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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

Dose

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

start dose

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

NDC

Each dosage strength of MIRCERA® is designated by a unique syringe plunger color.

Syringe spred

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 >

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References

1MIRCERA® [prescribing information]. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018.

IMPORTANT SAFETY INFORMATION

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

CHRONIC KIDNEY DISEASE:

  • 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:

  • 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 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.

CONTRAINDICATIONS

MIRCERA® is contraindicated in patients with:

  • Uncontrolled hypertension
  • Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs
  • History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria).

INCREASED MORTALITY, MYOCARDIAL INFARCTION, STROKE, AND THROMBOEMBOLISM

  • In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 to 14 g/dL) to lower targets (9 to 11.3 g/dL), ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups.
  • Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Use caution in patients with coexistent cardiovascular disease and stroke. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks.
  • In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. These adverse reactions included myocardial infarction and stroke.
  • In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.

INCREASED MORTALITY AND/OR INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE IN PATIENTS WITH CANCER

  • MIRCERA® is not indicated and is not recommended for use in the treatment of anemia due to cancer chemotherapy. A dose-ranging trial of MIRCERA® in 153 patients who were undergoing chemotherapy for non-small cell lung cancer was terminated prematurely because more deaths occurred among patients receiving
  • MIRCERA® than another ESA. ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. These findings were observed in studies of patients with advanced head and neck cancer receiving radiation therapy, in patients receiving chemotherapy for metastatic breast cancer or lymphoid malignancy, and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy.

HYPERTENSION

  • MIRCERA® is contraindicated in patients with uncontrolled hypertension.
  • In MIRCERA® clinical studies, approximately 27% of patients with CKD, including patients on dialysis and patients not on dialysis, required intensification of antihypertensive therapy. Hypertensive encephalopathy and/or seizures have been observed in patients with CKD treated with MIRCERA®.
  • Appropriately control hypertension prior to initiation of and during treatment with MIRCERA®. Reduce or withhold MIRCERA® if blood pressure becomes difficult to control. Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions.

SEIZURES

  • Seizures have occurred in patients participating in MIRCERA® clinical studies. During the first several months following initiation of MIRCERA®, monitor patients closely for premonitory neurologic symptoms. Advise patients to contact their healthcare practitioner for new-onset seizures, premonitory symptoms, or change in seizure frequency.

LACK OR LOSS OF HEMOGLOBIN RESPONSE TO MIRCERA®

  • For lack or loss of hemoglobin response to MIRCERA®, initiate a search for causative factors (e.g., iron deficiency, infection, inflammation, bleeding).
  • If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient response to MIRCERA® therapy.

PURE RED CELL APLASIA (PRCA)

  • Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in the postmarketing setting in patients treated with MIRCERA®. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. PRCA was not observed in clinical studies of MIRCERA®.
  • PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which MIRCERA® is not approved).
  • If severe anemia and low reticulocyte count develop during treatment with MIRCERA®, withhold MIRCERA® and evaluate patients for neutralizing antibodies to erythropoietin. Serum samples should be obtained at least a month after the last MIRCERA® administration to prevent interference of MIRCERA® with the assay. Contact Vifor at 1-800-576-8295 to perform assays for binding and neutralizing antibodies. Permanently discontinue MIRCERA® in patients who develop PRCA following treatment with MIRCERA® or other erythropoietin protein drugs. Do not switch patients to other ESAs as antibodies may cross-react.

SERIOUS ALLERGIC REACTIONS

  • Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including MIRCERA®) in the postmarketing setting. Discontinue MIRCERA® therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.

SEVERE CUTANEOUS REACTIONS

  • Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including MIRCERA®) in the postmarketing setting. Discontinue MIRCERA® therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.

DIALYSIS MANAGEMENT

  • Patients may require adjustments in their dialysis prescription after initiation of MIRCERA®. Patients receiving MIRCERA® may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.

ADVERSE EVENTS IN PATIENTS WITH CHRONIC KIDNEY DISEASE

  • Most frequent adverse reactions (≥5%) in adult patients with CKD treated with MIRCERA® were hypertension, diarrhea, nasopharyngitis, upper respiratory tract infection, headache, muscle spasms, procedural hypotension, fluid overload, vomiting, back pain, cough, hypotension, constipation, urinary tract infection, pain in extremity, arteriovenous fistula thrombosis, arteriovenous fistula site complication.
  • In pediatric patients on hemodialysis, all reported adverse reactions regardless of causality (more than 5% incidence) were headache, nasopharyngitis, hypertension, vomiting, bronchitis, abdominal pain, arteriovenous fistula thrombosis, cough, device related infection, hyperkalemia, pharyngitis, pyrexia, thrombocytopenia, and thrombosis in device.

INDICATIONS AND LIMITATIONS OF USE

  • 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, and 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.
  • MIRCERA® is not indicated and is not recommended for use in the treatment of anemia due to cancer chemotherapy, or as a substitute for RBC transfusions in patients who require immediate correction of anemia.
  • MIRCERA® has not been shown to improve quality of life, fatigue, or patient well-being.

Please see full Prescribing Information including Boxed WARNING, and Medication Guide (English, Español) for MIRCERA® (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use.