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Mircera

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Mircera

Mircera

PATIENT INFORMATION

MEDICATION GUIDE

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

Read this Medication Guide carefully before you start taking Mircera (methoxy polyethylene glycol-epoetin beta) and each time you refill your Mircera (methoxy polyethylene glycol-epoetin beta) prescription. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Mircera (methoxy polyethylene glycol-epoetin beta) ?

Mircera (methoxy polyethylene glycol-epoetin beta) stimulates your bone marrow to make more red blood cells. The increase in red blood cells also increases your hemoglobin level. 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 problems include:

Serious heart problems. These problems include heart attack, stroke, and congestive heart failure.

Blood clots. Mircera (methoxy polyethylene glycol-epoetin beta) treatment increases your chance of a blood clot. If you are scheduled for surgery, your healthcare provider may prescribe a blood thinner to prevent blood clots. Blood clots can form in your hemodialysis vascular access (such as arteriovenous fistulas) or in blood vessels, especially in the leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel to the lungs. If this happens, blood circulation in the lungs may be blocked (pulmonary embolus).

Tell your healthcare provider or get medical attention right away if you have any of these symptoms while taking Mircera (methoxy polyethylene glycol-epoetin beta) :

  • Chest pain
  • Trouble breathing or shortness of breath
  • Pain in the legs, with or without swelling
  • A cool or pale arm or leg
  • Sudden confusion or trouble speaking or understanding speech
  • Sudden numbness or weakness of the face, an arm or leg, especially on one side of the body
  • Sudden trouble seeing in one or both eyes
  • Sudden trouble walking, dizziness, loss of balance or coordination, loss of consciousness
  • Sudden severe headache with no known cause
  • Seizures (convulsions)
  • Blood clots in your hemodialysis vascular access (such as arteriovenous fistulas).

It is important for you to have the blood tests ordered by your healthcare provider. Your healthcare provider will try to keep your hemoglobin level between 10 and 12 g/dL.

Mircera (methoxy polyethylene glycol-epoetin beta) is not used to treat anemia caused by cancer chemotherapy. In patients with cancer, drugs that act like Mircera (methoxy polyethylene glycol-epoetin beta) increase the chance of dying sooner or making the cancer grow faster. In a clinical study of cancer patients, more deaths occurred among patients receiving Mircera (methoxy polyethylene glycol-epoetin beta) compared to another drug that also increases blood hemoglobin.

What is Mircera (methoxy polyethylene glycol-epoetin beta) ?

Mircera (methoxy polyethylene glycol-epoetin beta) is a man-made form of the human protein erythropoietin. Erythopoietin is normally produced by the kidneys. Mircera (methoxy polyethylene glycol-epoetin beta) and other man-made erythropoietins are ESAs (Erythropiesis-Stimulating Agents). ESAs stimulate bone marrow to make red blood cells. The increase in red blood cells also increases the blood hemoglobin level. Your healthcare provider will prescribe the lowest dose of Mircera (methoxy polyethylene glycol-epoetin beta) needed to help increase your hemoglobin level to between 10 to 12 g/dL and to help avoid the need for red blood cell transfusions.

You may be asked to have certain blood tests, such as hemoglobin, hematocrit, or iron level measurements. Based on your test results, your healthcare provider will adjust the dose of Mircera (methoxy polyethylene glycol-epoetin beta) as needed to reach the right dose for you and to help prevent serious side effects. The right dose for you may change over time.

Mircera (methoxy polyethylene glycol-epoetin beta) is not used to treat anemia that is caused by other health problems, such as cancer.

Mircera (methoxy polyethylene glycol-epoetin beta) has not been studied in children.

Who should not take Mircera (methoxy polyethylene glycol-epoetin beta) ?

Do not take Mircera (methoxy polyethylene glycol-epoetin beta) if:

  • You have high blood pressure that is not controlled (uncontrolled hypertension)
  • You have allergies to Mircera (methoxy polyethylene glycol-epoetin beta) or other ESAs
  • You have anemia caused by cancer chemotherapy

What should I tell my healthcare provider before taking Mircera (methoxy polyethylene glycol-epoetin beta) ?

Mircera (methoxy polyethylene glycol-epoetin beta) 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 any history of stroke, blood clots or seizures
  • Have blood disorders (such as sickle cell anemia or clotting disorders)
  • Are pregnant, think you may be pregnant or plan to become pregnant. The effect of Mircera (methoxy polyethylene glycol-epoetin beta) on pregnant women is unknown. It is also not known if Mircera (methoxy polyethylene glycol-epoetin beta) could harm an unborn baby.
  • Are breast-feeding or plan to breast-feed. It is not known if Mircera (methoxy polyethylene glycol-epoetin beta) passes into human breast milk.

Tell your healthcare provider about all of the medicines you take, including prescription and non- prescription medicines, vitamins, and herbal supplements.

How should I take Mircera (methoxy polyethylene glycol-epoetin beta) ?

Mircera (methoxy polyethylene glycol-epoetin beta) is taken as either an intravenous (IV) or subcutaneous (SC) injection. It can take two to six weeks of treatment to see an increase in your hemoglobin level. If the desired increase is not seen, your healthcare provider may change your treatment dose.

  • Mircera (methoxy polyethylene glycol-epoetin beta) should be administered by your healthcare provider. In some cases, your healthcare provider may allow you or your caregiver to give the injections at home.
  • If you or your caregiver are allowed to give the injections at home, it is important that you carefully follow the instructions that your healthcare provider gives you. Be sure that you read, understand, and follow the "Patient Instructions for Use."
  • Take Mircera (methoxy polyethylene glycol-epoetin beta) exactly as your healthcare provider tells you to. Do not change the dose of Mircera (methoxy polyethylene glycol-epoetin beta) unless told to by your healthcare provider. Your healthcare provider will show you or your caregiver how much Mircera (methoxy polyethylene glycol-epoetin beta) to use, how to inject it, how often it should be injected and how to safely throw away used needles and syringes.
  • Change the skin site for each injection to avoid soreness at any one site. Sometimes a problem may develop at the injection site. If there is a lump, swelling, or bruising at the injection site that does not go away, talk to your healthcare provider.
  • To use Mircera (methoxy polyethylene glycol-epoetin beta) safely at home, it is important that you:
    • Use the contents of a vial or prefilled syringe one time only
    • Throw away any solution remaining in the vial after use
    • Use a needle and syringe only one time for injection
  • If you have a hemodialysis vascular access, regularly check it to make sure it is working. Call your healthcare provider or dialysis center right away if you have any problems or questions.
  • If you miss one dose of Mircera (methoxy polyethylene glycol-epoetin beta) , take your dose right away and then continue as you have been told by your healthcare provider. If you miss more than one dose, call your healthcare provider right away for instructions on what to do.
  • If you take more than the prescribed amount of Mircera (methoxy polyethylene glycol-epoetin beta) , call your healthcare provider right away for instructions on what to do.
  • Continue to follow your healthcare provider's instructions for diet, dialysis, and medicines including medicines for high blood pressure, while taking Mircera (methoxy polyethylene glycol-epoetin beta) .

What are possible side effects of Mircera (methoxy polyethylene glycol-epoetin beta) ?

Mircera (methoxy polyethylene glycol-epoetin beta) can cause serious side effects. See "What is the most important information I should know about Mircera (methoxy polyethylene glycol-epoetin beta) ?"

Other side effects, which may be serious include:

  • High blood pressure. Your blood pressure may go up when the numbers of red blood cells increase while taking Mircera (methoxy polyethylene glycol-epoetin beta) . This can happen even if you have never had high blood pressure before. Your healthcare provider or caregiver should check your blood pressure often. If you have a history of heart problems or high blood pressure, talk with your healthcare provider about how often to check your blood pressure. Call your healthcare provider if your blood pressure changes from what is normal for you. If your blood pressure does increase, your healthcare provider may prescribe new or more blood pressure medicine.
  • Seizures. Seizures can occur in people receiving Mircera (methoxy polyethylene glycol-epoetin beta) . If you have any seizures while taking Mircera (methoxy polyethylene glycol-epoetin beta) , get medical help right away and tell your healthcare provider.
  • Serious allergic reaction. Mircera (methoxy polyethylene glycol-epoetin beta) may cause a serious allergic reaction. Symptoms of a serious allergic reaction may include: a rash all over the body, shortness of breath, wheezing, dizziness, fainting, swelling around the mouth or eyes, fast pulse, or sweating. If a serious allergic reaction occurs, stop using Mircera (methoxy polyethylene glycol-epoetin beta) and call your healthcare provider or get emergency medical help right away.
  • No response or loss of your hemoglobin response to Mircera (methoxy polyethylene glycol-epoetin beta) . If your hemoglobin does not reach the desired level of 10 to 12 g/dL or your hemoglobin does not stay within this level, your healthcare provider will look for the cause of the problem. Your dose of Mircera (methoxy polyethylene glycol-epoetin beta) or other medicines may need to be changed.
  • Antibodies to Mircera (methoxy polyethylene glycol-epoetin beta) . Your body may make antibodies to Mircera (methoxy polyethylene glycol-epoetin beta) . 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.

The most common side effects you may have when taking Mircera (methoxy polyethylene glycol-epoetin beta) are:

Other side effects when taking Mircera (methoxy polyethylene glycol-epoetin beta) may include:

  • Decreased blood pressure (hypotension)
  • Vomiting
  • Constipation
  • Urinary tract infections
  • Body or muscle aches, including back pain
  •  Swelling in your arms or legs with or without shortness of breath
  • Problems with your hemodialysis vascular access (such as arteriovenous fistulas), including clotting and fistula site problems
  • Injection site reactions such as redness, swelling, or itching. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Mircera (methoxy polyethylene glycol-epoetin beta) . Your healthcare provider or pharmacist can give you a more complete list.

How should I store Mircera (methoxy polyethylene glycol-epoetin beta) ?

  • Keep Mircera (methoxy polyethylene glycol-epoetin beta) in the original package. Protect Mircera (methoxy polyethylene glycol-epoetin beta) from light. Do not use Mircera (methoxy polyethylene glycol-epoetin beta) that has been left in bright light.
  • Do not shake Mircera (methoxy polyethylene glycol-epoetin beta)
  • Store Mircera (methoxy polyethylene glycol-epoetin beta) in the refrigerator at 36°F to 46°F (2°C to 8°C)
  • If a refrigerator is not available, Mircera (methoxy polyethylene glycol-epoetin beta) Prefilled Syringes can be stored at room temperature 77°F or less (25°C or less) for up to 30 days
  • Mircera (methoxy polyethylene glycol-epoetin beta) Vials can be stored at room temperature 77°F or less (25°C or less) for up to 7 days
  • Do not freeze Mircera (methoxy polyethylene glycol-epoetin beta) . Do not use Mircera (methoxy polyethylene glycol-epoetin beta) that has been frozen or improperly refrigerated. Talk to your healthcare provider or pharmacist with any questions about storing Mircera (methoxy polyethylene glycol-epoetin beta) .

Keep Mircera (methoxy polyethylene glycol-epoetin beta) and all medicines out of the reach of children.

General Information about Mircera (methoxy polyethylene glycol-epoetin beta)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide/Do not use Mircera (methoxy polyethylene glycol-epoetin beta) for a condition for which it was not prescribed. Do not give Mircera (methoxy polyethylene glycol-epoetin beta) 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 (methoxy polyethylene glycol-epoetin beta) . If you would like to know more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Mircera (methoxy polyethylene glycol-epoetin beta) that is written for health professionals. For more information, go to www.MIRCERA (methoxy polyethylene glycol-epoetin beta) .com OR call 1-800-526-6367.

What are the ingredients in Mircera?

Active ingredient: methoxy polyethylene glycol-epoetin beta

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

This Medication Guide has been approved by the U.S. Food and Drug Administration

Patient Instructions for Use

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

Single Use Prefilled Syringe (for Injection)

Read the Medication Guide that comes with Mircera (methoxy polyethylene glycol-epoetin beta) for the most important information you need to know. It is also very important that you carefully read and understand these instructions for how to give yourself the correct dose of Mircera (methoxy polyethylene glycol-epoetin beta) .

When you receive your supply of Mircera (methoxy polyethylene glycol-epoetin beta) , make sure that:

  1. The name Mircera (methoxy polyethylene glycol-epoetin beta) appears on the pack.
  2. Mircera (methoxy polyethylene glycol-epoetin beta) is used before the expiration date on the pack. Do not use Mircera (methoxy polyethylene glycol-epoetin beta) after the expiration date.
  3. The dosage strength on the Mircera (methoxy polyethylene glycol-epoetin beta) pack matches the strength prescribed [number of micrograms (meg)].
  4. The liquid in Mircera (methoxy polyethylene glycol-epoetin beta) is clear and colorless to slightly yellow. Do not use Mircera (methoxy polyethylene glycol-epoetin beta) if the liquid appears discolored or cloudy, or if it appears to have lumps, flakes or particles in it.
  5. The needle cover is on the prefilled syringe of Mircera (methoxy polyethylene glycol-epoetin beta) . Do not use the prefilled syringe of Mircera (methoxy polyethylene glycol-epoetin beta) if the cover on the needle is off.
  6. The prefilled syringe and needle used for administration of Mircera (methoxy polyethylene glycol-epoetin beta) is the one prescribed by your healthcare provider. The dose of Mircera (methoxy polyethylene glycol-epoetin beta) will be measured in micrograms (meg). Mircera (methoxy polyethylene glycol-epoetin beta) can be given either by a prefilled syringe or a vial using a syringe and needle. Mircera (methoxy polyethylene glycol-epoetin beta) prefilled syringes and vials'come in several different strengths. If you change from using the vials (syringes and needles) of Mircera (methoxy polyethylene glycol-epoetin beta) to the prefilled syringes, the strength of medicine will be different. Talk with your healthcare provider or pharmacist to be sure you understand the difference. Use the prefilled syringe only once. Throw away the prefilled syringe in a puncture-proof disposable container after use as instructed by your healthcare provider.

Your healthcare provider should tell you how to give the correct dose of Mircera (methoxy polyethylene glycol-epoetin beta) :

  • How much Mircera (methoxy polyethylene glycol-epoetin beta) to use
  • How to inject
  • How often it should be injected
  • How to throw away used syringes

IMPORTANT: FOLLOW THESE INSTRUCTIONS TO GIVE MIRCERA (methoxy polyethylene glycol-epoetin beta) INJECTIONS AND AVOID POSSIBLE INFECTION.

SETTING UP FOR AN INJECTION

  1. Find a clean, flat work surface such as a table.
  2. Take a pack of Mircera (methoxy polyethylene glycol-epoetin beta) from the refrigerator. Do not freeze Mircera (methoxy polyethylene glycol-epoetin beta) or use a prefilled syringe that has been frozen. Do not shake Mircera (methoxy polyethylene glycol-epoetin beta) or leave it in bright light. Shaking the prefilled syringe or exposing it to light may damage Mircera (methoxy polyethylene glycol-epoetin beta) and it may not work as well. If the Mircera (methoxy polyethylene glycol-epoetin beta) prefilled syringe has been shaken, the solution may look foamy and should not be used.
  3. Take the prefilled syringe of Mircera (methoxy polyethylene glycol-epoetin beta) out of its pack and place it on your flat work surface.
  4. Use a prefilled syringe only once.
  5. Gather the supplies you will need for an injection (see Figure 1). You will need:

    • Mircera prefilled syringe with a clear plastic needle guard attached Mircera prefilled syringe
    • One alcohol swab and one cotton ball or gauze One alcohol swabone cotton ball or gauze
    • Puncture-proof disposable container, which will be given to you by your healthcare provider, for safely throwing away the prefilled syringe after injection Puncture-proof disposable container

Figure 1.

6. Wash your hands well with soap and warm water before preparing the dose.

PREPARING THE DOSE OF Mircera (methoxy polyethylene glycol-epoetin beta)

  1. Open the wrapper and remove the prefilled syringe and needle.
  2. Break the seal and remove the plastic cap from the back of the needle (see Figure 2).
  3. Preparing The Dose Of Mircera - illustration 1

    Figure 2.
  4. Remove the rubber tip cap from the prefilled syringe. It may require a strong pull (see Figure 3).
  5. Preparing The Dose Of Mircera - illustration 2

    Figure 3.
  6. Attach the needle to the prefilled syringe (see Figure 4)
  7. Preparing The Dose Of Mircera - illustration 3

    Figure 4.
  8. Put the prefilled syringe on its side with the needle cover on. This will keep the needle from touching anything before you use it (see Figure 5).
  9. Preparing The Dose Of Mircera - illustration 4

    Figure 5.

SELECTING AND PREPARING THE INJECTION SITE

1. Choose an injection site (see Figure 6). The three sites where you can inject Mircera (methoxy polyethylene glycol-epoetin beta) 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)

Choosing an injection site - illustration

Choose a new injection site each time you inject Mircera (methoxy polyethylene glycol-epoetin beta) . This helps to avoid soreness at any one site.

Do not inject Mircera (methoxy polyethylene glycol-epoetin beta) into an area on your body that is tender, red, bruised, hard, or that has scars or stretch marks.

2. Clean the injection site with a new alcohol swab. Do not touch this area again before giving the injection (see Figure 7).

Clean the injection site with a new alcohol swab - illustration

INJECTING THE DOSE OF Mircera (methoxy polyethylene glycol-epoetin beta) FOR PATIENTS NOT ON HEMODIALYSIS

  1. Remove the plastic cover from the needle (see Figure 8).
    Remove the plastic cover from the needle - illustration

  2. Remove air bubbles from the syringe. Hold the prefilled syringe with the needle pointing up. Tap the prefilled syringe gently to bring the bubbles to the top. Push the plunger up slowly to the correct dose.
  3. Hold the prefilled syringe in the hand that you will use to inject Mircera (methoxy polyethylene glycol-epoetin beta) . Use the other hand to pinch a fold of skin at the cleaned injection site (see Figure 9).

    Pinch a fold of skin at the cleaned injection site - illustration

  4. Hold the prefilled syringe like a pencil. Insert the needle in a quick "dart like" motion. Inject either at a slight angle (45 degree angle) or straight up and down (90 degree angle) into the skin (see Figure 10).
    Hold the prefilled syringe like a pencil - illustration

  5. Pull the plunger back slightly after inserting the needle into the skin. If blood comes into the prefilled syringe, do not inject Mircera (methoxy polyethylene glycol-epoetin beta) because the needle has entered a blood vessel. Remove the needle from the skin. Slightly reposition the needle within the cleaned area and repeat. If blood does not come, slowly push the plunger all the way down until all the medicine is injected. The plastic needle guard (a safety mechanism to prevent accidental needle sticks) will not move forward to cover the needle unless the full dose is given, (see Figure 11).

    Injecting - illustration

  6. Take the needle out of the skin without releasing the plunger (see Figure 12).

    Take the needle out of the skin without releasing the plunger - illustration

  7. Release the plunger after removing the needle from the skin. This allows the syringe to move back until the entire needle is guarded (see Figure 13).

    Release the plunger - illustration

  8. Place a cotton ball or gauze over the injection site and press for several seconds (see Figure 14).

    Place a cotton ball or gauze over the injection site - illustration

  9. Dispose of the syringe with any remaining liquid in the puncture-proof disposable container. Use the prefilled syringe one time only.

FOR PATIENTS ON HEMODIALYSIS USING VENOUS INJECTION

  1. Clean the venous port of the hemodialysis tubing with a new alcohol swab (see Figure 15).

    For Patients On Hemodialysis Using Venous Injection - illustration 1

  2. Insert the needle of the syringe into the cleaned venous port and push the plunger all the way down to inject all the medicine (see Figure 16).

    For Patients On Hemodialysis Using Venous Injection - illustration 2

  3. Remove the syringe from the venous port. Dispose of the syringe with any remaining liquid in the puncture- proof disposable container. Use the prefilled syringe one time only.

Disposing of Syringes and Needles

Follow the required state and local laws for disposal of needles and syringes. Ask your healthcare provider or pharmacist about correct disposal of used syringes and needles.

Use the information below as a general guide:

  • never re-use a syringe or needle
  • place used syringes and needles in the puncture-proof disposable container
  • DO NOT use glass or clear plastic containers to throw away syringes and needles
  • Throw away the full puncture-proof disposable container as instructed by your healthcare provider or pharmacist

DO NOT throw away the puncture-proof disposable container in your household trash. DO NOT recycle. Keep the container out of the reach of children.

Patient Instructions for Use

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

Single Use Vial (for Injection)

Read the Medication Guide that comes with Mircera (methoxy polyethylene glycol-epoetin beta) for the most important information you need to know. It is very important that you carefully read and understand these instructions for how to give yourself the correct dose of Mircera (methoxy polyethylene glycol-epoetin beta) .

When you receive your supply of Mircera (methoxy polyethylene glycol-epoetin beta) , make sure that:

  1. The name Mircera (methoxy polyethylene glycol-epoetin beta) appears on the pack.
  2. Mircera (methoxy polyethylene glycol-epoetin beta) is used before the expiration date on the pack. Do not use Mircera (methoxy polyethylene glycol-epoetin beta) after the expiration date.
  3. The dosage strength on the Mircera (methoxy polyethylene glycol-epoetin beta) pack matches the strength prescribed [number of micrograms (meg)].
  4. The liquid in Mircera (methoxy polyethylene glycol-epoetin beta) is clear and colorless to slightly yellow. Do not use Mircera (methoxy polyethylene glycol-epoetin beta) if the liquid appears discolored or cloudy, or if it appears to have lumps, flakes or particles in it.
  5. The colored cap is on the vial of Mircera (methoxy polyethylene glycol-epoetin beta) . Do not use the vial of Mircera (methoxy polyethylene glycol-epoetin beta) if the colored cap has been removed.
  6. The disposable syringe and needle used for administration of Mircera (methoxy polyethylene glycol-epoetin beta) are the ones prescribed by your healthcare provider. Mircera (methoxy polyethylene glycol-epoetin beta) can be given either by a prefilled syringe or a vial using a syringe and needle. Mircera (methoxy polyethylene glycol-epoetin beta) vials and prefilled syringes come in several different strengths. If you change from using the vials (syringes and needles) of Mircera (methoxy polyethylene glycol-epoetin beta) to the prefilled syringes, the strength of medicine will be different. Talk with your healthcare provider or pharmacist to be sure you understand the difference. Use the disposable syringe and needle only once. Throw away the syringe and needle in a puncture-proof disposable container after use as instructed by your healthcare provider.

Your healthcare provider should tell you how to give the correct dose of Mircera (methoxy polyethylene glycol-epoetin beta) :

  • How much Mircera (methoxy polyethylene glycol-epoetin beta) to use
  • How to inject
  • How often it should be injected
  • How to throw away used needles and syringes

The dose will be measured in meg per milliliters (mL). Use only a disposable syringe that is marked in tenths of mL (for example, 0.2 mL). Your healthcare provider may refer to an "mL" as a "cc" (1 mL = 1 cc). Do not use an unmarked syringe. Using an unmarked syringe can lead to a mistake in the dose. If you do not use the correct syringe, you could inject too much or too little Mircera (methoxy polyethylene glycol-epoetin beta) .

IMPORTANT: FOLLOW THESE INSTRUCTIONS TO GIVE MIRCERA (methoxy polyethylene glycol-epoetin beta) INJECTIONS AND AVOID POSSIBLE INFECTION.

SETTING UP FOR AN INJECTION

  1. Find a clean, flat work surface such as a table.
  2. Take a pack of Mircera (methoxy polyethylene glycol-epoetin beta) from the refrigerator. Do not freeze Mircera (methoxy polyethylene glycol-epoetin beta) or use a vial that has been frozen. Do not shake Mircera (methoxy polyethylene glycol-epoetin beta) or leave it in bright light. Shaking the vial or exposing it to light may damage Mircera (methoxy polyethylene glycol-epoetin beta) and it may not work as well. If the Mircera (methoxy polyethylene glycol-epoetin beta) vial has been shaken, the solution may look foamy and should not be used.
  3. Take the vial of Mircera (methoxy polyethylene glycol-epoetin beta) out of its pack and place it on your flat work surface.
  4. Use a vial only once. Do not put the needle through the rubber stopper more than once.
  5. Gather the supplies you will need for an injection (see Figure 1). You will need:
  • Mircera (methoxy polyethylene glycol-epoetin beta) vial and the correct disposable syringe and needle
  • Two alcohol swabs and one cotton ball or gauze
  • Puncture-proof disposable container, which will be given to you by your healthcare provider, for safely throwing away the needle and syringe after injection
Supplied needed for an injection - illustration

6.Wash your hands well with soap and warm water before preparing the dose.

PREPARING THE DOSE OF Mircera (methoxy polyethylene glycol-epoetin beta)

  1. Remove the protective colored cap from the vial (see Figure 2).


  2. Preparing The Dose Of Mircera - illustration 1

  3. Clean the rubber stopper on the vial with one alcohol swab and put the vial on your flat work surface (see Figure 3).


  4. Preparing The Dose Of Mircera - illustration 2

  5. Check the package containing the disposable syringe. If the syringe package is not damaged, open it and take out the syringe. If the package is damaged or has already been opened, do not use that syringe. Throw it away in the puncture-proof disposable container and get a new one.
  6. Pull off the needle cover. Then, pull back on the plunger to the dose of Mircera (methoxy polyethylene glycol-epoetin beta) that your healthcare provider has given you (in mL or cc). This will pull air into the syringe (see Figure 4).


  7. Preparing The Dose Of Mircera - illustration 3

  8. Keep the vial on your flat work surface and insert the needle straight down through the rubber stopper (see Figure 5).


  9. Preparing The Dose Of Mircera - illustration 4

  10. Push down on the plunger of the syringe to inject the air from the syringe into the vial. The air injected into the vial will allow Mircera (methoxy polyethylene glycol-epoetin beta) to be easily withdrawn into the syringe (see Figure 6).


  11. Preparing The Dose Of Mircera - illustration 5

  12. Turn the vial upside down, keeping the needle inside the vial. Make sure that the tip of the needle is in the Mircera (methoxy polyethylene glycol-epoetin beta) liquid. Your other hand will be free to move the plunger. Slowly pull back on the plunger to fill the syringe with Mircera (methoxy polyethylene glycol-epoetin beta) liquid to the number (mL or cc) that matches the dose your healthcare provider has given you (see Figure 7).


  13. Preparing The Dose Of Mircera - illustration 6

  14. Check for air bubbles in the syringe, keeping the needle inside the vial. Small air bubbles are harmless, but too large an air bubble will not let you draw up the right amount of Mircera (methoxy polyethylene glycol-epoetin beta) . To remove air bubbles, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe.
  15. Slowly push on the plunger to push the solution and the air bubbles out of the syringe and back into the vial (see Figure 8).


  16. Preparing The Dose Of Mircera - illustration 7

  17. Once again, pull the plunger back to the number on the syringe that matches your dose while making sure the tip of the needle is in the liquid. Check again for air bubbles. If there are still air bubbles, remove them by repeating Steps 8 through 10 (see Figure 9).


  18. Preparing The Dose Of Mircera - illustration 8

  19. Once you have gotten rid of all air bubbles, check again to make sure you have the right dose. Put the vial on its side with the needle still in it. This will keep the needle from touching anything before you use it (see Figure 10).


  20. Preparing The Dose Of Mircera - illustration 9

SELECTING AND PREPARING THE INJECTION SITE

1. Choose an injection site (see Figure 11). The three sites where you can inject Mircera (methoxy polyethylene glycol-epoetin beta) 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)


  • choosing an injection site - illustration

Choose a new injection site each time you inject Mircera (methoxy polyethylene glycol-epoetin beta) . This helps to avoid soreness at any one site.

Do not inject Mircera (methoxy polyethylene glycol-epoetin beta) into an area on your body that is tender, red, bruised, hard, or that has scars or stretch marks.

2. Clean the injection site with a new alcohol swab. Do not touch this area again before giving the injection (sec Figure 12).

cleaning the injection site - illustration

INJECTING THE DOSE OF Mircera (methoxy polyethylene glycol-epoetin beta) FOR PATIENTS NOT ON HEMODIALYSIS

  1. Hold the syringe in the hand that you will use to inject Mircera (methoxy polyethylene glycol-epoetin beta) . Use the other hand to pinch a fold of skin at the cleaned injection site (see Figure 13).


  2. Injecting The Dose Of Mircera For Patients Not On Hemodialysis - illustration 1

  3. Hold the syringe like a pencil. Insert the needle in a quick "dart like" motion. Inject either at a slight angle (45 degree angle) or straight up and down (90 degree angle) into the skin (see Figure 14).


  4. Injecting The Dose Of Mircera For Patients Not On Hemodialysis - illustration 2

  5. Pull the plunger back slightly after inserting the needle into the skin. If blood comes into the syringe, do not inject Mircera (methoxy polyethylene glycol-epoetin beta) because the needle has entered a blood vessel. Remove the needle from the skin. Slightly reposition the needle within the cleaned area and repeat. If blood does not come, slowly push the plunger all the way down, until all the medicine is injected (see Figure 15).


  6. Injecting The Dose Of Mircera For Patients Not On Hemodialysis - illustration 3

  7. Take the needle out of the skin. Place a cotton ball or gauze over the injection site and press for several seconds (see Figure 16).


  8. Injecting The Dose Of Mircera For Patients Not On Hemodialysis - illustration 4

  9. Dispose of the syringe and needle and the vial with any remaining liquid in the puncture-proof disposable container. Use the disposable syringe, needle and vial of medicine one time only.

FOR PATIENTS ON HEMODIALYSIS USING VENOUS INJECTION

  1. Clean the venous port of the hemodialysis tubing with a new alcohol swab (see Figure 17).


  2. For Patients On Hemodialysis Using Venous Injection - Illustration 1

  3. Insert the needle of the syringe into the cleaned venous port and push the plunger all the way down to inject all the medicine (see Figure 18).


  4. For Patients On Hemodialysis Using Venous Injection - Illustration 2

  5. Remove the syringe from the venous port. Dispose of the syringe and needle and the vial with any remaining liquid in the puncture-proof disposable container. Use the disposable syringe, needle and vial of medicine one time only.

Disposing of Syringes and Needles

Follow the required state and local laws for disposal of needles and syringes. Ask your healthcare provider or pharmacist about correct disposal of used syringes and needles.

Use the information below as a general guide:

  • Never re-use the needle and syringe
  • Place used needle and syringe in the puncture-proof disposable container
  • DO NOT use glass or clear plastic containers to throw away the needle and syringe
  • Throw away the full puncture-proof disposable container as instructed by your healthcare provider or pharmacist

Last reviewed on RxList: 12/20/2007
This monograph has been modified to include the generic and brand name in many instances.

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