Epogen Information and Uses

Epogen

Epogen (generic: epoetin alfa) is a prescription medication used to treat anemia due to Chronic Kidney Disease (CKD), chemotherapy lasting at least two months, or use of Zidovudine (medication used in HIV-infected patients). Epogen belongs to a group of drugs called erythropoiesis-stimulating agents, which help increase the amount of red blood cells.

This medication comes in an injectable form to be injected through a vein (IV) or just under the skin.

Some of the common side effects of Epogen include nausea and vomiting, fever, and tiredness.

Uses of Epogen

Epogen is a prescription medication used to treat anemia due to Chronic Kidney Disease (CKD), chemotherapy lasting at least two months, or use of Zidovudine (medication used in HIV-infected patients).

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

Side Effects of Epogen

Epogen may cause serious side effects.

See "Drug Precautions".
High blood pressure. High blood pressure is a common side effect of Epogen in patients with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medicine while taking 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 does go up, your healthcare provider may prescribe new or more blood pressure medicine.
Seizures. If you have any seizures while taking Epogen, get medical help right away and tell your healthcare provider.
Antibodies to Epogen. Your body may make antibodies to Epogen. These antibodies can block or lessen your body’s ability to make red blood cells and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting. You may need to stop taking Epogen.
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 Epogen and call your healthcare provider or get medical help right away.
Dangers of giving Epogen to newborns, infants, and pregnant or breastfeeding women. Do not use Epogen from multi-dose vials in newborns, infants, pregnant or breastfeeding women because the Epogen 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. Epogen that comes in single-dose vials does not contain benzyl alcohol.

Common side effects of Epogen include:

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

These are not all of the possible side effects of Epogen. 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.

Epogen Precautions

Using Epogen can lead to death or other serious side effects.

For patients with cancer:

Your healthcare provider has received special training through the ESA APPRISE Oncology Program in order to prescribe Epogen. Before you can begin to receive Epogen, you must sign the patient-healthcare provider acknowledgment form. When you sign this form, you are stating that your healthcare provider talked with you about the risks of taking Epogen.

These risks include that your tumor may grow faster and you may die sooner if you choose to take Epogen.

You should talk with your healthcare provider about:

Why Epogen treatment is being prescribed for you.
What are the chances you will get red blood cell transfusions if you do not take Epogen.
What are the chances you will get red blood cell transfusions even if you take Epogen.
How taking Epogen may affect the success of your cancer treatment.

After you have finished your chemotherapy course, Epogen treatment should be stopped.

For all patients who take Epogen, including patients with cancer or chronic kidney disease:

If you decide to take Epogen, your healthcare provider should prescribe the smallest dose of Epogen that is needed to reduce your chance of getting red blood cell transfusions.
You may get serious heart problems such as heart attack, stroke, heart failure, and may die sooner if you are treated with Epogen to reach a normal or near-normal hemoglobin level.
You may get blood clots at any time while taking Epogen. If you are receiving Epogen 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 of blood clots:

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

Do not take Epogen if you:

Have cancer and have not been counseled by your healthcare provider regarding the risks of Epogen or if you have not signed the patient-healthcare provider acknowledgment form before you start Epogen treatment.
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 Epogen or other erythropoietin protein medicines.
Have had a serious allergic reaction to Epogen.

Do not give Epogen from multidose vials to:

Pregnant or breastfeeding women
Babies

Inform MD

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.
Are breastfeeding or planning to breastfeed.

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

Epogen and Pregnancy

Tell your healthcare provider if you are pregnant or planning to become pregnant. It is not known if Epogen may harm your unborn baby. Talk to your healthcare provider about possible pregnancy and birth control choices that are right for you. If you are pregnant, discuss with your healthcare provider about enrolling in Amgen's Pregnancy Surveillance Program or call 1-800-772-6436 (1-800-77-AMGEN).

Epogen and Lactation

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. It is not known if Epogen passes into breast milk.

Epogen Usage

For patients with cancer:

Before you begin to receive Epogen, your healthcare provider will:

Ask you to review the Epogen Medication Guide that comes with the medication.
Explain the risks of Epogen and answer all your questions about Epogen.
Have you sign the patient-healthcare provider acknowledgment form.

For all patients who take Epogen:

Continue to follow your healthcare provider’s instructions for diet, and medicines, including medicines for high blood pressure, while taking Epogen.
Have your blood pressure checked as instructed by your healthcare provider.
If you or your caregiver has been trained to give Epogen shots (injections) at home:
- Be sure that you read, understand, and follow the “Instructions for Use” that come with Epogen.
- Take Epogen exactly as your healthcare provider tells you to. Do not change the dose of Epogen unless told to do so by your healthcare provider.
- Your healthcare provider will show you how much Epogen 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 Epogen, call your healthcare provider right away and ask what to do.
- If you take more than the prescribed amount of Epogen, call your healthcare provider right away.

Epogen Dosage

Take Epogen exactly as prescribed. Follow the directions on your prescription label carefully.

The Epogen dose your healthcare provider recommends will depend upon several factors including:

your response to Epogen (blood test results);
your medical condition that is causing your anemia;
your weight;
other medicines you take;
and other medical conditions you have.

Do not change the dose of Epogen unless told to do so by your healthcare provider.

Epogen Overdose

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

Other Requirements

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

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

Epogen FDA Warning

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 Epogen 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: