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 Oct 12, 2023.

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 [see Warnings and Precautions (5.9)]. 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.

Patients with Chronic Kidney Disease

Individualize dosing and use the lowest dose of Mircera sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. 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. 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 [see Boxed Warning and Clinical Studies (14)].

For all patients with CKD:

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.

•: Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
•: If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Mircera by 25% or more as needed to reduce rapid responses.
•: 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 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.

Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh.

For Adult Patients with CKD on dialysis:

•: Initiate Mircera treatment when the hemoglobin level is less than 10 g/dL.
•: If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Mircera.
•: 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 [see Adverse Reactions (6.2)].
•: 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:

•

Consider initiating Mircera treatment only when the hemoglobin level is less than 10 g/dL and the following considerations apply:

o: The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and,
o: Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.

•

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.

•

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.

•

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 [see Patient Counseling Information (17)].

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.

Table 1 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
Previous Weekly Epoetin alfa Dose (units/week)	Previous Weekly Darbepoetin alfa Dose (mcg/week)	Once Monthly (mcg/month)	Once Every Two Weeks (mcg/every two weeks)
less than 8000	less than 40	120	60
8000 to 16000	40 to 80	200	100
more than 16000	more than 80	360	180

For Pediatric Patients with CKD on hemodialysis:

Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis

Administer Mircera intravenously once every 4 weeks to pediatric patients (ages 5 to 17 years) whose hemoglobin level has been stabilized by treatment with an ESA. Administer Mircera as an intravenous injection at the dose (in micrograms) based on the total weekly ESA dose at the time of conversion (see Table 2).

Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA
Epoetin alfa	Darbepoetin alfa
4 x previous weekly epoetin alfa dose (Units)/125 e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks	4 x previous weekly darbepoetin alfa dose (mcg)/0.55 e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks

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.

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.