Active ingredient
- methoxy polyethylene glycol-epoetin beta
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/07/400/010, EU/1/07/400/008, EU/1/07/400/012, EU/1/07/400/017, EU/1/07/400/024, EU/1/07/400/011, EU/1/07/400/020, EU/1/07/400/023, EU/1/07/400/013, EU/1/07/400/021, EU/1/07/400/009, EU/1/07/400/022.
Mircera solution for injection in pre-filled syringe
Package leaflet: Information for the user
MIRCERA
30 micrograms/0.3 ml solution for injection in pre-filled syringe
40 micrograms/0.3 ml solution for injection in pre-filled syringe
50 micrograms/0.3 ml solution for injection in pre-filled syringe
60 micrograms/0.3 ml solution for injection in pre-filled syringe
75 micrograms/0.3 ml solution for injection in pre-filled syringe
100 micrograms/0.3 ml solution for injection in pre-filled syringe
120 micrograms/0.3 ml solution for injection in pre-filled syringe
150 micrograms/0.3 ml solution for injection in pre-filled syringe
200 micrograms/0.3 ml solution for injection in pre-filled syringe
250 micrograms/0.3 ml solution for injection in pre-filled syringe
360 micrograms/0.6 ml solution for injection in pre-filled syringe
methoxy polyethylene glycol-epoetin beta
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
1. What MIRCERA is and what it is used for
2. What you need to know before you use MIRCERA
3. How to use MIRCERA
4. Possible side effects
5. How to store MIRCERA
6. Contents of the pack and other information
1. What MIRCERA is and what it is used for
This medicine is prescribed to you because you have anaemia caused by your chronic kidney disease and associated with typical symptoms, such as tiredness, weakness and shortness of breath. 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).
MIRCERA is indicated to treat only the symptomatic anaemia caused by chronic kidney disease. Its use is limited to adult patients (aged 18 years or older).
MIRCERA is a medicine produced by gene-technology. Like the natural hormone erythropoietin, MIRCERA increases the number of red blood cells and haemoglobin level in your blood.
2. What you need to know before you use MIRCERA
Do not use MIRCERA
Warnings and precautions
The safety and efficacy of MIRCERA therapy in other indications, including anaemia in patients with cancer, has not been established.
Before treatment with MIRCERA
During treatment with MIRCERA
Children and adolescents
Treatment with MIRCERA is not recommended in children and adolescents, because it has not been studied in these patients.
Take special care with other products that stimulate red blood cell production: MIRCERA is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does. Your healthcare professional will always record the exact product you are using.
Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications.
If you develop a serious rash or another of these skin symptoms stop taking Mircera and contact your doctor or seek medical attention immediately.
Other medicines and MIRCERA
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. No interaction studies have been performed. There is no evidence that MIRCERA interacts with other medicines.
MIRCERA with food and drink
Food and drink do not affect MIRCERA.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
MIRCERA has not been studied in pregnant or breast-feeding women.
Tell your doctor if you are pregnant, think you are pregnant or intend to become pregnant. Your doctor will consider what is the best treatment for you during pregnancy.
Tell your doctor if you are breast-feeding or intend to breast-feed. Your doctor will advise if you should stop or continue breast-feeding and stop or continue your treatment.
MIRCERA has not shown evidence of impaired fertility in animals. The potential risk for humans is unknown.
Driving and using machines
MIRCERA does not affect your ability to drive and use machines.
Important information about some of the ingredients of MIRCERA
This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium-free’.
3. How to use MIRCERA
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
If you do not respond adequately to MIRCERA, your doctor will check your dose and will inform you if you need to change doses of 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 yourself (see instructions at the end of this leaflet.)
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.
If you are not on dialysis, the recommended starting dose of MIRCERA is 1.2 micrograms for every kilogram of your body weight to be administered under the skin once every month as a single injection. Alternatively, your doctor may decide to administer a starting dose of MIRCERA of 0.6 micrograms for every kilogram of your body weight. The dose is to be administered once every two weeks as a single injection under the skin or into a vein. Once your anaemia is corrected your doctor may change your dosing to once a month administration.
If you are on dialysis, the recommended starting dose is 0.6 micrograms for every kilogram of your body weight. The dose is to be administered once every two weeks as a single injection under the skin or into a vein. Once your anaemia is corrected your doctor may change your dosing to once a month administration.
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.
Your doctor may replace your current medicine with MIRCERA. Your doctor will decide to treat you with MIRCERA administered as a single injection once a month. 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.
Your doctor may increase or decrease your dose or temporarily stop your treatment to adjust your haemoglobin to an appropriate level for you. Dose changes will not be made more often than once a month.
If you use more MIRCERA than you should
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 doses.
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 this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below:
A common side effect (may affect up to 1 in 10 people) is hypertension (high blood pressure).
Uncommon side effects (may affect up to 1 in 100 people) are:
Rare side effects (may affect up to 1 in 1000 people) are:
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. There have been reports of platelet counts below the normal range (thrombocytopenia) in the post-marketing setting.
Hypersensitivity reactions, including cases of anaphylactic reaction and serious skin rashes including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis have been reported in association with epoetin treatment. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using Mircera if you develop these symptoms and contact your doctor or seek medical attention immediately, see also section 2.
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 side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store MIRCERA
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Keep the pre-filled syringe in the outer carton in order to protect from light.
You may remove your MIRCERA pre-filled syringe from the refrigerator and store it at a room temperature not above 30 °C for a single period of one month. During this period when you have stored MIRCERA at a room temperature not above 30 °C you may not put MIRCERA back in the refrigerator before use. Once you have removed your medicine from the refrigerator you must use it within this period of one month.
Only solutions which are clear, colourless to slightly yellowish and free of visible particles must be injected.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What MIRCERA contains
What MIRCERA looks like and contents of the pack
MIRCERA is a solution for injection in pre-filled syringe.
The solution is clear, colourless to slightly yellowish and free of visible particles.
MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. Each pre-filled syringe contains 0.3 ml or 0.6 ml. MIRCERA is available, for all strengths, in pack sizes of 1 and also pack size of 3 for the strengths 30, 50, 75 micrograms/0.3ml. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in October 2019.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
MIRCERA pre-filled syringe Instructions For Use
The following instructions explain how to use the MIRCERA pre-filled syringe to give yourself an injection.
It is important to read and follow these instructions carefully so that you are able to use the pre-filled syringe correctly and safely. Do not attempt to administer an injection until you are sure that you understand how to use the pre-filled syringe.
IMPORTANT INFORMATION
STORAGE
Keep the syringe and the puncture-resistant/ sharps container out of the reach of children.
Store the syringe in its original box until ready to use.
Always store the syringe in a refrigerator at a temperature of 2 - 8°C (35.6 - 46.4°F). Do not allow the medicine to freeze, and protect the medicine from light. Keep the syringe dry.
MATERIALS Included in the pack:
A pre-filled syringe of MIRCERA and a separate injection needle
Not included in the pack:
Cleansing alcohol swabs
Sterile cotton ball or gauze
Puncture-resistant container or sharps container for safe disposal of needle and used syringe
Assemble all of the supplies you will need for an injection on a clean, well-lit flat surface such as a table.
HOW TO GIVE THE INJECTION
Step 1: Allow the syringe to adjust to room temperature
Remove the box containing the MIRCERA pre-filled syringe from the refrigerator. Keep the syringe in the box to protect it from light and allow it to reach room temperature for at least 30 minutes.
Remove the plastic tray of the MIRCERA pre-filled syringe from the box without peeling back the protective film.
Step 2: Clean your hands
Disinfect your hands well with soap and warm water or hands sanitizer.
Step 3: Unpack and visually inspect the pre-filled syringe
Peel back the protective film from the plastic tray and remove the needle and the syringe, holding the syringe by the middle of the body without touching the release clips.
Examine the syringe and check the expiration date on the syringe and box. This is important to ensure that the syringe and medicine are safe to use.
Do NOT use the syringe if:
Step 4. Attach the needle to the syringe
Grasp the packaged needle firmly in both hands. Break the seal of the needle, using a twisting motion, and remove the needle cap as pictured. Immediately throw away the needle cap in the sharps/ puncture-resistant container or sharps container.
Grasp the syringe and the rubber tip cap firmly and remove the rubber tip cap from the syringe (bend and pull).
Attach the needle to the syringe by pushing it firmly onto the syringe.
Step5. Remove the needle shield and prepare for injection
Hold the syringe firmly with one hand and pull off the needle shield with the other hand. Throw away the needle shield in the puncture-resistant container or sharps container.
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 the remove all air, as shown to you by a healthcare professional.
Step 6. Perform the injection
There are two different ways (routes) to inject MIRCERA into your body. Follow the recommendations of your healthcare professional about how you should inject MIRCERA.
Subcutaneous route:
If you are advised to inject MIRCERA under your skin, please administer your dose as described below.
Choose one of the recommended injection sites as shown.
You may inject MIRCERA into the upper arm, thigh or abdomen, except around the navel (belly button).
Clean the chosen injection site area using an alcohol pad to reduce the risk of infection; carefully follow the instructions of the alcohol pad.
To be sure the needle can be inserted correctly under the skin, use your free hand to pinch a fold of loose skin at the clean injection site. Pinching the skin is important to ensure that you inject under the skin (into fatty tissue) but not any deeper (into muscle). Injection into muscle could result in an uncomfortable injection.
Fully insert the needle into the skin in a quick, “dart-like” motion. Slowly push the plunger with the thumb while holding the syringe with the forefinger and the middle finger against the finger grips until all the medicine is injected.
Do not move the needle while it is inserted in the skin
Do not release the plunger before the end of injection or before the plunger is completely depressed.
Take the needle out of the skin WITHOUT releasing the plunger.
Release the plunger, allowing the needle guard to protect the needle.
Now, the tear-off label can be removed, if necessary.
Place a sterile cotton ball or gauze over the injection site and press for several seconds.
Dispose of the syringe:
Intravenous route:
If your healthcare professional has recommended injection of MIRCERA into a vein, you should follow the procedure described below.
After preparation of the syringe as described in steps 1 to 5:
Wipe off the venous port of the hemodialysis as instructed by your healthcare provider
Insert the needle of the pre-filled syringe into the cleaned venous port.
Push the plunger with the thumb while holding the syringe with the forefinger and the middle finger against the finger grips until all the medicine is injected.
Remove the pre-filled syringe from the venous port WITHOUT releasing the plunger.
Release the plunger, allowing the needle guard to protect the needle. Now, the tear-off label can be removed, if necessary.
Dispose of the syringe
Throw away used syringes in a puncture-resistant container.
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