Epoetin alfa (Injection)

As a colony-stimulating factor, epoetin alfa stimulates the cells in bone marrow to multiply, forming a colony of red blood cells.

Overview

Epoetin alfa is a synthetic protein that aids in the production of red blood cells. The levels of this protein in the body can reduce when the patient is suffering from a kidney failure due to chronic kidney disease or when taking certain medications. When the body fails to synthesize enough red blood cells, you may develop a condition called anemia.

How it works

Epoetin alfa is naturally produced in the body by the kidney. It signals the bone marrow to synthesize red blood cells (RBCs), which transport oxygen and nutrients throughout the body. Epogen works by increasing the production of red blood cells in the body. It achieves this by stimulating the cells in the bone marrow to multiply and form colonies of identical cells.

Belonging to a class of medications called colony-stimulating factors, epoetin alfa is used to treat anemia in patients with chronic kidney disease (CKD) because their kidneys are naturally unable to synthesize erythropoietin. It is also used to treat patients with non-myeloid cancers (cancer of the bone marrow). These patients tend to develop anemia during chemotherapy treatment. When cancer patients are taken through chemotherapy, their bodies fail to produce enough erythropoietin. Epoetin alfa is a product of genetic engineering of the ovarian cells of the Chinese hamster, and it is synthesized through recombinant DNA technology in bacteria. It is important to state that epoetin alfa does not cure the underlying causes of anemia. Thus, unless these underlying causes can be reversed, epoetin alfa treatment should be continued indefinitely.

Type Of Medicine

  • Colony stimulating factor

Conditions Treated

Epoetin alfa side effects

Seek help from your healthcare provider if you notice signs of any allergic reaction. These can be in the forms of profuse sweating immediately after getting an injection, hives, wheezing, rapid pulse, breathing difficulty, swelling on the face, tongue, throat, or lips, and severe dizziness.

Because epoetin alfa increases your risk of life-threatening circulation or heart problems, including the risk of a stroke or a heart attack. This risk increases if you use the medication for a long time. Thus, be sure to seek immediate medical help if you experience any of the following:

  • Symptoms of heart attack these include nausea, chest pain or pressure, severe sweating, and pain that spreads to your shoulder or jaw.
  • Signs of strokethese can be in the forms of sudden weakness or numbness on one side of the body, difficulty of speech, sudden and sharp headache, vision and balance problems
  • Blood clot signs these can be in the forms of swelling, pain, warmth, cold feeling, redness or pale appearance on your limbs
  • Dangerously high blood pressure that is characterized by blurred vision, strong-sharp headache, pounding on the ears or neck, anxiety and confusion, irregular heartbeats, severe chest pain, nosebleed.
  • Seizures and convulsions
  • Unusual fatigue

Some common epoetin alfa side effects

  • Elevated blood pressure
  • Pain in the joints, bone, and muscles
  • Fever that is accompanied by frequent coughs
  • Itching and rashes
  • Nausea and vomiting
  • Pain in the mouth
  • Strong sharp headache immediately after an injection
  • Pain or redness on the spot where the medicine is injected

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

Epoetin alfa dosage and direction of use

Epoetin alfa is administered as an injection. It is administered in the hospital or clinic setting after a kidney dialysis treatment. The drug can be injected under the skin or into a vein. If you are going to use this medication from home, then your healthcare provider will teach you how to administer the injection.

Cancer patients intending to use epoetin alfa should read and familiarize themselves with the ESA APPRISE Oncology Program before using this medication. Be sure to understand how the program works and talk to your healthcare provider if you have any questions.

Important note:

Each single-use vial of epoetin alfa should be used only once. Dispose of any unused medicine if there is any left after injecting your dose. In case of multi-dose vial, all unused medication should be disposed of 21-days after the first use

If you are using epoetin alfa from home:

  • Store the glass containers (vials) in the refrigerator away from bright light. However, ensure that the vials do not freeze.
  • When it is time for the injection, carefully examine the medicine in the vial. Do not use medicine that has changed color or has precipitates floating in it
  • Use a new syringe and needle each time you inject yourself
  • Your healthcare provider should show you the body part where this shot should be given
  • If you are using vials that have one dose, use each vial only once and dispose of the extra medicine. Do not keep an opened vial for later use
  • If you are using vials that contain medicine for multiple doses, put them back in the refrigerator after an injection. Dispose of any opened vial with unused medicine after 21 days
  • Safely dispose of all used syringes and needles

Epoetin alfa dosing

The dosage for this medication differ from patient to patient. Be sure to follow your healthcare provider's direction. The information below is only the average doses for this drug. If your prescribed dosage is different, do not change it unless upon approval by your healthcare provider.

Like with other medications, the amount of epoetin alfa you take depends on the strength of the medication, the number of doses you are prescribed for each day, and time allowed between the injections. The length of time you take this medication depends on the condition for which you are taking it.

1. Treating anemia that is caused by chronic kidney failure

Teenagers and adults Dosage depends on the patient's body weight and must be determined by the healthcare provider. The starting dose is 50 to 100 units per kg body weight administered intravenously or under the skin three times a week. Your healthcare provider might adjust the dosage based on your response to the medicine to determine the right dosage for you.

Children (1 month to 12 years old) the dosage is determined by the body weight and must be determined by the healthcare provider. The starting dose is 50 units per kg body weight administered intravenously or under the skin three times a week. The healthcare provider may adjust the dosage to determine the best dose for the patient.

The use of this medication in infants younger than one month old should be determined by the doctor.

2. For treating anemia after chemotherapy treatment

Teenagers and adults- the dosage is based on body weight and must be determined by the patient's healthcare provider. The starting dose should be 150 units per kilogram body weight injected under the skin three times per week. This dosage may be adjusted to find the best dose for the patient.

Children one month to 12 years of age the dosage is based on body weight and must be determined by the patient's healthcare provider. The starting dose is 60 units per kilogram body weight administered intravenously once per week. The dosage may be adjusted to find the best dose for the patient.

The use of this medication in infant should be approved by the healthcare provider

3. Treating anemia after HIV therapy

Adults dosage is based on body weight and must be determined by the patient's healthcare provider. The starting dose is 100 units per kg of body weight administered intravenously or under the skin three times per week for up to 8 weeks.

Children and teenagers aged 8 months to 17 years the dosage determined by the healthcare provider based on the patient's body weight. The starting dose is 50 units per kg body weight administered intravenously or under the skin two to three times per day. The doctor may adjust the dosage to determine what is best for the patient.

The use of epoetin alfa on infants under 8 months of age should be determined by the doctor.

4. Treating anemia after surgery

Adults and teenager' the dosage should be determined by the healthcare provider based on the patient's body weight. The starting dose is 300 units per kg body weight administered 10 days before the procedure, on the day of surgery, and four days after the procedure.

Children one month to 12 years' the dosage is based on the patient's body weight and must be determined by the healthcare provider.

The use of this medication on infant younger than one month old must be determined by the healthcare provider.

Missed dose

If you miss a dose of epoetin alfa, take it as soon as you can. However, skip the missed dose and assume your regular dosing schedule if it is almost time for your next dose. Do not make up for the missed dose by double dosing.

Drugs and foods to avoid while taking epoetin alfa.

Be sure to check with your healthcare provider before combining this epoetin alfa with other medications. These include vitamins, over-the-counter medications, as well as supplements and herbal products.

When not to use epoetin alfa

Epoetin alfa is not fit for use by everyone. You should not take this medication if you are allergic to epoetin alfa or any of its ingredients, or if you suffered from pure red cell aplasia after taking epoetin alfa or similar medications.

What happens if you overdose epoetin alfa

Call the Poison Help line at 1-800-222-1222 or seek medical attention in case of overdose. Some of the symptoms of epoetin alfa overdose include dizziness, headache, itching (especially after taking a shower), redness of the face, fullness in your upper stomach, breathing difficulty, and blurred vision.

Epoetin alfa interactions

Epoetin alfa may cause seizures. Thus, use caution when driving or handling any type of machinery that requires focus.

Drug interactions

1. Androgens- Androgens stimulate erythropoiesis. Thus, concurrent use of epoetin alfa with androgens can increase the patient's response to epoetin alfa, lowering the amount required for treating anemia.
2. Ethinyl Estradiol; Ferrous fumarate; Norethindrone Acetate' Inadequate iron stores interferes with the patient's response to epoetin alfa. Patients with chronic kidney disease requires supplemental iron during epoetin alfa treatment.
3. Thalidomide' epoetin alfa and thalidomide should be used cautiously because of increased risk of thromboembolism.

Other medications that interact with epoetin alfa include ferric carboxymaltose, ferumoxytol, fluoxomesterone, iron dextran, iron salts, iron sucrose, lenalidomide, methyltestosterone, nandrolone decanoate, oxandrolone, oxymetholone, peginesatide, polysaccharide-iron complex, dehydroepiandrosterone, prasterone, sodium ferric complex, testolactone, and testosterone.

Epoetin alfa warning

It is important that you discuss the risks and benefits of epoetin alfa with your healthcare provider before taking it. Since this medication may cause severe side effects including strokes, blood clots, and cardiovascular problems. It is important that you schedule regular laboratory check-ups so your healthcare provider can monitor your hemoglobin levels. The lowest possible, yet effective, dosage of this medication should be adopted.

When treating anemia related to cancer, epoetin alfa may increase the patient's risk of death and speed up the growth of your tumor. Thus, this medication should be prescribed by a specialized doctor after evaluating the patient's condition. Epoetin alfa treatment should be stopped after completing the chemotherapy treatment course as directed by your healthcare provider.

Before using epoetin alfa, brief your pharmacist or healthcare provider about your medical history, especially if you have blood disorders like sickle cell anemia or platelet problems, blood pressure, blood vessel problems, clotting or bleeding problems, metabolic disorders, seizures, metabolic disorders like porphyria, and vitamin deficiencies.

Patients with long-term kidney failures on dialysis may be at a greater risk of seizures during the first three months of epoetin alfa medication, possibly due to a sharp rise in the number of red blood cells. As such, these patients should be cautious and avoid operating machinery or driving while on epoetin alfa treatment.

Cut back on alcohol and beverage consumption while on epoetin alfa treatment because these might cause your risk of seizures.

High blood pressure

Epoetin alfa is contraindicated in patients with uncontrolled hypertension. Seizures and hypertensive encephalopathy have been reported in patients with chronic kidney disease receiving epoetin alfa treatment. It is important that the patient's blood pressure is appropriately controlled prior to the start of epoetin alfa treatment. Stop or reduce epoetin alfa treatment of the patient's blood pressure becomes difficult to control. The patient should also comply with antihypertensive therapy as well as dietary restrictions.

Seizures

Epoetin alfa increases the risk of risk of seizures in patients suffering with chronic kidney disease. Therefore, the patient should be closely monitored for premonitory neurologic symptoms during the first weeks of treatment with this medication.

Serious allergic reactions

Allergic reactions like angioedema, anaphylactic reactions, bronchospasm, urticaria, and skin rashes may occur during the first few weeks of epoetin alfa treatment. The medication should be stopped immediately if these allergic reactions become severe.

Severe cutaneous reactions

Some patients may suffer from blistering and skin exfoliation including Stevens-Johnson Syndrome and Erythema multiforme following epoetin alfa administration. Epoetin alfa treatment should be discontinued immediately if these reactions are detected.

Pregnancy

Epoetin alfa, when administered from multi-dose vials, may contain benzyl alcohol that is contraindicated in pregnant women. If administering this medication to a pregnant woman, be sure to use a single-dose vial that is free from benzyl alcohol. Epoetin alfa should never be mixed with bacteriostatic saline when treating pregnant women because it contains benzyl alcohol.

Fetal/ neonatal adverse reactions

Epoetin alfa's multiple dose contains benzyl alcohol a preservative associated with adverse reactions and fatality when intravenously administered to infants and neonates. There is a potential for similar fate when the fetus is exposed to benzyl alcohol. Be sure to discuss the need for birth control while you are on epoetin alfa treatment. Finally, it is not clear whether epoetin alfa can be passed to nursing babies via breast milk. Consult your healthcare provider before using this medication if you are breastfeeding.

Epoetin alfa and epilepsy

Epoetin alfa is known to trigger epileptic attacks. Thus, before taking this medication, tell your healthcare provider if you suffer from epilepsy. In addition, avoid driving or operating machinery that requires you to be alert while on this medication.

Epoetin alfa and cardiovascular conditions

Epoetin alfa can increase your risk of developing a life-threatening heart or circulatory condition, including stroke and a heart attack. This risk increases with the duration of use of this medication. In addition, epoetin alfa may shorten survival or remission time in patients with certain types of cancers. Therefore, be sure to talk to your healthcare provider about the risk factors involved before using this medication.

Other medical problems associated with epoetin alfa

The existence of other medical conditions may affect the use of epoetin alfa. Be sure to tell your healthcare provider if you have any of the following medical conditions:

  • Severe bleeding
  • Severe aluminum poisoning
  • Blood disorders like myelodysplastic syndrome and thalassemia
  • Folic acid, Vitamin B12, or iron deficiencies
  • Bone problems
  • Sickle cell anemia
  • Porphyrin (red blood cell pigment) metabolism disorder
  • Cancer, infection, or inflammation
  • Blood clots
  • Congestive heart failures
  • Heart bypass surgery
  • Heart attacks
  • Stroke
  • Heart or blood vessel disease
  • Thrombosis
  • Seizures
  • Hypertension
  • Pure red cell aplasia

Epoetin alfa storage

Epoetin alfa should be stored at 36F '46F (2 degrees C' 8 degrees C). However, the medication should be frozen. Multiple-use vials should be administered within 21 days of first use. Discard unused potions of single-use vials. All medication should be stored away from moisture and direct light. Do not use medications that have suspension or have changed color. All medications should be kept away from pets and children. Dispose of all expired or unused medications.

Summary

Epoetin alfa, brand name Epogen, is a synthetic option of the glycoprotein cytokine known as the human erythropoietin. Naturally, this glyocprotein is produced in the body by the kidneys. It works by stimulating the bone marrow to synthesize hemoglobin (red blood cells). Severe anemia is likely to occur when the body fails to synthesize the right amounts of erythropoietin. This is common in patients whose kidneys are not functioning properly as a result of chronic kidney conditions. Epoetin alfa is used for treating anemia in patients who are on dialysis. It may also be used for preventing or treating anemia that results from the aftermath of a surgical procedure. Epoetin alfa is also used for treating anemia in patients with HIV or some forms of cancer.

Epoetin alfa is only available with doctor's prescription.

It is important that you follow directions on your prescription label. Your healthcare provider may occasional change your dose based on your response and treatment needs. Never use this medication in smaller or larger amounts or for longer than recommended by your healthcare provider.

Epoetin alfa is administered intravenously or under the skin. Your healthcare provider may show you how to inject yourself at home. Do not inject yourself with epoetin alfa if you do not understand how to inject yourself and safely of the IV tubing, needles, and other items.

It is important that the patient takes frequent medical tests to be sure that epoetin alfa is not causing harmful side effects. Your treatment may also be delayed based on the outcome of these tests.

Your healthcare provider may recommend that you take blood pressure medication while on epoetin alfa therapy. Read the provided patient information, medication guides as well as provided instruction sheets and ask your doctor or pharmacist for clarification on what you do not understand.

If you are scheduled for surgery, inform your surgeon ahead (several weeks if possible) that you are on epoetin alfa. You may need additional medication to prevent blood clots during surgery.

Call your healthcare provider immediately if you feel light-headed, weak, breathing problems, or if your skin turns pale. These might be signs that your body is no longer responding to epoetin alfa.

Epoetin alfa is only part of the treatment regime that should include a special diet. Closely follow your doctor's instructions when using this medication.

The needle and syringe should only be used once and carefully disposed of after injection. Follow your state or city's guidelines on disposing of used medical equipment. As with other medication, keep epoetin alfa away from pets and children.

Important self-care tips

  • Consult with your healthcare provider regarding the use of iron supplements while on epoetin alfa treatment
  • Take small frequent meals, lozenges, or chewing gum if you experience nausea after receiving this injection.
  • Keep consumption of alcoholic beverages to a minimum, or avoid them completely, while taking this medication
  • Get adequate rest while taking this medication
  • Maintain proper nutrition
  • Discuss any side effects you might experience while taking this medication with your healthcare provider.