Mircera
Rx0.3 ml • IV/SC Injection
Indications & Uses
Mircera is indicated for:
Pharmacology
Methoxy polyethylene glycol-epoetin beta is a chemically synthesized continuous erythropoietin receptor activator. It differs from erythropoietin because an amide bond is built in between methoxy polyethylene glycol butanoic acid and either the N-terminal amino group or the ε amino group of lysine, mainly Lys52 and Lys45. The result is a molecule of approximately 60,000 daltons, and the PEG part of it is approximately 30,000 daltons.
Compared with erythropoietin, methoxy polyethylene glycol-epoetin beta behaves differently at the receptor. It attaches more slowly and comes off faster. Its specific activity is lower in vitro but higher in vivo, and its half-life is longer. These properties are what make a once monthly dosing regimen possible in patients.
Methoxy polyethylene glycol-epoetin beta stimulates erythropoiesis by acting on the erythropoietin receptor on progenitor cells in the bone marrow. The natural hormone erythropoietin is the primary growth factor for erythroid development. The kidney produces it and releases it into the bloodstream in response to hypoxia. When hypoxia occurs, the hormone interacts with erythroid progenitor cells to increase red cell production.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Methoxy Polyethylene Glycol-Epoetin Beta is given less often than other erythropoiesis stimulating agents (ESAs), because it stays in the body longer (its elimination half-life is longer). Treatment must be started under the supervision of a healthcare professional.
Treatment of anemic patients with chronic kidney disease: the solution can be given subcutaneously (s.c.) or intravenously (i.v.), depending on clinical preference. For a subcutaneous injection you can use the abdomen, arm or thigh. All three sites are equally suitable. Hemoglobin should be checked every two weeks until it is stable, and then periodically.
Patients not currently treated with an Erythropoiesis Stimulating Agent: for patients not on dialysis, the aim is to raise hemoglobin to greater than 11 g/dl (6.83 mmol/L). The recommended starting dose is 1.2 microgram/kg body weight once every month as a single subcutaneous injection. Another option is a starting dose of 0.6 microgram/kg body weight once every two weeks as a single IV or SC injection. For patients on dialysis, with the same aim of greater than 11 g/dl (6.83 mmol/L), the recommended starting dose is 0.6 microgram/kg body weight once every two weeks as a single IV or SC injection.
The dose may be increased by approximately 25 to 50% of the previous dose if hemoglobin rises by less than 1.0 g/dl (0.621mmol/l) over a month. Further increases of approximately 25 to 50% can be made at monthly intervals until the individual target hemoglobin level is reached. If hemoglobin rises by more than 2 g/dl (1.24 mmol/l) in one month, the dose is to be reduced by approximately 25 to 50%. If hemoglobin goes above 13 g/dl (8.07 mmol/l), therapy is to be interrupted until the level falls below 13 g/dl, and then restarted at approximately 50% of the dose given before. In regions where the upper limit of hemoglobin has been set at 12 g/dl, dose adjustments of 25% should be considered. After a dose interruption, hemoglobin is expected to fall by approximately 0.35 g/dl per week.
Patients treated once every two weeks whose hemoglobin is above 11 g/dl (6.83 mmol/l) may be given Methoxy Polyethylene Glycol-Epoetin Beta once monthly, using a dose equal to twice the previous once every two weeks dose. Doses should not be adjusted more often than once a month.
Patients currently treated with an Erythropoiesis Stimulating Agent: patients on an ESA can be switched to this medicine once a month or, if wanted, once every two weeks, as a single i.v. or s.c. injection. The starting dose depends on the weekly dose of darbepoetin alfa or epoetin the patient was receiving at the time of the switch, as set out in Tables 1 and 2 below. The first injection should be given at the next scheduled dose of the darbepoetin alfa or epoetin the patient was using before.
Side Effects
Methoxy Polyethylene Glycol-Epoetin Beta can cause hypertension, vascular access thrombosis, headache and hypersensitivity. Hypertensive encephalopathy can also occur. A rash is possible too, either maculo-papular or serious.
Cautions & Contraindications
Warnings & Precautions
Patients with serum ferritin below 100 µg/l, or transferrin saturation below 20%, should be given supplementary iron therapy. Iron status needs to be checked in every patient before treatment and during it, so that erythropoiesis works effectively. Lack of effect The most common reasons for an incomplete response to ESAs are iron deficiency and inflammatory disorders. Other conditions can also weaken the effect of ESA therapy: chronic blood loss, bone marrow fibrosis, severe aluminium overload from the treatment of renal failure, folic acid or vitamin B12 deficiencies, and hemolysis. If all of these have been excluded and the patient has a sudden drop of hemoglobin along with reticulocytopenia and anti erythropoietin antibodies, the doctor should consider examining the bone marrow to diagnose Pure Red Cell Aplasia (PRCA). If PRCA is diagnosed, therapy with MIRCERA must be stopped, and the patient should not be switched to another ESA. PRCA PRCA caused by anti-erythropoietin antibodies has been reported with ESAs, including MIRCERA. These antibodies have been shown to cross-react with all ESAs. So patients who are suspected or confirmed to have antibodies to erythropoietin should not be switched to MIRCERA. Blood pressure monitoring As with other ESAs, blood pressure may rise while anemia is being treated with MIRCERA. It should be properly controlled before treatment, when treatment starts, and throughout. If high blood pressure is hard to control with medicines or dietary measures, the dose of MIRCERA must be reduced or withheld.
Contraindications
Methoxy Polyethylene Glycol-Epoetin Beta must not be given to patients who have uncontrolled hypertension. It also must not be given to anyone with a known hypersensitivity to the active substance or to any of the excipients.
Pregnancy & Breastfeeding
Pregnancy: There isn't enough data on the use of Methoxy Polyethylene Glycol-Epoetin Beta in pregnant women. Animal studies don't point to any direct or indirect harmful effects on pregnancy, on the development of the embryo or fetus, on childbirth, or on development after birth. Even so, take care when prescribing this preparation to pregnant women.
Nursing Mothers: No one knows whether methoxy polyethylene glycol-epoetin beta passes into human breast milk. One animal study did show that it passes into the mother's milk. Whether to continue or stop breast-feeding, or to continue or stop therapy with this preparation, should be decided by weighing two things: the benefit of breast-feeding to the child and the benefit of the therapy to the woman.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Methoxy Polyethylene Glycol-Epoetin Beta is not recommended for patients under 18 years of age, because there isn't enough data on its safety and efficacy in this group.
Elderly: patients aged 65 years or older don't need any change to the starting dose.
Hepatic impairment: the starting dose doesn't need adjusting, and no dose modification rules apply, in patients with any degree of hepatic impairment.
Overdose
Methoxy Polyethylene Glycol-Epoetin Beta has a wide therapeutic range, but each person responds differently, so this has to be considered when treatment is started. An overdose can cause an exaggerated pharmacodynamic effect, such as excessive erythropoiesis. If the haemoglobin level becomes too high, Methoxy Polyethylene Glycol-Epoetin Beta should be withheld for the time being. Phlebotomy may be performed if it is clinically indicated.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Don't use this medicine after the expiry date (EXP) printed on the pack. Keep it in the refrigerator at 2°C to 8°C, and leave the pre-filled syringe in its outer carton so the light can't reach it. Do not freeze it.
The patient may take the medicine out of the refrigerator and keep it at room temperature (not above 30°C), but only for one single period of 1 month. Once it has been taken out of the refrigerator, it must be used within that period.
Drug Interactions
Common questions about Mircera 0.3 ml
What is Mircera 0.3 ml IV/SC Injection?
Mircera 0.3 ml IV/SC Injection is a medicine that contains Methoxy Polyethylene Glycol-Epoetin Beta. It is made by Radiant Pharmaceuticals Ltd. It belongs to the Drugs for Haemolytic Hypoplastic & Renal Anemia group of medicines.
What is Mircera used for?
Mircera is used for: Anemia.
What are the side effects of Mircera?
Methoxy Polyethylene Glycol-Epoetin Beta can cause hypertension, vascular access thrombosis, headache and hypersensitivity. Hypertensive encephalopathy can also occur.
Can I take Mircera during pregnancy or while breastfeeding?
Pregnancy: There isn't enough data on the use of Methoxy Polyethylene Glycol-Epoetin Beta in pregnant women. Animal studies don't point to any direct or indirect harmful effects on pregnancy, on the development of the embryo or fetus, on childbirth, or on development after birth. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Mircera?
Methoxy Polyethylene Glycol-Epoetin Beta has a wide therapeutic range, but each person responds differently, so this has to be considered when treatment is started. An overdose can cause an exaggerated pharmacodynamic effect, such as excessive erythropoiesis. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Mircera?
Don't use this medicine after the expiry date (EXP) printed on the pack. Keep it in the refrigerator at 2°C to 8°C, and leave the pre-filled syringe in its outer carton so the light can't reach it.
Can I take other medicines with Mircera?
Some medicines can interact with Methoxy Polyethylene Glycol-Epoetin Beta, for example: Polyethylene Glycol. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Mircera?
Mircera is a prescription (Rx) medicine. Take it as your doctor advises.