Medicine overview
Indications of Mircera 50 µg
Mircera 50 µg is indicated for the treatment of anaemia associated with chronic kidney disease in adult patients.
Theropeutic Class
Drugs for Haemolytic Hypoplastic & Renal Anemia
Pharmacology
Mircera 50 µg is an erythropoietin receptor activator with greater activity as well as increased half-life, in contrast to erythropoietin. Mircera 50 µg stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Mircera 50 µg interacts with erythropoietin receptors on the surface of erythroid progenitor cells in the bone marrow, stimulating red blood cell production. Mircera 50 µg has a longer half-life than other erythropoiesis-stimulating agents, allowing for less frequent dosing while maintaining effective haemoglobin levels in patients with chronic kidney disease.
Dosage & Administration of Mircera 50 µg
Anemia Associated with Chronic Renal Failure:
Do not increase dose more frequently than every 4 weeks. If hemoglobin rises rapidly (>1 g/dL in any 2-week period), reduce dose by 25% or more. For patients who do not respond adequately, if hemoglobin has not increased by >1 g/dL after 4 weeks, increase dose by 25%. If no response over 12-week escalation, increasing Mircera 50 µg dose further is unlikely to improve response — use lowest effective dose and discontinue Mircera 50 µg if responsiveness does not improve.
Patients with Chronic Renal Failure on Dialysis:
Initiate Mircera 50 µg when hemoglobin < 10 g/dL. Reduce or interrupt if hemoglobin approaches 11 g/dL. Initial dose: 0.6 mcg/kg IV/SC q2 weeks. Once stabilized, may administer once monthly at twice the every-two-week dose.
Patients with Chronic Renal Failure not on Dialysis:
Consider initiating only when hemoglobin < 10 g/dL; reduce or interrupt if >10 g/dL. Initial dose: 0.6 mcg/kg IV/SC q2 weeks. Once stabilized, may administer once monthly.
Switching from Other ESA:
Epoetin 8000-16000 units/week or darbepoetin 40-80 mcg/week → 200 mcg/month or 100 mcg/q2week IV/SC.Epoetin >16000 units/week or darbepoetin >80 mcg/week → 360 mcg/month or 180 mcg/q2week IV/SC.
Interaction of Mircera 50 µg
No interaction studies have been performed. There is no evidence that Mircera 50 µg alters the metabolism of other medicinal products.
Contraindications
Mircera 50 µg is contraindicated in patients with known hypersensitivity to the active substance or any of the excipients. Mircera 50 µg is also contraindicated in patients with uncontrolled hypertension
Side Effects of Mircera 50 µg
Hypertension (13%), Diarrhea (11%), Nasopharyngitis (11%), Headache (9%), Upper respiratory tract infection (9%), Cough (6%), Hypotension (5%), Urinary tract infection (5%), Procedural arteriovenous fistula thrombosis (5%), 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
Pregnancy & Lactation
Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of Mircera 50 µg in pregnant women despite potential risks. It is not known whether Mircera 50 µg is excreted in breast milk; use caution when administering Mircera 50 µg to a nursing woman.
Precautions & Warnings
Discontinue Mircera 50 µg if pure red cell aplasia develops. Adequate control of blood pressure must be maintained during Mircera 50 µg therapy. Use with caution in patients with hemoglobinopathies, history of seizures, or platelet level >500 × 10⁹/L. Mircera 50 µg has not been studied in patients under 18 years of age.
Storage Conditions
Store Mircera 50 µg in a refrigerator between 2°C to 8°C. Do not freeze. Keep Mircera 50 µg in the original carton to protect from light. Keep out of the reach of children.
Drug Classes
Erythropoiesis-Stimulating Agents (ESA).
Mode Of Action
Mircera 50 µg acts as an erythropoietin receptor activator. Mircera 50 µg binds to and activates the erythropoietin receptor on erythroid progenitor cells in the bone marrow, stimulating red blood cell production. Due to its pegylation with methoxy polyethylene glycol, Mircera 50 µg has a longer circulating half-life compared to other erythropoiesis-stimulating agents, allowing for less frequent administration.
Pediatric Uses
The safety and effectiveness of Mircera 50 µg in pediatric patients under 18 years of age have not been established. Mircera 50 µg should be used with extreme caution in pediatric patients and only when the potential benefit justifies the potential risk.
Frequently Asked Questions
What is Mircera 50 µg used for?
Mircera 50 µg is indicated for the treatment of anaemia associated with chronic kidney disease in adult patients.
What is the dosage of Mircera 50 µg?
Anemia Associated with Chronic Renal Failure: Do not increase dose more frequently than every 4 weeks. If hemoglobin rises rapidly (>1 g/dL in any 2-week period), reduce dose by 25% or more. For patients who do not respond adequately, if hemoglobin has not increased by >1 g/dL after 4 weeks, increase dose by 25%. If no response over 12-week escalation, increasing Mircera 50 µg dose further is unli…
What are the side effects of Mircera 50 µg?
Hypertension (13%), Diarrhea (11%), Nasopharyngitis (11%), Headache (9%), Upper respiratory tract infection (9%), Cough (6%), Hypotension (5%), Urinary tract infection (5%), Procedural arteriovenous fistula thrombosis (5%), Coronary artery disease, Anemia, Septic shock, Serious cardiovascular and thromboembolic events, Seizures, Immunogenicity related PRCA, Increased mortality and/or tumor progres…
Who should not take Mircera 50 µg?
Mircera 50 µg is contraindicated in patients with known hypersensitivity to the active substance or any of the excipients. Mircera 50 µg is also contraindicated in patients with uncontrolled hypertension
What precautions should be taken with Mircera 50 µg?
Discontinue Mircera 50 µg if pure red cell aplasia develops. Adequate control of blood pressure must be maintained during Mircera 50 µg therapy. Use with caution in patients with hemoglobinopathies, history of seizures, or platelet level >500 × 10⁹/L. Mircera 50 µg has not been studied in patients under 18 years of age.
Is Mircera 50 µg safe during pregnancy and breastfeeding?
Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of Mircera 50 µg in pregnant women despite potential risks. It is not known whether Mircera 50 µg is excreted in breast milk; use caution when administering Mircera 50 µg to a nursing woman.
The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.