1. Why am I using Mircera?

Mircera contains the active ingredient methoxy polyethylene glycol-epoetin beta. Mircera is used to treat anaemia caused by chronic kidney disease (kidney failure).
For more information, see Section 1. Why am I using Mircera? in the full CMI.

2. What should I know before I use Mircera?

Do not use if you have ever had an allergic reaction to Mircera or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Mircera? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Mircera and affect how it works. Tell your doctor or pharmacist if you are taking any medicines, including any that you can get without a prescription or if you are unsure about any medicine.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Mircera?

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 under the skin yourself (see instructions "How to self-inject Mircera".)
Mircera can be injected under the skin on the abdomen, arm or thigh or into a vein. Your doctor will decide which is best for you. More instructions can be found in Section 4. How do I use Mircera? in the full CMI.

5. What should I know while using Mircera?

For more information, see Section 5. What should I know while using Mircera? in the full CMI.

6. Are there any side effects?

Common side effects include: back or join pain, muscle spasms, changes in blood pressure, ringing in ears, vision problems, diarrhoea, constipation, nausea, vomiting, stomach pain, indigestion, sore throat or nose, fever, cough, shortness of breath, difficulty sleeping, pain with urination, swelling of ankles, feet or hands, feel tired, itching, hot flushes. Serious side effects include blood clots in your dialysis access, bleeding or bruising more easily, chest pain, feeling of tightness in chest, headache, red skin reaction. These side effects require medical attention.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Mircera^® (Pronounced "meer-seh-ra")

Active ingredient(s): methoxy polyethylene glycol-epoetin beta

Consumer Medicine Information (CMI)

This leaflet provides important information about using Mircera. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Mircera.

Where to find information in this leaflet:

1. Why am I using Mircera?

Mircera contains the active ingredient methoxy polyethylene glycol-epoetin beta. Mircera is used to treat anaemia caused by chronic kidney disease (kidney failure).

Anaemia is a condition caused by low levels of red blood cells, resulting in low haemoglobin, a protein that transports oxygen in the blood. Consequently your body’s tissues might not receive enough oxygen. Symptoms may include tiredness, weakness and shortness of breath.

Mircera belongs to a group of medicines known as hormones. The kidneys produce the natural hormone erythropoietin, which stimulates the production of red blood cells in the bone marrow and spleen.

Like erythropoietin, Mircera works by increasing the number of red blood cells and the haemoglobin level in your blood. It will reduce your need for blood transfusions. Compared to other erythropoietin medicines, Mircera can stay in your body longer, therefore requiring fewer injections for your treatment.

Mircera is used to treat anaemia caused by chronic kidney disease. It has not been shown that Mircera can be used to treat anaemia caused by other diseases.

Your doctor, however, may have prescribed Mircera for another purpose.

Ask your doctor if you have any questions about why Mircera has been prescribed for you.

Mircera is not addictive.

This medicine is available only with a doctor's prescription.

2. What should I know before I use Mircera?

Warnings

Do not use Mircera if:

• you are allergic to methoxy polyethylene glycol-epoetin beta, any other similar medicines (i.e. containing erythropoetin) or any of the ingredients listed at the end of this leaflet.
  • Some of the symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or gives on the skin.
  • Always check the ingredients to make sure you can use this medicine.
• You have high blood pressure that is not well controlled.
• The package is torn or shows signs of tampering.
• The expiry date (EXP) printed on the pack has passed.

If you take this medicine after the expiry date has passed, it may not work as well.

• You are not sure if you should be using Mircera, talk to your doctor.
• You are healthy or have not been prescribed Mircera. Using it can lead to too high haemoglobin levels and cause problems with the heart or blood vessels that may be life-threatening.
• Do not give Mircera to children or adolescents under the age of 18 years.

The safety and effectiveness of Mircera have not been established in these patients.

Check with your doctor if you:

• have any of the following medical conditions:
  • Disorders associated with abnormal haemoglobin (haemoglobinopathies);
  • Blood clotting diseases, which mean you bleed or bruise more easily;
  • High blood pressure - it is important to follow your doctor's instructions to control your blood pressure, including taking blood pressure medicines and changes to your diet;
  • Cancer;
  • Epilepsy or seizures;
  • Any other illness or health problems. A number of conditions such as vitamin deficiencies may affect how well you respond to Mircera;
• Have any allergies to any other medicines, foods, preservatives or dyes.
• Plan to have surgery.
• take any medicines for any other condition
• Have not told your doctor about any of the above, tell them before you start using Mircera.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

• Mircera is not generally recommended for use in pregnant women unless the benefits of treatment outweigh the risk to the unborn baby.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

• It is not known whether Mircera passes into breast milk. Your doctor will discuss the risks and benefits of using Mircera if you are breast-feeding.

Blood and Blood Pressure

• Your doctor will check the amount of iron in your blood before and during your Mircera treatment. If the amount is too low your doctor may recommend you take iron supplements.
• Your doctor will check your blood pressure before and during your Mircera treatment. It is important to follow your doctor’s instructions to control your blood pressure, including taking blood pressure medicines and changes to your diet. If your blood pressure cannot be controlled your doctor may stop your Mircera treatment or reduce the dose.
• A condition called pure red cell aplasia (stopped or reduced production of red blood cells due to your body producing antibodies against erythropoietin) has been observed in some patients treated with erythropoietin products including Mircera. If your doctor suspects or confirms that you have these antibodies in your blood you must not be treated with Mircera.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may be affected by Mircera, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while using Mircera.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Mircera.

4. How do I use Mircera?

Use Mircera exactly as your doctor has prescribed.

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 under the skin yourself (see instructions "How to self-inject Mircera".)

Mircera can be injected under the skin on 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 that monitor your haemoglobin levels and making sure they do not exceed a certain level. High haemoglobin levels could put you at risk of heart or blood vessel problems which could increase the risk of death. If necessary, your dose may be changed by your doctor during therapy according to your response.

If you have not been treated with an erythropoietin medicine

If you are not currently on dialysis, the recommended starting dose of Mircera is 1.2 micrograms for every kilogram of your body weight once per month or if you prefer 0.6 micrograms for every kilogram of your body weight once every 2 weeks.

If you are currently on dialysis, the recommended starting dose of Mircera is 0.6 micrograms for every kilogram of your body weight once every 2 weeks.

Your haemoglobin level should be tested regularly. Depending on the result, your doctor may increase or decrease your Mircera dose. Dose changes should not be made more often than once a month.

Once your anaemia is corrected, your doctor may change your injection to once a month.

If you are already being treated with an erythropoietin medicine

Your doctor may replace your current medicine with Mircera.

Your doctor will calculate your Mircera starting dose based on the last dose of your previous medicine. The first Mircera dose will be given on the planned injection day of your previous medicine. Mircera will be given as a single injection once a month (or if you prefer, once every two weeks).

Your haemoglobin level should be tested regularly. Depending on the result, your doctor may increase or decrease your Mircera dose, or temporarily stop treatment. Dose changes should not be made more often than once a month.

Treatment with Mircera is normally long-term. It can however, be stopped on the advice of your doctor at any time. Continue using Mircera until your doctor tells you to stop.

When to use Mircera

• Mircera should be used as a single injection once a month (or if you prefer, once every two weeks) depending on your body weight.

How to self-inject Mircera

Your doctor may discuss with you whether it would be more convenient for you to inject Mircera yourself at home. This is a simple procedure and many patients prefer it. Always use Mircera exactly as your doctor has told you. Check with your doctor or nurse if you are unsure.

The Mircera pre-filled syringe is ready for use and can be injected by yourself either under the skin (on the abdomen, arm or thigh) or if you are on haemodialysis, through the haemodialysis vascular access according to your doctor’s advice.

Each pre-filled syringe is to be used for a single injection only. Do not mix Mircera solution with other injectable medicines.

Setting up for an injection

Before you begin

1. Find a clean, comfortable area
2. Gather all the supplies you will need;

Included in the pack:

• A Mircera pre-filled safety syringe and a separate needle.

Not included in the pack:

• Cleansing alcohol swabs.
• Cotton wool or dry sterile pad.
• A sharps (puncture proof) disposal container.

3. Remove an individual dose of Mircera from the fridge and allow it to reach room temperature. This should take about 30 minutes. Do not warm up the syringe in any other way.

Do not shake the pre-filled syringe. If the solution has been shaken and appears foamy, do not use it (shaking Mircera or exposing it to light may damage the medicine).

Check the expiration date stated on the outer carton and pre-filled syringe label after 'EXP' to make sure that it has not expired. The expiry date refers to the last day of that month. Do not use Mircera after the expiry date.

Preparing the Mircera pre-filled syringe and needle for injection

4. Wash your hands with soap and water. Cleanliness is vital during the injection procedure.
5. Take the pre-filled syringe and needle out of the blister packaging.

6. Only use if the solution is clear, colourless (slightly yellow in colour is acceptable) and there are no visible particles.
7. Grasp the needle shield (C) firmly in both hands. Remove the plastic cap (B), twist then pull.

DO NOT REMOVE THE NEEDLE SHEILD (C). DO NOT TOUCH THE PLUNGER ROD (E) OR FINGER RESTS (F) AT THIS TIME. Doing so will release the needle guard (G) and you will be unable to inject your dose of Mircera.

8. Remove the rubber cap (D) from the syringe (bend and pull).

9. Attach the needle with needle shield (A and C) to the syringe (H) by pushing firmly together.

10. Remove the needle shield (C) and prepare for injection.

To remove air bubbles from the pre-filled syringe, hold the syringe with the needle pointing up. Tap the syringe gently to bring any bubbles to the top.

Push the plunger up slowly to remove all air, as shown to you by a healthcare professional.

Injecting the solution

If your doctor has advised you to inject Mircera into a vein (e.g. through the haemodialysis vascular access) please administer your dose as shown by your healthcare professional.

If you have been advised to inject Mircera under your skin please follow the subsequent instructions step by step.

11. Select the injection site on the outer upper arm, abdomen (away from your navel or waistline) or thigh as shown below. The back of the upper arm is not a recommended site for self-injection. Use this injection site only if you inject someone else.

You should use a different injection site each time you administer an injection, at least three centimetres from the area you used for the previous injection. Do not inject areas that could be irritated by a belt or waistband.

Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.

12. Clean the skin where the injection is to be made with a cleansing alcohol swab. Wait for the area to dry.

13. Hold the syringe firmly with one hand and pull off the needle shield (C) with the other hand. Throw away the needle shield in the puncture-resistant or sharps container.

Do not touch the needle or let it touch any surface, as the needle may become contaminated and may cause injury if touched.

You may see a drop of liquid at the end of the needle. This is normal.

14. With one hand, pinch a fold of loose skin. Insert the needle into the pinched skin, using a quick “dart like” motion, as shown by your healthcare professional.

15. Slowly press the plunger rod (E) with your thumb while holding the finger rests (F), until the full dose has been given.

Do not release the plunger rod (E).