Mircera Injection
Methoxy Polyethyelene Glycol-Epoetin Beta
50mcg
ROCHE Pharma
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Retail Price | 10962.35 NPR |
Available as:
Indications
Mircera Injection is used for:
Anaemia associated with chronic kidney disease
Adult Dose
Patients with chronic renal failure on dialysis
Initiate treatment when hemoglobin level < 10 g/dL
If hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt dose
Dose if not currently on ESA therapy: 0.6 mcg/kg IV/SC q2week initially
Once hemoglobin has been stabilized, dose may be administered once monthly using a dose that is twice that of every-two-week dose and subsequently titrated as necessary
Patients with chronic renal failure not on dialysis
Consider initiating treatment only when hemoglobin level is < 10 g/dL and the following considerations apply. Rate of hemoglobin decline indicates likelihood of requiring a RBC transfusion and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal
If hemoglobin level >10 g/dL, reduce or interrupt dose, and use lowest dose sufficient to reduce need for RBC transfusions
Dose if not currently on ESA therapy: 0.6 mcg/kg IV/SC q2week initially
Once 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
Switching Patients Currently on Other ESA
Receiving epoetin <8000 units/week or darbepoetin <40 mcg/week: 120 mcg/qmonth or 60 mcg/q2week IV/SC
Receiving epoetin 8000-16000 units/week or darbepoetin 40-80 mcg/week: 200 mcg/qmonth or 100 mcg/q2week IV/SC
Receiving epoetin >16000 units/week or darbepoetin >80 mcg/week: 360 mcg/qmonth or 180 mcg/q2week IV/SC
Anemia Associated with Chronic Renal Failure
Do not increase dose more frequently than q4weeks; decreases in dose can occur more frequently; avoid frequent dose adjustments
If hemoglobin rises rapidly (e.g., > 1 g/dL in any 2-week period), reduce dose by 25% or more as needed to reduce rapid responses
For patients who do not respond adequately, if hemoglobin has not increased by >1 g/dL after 4 weeks of therapy, increase dose by 25%
For patients who do not respond adequately over a 12-week escalation period, increasing dose further is unlikely to improve response and may increase risks; use lowest dose that will maintain a hemoglobin level sufficient to reduce need for RBC transfusions; evaluate other causes of anemia; discontinue if responsiveness does not improve
Dose Adjustment
Dose adjustments should NOT be >qMonth
Child Dose
Safety & efficacy not established
Renal Dose
Administration
IV route is recommended for patients receiving hemodialysis because IV route may be less immunogenic
SC: inject in abdomen, arm or thigh
Contra Indications
Hypersensitivity. Uncontrolled HTN.
Precautions
Discontinue if pure red cell aplasia. Adequate control of BP. Hemoglobinopathies, seizures, platelet level >500 x 109/L. Patients <18 yr.
Lactation: not known if excreted in breast milk, use caution
Pregnancy-Lactation
Interactions
No interaction studies have been performed. There is no evidence that Mircera alters the metabolism of other medicinal products.
Adverse Effects
Side effects of Methoxy Polyethyelene Glycol-Epoetin Beta :
>10%
Hypertension (13%),Diarrhea (11%),Nasopharyngitis (11%)
1-10%
Headache (9%),Upper respiratory tract infection (9%),Cough (6%),Hypotension (5%),Urinary tract infection (5%),Procedural arteriovenous fistula thrombosis (5%)
Frequency Not Defined
Coronary artery disease,Anemia,Septic shock,Serious cardiovascular and thromboembolic events,Seizures,Immunogenicity related PRCA,Increased mortality and/or tumor progression in cancer patients,Increased mortality,Concomitant termination of other CRF therapy,Stevens-Johnson syndrome,Toxic epidermal necrolysis
Mechanism of Action
Methoxy Polyethyelene Glycol-Epoetin Beta is an erythropoietin receptor activator w/ greater activity as well as increased half-life, in contrast to erythropoietin.
Note
Mircera 50mcg Injection manufactured by ROCHE Pharma. Its generic name is Methoxy Polyethyelene Glycol-Epoetin Beta. Mircera is availble in Nepal.
Farmaco Nepal drug index information on Mircera Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.