Mircera (methoxy polyethylene glycol-epoetin beta)

Individualize dosing and use the lowest dosage of methoxy polyethylene glycol-epoetin beta sufficient to reduce the need for RBC transfusions. In clinical trials, administration of ESAs, to targethemoglobin levels >11 g/dLincreased the risk of death, serious adverse cardiovascular reactions, and stroke. No target hemoglobin level, erythropoiesis-stimulating agent (ESA) dose, or dosing strategy has been identified that decreases these risks. Weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events.

When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy, consider the rate of increase or decrease in hemoglobin concentration, responsiveness to the ESA, and hemoglobin concentration variability. A single hemoglobin excursion may not require a dosage change.

Avoid frequent dosage adjustments of methoxy polyethylene glycol-epoetin beta. Do not increase dosage more frequently than once every 4 weeks; decreases in dosage can occur more frequently. If the hemoglobin concentration rises rapidly (e.g., >1 g/dL in any 2-week period), reduce the dosage by >=25% as needed to reduce rapid responses. If the hemoglobin concentration has not increased by >1 g/dL after 4 weeks of therapy, increase the dosage by 25%.

If an adequate response is not obtained over a 12-week period of escalating dosages, evaluate the patient for other causes of anemia; further dosage increases are unlikely to improve patient response and may increase risks of therapy. Use the lowest dosage that will maintain a hemoglobin concentration sufficient to reduce the need for RBC transfusions. If responsiveness does not improve, discontinue the drug.

Methoxy polyethylene glycol-epoetin beta is administered by IV or subcutaneous injection. Administer by IV or subcutaneous injection in adult patients, and only by IV injection in pediatric patients. For subcutaneous administration, inject methoxy polyethylene glycol-epoetin beta in the abdomen, arm, or thigh.

Methoxy polyethylene glycol-epoetin beta injection is available as single-dose prefilled syringes in various strengths for IV or subcutaneous administration.

Methoxy polyethylene glycol-epoetin beta is preservative-free; discard any unused portions. Do not mix the drug with any parenteral solution.

Inspect the prefilled syringes visually for particulate matter and/or discoloration prior to administration; do not use if either is observed. Avoid vigorous shaking of the syringes or prolonged exposure to light.

Do not pool unused portions from the prefilled syringes. Do not use the prefilled syringe more than once.

Store methoxy polyethylene glycol-epoetin beta syringes in the refrigerator at 2-8degreesC in the original carton to protect from light. Do not freeze or shake. The patient may store methoxy polyethylene glycol-epoetin beta at room temperature up to 25degreesC in the original carton for up to 30 days.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug interaction studies have been performed with methoxy polyethylene glycol-epoetin beta.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Uncontrolled hypertension.

*Pure red cell aplasia (PRCA) that begins after treatment with methoxy polyethylene glycol-epoetin beta or other erythropoietin protein drugs.

*History of serious or severe allergic reactions (including anaphylaxis) to methoxy polyethylene glycol-epoetin beta.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common adverse reactions (>=10%) are hypertension, diarrhea, and nasopharyngitis.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

The efficacy and safety of methoxy polyethylene glycol-epoetin beta for the treatment of anemia due to CKD have been established in pediatric patients 5-17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA. Use of methoxy polyethylene glycol-epoetin beta in this age group is supported by evidence from adequate and well-controlled studies in adults and a dose-finding study in 64 pediatric patients 5-17 years of age with CKD on hemodialysis. The observed safety profile in pediatric patients was similar to that found in adults.

The efficacy and safety of methoxy polyethylene glycol-epoetin beta have not been established in pediatric patients <5 years of age. The efficacy and safety of subcutaneously-administered methoxy polyethylene glycol-epoetin beta have not been established in pediatric patients of any age. Efficacy and safety of methoxy polyethylene glycol-epoetin beta have not been established for the treatment of anemia in pediatric patients with CKD on peritoneal dialysis; the treatment of anemia in pediatric patients with CKD who are not yet on dialysis; and for pediatric patients whose hemoglobin level has not been previously stabilized by treatment with an ESA.

Available data from a small number of published case reports and postmarketing experience with methoxy polyethylene glycol-epoetin beta 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 (e.g., hypertension, pre-eclampsia, miscarriage, premature birth, low-birth-weight, polyhydramnios, intrauterine growth restriction).

In animal reproduction studies, subcutaneous administration of methoxy polyethylene glycol-epoetin beta to rats and rabbits during pregnancy adversely affected offspring at doses 17-fold greater than the recommended human dose.

It is not known whether methoxy polyethylene glycol-epoetin beta is distributed into human milk; however, endogenous erythropoietin is present in human milk. When methoxy polyethylene glycol-epoetin beta was administered to lactating rats, the drug was detected in maternal milk. The effects of methoxy polyethylene glycol-epoetin beta on breast-fed infants or on milk production are unknown.

A clear determination of the risks of methoxy polyethylene glycol-epoetin beta to breast-fed infants cannot be made due to lack of clinical data during lactation. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for methoxy polyethylene glycol-epoetin beta and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients, but recommends cautious dosage selection, usually starting at the low end of the dosing range, due to the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy.

Clinical studies of methoxy polyethylene glycol-epoetin beta did not include sufficient numbers of patients >=65 years of age to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, select dosage with caution in geriatric patients, usually starting at the low end of the dosing range; geriatric patients have a greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy.