Mircera ® Injection

Mircera is prescribed for you because you have anaemia due to chronic renal impairment. This means that you have too few red blood cells and your haemoglobin level is too low (your body’s tissues might not receive enough oxygen). The symptoms may be fatigue, weakness and shortness of breath. Mircera increases the number of red blood cells and haemoglobin level in your blood. Mircera is used to treat the anaemia caused by your chronic kidney disease. It has not been shown that Mircera can be used to treat anaemia caused by other diseases.

Only limited data on the safety and efficacy of Mircera in children less than 18 years of age is available, therefore you must not use Mircera if you are younger than 18 years of age.

Do not use Mircera

• if you are hypersensitive (allergic) to methoxy polyethylene glycol-epoetin beta or to any of the other ingredients of Mircera,
• if you have high blood pressure that is not controlled.
• if you are pregnant or breastfeeding your baby

Before treatment with Mircera

A condition called Pure Red Cell Aplasia (PRCA, i.e. stopped or reduced production of red blood cells) due to anti-erythropoietin antibodies was observed in some patients treated with Mircera. If your doctor suspects or confirms that you have these antibodies in your blood you must not be treated with Mircera.

During treatment with Mircera

• your doctor may initiate treatment with Mircera if your haemoglobin level is 10 g/dℓ (6,21 mmol/L) or less,
• your doctor will check the amount of iron in your blood before and during Mircera treatment.
• if the amount is too low your doctor may give you an additional iron therapy,
• your doctor will check your blood pressure before and during your Mircera treatment. If your blood pressure is high and cannot be controlled either by medicine or a special diet, your doctor will interrupt your Mircera treatment and reduce the dose,
• your doctor will check that your haemoglobin does not exceed 11 g/dℓ, as high haemoglobin could put you at risk of having a problem of the heart or the blood vessels and could increase risk of thrombosis (clotting), including pulmonary embolism, myocardial infarction (heart attack), stroke and death,
• contact your doctor if you feel tired, weak or have shortness of breath as this could mean that your Mircera treatment is not effective. Your doctor will check that you do not have other causes of anaemia and may perform blood tests or examine your bone marrow. If you have developed Pure Red Cell Aplasia your Mircera treatment will be discontinued. You will not receive another ESA and your doctor will treat you for this condition.

Children and adolescents

Treatment with Mircera is not recommended in children and adolescents as there is only limited data in these patients.

Take special care with Mircera: If you are a patient with hepatitis C and you receive interferon and ribavirin

You should discuss this with your doctor because a combination of ESAs with interferon and ribavirin has led to a loss of effect and development of a condition called Pure Red Cell Aplasia (PRCA), a severe form of anaemia in rare cases. S are not approved in the management of anaemia associated with hepatitis C.

Drug abuse and dependence: If you misuse Mircera and take it when you don’t have anaemia, you could have excessive levels of haemoglobin in your blood which can cause life threatening complications to your heart and blood systems.

Always use Mircera exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Treatment with Mircera must be started under the supervision of a healthcare professional. Further injections can be given by a healthcare professional or, after you have been trained, you can inject Mircera yourself. Mircera can be injected under the skin in the abdomen, arm or thigh; or into a vein. Your doctor will decide which is best for you.

Your doctor will carry out regular blood tests to monitor how your anaemia is responding to treatment by measuring your haemoglobin level. Your doctor will decide on the dose that is most suitable for you. Your doctor may increase or decrease your dose or temporarily stop your treatment to adjust your haemoglobin level, as appropriate for you. Dose changes will not be made more often than once a month.

If you use more Mircera than you should

Do not share medicines prescribed for you with another person. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Please contact your doctor or pharmacist if you used too large a dose of Mircera as it may be necessary to perform some blood tests and interrupt your treatment.

If you forget to use Mircera

If you miss a dose of Mircera, administer the missed dose as soon as you remember and talk to your doctor about when to use the next dose.

If you stop using Mircera

Treatment with Mircera is normally long-term. It can, however, be stopped on the advice of your doctor at any time. If you have any further questions on the use of Mircera, ask your doctor or pharmacist.

Mircera can cause side effects.

Not all side effects reported for Mircera are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Mircera, consult your doctor, pharmacist or other healthcare professional for advice. Hypersensitivity reactions, including cases of anaphylactic reaction, have been reported. Cases of thrombosis, including pulmonary embolism, have been reported in the post-marketing setting.

Common side effects: high blood pressure

Uncommon side effects

• headache,
• vascular access thrombosis (blood clots in your dialysis access).

Rare side effects:

• hypertensive encephalopathy (very high blood pressure that can result in headache, especially sudden, stabbing, migraine-like headache, confusion, speech disturbances, fits or convulsions). If you have these symptoms please contact your doctor immediately to receive treatment,
• maculo-papular rash (red skin reaction that can include pimples or spots),
• hot flushes,
• hypersensitivity (severe allergic reaction that can cause unusual wheezing or difficulty in breathing; swollen tongue, face or throat, or swelling around the injection site, or make you feel light-headed, faint or cause you to collapse). If you have these symptoms please contact your doctor immediately to receive treatment.

During clinical studies patients had a slight decrease in their platelet blood counts. Some patients had platelet counts below the normal range.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist. As with other ESAs, cases of thrombosis, including pulmonary embolism, have been reported in the post-marketing setting. A condition called Pure Red Cell Aplasia (PRCA, stopped or reduced production of red blood cells) due to anti-erythropoietin antibodies was observed in some patients treated with ESAs, including MIRCERA.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reaction Report Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8

Store all medicines out of reach of children. Do not use Mircera after the expiry date which is stated on the outer carton and pre-filled syringe label after ‘EXP’. The expiry date refers to the last day of that month. Store in a refrigerator (2 °C – 8 °C). Do not freeze. Do not shake the pre-filled syringe. Keep the pre-filled syringe in the outer carton in order to protect from light. You may remove Mircera from the refrigerator and store it at room temperature (not above 30 °C) for a period of one month and on one occasion only.

Once you have removed your medicine from the refrigerator you must use it within this period of one month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.