Methoxy polyethylene glycol/epoetin beta

Methoxy polyethylene glycol/epoetin beta is a combination of prescription medications used for the treatment of anemia associated with chronic renal failure. 

• Methoxy polyethylene glycol/epoetin beta is available under the following different brand names: Mircera

Common side effects of Methoxy polyethylene glycol/epoetin beta include:

• diarrhea,
• stuffy nose,
• sinus pain, and
• sore throat

Serious side effects of Methoxy polyethylene glycol/epoetin beta include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• itching,
• sweating,
• wheezing,
• dizziness,
• fainting,
• fever,
• sore throat,
• burning eyes,
• skin pain,
• red or purple skin rash with blistering and peeling,
• severe headache,
• blurred vision,
• pounding in the neck or ears,
• anxiety,
• nosebleed,
• shortness of breath,
• swelling,
• rapid weight gain,
• chest pain or pressure,
• pain spreading to the jaw or shoulder,
• nausea,
• sudden numbness or weakness (especially on one side of the body),
• slurred speech,
• sudden confusion,
• problems with vision or balance,
• cold or pale arm or leg,
• sudden mood changes,
• unusual tiredness,
• sensitivity to light or noise,
• trouble concentrating, and
• seizure

Rare side effects of Methoxy polyethylene glycol/epoetin beta include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

 Adult and pediatric dosage

The injectable solution, single-dose prefilled syringe

• 30 mcg/0.3 mL
• 50 mcg/0.3 mL
• 75 mcg/0.3 mL
• 100 mcg/0.3 mL
• 120 mcg/0.3 mL
• 150 mcg/0.3 mL
• 200 mcg/0.3 mL
• 250 mcg/0.3 mL
• 360 mcg/0.6 mL

Anemia Associated with Chronic Renal Failure

• Adult dosage
• Do not increase the dose more frequently than every 4 weeks; decreases in dose can occur more frequently; avoid frequent dose adjustments
• If hemoglobin rises rapidly (e.g., above 1 g/dL in any 2-week period), reduce the dose by 25% or more as needed to reduce rapid responses
• For patients who do not respond adequately, if hemoglobin has not increased by above 1 g/dL after 4 weeks of therapy, increase the dose by 25%
• For patients who do not respond adequately over a 12-week escalation period, increasing the Mircera dose further is unlikely to improve response and may increase risks; use the lowest dose that will maintain a hemoglobin level sufficient to reduce the 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 less than 10 g/dL
  • If hemoglobin level (Hgb) is above 11 g/dL, reduce or interrupt the dose
  • Dose if not currently on ESA therapy: 0.6 mcg/kg IV/SC every 2 weeks 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
• Patients with chronic renal failure not on dialysis
  • Consider initiating treatment only when the hemoglobin level is less than 10 g/dL and the following considerations apply
  • The rate of hemoglobin decline indicates the likelihood of requiring an RBC transfusion and reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal
  • If the hemoglobin level is above 10 g/dL, reduce or interrupt the dose, and use the lowest dose sufficient to reduce the need for RBC transfusions
  • Dose if not currently on ESA therapy: 0.6 mcg/kg IV/SC every 2 weeks 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 less than 8000 units/week or darbepoetin less than 40 mcg/week: 120 mcg/every month or 60 mcg/every 2 weeks IV/SC
  • Receiving epoetin 8000-16000 units/week or darbepoetin 40-80 mcg/week: 200 mcg/month or 100 mcg/every 2 Weeks IV/SC
  • Receiving epoetin more than 16000 units/week or darbepoetin more than 80 mcg/week:360 mcg/Month or 180 mcg/every 2 weeks IV/SC

Pediatric dosage

• Aged below 5 years: Safety and efficacy not established
• Aged 5-17 years
  • Administer IV once every 4 weeks 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 every 4 weeks)
  • 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 every 4 weeks)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Methoxy polyethylene glycol/epoetin beta has no noted severe interactions with any other drugs.
• Methoxy polyethylene glycol/epoetin beta has no noted serious interactions with any other drugs.
• Methoxy polyethylene glycol/epoetin beta has no noted moderate interactions with any other drugs.
• Methoxy polyethylene glycol/epoetin beta has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Uncontrolled hypertension
• PRCA beginning after treatment or other erythropoietin protein
• History of serious or severe allergic reactions

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Methoxy polyethylene glycol/epoetin beta?”
• Long-Term Effects
• See “What Are Side Effects Associated with Using Methoxy polyethylene glycol/epoetin beta?”

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 a 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 a 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

• 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

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