EPOETIN ALFA

COMMON BRAND NAME(S): Epogen, Procrit

GENERIC NAME(S): EPOETIN ALFA

Description: Epoetin alfa stimulates the production of red blood cells, thereby also controlling the production of erythropoietin, the signal that tells the bone marrow to produce more blood.

Uses

Indications:

This medication is used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic kidney failure), people receiving zidovudine to treat HIV, and people receiving chemotherapy for certain types of cancer (non-myeloid cancers).

It may also be used in anemic patients to reduce the need for blood transfusions before certain planned surgeries that have a high risk of blood loss (usually combined with the “blood thinner” warfarin).

Contraindications:

Should not be given to patients with:

Uncontrolled hypertension.
Known hypersensitivity to mammalian cell-derived products.
Known hypersensitivity to Albumin (Human).

How to use epoetin alfa injection

ADULTS:

Anemia Associated with Zidovudine

Initial: 100 units/kg subcutaneously or IV 3 times a week.

Anemia Associated with Chemotherapy

Initial: 150 units/kg subcutaneously 3 times weekly or 40,000 units subcutaneously once weekly until completion of chemotherapy course.

Anemia Associated with Chronic Renal Failure

50 to 100 units/kg subcutaneously or IV 3 times weekly.  The intravenous route is recommended for patients on hemodialysis.

Anemia Prior to Surgery

In patients with hemoglobin greater than 10 to less than or equal to 13 g/dL scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogenic blood transfusions: 300 units/kg/day subcutaneously for 10 days before and on the day of surgery, and 4 days after surgery for a total of 14 days of epoetin therapy.  Alternate dosage schedule: 600 units/kg subcutaneously in once weekly doses (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.

Pediatric:

Anemia Associated with Zidovudine

Infants and Children 8 months to 17 years: Limited data available; doses ranging from 50 to 400 units/kg 2 to 3 times/week have been reported. If patients have not responded satisfactorily to a dose of 300 units/kg 3 times weekly, it is unlikely that they will respond to higher doses.

Anemia Associated with Chemotherapy

Infants and Children 6 months to 18 years: Doses ranging from 25 to 300 units/kg 3 to 7 times a week have been reported.  Manufacturer’s recommendation: Starting dose: Using intravenous administration only: 600 units/kg weekly (not to exceed 40,000 units/week); may increase to 900 units/kg weekly (not to exceed 60,000 units/week).

Anemia Associated with Chronic Renal Failure

Starting dose for infants, children and adolescents: 50 units/kg, intravenously or subcutaneously, 3 times weekly. Increase dose by 25% if hemoglobin is less than 10 g/dL and has not increased by 1 g/dL after 4 weeks of therapy or if hemoglobin decreases below 10 g/dL. In patients on hemodialysis, the intravenous route is recommended.

Anemia

The safety and efficacy of epoetin alfa in children have not been established. However, the use of epoetin alfa may be appropriate in some situations.  Anemia of prematurity: Dosing range: 500 to 1250 units/kg/week divided into 2 to 5 doses for 10 doses; commonly used dose: 250 units/kg/dose 3 times weekly; supplement with oral iron therapy 3 to 8 mg/kg/day.

Warnings

You should not use this medication if you have untreated or uncontrolled high blood pressure, if you are allergic to epoetin alfa or darbepoetin alfa (Aranesp), or if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using either of these two drugs.

Before using epoetin alfa, tell your doctor if you have epilepsy or a history of seizures. Epoetin alfa may cause seizures. Be careful if you drive or do anything that requires you to be awake and alert.

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use epoetin alfa. Epoetin alfa may also shorten remission time or survival time in some people with certain types of cancer.

Side Effects

You should check with your doctor immediately if any of these side effects occur when taking epoetin alfa:

More common

Chest pain
fever
headache
increased blood pressure
shortness of breath
swelling of the face, fingers, ankles, feet, or lower legs
weight gain

Less common

Anxiety
blurred vision
change in skin color
change in vision
convulsions (seizures)
cough
dizziness or lightheadedness
double vision
fainting
fast heartbeat
migraine headache
nausea
pain or discomfort in the arms, jaw, back, or neck
pain, tenderness, or swelling of the foot or leg
pains in the chest, groin, or legs, especially calves of the legs
pale skin
partial or complete loss of vision in the eye
severe headaches of sudden onset
skin rash or hives
slurred speech
sore throat
sudden and severe inability to speak
sudden loss of coordination
sudden vision changes
sweating
temporary blindness
tenderness, pain, swelling, warmth, or skin discoloration at the injection site
unusual bleeding or bruising
unusual tiredness or weakness
vision problems
vomiting
weakness in the arm or leg on one side of the body, sudden and severe

Some of the side effects that can occur with epoetin alfa may not need medical attention:

More common

Abdominal or stomach pain and swelling
bone or joint pain, muscle aches, chills, shivering, or sweating
constipation
diarrhea
dizziness
general feeling of tiredness or weakness
heartburn or belching, acid or sour stomach
inability to sleep
itching or stinging at the injection site
loss of strength or energy
muscle pain or weakness
skin pain
stomach discomfort, upset, or pain
weight loss

Precautions

Precautions

General:

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Allergy: Before using epoetin alfa, tell your doctor or pharmacist if you are allergic to it; or to other drugs that cause more red blood cells to be made (such as darbepoetin alfa); or to products containing human albumin; or if you have any other allergies.
Medical History: Before using this medication, tell your doctor or pharmacist if you had: high blood pressure, other blood disorders (such as sickle cell anemia, white blood cell or platelet problems, bone marrow problems), seizure disorder, a certain metabolic disorder (porphyria), certain vitamin deficiencies (folic acid, vitamin B12).
Infections: Some forms of this medication are made from human blood. Even though the blood is carefully tested and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, virus infections such as hepatitis). Consult your doctor or pharmacist for more information.

Pregnancy Risk: Category C. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Breastfeeding: It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

No evidence of interactions with other drugs detected.

Overdose & Brands

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood count that includes hemoglobin and hematocrit, reticulocyte count) must be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

Blood tests for your iron levels will also be performed and you may be prescribed iron supplements to take. Your doctor may recommend that you eat a well-balanced diet rich in iron (such as raisins, figs, meat, eggs, vegetables, iron-fortified cereals). Follow your doctor’s instructions and dietary recommendations.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store in the refrigerator. Do not freeze. Let the medication come to room temperature before using. For the single-use vials, discard any unused medication right away. For the multi-use vials, store opened vials in the refrigerator and discard any unused medication after 3 weeks. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Brands

Available Brands:

Epokine [ CJ Corp ]	Eposino [ Shandong Kexing ]
Eposis [ Daewoong ]	Epovax [ Rabvax & Serum Asia Pharma ]
Eprex [ Janssen ]	Hemapo [ MPL ]
Renogen [ Biomedis ]

Also marketed as

Efotin [ Beijing Four Rings ]	Epogen [ Harbin ]
Epotin [ Julphar ]