Epoetin alfa

What is Epoetin alfa?

• Epoetin alfa (Retacrit; Epogen; Procrit) is an erythropoiesis-stimulating agent (ESA) used used to treat anemia, commonly associated with chronic kidney failure and cancer chemotherapy.

What are the uses of this medicine?

Epoetin alfa (Retacrit;Epoge; Procrit) 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 Retacrit.
• A medicine called zidovudine (AZT) used to treat HIV infection.

• Epoetin alfa 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 Epoetin alfa, even if you do not have an increase in your hemoglobin level.

Limitations of Use:

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

Epoetin alfa 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.
• If your anemia caused by chemotherapy treatment can be managed by RBC transfusion.
• In place of emergency treatment for anemia (RBC transfusions).

Epoetin alfa should not be used to reduce the chance you will need 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.

How does this medicine work?

• Epoetin alfa is a form of erythropoietin (a substance naturally made by the kidneys) that is made in the laboratory.
• It helps the bone marrow make more red blood cells.
• Epoetin alfa is a type of antianemic and a type of erythropoiesis-stimulating agent.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Have cancer and have not been counseled by your healthcare provider about treatment with Epogen.
• 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 Epoetin alfa from multiple-dose vials to:

• Pregnant or breastfeeding women
• Babies

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Initial U.S. Approval: 1989

How should this medicine be used?

• Evaluate iron status before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia before initiating treatment.

Recommended dosage:

• Patients with CKD:
• Initial dose: 50 to 100 Units/kg 3 times weekly (adults) and 50 Units/kg 3 times weekly (pediatric patients).
• Individualize maintenance dose. Intravenous route recommended for patients on hemodialysis.
• Patients on Zidovudine due to HIV-infection: 100 Units/kg 3 times weekly.

Patients with Cancer on Chemotherapy:

• 40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg intravenously weekly (pediatric patients ≥ 5 years).

Surgery Patients:

• 300 Units/kg per day daily for 15 days or 600 Units/kg weekly.

In pregnant women, lactating women, neonates, infants:

• Use only single-dose vials.

Administration:

• Epoetin alfa injection products come as a solution (liquid) to inject subcutaneously (just under the skin) or intravenously (into a vein).
• If you or your caregiver has been trained to give Epoetin alfa shots (injections) at home:
• Be sure that you read, understand, and follow the "Instructions for Use" that come with Epoetin alfa.
• Take Epoetin alfa exactly as your healthcare provider tells you to. Do not change the dose ofEpoetin alfa unless told to do so by your healthcare provider.
• Your healthcare provider will show you how much Epoetin alfa 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 Epoetin alfa, call your healthcare provider right away and ask what to do.
• If you take more than the prescribed dose of Epoetin alfa, call your healthcare provider right away.
• During treatment with Epoetin alfa, 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 dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection:

• 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, and 10,000 Units/mL in single-dose vials.
• 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL in multiple-dose vials containing benzyl alcohol.

This medicine is available in fallowing brand namesː

• Retacrit; Epogen; Procrit

What side effects can this medication cause?

The most common side effects of this medicine include:

• joint, muscle, or bone pain
• fever
• cough
• dizziness
• high blood sugar
• low potassium levels in the blood
• chills
• rash
• nausea
• vomiting
• blood vessel blockage
• low white blood cells
• trouble sleeping
• difficulty swallowing
• soreness of mouth
• itching
• headache
• respiratory infection
• weight decrease
• depression
• muscle spasm

Epoetin alfa may cause serious side effects, including:

• Serious heart problems, such as heart attack or heart failure, and stroke
• Blood clots
• High blood pressure
• Seizures
• Antibodies to Epoetin alfa
• Serious allergic reactions
• Severe skin reactions
• Dangers of using multiple-dose vials in newborns, infants, and pregnant or breastfeeding women

What special precautions should I follow?

• Evaluate iron status before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia before initiating treatment.
• Use only single-dose vials for pregnant women, lactating women, neonates, infants.
• Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Use caution in patients with coexistent cardiovascular disease and stroke.
• Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer.
• Epoetin alfa is contraindicated in patients with uncontrolled hypertension. Control hypertension prior to initiating and during treatment with Epoetin alfa.
• Epoetin alfa products increase the risk for seizures in patients with CKD. Increase monitoring of these patients for changes in seizure frequency or premonitory symptoms.
• Cases of Pure Red Cell Aplasia (PRCA) and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with epoetin alfa. If severe anemia and low reticulocyte count develop during Epoetin alfa treatment, withhold Epoetin alfa and evaluate for PRCA.
• Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. Discontinue epoetin alfa and manage reactions.
• Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including epoetin alfa). Discontinue Retacrit .
• Phenylalanine can be harmful to patients with phenylketonuria (PKU). Retacrit contains phenylalanine, a component of aspartame. Contains phenylalanine
• Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated for use in neonates, infants, pregnant women, and lactating women.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• can cause hemoglobin levels above the desired level
• severe hypertension

Management of overdosage:

• Overdosage should be managed with discontinuation or reduction of epoetin alfa dosage and/or with phlebotomy, as clinically indicated.

Can this medicine be used in pregnancy?

• Retacrit; Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in pregnant women.
• The limited available data on epoetin alfa use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• The multiple-dose vials are formulated with benzyl alcohol and are contraindicated for use in neonates and infants.
• It is not known if epoetin alfa is safe and effective in treating anemia in children less than 1 month old who have chronic kidney disease and in children less than 5 years old who have anemia caused by chemotherapy.

What are the active and inactive ingredients in this medicine?

Retacrit: Active Ingredient: epoetin alfa-epbx Inactive Ingredients:

• Multiple-dose vials contain benzyl alcohol.
• All single-dose vials contain calcium chloride dehydrate, glycine, isoleucine, leucine, L-glutamic acid, phenylalanine, polysorbate 20, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and threonine, in water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust the pH.
• All multiple-dose vials contain benzyl alcohol, L-methionine, polysorbate 20, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and sucrose, in water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust the pH.

Epogen: Active ingredient:

• epoetin alfa

Inactive ingredients:

• Multiple-dose vials contain benzyl alcohol.
• All vials contain albumin (human), citric acid, sodium chloride, sodium citrate, and Water for Injection.

Who manufactures and distributes this medicine?

Retacrit:

• Manufactured by Hospira, Inc., a Pfizer Company, Lake Forest, IL USA
• Distributed by Vifor (International) Inc., Rechenstrasse 37, 9014 St. Gallen, Switzerland

Epogen:

• Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, CA U.S.A.

What should I know about storage and disposal of this medication?

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

• Dailymed label info on Epoetin alfa
• FDA Epoetin alfa

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