Dosing & Uses
Dosage Forms & Strengths
methoxy polyethylene glycol/epoetin beta
injectable solution, single-dose prefilled syringe
- 30mcg/0.3mL
- 50mcg/0.3mL
- 75mcg/0.3mL
- 100mcg/0.3mL
- 120mcg/0.3mL
- 150mcg/0.3mL
- 200mcg/0.3mL
- 250mcg/0.3mL
- 360mcg/0.6mL
Anemia Associated with Chronic Renal Failure
Do not increase dose more frequently than q4weeks; decreases in dose can occur more frequently; avoid frequent dose adjustments
If hemoglobin rises rapidly (eg, >1 g/dL in any 2-week period), reduce dose by 25% or more as needed to reduce rapid responses
For patients who do not respond adequately, if hemoglobin has not increased by >1 g/dL after 4 weeks of therapy, increase dose by 25%
For patients who do not respond adequately over a 12-week escalation period, increasing Mircera dose further is unlikely to improve response and may increase risks; use lowest dose that will maintain a hemoglobin level sufficient to reduce need for RBC transfusions; evaluate other causes of anemia; discontinue Mircera if responsiveness does not improve
Patients with chronic renal failure on dialysis
- Initiate Mircera treatment when hemoglobin level < 10 g/dL
- If hemoglobin level (Hgb) ≥11 g/dL, reduce or interrupt dose
- Dose if not currently on ESA therapy: 0.6 mcg/kg IV/SC q2week initially
- Once hemoglobin has been stabilized, administer dose once monthly using a dose that is twice that of every-two-week dose and subsequently titrated as necessary
Patients with chronic renal failure not on dialysis
- Consider initiating treatment only when hemoglobin level is <10 g/dL and the following considerations apply
- Rate of hemoglobin decline indicates likelihood of requiring a RBC transfusion and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal
- If hemoglobin level >10 g/dL, reduce or interrupt dose, and use lowest dose sufficient to reduce need for RBC transfusions
- Dose if not currently on ESA therapy: 0.6 mcg/kg IV/SC q2week initially
- Once hemoglobin has been stabilized, administer dose once monthly using a dose that is twice that of the every-two-week dose and subsequently titrated as necessary
Switching Patients Currently on Other ESA
- Receiving epoetin <8000 units/week or darbepoetin <40 mcg/week: 120 mcg/qMonth or 60 mcg/q2Week IV/SC
- Receiving epoetin 8000-16000 units/week or darbepoetin 40-80 mcg/week: 200 mcg/qMonth or 100 mcg/q2Week IV/SC
- Receiving epoetin >16000 units/week or darbepoetin >80 mcg/week:360 mcg/qMonth or 180 mcg/q2Week IV/SC
Dosage Modifications
Pharmacokinetics of methoxy polyethylene glycol-epoetin beta were not altered by age (6-89 years), gender, race, severe hepatic impairment (Child-Pugh Class C), site of subcutaneous injection (abdomen, arm or thigh), or the use of dialysis
Dosing Considerations
Limitations of use
- Not indicated and is not recommended for use in the treatment of anemia due to cancer chemotherapy; as a substitute for RBC transfusions in patients who require immediate correction of anemia
- Mircera has not been shown to improve quality of life, fatigue, or patient wellbeing
Dosage Forms & Strengths
methoxy polyethylene glycol/epoetin beta
injectable solution, single-dose prefilled syringe
- 30mcg/0.3mL
- 50mcg/0.3mL
- 75mcg/0.3mL
- 100mcg/0.3mL
- 120mcg/0.3mL
- 150mcg/0.3mL
- 200mcg/0.3mL
- 250mcg/0.3mL
- 360mcg/0.6mL
Anemia Associated with Chronic Renal Failure
Indicated for the treatment of anemia associated with chronic kidney disease (CKD) in pediatric patients (5-17 years) on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA
<5 years: Safety and efficacy not established
5-17 years
- Administer IV once q4Weeks whose hemoglobin level has been stabilized by treatment with an ESA
Starting doses for patients currently receiving an ESA
- Epoetin alfa: 4 x previous weekly epoetin alfa dose (Units)/125 (eg, 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera IV once q4Weeks)
- Darbepoetin alfa: 4 x previous weekly darbepoetin alfa dose (mcg)/0.55 (eg, 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera IV once q4weeks)
Dosage Modifications
Pharmacokinetics of methoxy polyethylene glycol-epoetin beta were not altered by age (6-89 years), gender, race, severe hepatic impairment (Child-Pugh Class C), site of subcutaneous injection (abdomen, arm or thigh), or the use of dialysis
Adverse Effects
>10%
Hypertension (13%)
Diarrhea (11%)
Nasopharyngitis (11%)
1-10%
Headache (9%)
Upper respiratory tract infection (9%)
Muscle spasms (8%)
Procedural hypotension (8%)
Fluid overload (7%)
Back pain (6%)
Cough (6%)
Vomiting (6%)
Hypotension (5%)
Urinary tract infection (5%)
Arteriovenous fistula thrombosis (5%)
Arteriovenous fistula site complication (5%)
Pain in extremity (5%)
Constipation (5%)
Frequency Not Defined
Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Warnings
Black Box Warnings
Erythropoiesis-stimulating agents (ESAs) increase the risk of the death, myocardial infarction, stroke, and venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence
Chronic kidney disease
- In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target a Hgb <11 g/dL
- No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks
- Use the lowest dose sufficient to reduce the need for red blood cell (RBC) transfusions
Cancer
- Not indicated and not recommended for the treatment of anemia due to cancer chemotherapy
- A dose-ranging study ended early owing to the increased deaths among patients receiving Mircera than another ESA
- ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers
Contraindications
Uncontrolled hypertension
PRCA beginning after treatment or other erythropoietin protein
History of serious or severe allergic reactions
Cautions
In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13-14 g/dL) to lower targets (9-11.3 g/dL), ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups; use caution in patients with coexistent cardiovascular disease and stroke (see Black Box Warnings)
Increased mortality and/or tumor progression in patients with cancer
Not approved for chemotherapy-induced anemia
Caution in history of cardiovascular disease or HTN; control hypertension prior to initiating and during therapy
Risk of HTN, encephalopathy early in treatment
Seizures reported in chronic kidney disease patients participating in clinical studies; increase monitoring of these patients for changes in seizure frequency or premonitory symptoms
Risk of developing treatment-associated antibodies (Abs) if: sudden loss of treatment response; severe anemia & low reticulocyte count
Risk of developing pure red cell aplasia (PRCA) & severe anemia, with or w/out other cytopenias
Evaluate for PRCA if lack/loss of response to Micera develops, in absence of other etiology; if severe anemia and low reticulocyte count develop during treatment, withhold therapy and evaluate for PRCA
Not for use as substitute for RBC transfusions in patients who require immediate correction of anemia
Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, tachycardia, pruritus skin rash, urticaria, and Stevens-Johnson syndrome/toxic epidermal necrolysis reported; if serious allergic or anaphylactic reaction occurs due to therapy, immediately and permanently discontinue treatment and administer appropriate therapy
Blistering and skin exfoliation reactions including erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), in the postmarketing setting; discontinue therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected
Patients may require adjustments in their dialysis prescription after initiation treatment; patients may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis
Pregnancy & Lactation
Pregnancy
Available data from published case reports and postmarketing experience with use in pregnancy are insufficient to identify a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Chronic kidney disease is associated with maternal and embryo-fetal risks
Animal data
- In animal reproduction studies, administration of methoxy polyethylene glycolepoetin beta to rats and rabbits during pregnancy and lactation adversely affected offspring at doses 17-fold and greater than the recommended human dose
Clinical consideration
- Pregnancy in women with chronic kidney disease has been associated with adverse outcomes (eg, hypertension, pre-eclampsia, miscarriage, premature birth, low-birth-weight, polyhydramnios, and intrauterine growth restriction)
Lactation
There are no data on the presence of methoxy polyethylene glycol-epoetin beta in human milk, the effects on the breastfed child, or the effects on milk production
However, endogenous erythropoietin is present in human milk
Animal data
- In rats, methoxy polyethylene glycol-epoetin beta was present in maternal milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Erythropoietin receptor activator with greater activity in vivo as well as increased half-life, in contrast to erythropoietin
Erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia
In response to hypoxia, erythropoietin interacts with erythroid progenitor cells to increase red cell production; production of endogenous erythropoietin is impaired in patients with CKD and erythropoietin deficiency is the primary cause of their anemia
Absorption
Peak plasma time: SC: 72 hr
Bioavailability: SC: 62%
Onset: 7-15 day post-initial dose
Distribution
Vd (steady-state): 61 mL/kg
Excretion
Total clearance (0.4 mcg/kg IV dose, peritoneal dialysis) 0.47 mL/hr/kg
Half-life
- IV, peritoneal dialysis: 119 hr
- SC, peritoneal dialysis: 124 hr
Administration
IV Incompatibilities
Do not dilute or administer with other solutions
IV Preparation
DO NOT pool unused portions or use vial or syringe more than once
DO NOT shake vigorously or prolong exposure to light
Do not mix Mircera w/ any parenteral solution
Do not dilute or administer in conjunction with other drug solutions
Inspect visually for particulate matter & coloration prior to administration
Do not use if particulate matter or coloration besides colorless to slight yellowish present
Discard unused portion
IV Administration
Single injection
SC Administration
Administer in the abdomen, arm, or thigh
Administer either IV/SC in adult patients and only IV in pediatric patients
Using the prefilled syringe, fully depress the plunger during injection in order for the needle guard to activate
Following administration, remove needle from the injection site and then release the plunger to allow the needle guard to move up until the entire needle is covered
Storage
Refrigerate at 2-8°C (36-46°F) in the original carton to protect from light
Do not freeze or shake
The end-user may store at room temperature <25°C (77°F) in the original carton <30 days; discard after 30 days
Images
Patient Handout
epoetin beta, methoxy polyethylene glycol injection
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA - INJECTION
COMMON BRAND NAME(S): Mircera
WARNING: Discuss the risks and benefits of methoxy polyethylene glycol-epoetin beta with your doctor, as this medication may rarely cause very serious (possibly fatal) side effects, including blood clots, heart attack, stroke, or heart failure. It is very important to keep all lab appointments since your doctor will need to carefully check your red blood cell count and hemoglobin level. The lowest effective dose of this medication should be used.When used to treat anemia related to cancer, this medication may also increase the risk of death and/or cause the tumor to grow faster. This medication is not approved for the treatment of anemia related to cancer. Ask your doctor about the risks and benefits of this medication, as well as other effective and possibly safer treatments for anemia related to cancer.
USES: This medication is used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic kidney disease). It works by signaling the bone marrow to make more red blood cells. Methoxy polyethylene glycol-epoetin beta helps to reverse anemia. It also helps to reduce the need for blood transfusions. This medication is very similar to the natural substance in your body (erythropoietin) that prevents anemia.
HOW TO USE: Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using methoxy polyethylene glycol-epoetin beta and each time you get a refill. If you have any questions, ask your doctor or pharmacist.For adults, inject this medication into a vein or under the skin as directed by your doctor, usually every 2 to 4 weeks. Hemodialysis patients should receive this medication by injection into a vein.For children, inject this medication only into a vein as directed by the doctor, usually every 4 weeks.If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package.Do not shake the medication and do not mix it with other medications. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Before injecting each dose, clean the injection site with rubbing alcohol. If you are injecting methoxy polyethylene glycol-epoetin beta under the skin, change the injection site each time to lessen injury under the skin.Learn how to store and discard medical supplies safely.The dosage is based on your medical condition, weight, and response to treatment. Blood tests should be done often to check how well this medication is working and to decide the correct dose for you. Consult your doctor for more details.Use this medication regularly to get the most benefit from it. To help you remember, it may help to mark your calendar with a reminder.Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.It may take 2 to 6 weeks before your red blood cell count increases. Tell your doctor if your symptoms do not get better or if they get worse.
SIDE EFFECTS: Headache, body aches, diarrhea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Methoxy polyethylene glycol-epoetin beta may sometimes cause or worsen high blood pressure, especially in patients with long-term kidney failure. This effect may be caused by the number of red blood cells increasing too quickly, usually within the first 3 months of starting treatment. If you have high blood pressure, it should be well controlled before beginning treatment with this medication. Your blood pressure should be checked often. Ask your doctor if you should learn how to check your own blood pressure. If high blood pressure develops or worsens, follow your doctor's instructions about diet changes and starting or adjusting your high blood pressure medication. Lowering high blood pressure helps prevent strokes, heart attacks, and further kidney problems. Keep all lab appointments to have your red blood cell count/hemoglobin level tested regularly to reduce the chance of this side effect.Rarely, this medication may suddenly stop working well after a period of time because your body may make antibodies to it. A very serious anemia can result. Tell your doctor right away if symptoms of anemia return (such as increased tiredness, low energy, pale skin color, shortness of breath).Tell your doctor right away if you have any serious side effects, including: symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).Get medical help right away if you have any very serious side effects, including: seizures.This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the legs or lungs). Get medical help right away if you have: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes, blood clots in your hemodialysis vascular access site.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, fast heartbeat.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using methoxy polyethylene glycol-epoetin beta, tell your doctor or pharmacist if you are allergic to it; or to other drugs that cause more red blood cells to be made (such as epoetin alfa, darbepoetin alfa); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart disease (such as heart failure, past heart attack/stroke), seizure disorder, severe anemia caused by antibodies to past erythropoietin-type treatment (pure red cell aplasia).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood pressure, complete blood count that includes hemoglobin level) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.Blood tests for your iron levels will also be done and you may be prescribed iron supplements to take. Your doctor may recommend that you eat a well-balanced diet rich in iron (such as raisins, figs, meat, eggs, vegetables, iron-fortified cereals). Follow your doctor's instructions and dietary recommendations.
MISSED DOSE: If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Store in the refrigerator. Do not freeze. This medication may also be stored at room temperature for up to 30 days. Protect it from light. Store the medication in the original carton until ready for use. Let the medication come to room temperature before using. After each dose, throw away any unused medication right away. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2021. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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