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Mircera

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Mircera

PATIENT INFORMATION

MIRCERA®
(mir-SER-ah)
(methoxy polyethylene glycol-epoetin beta)

Read this Medication Guide:

  • before you start Mircera.
  • if you are told by your healthcare provider that there is new information about Mircera.
  • if you are told by your healthcare provider that you may inject Mircera at home, read this Medication Guide each time you receive a new supply of medicine.

This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Talk with your healthcare provider regularly about the use of Mircera and ask if there is new information about Mircera.

What is the most important information I should know about Mircera?

Mircera may cause serious side effects that can lead to death, including:

For people with cancer: Mircera is not for use to treat anemia that is caused by cancer chemotherapy. If you have certain cancers, your tumor may grow faster and you may die sooner if you take Mircera.

  • Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with Mircera to increase red blood cells (RBCs) to near the same level found in healthy people.
  • Blood clots. Blood clots may happen at any time while taking Mircera. If you are receiving Mircera for any reason and you are going to have surgery, talk to your healthcare provider about whether or not you need to take a blood thinner to lessen the chance of blood clots during or following surgery. Clots can form in blood vessels (veins), especially in your leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus).
  • Call your healthcare provider or get medical help right away if you have any of these symptoms:
    • Chest pain
    • Trouble breathing or shortness of breath
    • Pain in your legs, with or without swelling
    • A cool or pale arm or leg
    • Sudden confusion, trouble speaking, or trouble understanding others' speech
    • Sudden numbness or weakness in your face, arm or leg, especially on one side of your body
    • Sudden trouble seeing
    • Sudden trouble walking, dizziness, loss of balance or coordination
    • Loss of consciousness (fainting)
    • Hemodialysis vascular access stops working

See “What are the possible side effects of Mircera?” below for more information.

If you decide to take Mircera, your healthcare provider should prescribe the smallest dose of Mircera that is necessary to reduce your chance of needing red blood cell transfusions.

What is Mircera?

Mircera is a prescription medicine used to treat anemia. People with anemia have a lower-than­normal number of RBCs. Mircera works like the human protein called erythropoietin to help your body make more RBCs. Mircera is used to reduce or avoid the need for RBC transfusion.

Mircera may be used to treat anemia if it is caused by chronic kidney disease (you may or may not be on dialysis).

If your hemoglobin level stays too high or if your hemoglobin goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take Mircera, even if you do not have an increase in your hemoglobin level. Mircera is not for use for the treatment of anemia:

  • that is caused by cancer chemotherapy
  • in place of emergency treatment for anemia (red blood cell transfusions)

Mircera has not been proven to improve the quality of life, fatigue, or well-being.

It is not known if Mircera is safe and effective in children.

Who should not take Mircera?

Do not take Mircera if you:

  • Have high blood pressure that is not controlled (uncontrolled hypertension)
  • Have been told by your healthcare provider that you have or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with Mircera or other erythropoietin protein medicines
  • Have had serious allergic reactions to Mircera

What should I tell my healthcare provider before taking Mircera?

Mircera may not be right for you. Tell your healthcare provider about all of your medical conditions, including if you:

  • Have heart disease
  • Have or develop cancer
  • Have high blood pressure
  • Have had a seizure (convulsion) or stroke
  • Have any other medical conditions
  • Are pregnant or plan to become pregnant. It is not known if Mircera may harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. It is not known if Mircera passes into your breast milk.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider when you get a new medicine.

How should I take Mircera?

  • If you or your caregiver has been trained to give Mircera shots (injections) at home:
    • Be sure that you read, understand, and follow the “Instructions for Use” that come with Mircera.
    • Take Mircera exactly as your healthcare provider tells you to. Do not change the dose of Mircera unless told to by your healthcare provider.
    • Your healthcare provider will show you how much Mircera to use, how to inject it, how often it should be injected, and how to safely throw away the used prefilled syringes and needles.
    • If you take more than your prescribed dose of Mircera, call your healthcare provider right away for instructions on what to do.
  • During treatment with Mircera, continue to follow your healthcare provider's instructions for diet, dialysis, and medicines, including medicines for high blood pressure.
  • Have your blood pressure checked as instructed by your healthcare provider.

What are possible side effects of Mircera?

Mircera may cause serious side effects.

  • See “What is the most important information I should know about Mircera?”
  • High blood pressure. High blood pressure is a common side effect of Mircera in patients with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medicine while taking Mircera. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often. If your blood pressure does go up, your healthcare provider may prescribe new or more blood pressure medicine.
  • Seizures. If you have any seizures while taking Mircera, get medical help right away and tell your healthcare provider.
  • No response or loss of your hemoglobin response to Mircera. If your hemoglobin does not increase, or if the increase cannot be maintained, your healthcare provider will look for the cause of the problem. Your dose of Mircera or other medicines may need to be changed.
  • Antibodies to Mircera. Your body may make antibodies to Mircera. These antibodies can block or reduce your body's ability to make red blood cells, and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness or fainting. You may need to stop taking Mircera.
  • Serious allergic reaction. Serious allergic reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness and fainting because of a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have a serious allergic reaction, stop using Mircera and call your healthcare provider or get emergency medical help right away.

Common side effects of Mircera include:

  • Diarrhea
  • Upper respiratory tract infections (cold, cough and sinus infections)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Mircera. Your healthcare provider can give you a more complete list. Tell your healthcare provider about any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1­800-FDA-1088.

How should I store Mircera?

  • Store Mircera prefilled syringes in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • If a refrigerator is not available, Mircera prefilled syringes can be stored at room temperature 77°F (25°C) for no more than 30 days.
  • Do not freeze Mircera. Do not use Mircera that has been frozen or improperly refrigerated.
  • Keep Mircera in the original package.
  • Protect Mircera from light.
  • Do not shake Mircera.

Keep Mircera and all medicines out of the reach of children.

General information about Mircera

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Mircera for a condition for which it was not prescribed. Do not give Mircera to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Mircera. If you would like more information about Mircera, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Mircera that is written for health professionals.

What are the ingredients in Mircera?

Active ingredient: methoxy polyethylene glycol-epoetin beta

Inactive ingredients: sodium phosphate, sodium sulphate, mannitol, methionine and poloxamer 188

Instructions for Use

MIRCERA®
(mir-SER-ah)
(methoxy polyethylene glycol-epoetin beta) Injection Single-Dose Prefilled Syringe

Read the Medication Guide that comes with Mircera for the most important information you need to know. The following instructions explain how to give yourself or another individual an injection of Mircera using the single-dose prefilled syringe. Be sure that you read, understand and follow these instructions before injecting a dose of Mircera so that you are able to use the prefilled syringe correctly and safely. Your healthcare provider should show you how to correctly prepare and inject Mircera using the single-dose prefilled syringe before you use it for the first time. Ask your healthcare provider or pharmacist if you have any questions about Mircera.

When you receive your Mircera prefilled syringes, make sure that:

  • The name Mircera appears on the pack.
  • The pack is not damaged. Do not use Mircera if the syringe, the pack or the plastic tray containing the syringe appears to be damaged.
  • The expiration date on the pack has not passed. Do not use Mircera after the expiration date on the pack.
  • The strength (mcg/mL) on the Mircera pack is the same as the strength (mcg/mL) prescribed by your healthcare provider. Mircera prefilled syringes come in several different strengths measured in mcg/mL. Depending on your prescribed dose you may:
    • receive more than one strength of Mircera prefilled syringes
    • need to give more than one injection to receive a complete dose

Important Information:

  • Your healthcare provider may decide that you or a caregiver may give Mircera at home by an injection under your skin (subcutaneous) or by an intravenous (IV) injection. Your healthcare provider or nurse will train you how to prepare and inject Mircera properly. It is important that you do not try to give Mircera unless you or your caregiver has received training from your healthcare provider.
  • Keep the Mircera prefilled syringe in the sealed pack until you are ready to use it.
  • Do not hold or pull the prefilled syringe by the plunger.
  • Do not remove the needle shield until you are ready to give an injection.
  • Do not inject through clothing.
  • Do not touch the release clips before use (see Figure A). Touching them may cause the needle safety device to be released too early and make the prefilled syringe unusable.
  • Throw away (dispose of) the used Mircera prefilled syringe right away after use. Do not reuse a Mircera prefilled syringe or needle. See “Disposing of used prefilled syringes and needles” at the end of this Instructions for Use.

Storage

How should I store Mircera?

  • Store Mircera in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • If a refrigerator is not available, Mircera prefilled syringes can be stored at room temperature 77°F or less (25°C or less) for no more than 30 days.
  • Do not freeze Mircera. Do not use Mircera that has been frozen.
  • Keep Mircera in the original package.
  • Protect Mircera from light.
  • Do not shake Mircera.

Keep Mircera and all medicines out of the reach of children.

Materials

Materials included in the Mircera prefilled syringe pack (Figure A):

  • A prefilled syringe containing Mircera
  • A separate injection needle

Figure A

Materials included in the Mircera prefilled syringe pack - Illustration

Materials not included in the Mircera prefilled syringe pack (Figure B):

Figure B

Materials not included in the Mircera prefilled syringe pack - Illustration

Important: Follow these instructions exactly to help avoid infections.

Preparing for an injection:

1. Gather all of the materials you will need for an injection on a clean, well-lit, flat work surface such as a table.

2. Allow the syringe to reach room temperature: Carefully remove your prescribed pack of Mircera from the refrigerator (see Figure C).

  • Keep the prefilled syringe in the pack to protect it from light and allow it to reach room temperature for about 30 minutes.

Figure C

Carefully remove your prescribed pack of Mircera from the refrigerator - Illustration

Do not warm up the prefilled syringe in any other way.

3. Open the pack and remove the plastic tray containing the Mircera prefilled syringe without peeling back the protective film (see Figure D).

Figure D

Plastic tray containing the Mircera prefilled syringe - Illustration

4. Wash your hands well with soap and warm water (see Figure E).

Figure E

Wash your hands well - Illustration

5. Remove and inspect the prefilled syringe. Open the plastic tray by peeling back the protective film. Remove the prefilled syringe by holding the syringe by the device body (see Figure F). Do not touch the release clips.

  • Only handle the prefilled syringe by the device body. Touching the release clips could cause the needle safety device to be released too early.
  • Remove the needle from the plastic tray.

Figure F

Remove the needle from the plastic tray - Illustration

6. Inspect the medicine and prefilled syringe (see Figure G.).

Do not use the prefilled syringe if:

  • The prefilled syringe has been dropped or shaken
  • Any part of the prefilled syringe appears cracked or damaged
  • The liquid is foamy, cloudy, hazy or contains particles
  • The expiration date has passed.

Figure G

Inspect the medicine and prefilled syringe - Illustration

Attach needle to prefilled syringe:

7. Grab the prefilled syringe by the finger grips. Carefully pull the rubber tip cap away from the prefilled syringe. It may require a strong bend and pull to remove it (see Figure H).

Figure H

Pull the rubber tip cap away - illustration

  • Throw away (dispose of) the rubber tip cap in the sharps disposal container
  • Do not touch the release clips.
  • Do not push or pull on the plunger.

Place the syringe on your work surface. Be careful that the tip of the prefilled syringe does not touch anything. If the tip of the syringe touches anything, dispose of the prefilled syringe (see “Disposing of used prefilled syringes and needles” below) and use a new prefilled syringe and needle for the injection.

8. Grab the packaged needle firmly in both hands. Break the seal of the needle, using a twisting motion, and remove the plastic needle cap (see Figure I).

  • Throw away (dispose of) the needle cap right away in the sharps disposal container.
  • Do not remove the needle shield that protects the needle.

Figure I

Remove the plastic needle cap - Illustration

9. Attach the needle to the prefilled syringe by pushing it firmly onto the prefilled syringe (see Figure J).

Figure J

Attach the needle to the prefilled syringe - Illustration

10. Put the prefilled syringe on its side with the needle shield on. This will keep the needle from touching anything before you use it.

Follow your healthcare provider's instructions for how you should inject Mircera.

Subcutaneous (under the skin) injection:

If your healthcare provider tells you to inject Mircera under your skin, give your dose as described below:

Selecting and preparing a subcutaneous injection site:

11. Choose an injection site as shown in Figure K. The three sites where you can inject Mircera include:

  • the outer area of the upper arms
  • the front of the middle thighs
  • the abdomen, except for the two-inch area around the navel (belly-button)

Choose a new injection site each time you inject Mircera, at least 1-inch from the area you used for the previous injection. This helps to avoid soreness at any one site.

Figure K

Injection site - Illustration

Do not inject Mircera into moles or into an area of your body that is tender, red, bruised, hard, or that has scars or stretch marks, or is not intact.

Do not inject into areas that could be irritated by a belt or waistband.

12. Clean the injection site with an alcohol swab (see Figure L).

  • Let the skin dry for about 10 seconds.
  • Do not touch this area again before giving the injection.

Do not fan or blow on the clean area.

Figure L

Clean the injection site - Illustration

13. Hold the syringe firmly with one hand and pull off the needle shield with the other hand (see Figure M). Throw away the needle shield in the sharps disposal container.

  • Do not touch the needle or let it touch any surface.
  • You may see a drop of liquid at the end of the needle. This is normal.
  • Do not reattach the needle shield after removal.

Figure M

Pull off the needle shield - Illustration

14. Check the prefilled syringe for air bubbles. To remove air bubbles from the prefilled syringe, hold the syringe by the body with the needle pointing up. Tap the syringe gently to bring the air bubbles to the top (see Figure N).

Figure N

Remove air bubbles - Illustration

15. Push the plunger up gently and slowly until you see a drop of liquid coming out of the needle (see Figure O).

Figure O

Push the plunger up - Illustration

16. Find a comfortable position to give an injection of Mircera.

Hold the prefilled syringe in the hand that you will use to inject Mircera. Use the other hand to pinch a fold of loose skin at the cleaned injection site (see Figure P).

Figure P

Pinch a fold of loose skin - Illustration

17. Hold the prefilled syringe like a pencil. Fully and carefully insert the needle into the skin in a quick “dart­like” motion. Insert straight up and down (90 degree angle) into the skin. Keep the syringe in the skin and slowly let go of the pinch of skin.

Slowly push the plunger with your thumb all the way down while holding the syringe with the forefinger and the middle finger against the finger grips until all the medicine is injected (see Figure Q). The plastic needle guard (a safety guard to prevent accidental needle sticks) will not move forward to cover the needle unless the full dose is given.

  • 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 pushed down (depressed).

Figure Q

Push the plunger with your thumb - Illustration

18. Take the needle out of the skin without releasing the plunger (see Figure R).

Figure R

Take the needle out - Illustration

19. Release the plunger after removing the needle from the skin. This will allow the syringe to move back until the entire needle is covered with the needle guard (see Figure S).

Figure S

Release the plunger - Illustration

20. Now the tear-off label can be removed, if necessary to keep a record of the dose taken (see Figure T).

Figure T

Tear-off label - Illustration

21. After the injection: Place a sterile cotton ball or gauze over the injection site and press for several seconds (see Figure U).

  • Do not rub the injection site with an unclean hand or cloth.

If needed, you may cover the injection site with a small adhesive bandage.

Figure U

Place a sterile cotton ball or gauze over the injection site - Illustration

22. Dispose of the used prefilled syringe: Throw away (dispose of) the used prefilled syringe and the attached needle in the sharps container right away. Do not reuse your prefilled syringe or needle. See “Disposing of used prefilled syringes and needles” below.

Intravenous (IV) injection:

Injecting a dose of Mircera for people on hemodialysis using intravenous injection:

  • Mircera can be injected in your vein through a special access (venous) port placed by your healthcare provider. This type of Mircera injection is called an intravenous (IV) injection. If your healthcare provider has shown you or your caregiver how to inject Mircera intravenously, you should follow the steps described below.
  • If you have a hemodialysis vascular access, make sure that the venous port is working by checking it as your healthcare provider has shown you. Call your healthcare provider right away if you are having any problems or if you have any questions.

After you prepare the syringe as described in steps 7 to 10 above:

Clean the venous port of the hemodialysis tubing with an alcohol swab (see Figure A).

Figure A

Clean the venous port - Illustration

2. Hold the syringe firmly with one hand and pull off the needle shield with the other hand (see Figure B). Throw away the needle shield in the sharps disposal container.

  • Do not touch the needle or let it touch any surface.
  • You may see a drop of liquid at the end of the needle. This is normal.
  • Do not reattach the needle shield after removal.

Figure B

Pull off the needle shield - Illustration

3. Check the prefilled syringe for air bubbles. To remove air bubbles from the prefilled syringe, hold the syringe by the device body with the needle pointing up. Tap the syringe gently to bring the air bubbles to the top (see Figure C).

Figure C

Remove air bubbles -  Illustration

4. Push the plunger up gently and slowly until you see a drop of liquid coming out of the needle (see Figure D).

Figure D

Push the plunger up gently - Illustration

5. Insert the needle on the prefilled syringe into the cleaned venous port (see Figure E).

Figure E

Insert the needle on the prefilled syringe into the cleaned venous port - Illustration

6. Push the plunger with your thumb all the way down, while holding the syringe with the forefinger and the middle finger against the finger grips until all the medicine is injected (see Figure F). Pull back on the syringe and remove the needle from the venous port without releasing the plunger.

Figure F

Push the plunger - Illustration

The plastic needle guard (a safety guard to prevent accidental needle sticks) will not move forward to cover the needle unless the full dose is given (see Figure G).

  • Do not move the needle while it is inserted in the port.
  • Do not release the plunger before the end of injection or before the plunger is completely pushed down (depressed).

Figure G

The plastic needle guard - Illustration

Release the plunger after removing the needle from the port. This will allow the syringe to move back until the entire needle is covered with the needle guard (see Figure G).

7. Now the tear-off label can be removed, if necessary to keep a record of the dose taken (see Figure H).

Figure H

Tear-off label -- Illustration

8. Dispose of the used prefilled syringe: Throw away (dispose of) the used prefilled syringe and the attached needle in the sharps container right away. Do not reuse your prefilled syringe and needle. See “Disposing of used prefilled syringes and needles” below.

Disposing of used prefilled syringes and needles:

  • Put your used needles and prefilled syringes in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and prefilled syringes in your household trash.
  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
    • made of heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles, syringes and prefilled injectors. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
  • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

Always keep the sharps disposal container out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 5/9/2016
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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