

It increases risks of:

• heart attack
• stroke
• congestive heart failure
• blood clotting problems

Inform your doctor immediately if you experience:

• dizziness
• fainting spells
• severe tiredness
• chest pain
• trouble breathing
• a sudden or a severe headache
• problems with vision, speech or walking

As with many medications, there are several potential side effects associated with Mircera. Some people may experience none or minor side effects.

Consult with your doctor if they become problematic or frequent:

More common are:

• Blurred vision
• Body aches or pain
• Chills
• Confusion
• Cough
• Difficulty with breathing
• Dizziness
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Ear congestion
• Fever
• Headache
• Loss of voice

Less common are:

• Bladder pain
• Bloody or cloudy urine
• Difficult, burning, or painful urination
• Frequent urge to urinate
•  Lower back or side pain
• Pains in the chest, groin, or legs, especially calves of the legs
• Severe headaches of sudden onset

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.