Mircera 100 micrograms/0.3ml Solution for Injection

Mircera 100 micrograms/0.3ml Solution for Injection contains methoxy polyethylene glycol-epoetin beta 100 micrograms/0.3ml, a long-acting erythropoiesis-stimulating agent (ESA) given by injection to treat anaemia (low red blood cell count) associated with chronic kidney disease, in both dialysis and non-dialysis patients. It is a specialist biologic medicine used only under nephrology supervision.

Methoxy polyethylene glycol-epoetin beta acts on the same erythropoietin receptors as the body’s natural erythropoietin hormone, which is normally produced by the kidneys, stimulating the bone marrow to produce more red blood cells. Its pegylated (polyethylene glycol-attached) structure gives it a long, continuous receptor-activating effect, allowing much less frequent dosing than older erythropoietin medicines.

Methoxy polyethylene glycol-epoetin beta binds to and continuously activates erythropoietin receptors on red blood cell precursor cells in the bone marrow, stimulating their proliferation and maturation into mature red blood cells. The attached polyethylene glycol chain slows its clearance from the body, giving it a much longer duration of action than short-acting erythropoietin products.

Mircera 100 micrograms/0.3ml Solution for Injection is given by subcutaneous or intravenous injection by a healthcare professional, or by yourself or a caregiver only after specific training by your healthcare team on the correct injection technique. Do not shake the pre-filled syringe. Bring the syringe to room temperature before injecting if it has been refrigerated, and use a new needle and syringe for each injection as instructed.

Dosing is individualised by your nephrology specialist based on your body weight, haemoglobin level, and response to treatment, typically starting with correction-phase dosing that may later be adjusted to a maintenance dose given monthly. This medicine must never be self-initiated or have its dose self-adjusted; all dose changes are made by your treating doctor based on regular blood tests.

Use this product before the expiry date stated on the packaging. Do not use the medicine if the expiry date has passed.

Store in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled syringe in the outer carton to protect it from light, and do not shake it vigorously. This medicine must only be handled and administered under the supervision of your treating specialist or trained healthcare staff.

• High blood pressure (hypertension), which may require adjustment of your blood pressure medicines
• Headache
• Diarrhoea
• Injection site reactions or flu-like symptoms
• Serious: signs of a blood clot (leg swelling or pain, chest pain, sudden breathlessness), stroke-like symptoms, severe allergic reaction, or unusual bleeding, bruising, or profound fatigue (which may signal a rare loss of response called pure red cell aplasia) require immediate medical attention

• Known hypersensitivity to epoetin beta, methoxy polyethylene glycol-epoetin beta, or any ingredient in this product
• Uncontrolled high blood pressure
• Pure red cell aplasia that developed after previous treatment with any erythropoiesis-stimulating agent
• Use without regular haemoglobin and blood pressure monitoring by a specialist

• Iron supplementation is often needed alongside this medicine for it to work properly, as directed by your doctor based on your iron stores
• Other medicines that affect blood pressure may need dose adjustment, since this medicine can raise blood pressure
• This medicine is not normally combined with other erythropoiesis-stimulating agents

• This medicine must only be used under the supervision of your nephrology specialist, never self-initiated or self-adjusted
• Attend all scheduled blood tests to monitor your haemoglobin level and blood pressure
• Report any sudden leg swelling, chest pain, breathlessness, or stroke-like symptoms immediately
• Keep the syringe refrigerated and protected from light until you are ready to use it
• Tell your doctor immediately if you notice unusual bleeding, bruising, or worsening tiredness despite treatment
• Do not shake the syringe, as this can damage the medicine