Pronunciation:

meth-OX-ee pol-ee-ETH-i-leen GLYE-kol e-POE-e-tin BAY-ta

Brand Names:

• Mircera

Dosage Forms:

• Solution

Warnings:

Erythropoiesis-stimulating agents (ESAs) increase the risk for death, serious adverse cardiovascular reactions, and stroke when administered to target a hemoglobin of greater than 11 g/dL. A hemoglobin target level or dosing strategy that does not increase these risks has not been identified. Use the lowest dose that reduces the need for RBC transfusions. Methoxy polyethylene glycol-epoetin beta is not recommended for treatment of anemia due to cancer chemotherapy. ESAs may shorten overall survival and increase the risk of tumor progression or recurrence in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers .

Classifications:

Therapeutic—

Hematopoietic

Pharmacologic—

Erythropoietic

Uses of This Medicine:

Methoxy polyethylene glycol-epoetin beta injection is used to treat anemia in adults with chronic kidney disease (CKD) who may or may not be on dialysis or in children with CKD who are on dialysis. This medicine is not used to treat anemia caused by cancer medicines.

Methoxy polyethylene glycol-epoetin beta injection causes the bone marrow to produce red blood cells. If the body does not produce enough red blood cells, severe anemia can occur. This often occurs in people with chronic kidney failure whose kidneys are not working properly.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methoxy polyethylene glycol-epoetin beta injection in children 5 to 17 years of age when it is given through a needle placed into one of your child's veins. Safety and efficacy have not been established in children younger than 5 years of age or when it is given as a shot under the skin in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of methoxy polyethylene glycol-epoetin beta injection in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution or an adjustment in the dose in patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Inflammatory or metabolic conditions, chronic or
• Iron or vitamin deficiency or
• Metabolic or chronic inflammatory conditions—Should be corrected first before using this medicine.

• Blood clots, history of or
• Congestive heart failure or
• Heart attack, history of or
• Heart bypass surgery or
• Heart or blood vessel disease or
• Stroke, history of—The chance of side effects may be increased.

• Cancer—May cause some tumors to progress or come back.

• Hypertension (high blood pressure), controlled or
• Seizures, history of—Use with caution. May make these conditions worse.

• Hypertension (high blood pressure), uncontrolled or
• Pure red cell aplasia (bone marrow disease)—Should not be used in patients with these conditions.

• Patients receiving dialysis—May require an increase in the dose of blood thinner (eg, heparin) to prevent the blood from clotting too much.

Proper Use of This Medicine:

This medicine is usually given by your doctor. However, medicines given by injection are sometimes used at home. If you will be using this medicine at home, your doctor will teach you how the injections are to be given. Be sure you understand exactly how the medicine is to be injected.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine may be given as a shot under your skin (usually in the upper arms, thighs, or stomach) or into a vein. If your doctor tells you to inject it a certain way, follow your doctor's instructions.

If you are giving this medicine at home:

• Use a new needle and unopened syringe each time you inject your medicine.
• Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Do not inject into moles or areas that are tender, red, bruised, hard, or has scars, stretch marks, not intact, or that could be irritated by a belt or waistband. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.
• Check the liquid in the prefilled syringe. It must be clear or colorless to slightly yellow. Do not use it if the solution in the prefilled syringe becomes cloudy, discolored, or has particles in it. Do not shake.
• Do not save any leftover medicine from an open syringe. Use each syringe only 1 time.

People with kidney problems need to be on a special diet. Also, people with high blood pressure (which may be caused by kidney disease or by Mircera® treatment) may need to be on a special diet or take medicine to keep their blood pressure under control. After their anemia has been corrected, some people feel so much better that they want to eat more than before. To keep your kidney disease or your high blood pressure from getting worse, it is very important that you follow your special diet and you take your medicines regularly, even if you are feeling better.

In addition to Mircera®, your body needs iron and vitamins to make red blood cells. Your doctor may direct you to take iron or vitamin supplements. Be sure to follow your doctor's orders carefully.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled syringe):
  • For patients with chronic kidney disease not on dialysis:
    • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 1.2 microgram (mcg) per kilogram (kg) of body weight injected under the skin once every month. Some patients may receive a starting dose of 0.6 microgram (mcg) per kilogram (kg) of body weight injected into a vein or under the skin once every 2 weeks. Your doctor may adjust the dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For patients with chronic kidney disease on dialysis:
    • Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.6 microgram (mcg) per kilogram (kg) of body weight injected into a vein or under the skin once every 2 weeks. Your doctor may adjust the dose as needed.
    • Children 5 to 17 years of age—Dose is based on your child's hemoglobin level or whether he or she is receiving epoetin alfa or darbepoetin alfa and must be determined by your doctor. The dose may be 48 mcg (from epoetin) or 145.5 mcg (from darbepoetin) given through a needle placed into your child's vein once every 4 weeks.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

If you store this medicine at home, keep it in the original package until you are ready to use it. Protect it from direct light. You may store it at room temperature for up to 30 days. Throw away any unused medicine after 30 days.

Throw away used needles and syringes in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress regularly while you or your child are using this medicine. Blood tests are needed to check for unwanted effects. You may also need to monitor your blood pressure at home. If you notice any changes to your normal blood pressure, call your doctor right away.

This medicine may increase your risk of having heart attack, stroke, congestive heart failure, and blood clotting problems. Check with your doctor right away if you start having dizziness, fainting spells, severe tiredness, chest pain, trouble breathing, sudden or severe headache, or problems with vision, speech, or walking.

This medicine may also increase your risk of having serious heart and blood vessel problems such as a heart attack, congestive heart failure, or stroke. Check with your doctor right away if you start having dizziness, fainting spells, severe tiredness, chest pain, trouble with breathing, sudden or severe headache, or problems with vision, speech, or walking.

When used in patients with certain types of cancer (eg, breast, cervix, lymphoid, lung, head, or neck cancer), this medicine has shortened survival time and worsened the tumor or cancer in some patients. If you are concerned about this, talk with your doctor.

This medicine may cause convulsions (seizures), especially during the first few months of treatment. Talk with your doctor if you have concerns about this.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain after you receive the medicine.

Serious skin reactions (eg, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth of on the lips, or unusual tiredness or weakness.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery. Your doctor may want you to take a blood thinner (eg, warfarin) to prevent blood clots during or after surgery.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

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

nasal congestion

nervousness

pounding in the ears

runny nose

slow or fast heartbeat

sneezing

sore throat

sweating

unusual tiredness or weakness

Less common

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 the calves of the legs

severe headaches of sudden onset

sudden loss of coordination

sudden onset of slurred speech

sudden vision changes

Incidence not known

Blistering, peeling, or loosening of the skin

chest tightness

confusion

decreased urine output

diarrhea

difficulty with speaking

difficulty with swallowing

dilated neck veins

double vision

extreme tiredness or weakness

fast, pounding, or irregular heartbeat or pulse

hives or welts, itching, or skin rash

inability to move the arms, legs, or facial muscles

inability to speak

irregular breathing

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

pain or discomfort in the arms, jaw, back, or neck

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

redness of the skin

seizures

severe, sudden headache

slow or slurred speech

sores, ulcers, or white spots in the mouth or on the lips

sudden, severe weakness or numbness in the arm or leg

sweating

swelling of the face, fingers, feet, or lower legs

vision changes

vomiting

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

muscle spasms

Less common

Difficulty having a bowel movement

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.