Methoxy polyethylene Glycol-epoetin beta (Injection route)
meth-OX-ee pol-ee-ETH-i-leen GLYE-kol e-POE-e-tin BAY-ta
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 .
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:
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.
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.
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.
|All Trimesters||C||Animal 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.|
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.
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.
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.
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.
- For anemia from chronic kidney failure:
Call your doctor or pharmacist for instructions.
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:
- More common
- Blurred vision
- body aches or pain
- difficulty with breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- ear congestion
- loss of voice
- nasal congestion
- pounding in the ears
- runny nose
- slow or fast heartbeat
- sore throat
- 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
- 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
- severe, sudden headache
- slow or slurred speech
- sudden, severe weakness or numbness in the arm or leg
- sudden, unexplained shortness of breath
- swelling of the face, fingers, feet, or lower legs
- tightness in the chest
- vision changes
- weight gain
- More common
- Back pain
- muscle spasms
- Less common
- Difficulty having a bowel movement (stool)
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:
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:
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