Mircera

MIRCERA- methoxy polyethylene glycol-epoetin beta injection, solution
Vifor (International) Inc.

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE

Chronic Kidney Disease [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.
Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions.

Cancer [see Warnings and Precautions (5.2)]

Mircera is not indicated and is not recommended for the treatment of anemia due to cancer chemotherapy. A dose-ranging study of Mircera was terminated early because of more deaths among patients receiving Mircera than another ESA.
ESAs have shown 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.

1 INDICATIONS AND USAGE

1.1 Anemia Due to Chronic Kidney Disease

Mircera is indicated for the treatment of anemia associated with chronic kidney disease (CKD) in:

• adult patients on dialysis and adult patients not on dialysis.

pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA.

Limitations of Use

Mircera is not indicated and is not recommended:

In the treatment of anemia due to cancer chemotherapy [see Warnings and Precautions (5.2)].
As a substitute for RBC transfusions in patients who require immediate correction of anemia [see Clinical Pharmacology (12.2)].

Mircera has not been shown to improve symptoms, physical functioning, or health-related quality of life.

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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 as a single intravenous or subcutaneous injection once every two weeks. 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 0.6 mcg/kg body weight administered as a single intravenous or subcutaneous injection once every two weeks.
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

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

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