Mircera Dosage
Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL
Dosage form: injection, solution
Drug class: Recombinant human erythropoietins
Medically reviewed by Drugs.com. Last updated on Jun 5, 2024.
Important Dosing Information
Evaluation of Iron Stores and Nutritional Factors
Evaluate the iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy.
Monitoring of Response to Therapy
Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Mircera. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion.
Individualization of Dosing
Individualize and use the lowest dose of Mircera sufficient to reduce the need for RBC transfusions. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL for adult patients. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events.
For Adult Patients with CKD
Prefilled syringes are not designed for administration of partial doses. Round doses to the closest dose achievable with the prefilled syringes.
When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
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- Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
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- If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Mircera by approximately 25% to the closest dose achievable with the prefilled syringes to reduce rapid responses.
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- If the hemoglobin continues to rise following a dose reduction, discontinue Mircera until the hemoglobin level begins to decrease, at which point therapy should be restarted with a dose that is approximately 25% below the previously administered dose.
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- For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by approximately 25% to the closest dose achievable with the prefilled syringes.
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- 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.
Administer Mircera either intravenously or subcutaneously. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh.
For Adult Patients with CKD on dialysis:
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- Initiate Mircera treatment when the hemoglobin level is less than 10 g/dL.
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- If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Mircera.
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- The recommended starting dose of Mircera for the treatment of anemia in adult CKD patients who are not currently treated with an ESA is 0.6 mcg/kg body weight administered once every two weeks as a single intravenous or subcutaneous injection. The intravenous route is recommended for patients receiving hemodialysis because the intravenous route may be less immunogenic.
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- Once the hemoglobin has been stabilized, Mircera may be administered once monthly using a dose that is twice that of the every-two-week dose and subsequently titrated as necessary.
For Adult Patients with CKD not on dialysis:
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- Consider initiating Mircera treatment only when the hemoglobin level is less than 10 g/dL and the following considerations apply:
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- The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and,
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- Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
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- If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Mircera, and use the lowest dose of Mircera sufficient to reduce the need for RBC transfusions.
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- The recommended starting dose of Mircera for the treatment of anemia in adult CKD patients who are not currently treated with an ESA is 1.2 mcg/kg body weight administered once every month as a single subcutaneous injection. Alternatively, a starting dose of 0.6 mcg/kg body weight may be administered once every two weeks as a single intravenous or subcutaneous injection.
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- Once the hemoglobin has been stabilized, Mircera may be administered once monthly using a dose that is twice that of the every-two-week dose and subsequently titrated as necessary.
Refer patients who self-administer Mircera to the Instructions for Use.
Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD
Mircera can be administered once every two weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA (see Table 1). The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the total weekly ESA dose at the time of conversion.
Table1: Mircera Starting Doses for Adult Patients Currently Receiving an ESA
Previous Weekly Epoetin alfa Dose (units/week) |
Previous Weekly Darbepoetin alfa Dose (mcg/week) |
Mircera Dose |
|
Once Monthly (mcg/month) |
Once Every Two Weeks (mcg/every two weeks) |
||
Less than 8000 units |
Less than 40 mcg |
120 mcg |
60 mcg |
8000 units to 16000 units |
40 mcg to 80 mcg |
200 mcg |
100 mcg |
More than 16000 units |
More than 80 mcg |
360 mcg |
180 mcg |
For Pediatric Patients with CKD
Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD
Pre-filled syringes are not designed for administration of partial doses. Pediatric patients requiring a dose of less than 30 mcg of Mircera should not be treated with Mircera.
In patients less than 6 years of age, maintain the same route of administration as the previous ESA when switching from another ESA to Mircera.
Administer Mircera once every 4 weeks as an intravenous or subcutaneous injection to pediatric patients (ages 3 months to 17 years) whose hemoglobin level has been stabilized by treatment with an ESA. The starting dose of Mircera is calculated based on the total weekly ESA dose at the time of conversion. Refer to Table 2 for the dose of Mircera corresponding to the available commercial prefilled syringe strengths.
Table 2: Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA
Previous Weekly Epoetin Alfa or Epoetin Beta Dose (Units/Week) |
Previous Weekly Darbepoetin Alfa Dose (mcg/week) |
Mircera Dose |
Less than 1300 units |
Less than 6 mcg |
30 mcg |
1300 units to less than 2000 units |
6 mcg to less than 9 mcg |
50 mcg |
2000 units to less than 2700 units |
9 mcg to less than 12 mcg |
75 mcg |
2700 units to less than 3500 units |
12 mcg to less than 15 mcg |
100 mcg |
3500 units to less than 4200 units |
15 mcg to less than 19 mcg |
120 mcg |
4200 units to less than 5500 units |
19 mcg to less than 24 mcg |
150 mcg |
5500 units to less than 7000 units |
24 mcg to less than 31 mcg |
200 mcg |
7000 units to less than 9500 units |
31 mcg to less than 42 mcg |
250 mcg |
greater than or equal to 9500 units |
greater than or equal to 42 mcg |
360 mcg |
In patients <less than 6 years of age, maintain the same route of administration as the previous ESA when switching from another ESA to Mircera.
If a dose adjustment is required to maintain the hemoglobin concentration above 10 g/dl and within the target range, refer to Table 3 for the Mircera dose adjustment based on hemoglobin response. Dose adjustments should not be made more often than once every 4 weeks.
Table 3: Mircera Dose Adjustments for Pediatric Patients
Hemoglobin Assessment |
Compared with the Previous Mircera Dose |
Hb decreases by more than 1.0 g/dL compared with baseline Hb |
Increase dose by approximately 25% to the closest dose achievable with the prefilled syringes |
Hb is less than 10 g/dL and greater than or equal to 9 g/dL (Hb<10.0 and ≥9.0 g/dL) |
Increase dose by approximately 25% to the closest dose achievable with the prefilled syringes |
Hb is less than 9 g/dL (Hb <9.0 g/dL) |
Increase dose by approximately 50% to the closest dose achievable with the prefilled syringes |
Hb increases by more than 1.0 g/dL compared with the baseline Hb |
Decrease dose by approximately 25% to the closest dose achievable with the prefilled syringes |
Hb is increasing and is approaching 12 g/dL or Hb is greater than or equal to 12 g/dL (Hb≥12 g/dL) |
Decrease dose by approximately 25% to the closest dose achievable with the prefilled syringes |
If Hb exceeds 12 g/dL and continues to increase following a dose reduction |
Stop doses until Hb is less than 12.0 g/dL. Resume dose at approximately 25% below previous dose to the closest dose achievable with the prefilled syringes at next scheduled dosing day. |
Preparation and Administration of Mircera
Mircera is packaged as single-dose prefilled syringes. Mircera contains no preservatives. Discard any unused portion. Do not pool unused portions from the prefilled syringes. Do not use the prefilled syringe more than once.
Always store Mircera prefilled syringes in their original cartons. Vigorous shaking or prolonged exposure to light should be avoided.
Do not mix Mircera with any parenteral solution.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish.
For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. Following administration, remove the needle from the injection site and then release the plunger to allow the needle guard to move up until the entire needle is covered.
Children and adolescents less than 17 years of age should not self-inject Mircera. Intravenous and subcutaneous administration should be performed by a healthcare professional or adult caregiver.
See “Instructions for Use” for complete instructions on the preparation and administration of Mircera. Examine each prefilled syringe for the expiration date. Do not use Mircera after the expiration date.
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