Epogen

Epogen is a prescription medication used to treat anemia caused by chronic kidney disease, chemotherapy in patients with certain types of cancer, and the HIV medication zidovudine. Epogen is also used before and after certain types of surgery to decrease the chance that blood transfusions will be needed.

Epogen belongs to a group of drugs called erythropoiesis-stimulating agents (ESAs), which work by causing the bone marrow to make more red blood cells.

This medication is available in an injectable form to be given directly under the skin (subcutaneously) or directly into a vein (IV).

Common side effects of Epogen include high blood pressure, joint, muscle, or bone pain, fever, and cough. Epogen can also cause dizziness. Do not drive or operate heavy machinery until you know how Epogen affects you. 

Epogen is a prescription medication used to treat anemia (a lower than normal number of red blood cells) caused by:

• chronic kidney failure (kidneys stop working over a period of time)
• chemotherapy that will be used for at least two months after starting Epogen in patients with certain types of cancer
• HIV medication zidovudine

Epogen is also used before and after certain types of surgery to decrease the chance that blood transfusions (transfer of one person's blood to another person's body) will be needed due to blood loss.

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

• Amgen Inc

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

Common side effects of Epogen 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 Epogen 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.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medications you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Epogen including the following:

• high blood pressure. Your blood pressure may go up or be difficult to control with blood pressure medicine with the use of Epogen. 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 goes up, then your healthcare provide may prescribe new or more blood pressure medicine.
• seizures. If you have any seizures while taking Epogen, get medical help right away and contact your healthcare provider.
• antibodies to Epogen. Your body may make antibodies to Epogen, which can block or lessen your body's ability to make red blood cells and cause you to have severe anemia. Contact your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting.  You may need to stop Epogen if this occurs.
• serious allergic reactions. Serious allergic reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, and fainting from a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you experience a serious allergic reaction, stop using Epogen and get medical help right away and contact your healthcare provider.
• serious heart problems such as heart attack, heart failure, stroke. You can die sooner if you are treated with Epogen to increase red blood cells to near the same amount found in healthy people. Contact your healthcare provider immediately if you have any of the following symptoms: chest pain, shortness of breath, 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, or fainting.
• blood clots. Blot clots may happen at any time while taking Epogen. Clots can form in the blood vessels (veins), especially in your leg. Pieces of a blood clot can also travel to the lungs and block the blood circulation in the lungs. If you are taking Epogen and need surgery, then talk to your healthcare provider about whether you need to take a blood thinner to lessen the chance of blood clots during or after surgery. Contact your healthcare provider and get medical help right away if you have any of these symptoms: chest pain, shortness of breath, and pain or swelling in your legs.

Epogen can cause drowsiness. Do not drive or operate heavy machinery until you know how Epogen affects you.

Do not take Epogen if you:

• have cancer and have not been counseled by your healthcare provider about treatment with Epogen
• have high blood pressure that is not controlled
• 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 Epogen or other erythropoietin protein medicines
• have had a serious allergic reaction to Epogen

The following individuals should not receive Epogen from a multi-dose vial since it contains the preservative benzyl alcohol, which has been shown to cause brain damage, other serious side effects, and death in newborn and premature babies:

• pregnant or breastfeeding women
• babies

Medications can interact with certain foods.  In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Epogen, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Epogen, tell your doctor about all your medical conditions.  Especially tell your doctor if you:

• are allergic to Epogen or to any of its ingredients
• have heart disease
• have high blood pressure
• have had a seizure or stroke
• have any other medical conditions
• are pregnant or planning to become pregnant

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories -A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy. Epogen falls into category C.  In animal studies, pregnant animals were given this medication and had some babies born with problems.  No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

When Epogen is needed during pregnancy, only the single-dose benzyl alcohol-free medication vial should be used. 

If you are pregnant, discuss with your healthcare provider about enrolling in Amgen's Pregnancy Surveillance Program or call 1-800-772-6436.

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

It is not known if Epogen 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 Epogen.  The multi-dose vials of Epogen should not be used if you are breastfeeding since they contains benzyl alcohol.  See the "Drug Precautions" section.

Administer Epogen 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).

To inject Epogen follow these instructions:

1. Remove the vial of epogen 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 Epogen 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 Epogen 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 Epogen vial. Push the plunger of the syringe down to inject the air from the syringe into the Epogen 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 Epogen liquid. Keep the vial upside down, and slowly pull back on the plunger to fill the syringe with the Epogen 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 Epogen 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.

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 Epogen is in the syringe.

5. Remove the prepared syringe and needle from the vial of Epogen 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). 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. Epogen 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.

Take this medication exactly as prescribed by your doctor.  Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The dose of Epogen (epoetin alfa) is based on your weight and what condition you are taking the medication for. Your healthcare provider may change your epoetin alfa dose based on your hemoglobin (protein in red blood cells that carries oxygen) blood levels.

The recommended starting dose of Epogen (epoetin alfa) in adult patients with anemia caused by chronic kidney disease is an injection three times a week given directly into the vein (IV) or directly under the skin (subcutaneously). For children with anemia caused by chronic kidney disease, the recommended starting dose is an injection given three times a week by IV or subcutaneously.

The recommended starting dose of Epogen (epoetin alfa) in adult patients with anemia caused by the HIV medication zidovudine is an injection given three times a week into the vein (IV) or subcutaneously.

The recommended starting dose of Epogen (epoetin alfa) in adult patients with anemia caused by cancer chemotherapy is an injection given three times a week subcutaneously until the chemotherapy course is finished or an injection given once a week subcutaneously until the chemotherapy course is finished. The recommended starting dose of Epogen (epoetin alfa) in children with anemia caused by cancer chemotherapy is an injection given once a week by IV until the chemotherapy course is finished.

Epogen is also injected subcutaneously before and after certain types of surgery to decrease the chance that blood transfusions (transfer of one person's blood to another person's body) will be needed due to blood loss.

If you take too much Epogen, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Epogen is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Epogen in the refrigerator, but do not freeze it.
• Protect from light.
• Store Epogen in the carton until use.
• Keep this and all medicines out of reach of children.
• Keep all appointments with your doctor to check your blood pressure and lab work.
• Do not use a single-dose vial of Epogen more than one time. Throw it away after use even if there is medicine left in the vial.
• After removing a dose of Epogen from the multi-dose vial, store the vial in the refrigerator. Do not store the vial for more than 21 days. Throw the multi-dose vial away if there is not enough medicine left for another dose, or if it has been more than 21 days since you first put a needle into the vial.
• Do not shake Epogen.
• Do not use a vial of Epogen after the expiration date.
• Each time you receive Epogen make sure that the dose strength of the Epogen vial (number of Units per ml on the vial label) is the same as your healthcare provider prescribed.
• The liquid in the Epogen vial is clear and colorless. Do not use it if the liquid in the vial looks discolored or cloudy, or if the liquid has lumps, flakes, or particles.
• Do not use a vial of Epogen if the color cap on the top of the vial has been removed or is missing.
• Only use the disposable syringe and needle that your healthcare provider has prescribed.
• Place all used needles and syringes in a puncture-proof disposable container with a lid. Do not use glass or clear plastic containers. Keep the puncture-proof disposable container out of reach of children. When the puncture-proof disposable container is full, place tape around the cap or lid to make sure it does not come off. Throw away the container as instructed by your healthcare provider.

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

Chronic Kidney Disease:

• 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.

Cancer:

• 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 Epogen to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit 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.

Perisurgery:

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