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Methoxy polyethylene Glycol-epoetin beta (Injection route)

Pronunciation:

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

Brand Names:

  • Mircera

Dosage Forms:

  • Solution

Warnings:

Injection route(Solution)

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 patients with chronic kidney disease (CKD).

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 have not been performed on the relationship of age to the effects of methoxy polyethylene glycol-epoetin beta injection in the pediatric population. Safety and efficacy have not been established.

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 more monitoring or an adjustment in the dose of this medicine.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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
  • Vitamin deficiency—Should be corrected first before using this medicine.
  • Blood clots, history of or
  • Cancer 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.
  • 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 (PRCA, bone marrow disease)—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Mircera® is usually given by a doctor. However, medicines given by injection are sometimes used at home. If you will be using Mircera® 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 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.
  • Do not use if the solution in the prefilled syringe has changed color, or if you see particles in it.
  • Do not save any leftover medicine from an open syringe. Use each syringe only 1 time.
  • Throw away used needles and syringes in a hard, closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.

Many 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 to 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 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:
    • For anemia from chronic kidney failure:
      • 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—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. Do not freeze or shake the medicine. If necessary, you may store it at room temperature for up to 30 days.

Precautions While Using This Medicine:

It is very important that your doctor check your blood regularly while you are using this medicine. 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.

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 (such as warfarin) to prevent blood clots during or after surgery.

This medicine may increase risk of worsening of tumor in patients with cancer. Talk with your doctor about this risk.

Mircera® sometimes causes 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. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you receive the medicine.

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 or nurse 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 calves of the legs
severe headaches of sudden onset
sudden loss of coordination
sudden onset of shortness of breath for no apparent reason
sudden onset of slurred speech
sudden vision changes
Incidence not known
Confusion
decreased urine output
difficulty with speaking
difficulty with swallowing
dilated neck veins
double vision
extreme fatigue
fast, pounding, or irregular heartbeat or pulse
hives, itching, or skin rash
inability to move the arms, legs, or facial muscles
inability to speak
irregular breathing
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
pain or discomfort in the arms, jaw, back, or neck
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
redness of the skin
seizures
severe, sudden headache
slow or slurred speech
sudden, severe weakness or numbness in the arm or leg
sudden, unexplained shortness of breath
sweating
swelling of the face, fingers, feet, or lower legs
tightness in the chest
vision changes
vomiting
weight gain
welts

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
diarrhea
muscle spasms
Less common
Difficulty having a bowel movement (stool)

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.


Last Updated: 7/4/2017
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