Mircera solution for injection in pre-filled syringe – methoxy polyethylene glycol-epoetin beta for anaemia in chronic kidney disease

Mircera contains methoxy polyethylene glycol-epoetin beta, a medicine made by gene technology which, like the natural hormone erythropoietin, stimulates the production of red blood cells and raises haemoglobin. It is used for anaemia caused by chronic kidney disease, with tiredness, weakness and shortness of breath.

In Serbia it is authorised as Mircera®, solution for injection in pre-filled syringe, in strengths of 30, 50, 75 and 120 micrograms/0.3 ml (Roche). It is used in inpatient healthcare facilities and may exceptionally be dispensed on prescription to continue treatment at home.

What is Mircera used for and how is it given?

Key facts about the medicine

What is Mircera used for?

According to the package leaflet, Mircera is indicated for the treatment of symptomatic anaemia caused by chronic kidney disease in adults, and in paediatric patients aged 3 months to less than 18 years receiving maintenance therapy with erythropoiesis-stimulating agents after their haemoglobin has been stabilised with a previous medicine of this group.

Safety and efficacy in other indications, including anaemia in patients with cancer, have not been established.

How is it given and dosed?

Treatment is started under medical supervision; the doctor gives the lowest dose that controls the symptoms of anaemia and regularly monitors haemoglobin. It is injected under the skin (abdomen, upper arm, thigh) or into a vein. According to the leaflet:

• The dose is not changed more often than once a month.
• After training, adult patients may inject themselves following the instructions for use of the pre-filled syringe; children and adolescents must not inject themselves.
• The syringe is not designed for partial doses; use only a clear solution without particles.

Special patient groups

• Chronic kidney disease with poor response: multiple dose increases may raise the risk of heart attack and stroke – the doctor reviews the dose and looks for other causes of anaemia.
• Iron: the doctor checks iron before and during treatment and prescribes additional therapy if needed.
• Patients with cancer: erythropoiesis-stimulating agents may have a negative effect – talk to your doctor.
• Hepatitis C with interferon and ribavirin: loss of effect and PRCA have rarely been reported – inform your doctor.

Contraindications – when the medicine must not be used

Mircera must not be used if:

• you are allergic to methoxy polyethylene glycol-epoetin beta or any excipient;
• you have high blood pressure that cannot be controlled;
• the doctor suspects or has confirmed anti-erythropoietin antibodies (pure red cell aplasia – PRCA).

Warnings and precautions

The doctor will start treatment if haemoglobin is 10 g/dl or lower and then keep it between 10 and 12 g/dl, as too high a haemoglobin increases the risk of thrombosis, pulmonary embolism, heart attack and stroke. Blood pressure is checked before and during treatment; if it is high and cannot be corrected, the medicine is paused or the dose reduced.

Tell your doctor if you feel tired, weak or short of breath – treatment may not be effective. Caution is needed with haemoglobinopathies, bleeding, seizures and raised platelet counts. Healthy people must not use the medicine – misuse can lead to dangerous heart and blood vessel problems.

Interactions with other medicines, food and drink

No interaction studies have been performed and there is no evidence of interactions between Mircera and other medicines. Nevertheless, tell your doctor about all medicines you take. Food and drink do not affect the medicine.

Pregnancy and breast-feeding

• Pregnancy: the medicine has not been studied in pregnant women – the doctor will decide on the best treatment.
• Breast-feeding: it has not been studied in breast-feeding women; the doctor will advise whether to continue breast-feeding or treatment.
• Fertility: no effect on fertility was shown in animals; the potential risk for humans is unknown.

Driving and using machines

Mircera does not affect the ability to drive or use machines.

Possible side effects

• Common (up to 1 in 10): hypertension (high blood pressure).
• Uncommon (up to 1 in 100): headache, thrombosis at the dialysis vascular access site, low platelet count, thrombosis.
• Rare (up to 1 in 1,000): hypertensive encephalopathy (very high blood pressure with sudden throbbing headache, confusion, speech disturbance or seizures), pulmonary embolism, maculopapular rash, hot flushes, hypersensitivity.
• Reported with epoetins: anaphylactic reaction and severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis); PRCA due to anti-erythropoietin antibodies.

Report any suspected side effect to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: inform your doctor or pharmacist immediately – blood tests and a temporary pause in treatment may be needed.
• Missed dose: give it as soon as you remember and agree with your doctor when to give the next one.
• Stopping treatment: treatment is usually long-term; it is stopped only on your doctor’s advice.

Composition, pack and manufacturer

• Active substance: methoxy polyethylene glycol-epoetin beta – 30, 50, 75 or 120 micrograms per pre-filled syringe (0.3 ml).
• Excipients: sodium dihydrogen phosphate monohydrate; sodium sulfate; mannitol (E421); methionine; poloxamer 188; water for injections. Less than 1 mmol (23 mg) sodium per ml.
• Pack: 1 pre-filled glass syringe (0.3 ml) in a plastic tray and a separate 27G½ needle; alcohol swabs, sterile cotton/gauze and a sharps container are not included.
• Marketing authorisation holder: Roche d.o.o. Belgrade, Vladimira Popovića 8a, Belgrade – Novi Beograd; manufacturer: Roche Diagnostics GmbH, Sandhofer Strasse 116, Mannheim, Germany.

Storage

• Store in a refrigerator (2–8 °C); do not freeze; keep the syringe in the outer carton to protect from light.
• The patient may remove the medicine from the fridge once and store it at room temperature up to 30 °C for no more than one month; it must then not be returned to the fridge and must be used within that period.
• Keep out of the sight and reach of children; do not use after the expiry date.

Frequently asked questions

Can I inject Mircera myself at home?

Yes, if you are an adult and have been trained – treatment is started under medical supervision, and later injections may be given by a healthcare professional or by the patient following the syringe instructions. Children and adolescents must not inject themselves.

How often is Mircera given?

Depending on the situation, once every two weeks or once a month. The dose is based on body weight and haemoglobin and is not changed more often than once a month.

Why does the doctor monitor blood pressure and haemoglobin?

High blood pressure is the most common side effect, and too high a haemoglobin increases the risk of thrombosis, heart attack and stroke. Haemoglobin is therefore kept between 10 and 12 g/dl, and with uncontrolled blood pressure the medicine is paused or the dose reduced.

How long can Mircera be kept out of the fridge?

Once, for no more than one month at up to 30 °C. During this period it must not be returned to the fridge and must be used.

Sources

• ALIMS – Summary of Product Characteristics Mircera® 30 micrograms/0.3 ml (SmPC, Serbian)
• ALIMS – Package leaflet Mircera® 30/50/75/120 micrograms/0.3 ml (PIL, 30 mcg authorisation, Serbian)
• ALIMS – SmPC Mircera® 50 micrograms/0.3 ml (Serbian)
• ALIMS – PIL Mircera® (50 mcg authorisation, Serbian)
• ALIMS – SmPC Mircera® 75 micrograms/0.3 ml (Serbian)
• ALIMS – PIL Mircera® (75 mcg authorisation, Serbian)
• ALIMS – SmPC Mircera® 120 micrograms/0.3 ml (Serbian)
• ALIMS – PIL Mircera® (120 mcg authorisation, Serbian)

Date sources checked: 25.10.2026.