Mircera solution for injection in pre-filled syringe

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects , talk to your doctor. This includes any possible side effects not listed in this leaflet.

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

Do not use MIRCERA

• if you are allergic to methoxy polyethylene glycol-epoetin beta or to any of the other ingredients of this medicine (listed in section 6)
• if you have high blood pressure that cannot be controlled

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

• 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 erythropoiesis stimulating agents (ESAs), including MIRCERA.
• If your doctor suspects or confirms that you have these antibodies in your blood, you must not be treated 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 lead to a loss of effect and development of PRCA, a severe form of anemia, in rare cases. ESAs are not approved in the management of anaemia associated with hepatitis C.
• If you are a patient with chronic kidney disease and anemia treated with an ESA and are also a cancer patient you should be aware that ESAs, might have a negative impact on your condition. You should discuss options for anemia treatment with your doctor.
• It is not known if MIRCERA has a different effect in patients with haemoglobinopathies (disorders associated with abnormal haemoglobin), past or present bleeding, seizures or with a high blood platelet count. If you have any of these conditions, your doctor will discuss it with you and must treat you with caution.
• Healthy people should not use MIRCERA. Using it can lead to too high haemoglobin levels and cause problems with the heart or blood vessels that may be life-threatening.

During treatment with MIRCERA

• If you are a patient with chronic renal failure, and particularly if you do not respond properly to MIRCERA, your doctor will check your dose of MIRCERA because repeatedly increasing your dose of MIRCERA if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
• Your doctor may initiate treatment with MIRCERA if your haemoglobin level is 10 g/dl (6.21 mmol/l) or less. After initiation of therapy, your doctor will seek to maintain your haemoglobin level between 10 and 12 g/dl (7.45 mmol/l).
• 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 supplement.
• 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 appropriate medicines or a special diet, your doctor will interrupt your MIRCERA treatment or reduce the dose.
• Your doctor will check that your haemoglobin does not exceed a certain level, 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, including pulmonary embolism, myocardial infarction, stroke and death.
• Contact your doctor if you feel tired, weak or have shortness of breath, because 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 PRCA, 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, 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’.

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.

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.

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What MIRCERA contains

• The active substance is methoxy polyethylene glycol-epoetin beta. One pre-filled syringe contains:
  30, 40, 50, 60, 75, 100, 120, 150, 200 or 250 micrograms in 0.3 ml and 360 micrograms in 0.6 ml.
• The other ingredients are sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, poloxamer 188 and water for injections.

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 packsize of 3 for the strengths 30, 50, 75 micrograms/0.3ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

IMPORTANT INFORMATION

• Only use MIRCERA pre-filled syringeif you have been prescribed with this
• medication.
• Read the packaging and ensure you have the dose prescribed by your healthcare professional.
• Do not use the pre-filled syringe if syringe, or the plastic tray containing the syringe appears to be damaged.
• Do not use the syringe if the contents are cloudy, hazy or contain particles.
• Never attempt to take the syringe apart.
• Never pull on or handle the syringe by its plunger.
• Do not remove the needle shield until you are ready to perform an injection.
• Do not swallow the medicine in the syringe.
• Do not inject through clothing.
• Never re-use a syringe.
• Do not touch the release clips (see diagram below) as this may damage the syringe and make it unusable.

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.

• Not allowing the medicine to come to room temperature could result in an uncomfortable injection, and it may be difficult to depress the plunger.
• Do not warm up the syringe in any other way.

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.

• Only handle the syringe by the body, because any contact with the release clips could cause premature release of the safety device.

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:

• You have accidentally dropped the syringe.
• Any part of the syringe appears to be damaged.
• The contents are cloudy, hazy or contain particles.
• The expiration date has passed.

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.

• Do not remove the needle shield that protects the needle.

Grasp the syringe and the rubber tip cap firmly and remove the rubber tip cap from the syringe (bend and pull).

• Do not touch the release clips of the safety device.
• Do not push the plunger.
• Do not pull on the plunger.

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.

• Do not touch the needle or let it touch any surface, as the needle may become contaminated and may cause injury and pain if touched.
• You may see a drop of liquid at the end of the needle. This is normal.
• Never reattach the needle shield after removal.

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).

• You should use a different injection site each time you administer an injection, at least three centimeters 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.

Clean the chosen injection site area using an alcohol pad to reduce the risk of infection; carefully follow the instructions of the alcohol pad.

• Let the skin dry for approximately 10 seconds.
• Be sure not to touch the cleaned area prior to the injection and do not fan or blow on the clean area.

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.

• Do not rub the injection site with dirty hand or cloth.
• If needed, you may cover the injection site with a small bandage.

Dispose of the syringe:

• Throw away used syringes in a sharps/ puncture-resistant container.
• Do not try to replace the needle shield on the needle.
• Do not throw away used syringes or the sharps/ puncture-resistant container in household trash and do not recycle them.
• Dispose of the full container as instructed by your healthcare provider or pharmacist.

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.

• Do not try to replace the shield on the needle.
• Do not throw away used syringes or the puncture-resistant container in household trash and do not recycle them.
• Dispose of the full container as instructed by your healthcare provider or pharmacist.