Epoetin Alfa

No clinical studies have been done to demonstrate epoetin alfa drug interactions.

Anemia Due To Chronic Kidney Disease

Epogen is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion.

Anemia Due To Zidovudine In HIV-infected Patients

Epogen is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL.

Anemia Due To Chemotherapy In Patients With Cancer

Epogen is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

Reduction Of Allogeneic Red Blood Cell Transfusions In Patients Undergoing Elective, Noncardiac, Nonvascular Surgery

Epogen is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. Epogen is not indicated for patients who are willing to donate autologous blood pre-operatively.

Limitations Of Use

Epogen has not been shown to improve quality of life, fatigue, or patient well-being. Epogen is not indicated for use:

• In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
• In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
• In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion.
• In patients scheduled for surgery who are willing to donate autologous blood.
• In patients undergoing cardiac or vascular surgery.
• As a substitute for RBC transfusions in patients who require immediate correction of anemia.

PROCRIT®
(PRO'-KRIT)
(epoetin alfa) for Injection

Read this Medication Guide:

• before you start PROCRIT.
• if you are told by your healthcare provider that there is new information about PROCRIT.
• if you are told by your healthcare provider that you may inject PROCRIT 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 PROCRIT and ask if there is new information about PROCRIT.

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

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

For people with cancer:

• Your tumor may grow faster and you may die sooner if you choose to take PROCRIT. Your healthcare provider has received special training in order to prescribe PROCRIT and will talk with you in detail about these risks.

For all people who take PROCRIT, including people with cancer or chronic kidney disease:

• Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with PROCRIT 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 PROCRIT. If you are receiving PROCRIT 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 PROCRIT?” below for more information.

If you decide to take PROCRIT, your healthcare provider should prescribe the smallest dose of PROCRIT that is necessary to reduce your chance of needing RBC transfusions.

What is PROCRIT?

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

PROCRIT may be used to treat anemia if it is caused by:

• Chronic kidney disease (you may or may not be on dialysis).
• Chemotherapy that will be used for at least two months after starting PROCRIT.
• A medicine called zidovudine (AZT) used to treat HIV infection.

PROCRIT may also be used to reduce the chance you will need RBC transfusions if you are scheduled for certain surgeries where a lot of blood loss is expected.

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 PROCRIT, even if you do not have an increase in your hemoglobin level.

PROCRIT should not be used for treatment of anemia:

• If you have cancer and you will not be receiving chemotherapy that may cause anemia.
• If you have a cancer that has a high chance of being cured. Talk with your healthcare provider about the kind of cancer you have.
• In place of emergency treatment for anemia (RBC transfusions).

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

PROCRIT should not be used to reduce the chance of RBC transfusions if:

• You are scheduled for surgery on your heart or blood vessels.
• You are able and willing to donate blood prior to surgery.

Who should not take PROCRIT?

Do not take PROCRIT if you:

• Have cancer and have not been counseled by your healthcare provider about treatment with PROCRIT.
• 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 PROCRIT or other erythropoietin protein medicines.
• Have had a serious allergic reaction to PROCRIT.

Do not give PROCRIT from multidose vials to:

• Pregnant or breastfeeding women
• Babies

What should I tell my healthcare provider before taking PROCRIT?

PROCRIT may not be right for you. Tell your healthcare provider about all your health conditions, including if you:

• Have heart disease.
• Have high blood pressure.
• Have had a seizure (convulsion) or stroke.
• Have any other medical conditions.
• Are pregnant or planning to become pregnant. It is not known if PROCRIT may harm your unborn baby. Talk to your healthcare provider about possible pregnancy and birth control choices that are right for you.
• Are breastfeeding or planning to breastfeed. It is not known if PROCRIT passes into breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription 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 PROCRIT?

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

What are the possible side effects of PROCRIT?

PROCRIT may cause serious side effects.

• See “What is the most important information I should know about PROCRIT?”
• High blood pressure. High blood pressure is a common side effect of PROCRIT in patients with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medicine while taking PROCRIT. 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 PROCRIT, get medical help right away and tell your healthcare provider.
• Antibodies to PROCRIT. Your body may make antibodies to PROCRIT. These antibodies can block or lessen your body's ability to make RBCs 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 PROCRIT.
• Serious allergic reactions. 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 PROCRIT and call your healthcare provider or get medical help right away.
• Dangers of using PROCRIT from multi-dose vials in newborns, infants, and pregnant or breastfeeding women. Do not use PROCRIT from multi-dose vials in newborns, infants, pregnant or breastfeeding women because the PROCRIT in these vials contains benzyl alcohol. Benzyl alcohol has been shown to cause brain damage, other serious side effects, and death in newborn and premature babies. PROCRIT that comes in single-dose vials does not contain benzyl alcohol. See “Who should not take PROCRIT?”

Common side effects of PROCRIT include:

• joint, muscle, or bone pain
• fever
• cough
• rash
• nausea
• vomiting
• soreness of mouth
• itching
• headache
• redness and pain in the skin where PROCRIT shots were given

These are not all of the possible side effects of PROCRIT. 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 1-800-FDA-1088.

How should I store PROCRIT?

• Do not shake PROCRIT.
• Protect PROCRIT from light.
• Store PROCRIT in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze PROCRIT. Do not use PROCRIT that has been frozen.
• Throw away multidose vials of PROCRIT no later than 21 days from the first day that you put a needle into the vial.
• Single-dose vials of PROCRIT should be used only one time. Throw the vial away after use even if there is medicine left in the vial.

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

General information about PROCRIT

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use PROCRIT only for the condition for which it has been prescribed. Do not give PROCRIT to other patients even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about PROCRIT. If you would like more information about PROCRIT, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about PROCRIT that is written for healthcare professionals. For more information, go to the following website: www.PROCRIT.com or call 1-800-JANSSEN (1-800-526-7736).

What are the ingredients in PROCRIT?

Active Ingredient: epoetin alfa

Inactive Ingredients:

• Multidose vials contain benzyl alcohol.
• All vials contain albumin (human), sodium citrate, sodium chloride, and citric acid.
• Single-dose vials containing 40,000 Units of PROCRIT also contain sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrate.

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

Instructions for Use

PROCRIT®
(PRO'-KRIT)
(epoetin alfa)

Use these Instructions for Use if you or your caregiver has been trained to give PROCRIT injections at home. Do not give yourself the injection unless you have received training from your healthcare provider. If you are not sure about giving the injection or you have questions, ask your healthcare provider for help.

Before reading these Instructions for Use, read the Medication Guide that comes with PROCRIT for the most important information you need to know.

When you receive your PROCRIT vial and syringes make sure that:

• The name PROCRIT appears on the carton and vial label.
• The expiration date on the vial label has not passed. Do not use a vial of PROCRIT after the expiration date on the label.
• The dose strength of the PROCRIT vial (number of Units per mL on the vial label) is the same as your healthcare provider prescribed.
• You understand what the dose strength of PROCRIT means. PROCRIT vials come in several dose strengths. For example, the dose strength may be described as 10,000 Units/mL on the vial label. This strength means that 10,000 Units of medicine are contained in each 1 mL (milliliter) of liquid. Your healthcare provider may also refer to a mL as a “cc.” One mL is the same as one “cc.”
• The PROCRIT liquid in the vial is clear and colorless. Do not use PROCRIT if the liquid in the vial looks discolored or cloudy, or if the liquid has lumps, flakes, or particles.
• The PROCRIT vial has a color cap on the top of the vial. Do not use a vial of PROCRIT if the color cap on the top of the vial has been removed or is missing.
• Use only the type of disposable syringe and needle that your healthcare provider has prescribed.
• Do not shake PROCRIT. Shaking could cause PROCRIT not to work. If you shake PROCRIT, the solution in the vial may look foamy and should not be used.
• Do not freeze PROCRIT. Do not use a vial of PROCRIT that has been frozen.
• Store PROCRIT in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Keep PROCRIT away from light.
• Single-dose vials of PROCRIT should be used only one time. Throw the vial away after use even if there is medicine left in the vial.
• After removing a dose from the multidose vial, store the vial in the refrigerator (but not the freezer). Do not store the vial for more than 21 days.
• Throw away the multidose vial as directed by your healthcare provider:
  • if there is not enough medicine left in the multidose vial for another dose, or
  • if it has been more than 21 days since you first put a needle into the multidose vial.

How should I prepare for an injection of PROCRIT?

• Always keep an extra syringe and needle on hand.
• Follow your healthcare provider's instructions on how to measure your dose of PROCRIT. This dose will be measured in Units per mL or cc (1 mL is the same as 1 cc). Use a syringe that is marked in tenths of mL (for example, 0.2 mL or 0.2 cc). Using the wrong syringe can lead to a mistake in your dose and you could inject too much or too little PROCRIT.

Only use disposable syringes and needles. Use the syringes and needles only one time and then throw them away as instructed by your healthcare provider.

What do I need to know about the different types of PROCRIT vials?

PROCRIT comes in two different types of vials.

• Single-dose Vials
• Multidose Vials

The multidose vial of PROCRIT contains the preservative benzyl alcohol. Benzyl alcohol has been shown to cause brain damage, other serious side effects, and death in newborn and premature babies. PROCRIT that comes in single-dose vials does not contain benzyl alcohol.

Important: Follow these instructions exactly to help avoid infections.

Preparing the dose:

1. Remove the vial of PROCRIT from the refrigerator. During this time, protect the solution from light.

2. Do not use a single-dose vial of PROCRIT more than one time.

3. Do not shake PROCRIT.

4. Gather the other supplies you will need for your injection (vial, syringe, alcohol wipes, cotton ball, and a puncture-proof container for throwing away the syringe and needle). See Figure 1.

Figure 1

5. Check the date on the PROCRIT vial to be sure that the drug has not expired.

6. Wash your hands well with soap and water before preparing the medicine. See Figure 2.

Figure 2

7. Flip off the protective color cap on the top of the vial. Do not remove the grey rubber stopper. Wipe the top of the grey rubber stopper with an alcohol wipe. See Figures 3 and 4.

Figure 3 AND 4

8. Check the package containing the syringe. If the package has been opened or damaged, do not use that syringe. Throw away the syringe in the puncture-proof disposable container. If the syringe package is undamaged, open the package and remove the syringe.

9. Using a syringe and needle that has been recommended by your healthcare provider, carefully remove the needle cover. See Figure 5. Then draw air into the syringe by pulling back on the plunger. The amount of air drawn into the syringe should be equal to the amount (mL or cc) of the PROCRIT dose prescribed by your healthcare provider. See Figure 6.

Figure 5 AND 6

10. With the vial on a flat work surface, insert the needle straight down through the grey rubber stopper of the PROCRIT vial. See Figure 7.

11. Push the plunger of the syringe down to inject the air from the syringe into the vial of PROCRIT. The air injected into the vial will allow PROCRIT to be easily withdrawn into the syringe. See Figure 7.

Figure 7

12. Keep the needle inside the vial. Turn the vial and syringe upside down. Be sure the tip of the needle is in the PROCRIT liquid. Keep the vial upside down. Slowly pull back on the plunger to fill the syringe with PROCRIT liquid to the number (mL or cc) that matches the dose your healthcare provider prescribed. See Figure 8.

Figure 8

13. Keep the needle in the vial. Check for air bubbles in the syringe. A small amount of air is harmless. Too large an air bubble will give you the wrong PROCRIT dose. To remove air bubbles, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. Slowly push the plunger up to force the air bubbles out of the syringe. Keep the tip of the needle in the PROCRIT liquid. Pull the plunger back to the number on the syringe that matches your dose. Check again for air bubbles. If there are still air bubbles, repeat the steps above to remove them. See Figures 9 and 10.

Figure 9 AND 10

14. Double-check that you have the correct dose in the syringe. Lay the vial down on its side with the needle still in it until after you have selected and prepared your site for injection.

Selecting and preparing the injection site:

PROCRIT can be injected into your body using two different ways (routes) as described below. Follow your healthcare provider's instructions about how you should inject PROCRIT. In patients on hemodialysis, the intravenous (IV) route is recommended.

1. Subcutaneous Route:

• PROCRIT can be injected directly into a layer of fat under your skin. This is called a subcutaneous injection. When giving subcutaneous injections, follow your healthcare provider's instructions about changing the site for each injection. You may wish to write down the site where you have injected.
• Do not inject PROCRIT into an area that is tender, red, bruised, hard, or has scars or stretch marks. Recommended sites for injection are shown in Figure 11 below, including:
  • The outer area of the upper arms
  • The abdomen (except for the 2-inch area around the navel)
  • The front of the middle thighs
  • The upper outer area of the buttocks

Figure 11

• Clean the skin with an alcohol wipe where the injection is to be made. Be careful not to touch the skin that has been wiped clean. See Figure 12.

Figure 12

• Double-check that the correct amount of PROCRIT is in the syringe.
• Remove the prepared syringe and needle from the vial of PROCRIT and hold it in the hand that you will use to inject the medicine.
• Use the other hand to pinch a fold of skin at the cleaned injection site. Do not touch the cleaned area of skin. See Figure 13.

Figure 13

• Hold the syringe like you would hold a pencil. Use a quick “dart-like” motion to insert the needle either straight up and down (90-degree angle) or at a slight angle (45 degrees) into the skin. Inject the prescribed dose subcutaneously as directed by your doctor, nurse or pharmacist. See Figure 14.

Figure 14

• Pull the needle out of the skin and press a cotton ball or gauze over the injection site and hold it there for several seconds. Do not recap the needle.
• Dispose of the used syringe and needle as described below. Do not reuse syringes and needles.

2. Intravenous Route:

• PROCRIT can be injected in your vein through a special access port placed by your healthcare provider. This type of PROCRIT injection is called an intravenous (IV) injection. This route is usually for hemodialysis patients.
• If you have a dialysis vascular access, make sure it is working by checking it as your healthcare provider has shown you. Be sure to let your healthcare provider know right away if you are having any problems, or if you have any questions.
• Wipe off the venous port of the hemodialysis tubing with an alcohol wipe. See Figure 15.

Figure 15

• Insert the needle of the syringe into the cleaned venous port and push the plunger all the way down to inject all the PROCRIT. See Figure 16.

Figure 16

• Remove the syringe from the venous port. Do not recap the needle.
• Dispose of the used syringe and needle as described below.

How should I dispose of the vials, syringes, and needles?

Do not reuse the single-dose vials, syringes, or needles. Throw away the vials, syringes, and needles as instructed by your healthcare provider or by following these steps:

• Do not throw the vials, syringes, or needles in the household trash or recycle.
• Do not put the needle cover back on the needle.
• Place all used needles and syringes in a puncture-proof disposable container with a lid. Do not use glass or clear plastic containers, or any container that will be recycled or returned to a store.
• Keep the puncture-proof disposable container out of the reach of children.
• When the puncture-proof disposable container is full, tape around the cap or lid to make sure the cap or lid does not come off. Throw away the puncture-proof disposable container as instructed by your healthcare provider. There may be special state and local laws for disposing of used needles and syringes. Do not throw the puncture-proof disposable container in the household trash. Do not recycle.

Keep PROCRIT and all medicines out of reach of children.

These Instructions for Use have been approved by the U.S. Food and Drug Administration.

Serious side effects have been reported with epoetin alfa.  See the "Drug Precautions" section. 

Common side effects of epoetin alfa include the following:

• joint, muscle, or bone pain
• fever
• cough
• rash
• nausea
• vomiting
• mouth soreness
• itching
• headache
• redness and pain in the skin where injections were given

This is not a complete list of epoetin alfa side effects.  Ask your doctor or pharmacist for more information. 

Tell your doctor if you have any side effect that bothers you or that does not go away.  Call your doctor for medical advice about side effects. 

You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if epoetin alfa crosses into human milk.  Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, a choice should be made whether to stop nursing or stop the use of this medication.  Your doctor will decide if the benefits outweigh the risk of using epoetin alfa.  The multi-dose vials of epoetin alfa should not be used if you are breastfeeding since they contains benzyl alcohol.  See the "Drug Precautions" section.

Administer epoetin alfa exactly as prescribed.  This medication is available in an injectable form to be given directly under the skin (subcutaneously) or directly into a vein (IV) by you, your caregiver, or healthcare provider.

To inject epoetin alfa follow these instructions:

1. Remove the vial of epoetin alfa from the refrigerator.

2. Do not use the single-dose vial more than one time.

3. Do not shake the vial

4. Gather the other supplies you will need for the injection including the syringe, alcohol wipes. cotton ball, and a puncture-proof container for throwing away the syringe and needle.

5. Check the date on the epoetin alfa vial to make sure it has not expired.

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

7. Flip off the protective color cap on the top of the vial, but do not remove the grey rubber stopper.  Wipe off the top of the grey rubber stopper with an alcohol wipe.

8. Open the package containing the syringe.  Use only a needle and syringe that has been recommended by your healthcare provider.  Carefully remove the needle cover.  Next, draw air into the syringe by pulling back on the plunger.  The amount of air drawn into the syringe should equal the amount in milliliters (ml) of the epoetin alfa dose prescribed by your healthcare provider.

9. Place the vial on a flat work surface, and insert the needle straight down through the grey rubber stopper of the epoetin alfa vial.  Push the plunger of the syringe down to inject the air from the syringe into the epoetin alfa vial.

10. Keep the needle inside the vial, and turn the vial and syringe upside down, and make sure that the tip of the needle is in the epoetin alfa liquid.  Keep the vial upside down, and slowly pull back on the plunger to fill the syringe with the epoetin alfa liquid to the number (ml) that matches the dose your healthcare provider prescribed.

11. Keep the needle inside the vial and check for air bubbles in the syringe.  Too large an air bubble can give you the wrong dose.  To remove air bubbles, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe.  Slowly push the plunger up to force the air bubbles out of the syringe, and keep the tip of the needle in the epoetin alfa liquid.  Pull the plunger back to the number on the syringe that matches your dose.

12. Double-check that you have the correct dose in the syringe, and lay the vial down on its side with the needle still in it.  Now it is time to prepare the injection site.

Preparing the site for a subcutaneous (directly under the skin) injection

1. Follow your healthcare provider's instructions about changing the site for each injection.  It is a good idea to write down the site you have injected each time.  Do not inject epoetin alfa into an area that is tender, red, bruised, hard, or has scars or stretch marks. 

2. The following are recommended sites for injection:

• The outer area of the upper arms
• The abdomen (except for the 2 inch area around the navel)
• The front of the middle thighs
• The upper outer area of the buttocks

3. Clean the skin with an alcohol wipe where the injection is to be made, and make sure not to touch the skin that has been wiped clean.

4. Double-check that the correct amount of epoetin alfa is in the syringe.

5. Remove the prepared syringe and needle from the vial of epoetin alfa and hold it in the hand that you will use to inject the medicine.  Use the other hand to pinch a fold of skin at the cleaned injection site.  Hold the syringe like you would a pencil and use a quick motion to insert the needle either straight up and down (90-degree angle) or at a slight angle (45 degrees) into the skin and inject the medicine.

6. Pull the needle out of the skin and press a cotton ball or gauze over the injection site and hold it there for several seconds.  Do not recap the needle.  Dispose of the used syringe and needle as outlined in the "Other Requirements" section.  It is important not to reuse syringes and needles.

Preparing the site for an IV (into the vein) injection through a special access port

1. Epoetin alfa can be injected in your vein through a special access port placed by your healthcare provider generally for patients on hemodialysis (removes blood from the body and sends it across a special filter with solutions to remove harmful substances and then returns the blood to the body).

2. Check to make sure the access port is working, and let your healthcare provider know if there are any problems.

3. Wipe off the venous port of the hemodialysis tubing with an alcohol wipe.

4. Insert the needle of the syringe into the cleaned venous port and push the plunger all the way down to inject all of the medication.

5. Remove the syringe from the venous port, and do not recap the needle.

6. Dispose of the used syringe and needle as outlined in the "Other Requirements" section.

If you miss a dose, take the missed dose as soon as you remember.  If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time.  Do not take two doses of epoetin alfa at the same time.

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS, AND TUMOR PROGRESSION OR RECURRENCE.

• In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
• No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
• Use the lowest epoetin alfa dose sufficient to reduce the need for red blood cell (RBC) transfusions.

• ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
• Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense epoetin alfa to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit epogen.com/professional/popup-leavesite.html?url=http://www.esa-apprise.com/">www.esa-apprise.com or call 1-866-284-8089 for further assistance.
• To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.
• Use ESAs only for anemia from myelosuppressive chemotherapy.
• ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
• Discontinue following the completion of a chemotherapy course.

• Due to increased risk of Deep Venous Thrombosis (DVT), DVT prophylaxis is recommended.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

• Has pharmacologic actions identical to those of endogenous erythropoietin; interacts with progenitor stem cells to increase red cell production.1 2 3 4 5 7 8 10 11 18 19 21 23 25 32 33 34 37 43 51 52 53 54 55 58 70 71 120 121 122 159 164 166 174 187 206 222 305 366 400 405 408 414 453 464

Refer to adult dosing.

Note: Evaluate iron status in all patients before and during treatment and maintain iron repletion.

Anemia due to chemotherapy in cancer patients: Initiate treatment only if hemoglobin <10 g/dL and anticipated duration of myelosuppressive chemotherapy is at least 2 additional months. Titrate dosage to use the minimum effective dose that will maintain a hemoglobin level sufficient to avoid red blood cell transfusions. Discontinue erythropoietin following completion of chemotherapy.

Children ≥5 years and Adolescents: IV: Initial dose: 600 units/kg once weekly until completion of chemotherapy.

Dosage adjustments:

If hemoglobin does not increase by ≥1 g/dL and remains <10 g/dL after initial 4 weeks: Increase to 900 units/kg (maximum dose: 60,000 units); discontinue after 8 weeks of treatment if RBC transfusions are still required or there is no hemoglobin response.

If hemoglobin exceeds a level needed to avoid red blood cell transfusion: Withhold dose; resume treatment with a 25% dose reduction when hemoglobin approaches a level where transfusions may be required.

If hemoglobin increases >1 g/dL in any 2-week period or hemoglobin reaches a level sufficient to avoid red blood cell transfusion: Reduce dose by 25%.

Anemia due to chronic kidney disease (CKD): Individualize dosing and use the lowest dose necessary to reduce the need for RBC transfusions.

Chronic kidney disease patients ON dialysis (IV route is preferred for hemodialysis patients; initiate treatment when hemoglobin is <10 g/dL; reduce dose or interrupt treatment if hemoglobin approaches or exceeds 11 g/dL):

Pediatrics 1 month to 16 years: IV, SubQ: Initial dose: 50 units/kg 3 times a week

Dosage adjustments for chronic kidney disease patients: Do not increase dose more frequently than every 4 weeks (dose decreases may occur more frequently); avoid frequent dosage adjustments

If hemoglobin does not increase by >1 g/dL after 4 weeks: Increase dose by 25%

If hemoglobin increases >1 g/dL in any 2-week period: Reduce dose by ≥25%

Inadequate or lack of response over a 12-week escalation period: Further increases are unlikely to improve response and may increase risks; use the minimum effective dose that will maintain a hemoglobin level sufficient to avoid RBC transfusions and evaluate patient for other causes of anemia. Discontinue therapy if responsiveness does not improve.

Anemia due to zidovudine in HIV-infected patients: Titrate dosage to use the minimum effective dose that will maintain a hemoglobin level sufficient to avoid red blood cell transfusions. Hemoglobin levels should not exceed 12 g/dL. Children 8 months to 17 years (based on limited data): IV, SubQ: Reported dosing range: 50 to 400 units/kg 2 to 3 times a week

No dosage adjustment necessary.

Erythropoiesis-stimulating agents (ESAs) increase the risk of death, MI, stroke, venous thromboembolism, thrombosis of vascular access.

In controlled trials, patients experienced greater risks of death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target a hemoglobin level of greater than 11 g/dL. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Use the lowest epoetin alfa dose sufficient to reduce the need for RBC transfusions.

ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions. Use ESAs only for anemia from myelosuppressive chemotherapy. ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Discontinue following the completion of a chemotherapy course.

Due to increased risk of DVT, DVT prophylaxis is recommended.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site irritation, headache, nausea, vomiting, cough, bone pain, joint pain, muscle pain, muscle spasms, mouth sores, weight loss, or insomnia. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), angina, tachycardia, shortness of breath, excessive weight gain, swelling of arms or legs, difficulty swallowing, severe dizziness, passing out, confusion, seizures, severe headache, vision changes, severe loss of strength and energy, pale skin, coughing up blood, sweating a lot, cool or pale arms or legs, or abnormal gait (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Chronic Kidney Disease (CKD) Patients Not on Dialysis:
Initial dose: 50 to 100 units/kg IV or subcutaneously 3 times a week

Comments:
-Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal.

CKD Patients on Dialysis:
Initial dose: 50 to 100 units/kg IV or subcutaneously 3 times a week

Comments:
-Initiate treatment when hemoglobin is less than 10 g/dL.
-IV route is recommended for patients on hemodialysis.

5 to 18 Years:
Initial dose: 600 units/kg IV once a week
Duration of therapy: Until completion of chemotherapy course

Comments:
-Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned.
-Use the lowest dose necessary to avoid RBC transfusions.

Substance Name

Epoetin Alfa

CAS Registry Number

113427-24-0

Drug Class

Colony-Stimulating Factors

Hematinics

Hematopoietic Cell Growth Factors

Epoetin alfa is a man-made form of a protein that helps your body produce red blood cells. This protein may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.

Epoetin alfa is used to treat anemia caused by chemotherapy or chronic kidney disease, or anemia caused by taking zidovudine to treat HIV (human immunodeficiency virus).

Epoetin alfa is also used to reduce the need for red blood cell transfusions in people having certain types of surgery.

Epoetin alfa may also be used for purposes not listed in this medication guide.

Other drugs may interact with epoetin alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.