Mircera 250 ug/.3mL
Methoxy polyethylene glycol-epoetin beta · INJECTION, SOLUTION · Vifor (International) Inc.
Mircera is a injection, solution containing methoxy polyethylene glycol-epoetin beta at 250 ug/.3mL, taken intravenous. Manufactured by Vifor (International) Inc..
Key Facts
- Brand Name
- Mircera
- Generic Name
- Methoxy polyethylene glycol-epoetin beta
- NDC Code (Product)
59353-406- Manufacturer
- Vifor (International) Inc.
- Strength
- 250 ug/.3mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA125164
- Marketing Start
- 10/24/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Mircera is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: • adult patients on dialysis and adult patients not on dialysis ( 1.1 ). • pediatric patients 3 months to 17 years of age on dialysis or not on dialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA ( 1.1 ). Limitations of Use Mircera is not indicated and is not recommended for use: • In the treatment of anemia due to cancer chemotherapy ( 5.2 ). • As a substitute for RBC transfusions in patients who require immediate correction of anemia ( 12.2 ). Mircera has not been shown to improve quality of life, fatigue, or patient well-being. 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 3 months to 17 years of age on dialysis or not on dialysis 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 …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Mircera is administered by subcutaneous or intravenous injection ( 2.2 ). Adult Patients • Initial Treatment: (patients not currently treated with an ESA): • CKD patients on dialysis: 0.6 mcg/kg body weight administered once every two weeks ( 2.2 ). • CKD patients not on dialysis: 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 ( 2.2 ). • Conversion from Another ESA: • Dosed once monthly or once every two weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion ( 2.2 ). Pediatric Patients • Conversion from another ESA: dosed once every 4 weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion ( 2.2 ). • 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. 2.1 Important Dosing Information Evaluation of Iron Stores and Nutritional Factors Evaluate the iron status in all patients before and during treatment. Administer s…
Contraindications
4 CONTRAINDICATIONS Mircera is contraindicated in patients with: • Uncontrolled hypertension [see Warnings and Precautions ( 5.3 )] • Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs [see Warnings and Precautions ( 5.6 )] • History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria) [see Warnings and Precautions ( 5.7 , 5.8 )] . • Uncontrolled hypertension ( 4 ). • Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs ( 4 ). • History of serious allergic reactions to Mircera, including anaphylaxis ( 4 ).
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see Warnings and Precautions ( 5.1 )] • Increased Mortality and/or Tumor Progression in Patients with Cancer [see Warnings and Precautions ( 5.2 )] • Hypertension [see Warnings and Precautions ( 5.3 )] • Seizures [see Warnings and Precautions ( 5.4 )] • Pure Red Cell Aplasia [see Warnings and Precautions ( 5.6 )] • Serious Allergic Reactions [see Warnings and Precautions ( 5.7 )] • Severe Cutaneous Reactions [see Warnings and Precautions ( 5.8 )] The most common adverse reactions (≥ 10%) are hypertension, diarrhea, nasopharyngitis ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Vifor (International) Inc. at 1-800-576-8295, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of Mircera cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. Adult Patients…
Frequently Asked Questions
What is Mircera used for?
Mircera contains Methoxy polyethylene glycol-epoetin beta. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Mircera a controlled substance?
Mircera is not classified as a controlled substance by the DEA.
What is the generic name for Mircera?
The generic name for Mircera is Methoxy polyethylene glycol-epoetin beta. There are no other listed brand versions of Methoxy polyethylene glycol-epoetin beta.
What is the NDC code for Mircera 250 ug/.3mL?
The NDC (National Drug Code) for Mircera 250 ug/.3mL is 59353-406, listed by Vifor (International) Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)