Product Information & Dosing
Important Dosing Information1
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 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.
Treatment with MIRCERA®1
MIRCERA® Treatment for all Patients with CKD
- Individualize dosing and use the lowest dose of MIRCERA® sufficient to reduce the need for RBC transfusions.
- Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events.
Monitoring and Dose Adjustment
- 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.
Preparation and Administration
- MIRCERA® is administered either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients.
- When administered subcutaneously, MIRCERA® should be injected into the abdomen, arm, or thigh. 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. How to Use the MIRCERA®Prefilled Syringe.
- 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.
MIRCERA® Treatment in Adult Patients with CKD
MIRCERA® is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis.
MIRCERA® Treatment in Adult Patients with CKD on Dialysis
- Initiate MIRCERA® treatment when the hemoglobin level is less than 10 g/dL in adult patients with CKD who are not currently treated with an ESA.
- 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 patients with CKD 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 2 weeks.
- The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic.
- Once the hemoglobin has been stabilized, MIRCERA® may be administered once monthly using a dose that is twice that of the every-2-week dose and subsequently titrated as necessary.
MIRCERA® Treatment in 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: ○ The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion, and ○ 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 patients with CKD 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 2 weeks.
- Once the hemoglobin has been stabilized, MIRCERA® may be administered once monthly using a dose that is twice that of the every-2-week dose and subsequently titrated as necessary.
Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA®
- MIRCERA® can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA.
- 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.
MIRCERA® Starting Doses for Adult Patients Currently Receiving an ESA
MIRCERA® Dosing and Administration in Pediatric Patients
ONLY administer MIRCERA® intravenously in pediatric patients.
Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA® in Pediatric Patients with CKD on Hemodialysis
- Administer MIRCERA® intravenously once every 4 weeks to pediatric patients (ages 5-17 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.
MIRCERA® Starting Doses for Pediatric Patients Currently Receiving an ESA
Product Information1
How Supplied
- MIRCERA® injection is supplied in single-dose prefilled syringes (30 mcg, 50 mcg, 75 mcg, 100 mcg, 150 mcg, or 200 mcg in 0.3 mL) together with a 27-gauge, ½-inch needle.
- MIRCERA® is available in the following pack sizes:
NDC* Numbers
Each dosage strength of MIRCERA® is designated by a unique syringe plunger color.
Storage
- Store MIRCERA® in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.
- MIRCERA® may be stored at room temperature up to 25°C (77°F) in the original carton up to 30 days. Discard after 30 days.
For more information, please see the full Prescribing Information, including Boxed WARNING, and Medication Guide (English, Español) for MIRCERA®.
References >
References
1MIRCERA® [prescribing information]. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018.