Epoetin alfa

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Generic Name: Epoetin alfa Brand Name(s): Epoetin alfa.

Uses

What is Epoetin alfa used for?

Epoetin alfa is commonly 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 some types of cancer (cancer that does not involve the bone marrow or blood cells). 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 given with an anticoagulant/”blood thinner” medication such as warfarin to lower the risk of serious blood clots). Epoetin alfa works by signaling the bone marrow to make more red blood cells. This medication is very similar to the natural substance in your body (erythropoietin) that prevents anemia.

How should I take Epoetin alfa?

This medication is given as an injection under the skin or into a vein as directed by your doctor, usually 1 to 3 times a week. Patients getting this medication before surgery may have a special dosing schedule. Hemodialysis patients should receive this medication by injection into a vein.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional.

Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. If you are injecting this medication under the skin, before each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.

Learn how to store and discard medical supplies safely.

The dosage is based on your medical condition, weight, and response to treatment. Blood tests should be done often to check how well this medication is working and to decide the correct dose for you. Consult your doctor for more details.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day(s) of the week as directed.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

It may take 2 to 6 weeks before your red blood cell count increases. Tell your doctor if your symptoms do not get better or if they get worse.

How do I store Epoetin alfa?

Epoetin alfa is best stored in the refrigerator. To prevent drug damage, do not freeze. There may be different brands of Epoetin alfa that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Epoetin alfa down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Epoetin alfa?

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 if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol, polysorbate), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart disease (such as heart failure, past heart attack/stroke), seizure disorder, severe anemia caused by antibodies to past erythropoietin-type treatment (pure red cell aplasia).

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, viruses such as hepatitis). Consult your doctor or pharmacist for more information.

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

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

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

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Epoetin alfa during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this Epoetin alfa. This Epoetin alfa is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Epoetin alfa?

Headache, body aches, cough, or injection site irritation/pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Epoetin alfa may sometimes cause or worsen high blood pressure, especially in patients with long-term kidney failure. This effect may be caused by the number of red blood cells increasing too quickly, usually within the first 3 months of starting treatment. If you have high blood pressure, it should be well controlled before beginning treatment with this medication. Your blood pressure should be checked often. Ask your doctor if you should learn how to check your own blood pressure. If high blood pressure develops or worsens, follow your doctor’s instructions about diet changes and starting or adjusting your high blood pressure medication. Lowering high blood pressure helps prevent strokes, heart attacks, and further kidney problems. Keep all lab appointments to have your red blood cell count/hemoglobin level tested regularly to reduce the chance of this side effect.

Rarely, this medication may suddenly stop working well after a period of time because your body may make antibodies to it. A very serious anemia can result. Tell your doctor right away if symptoms of anemia return (such as increased tiredness, low energy, pale skin color, shortness of breath).

Get medical help right away if you have any very serious side effects, including: seizures.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the legs or lungs). Get medical help right away if you have: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes, blood clots in your hemodialysis vascular access site.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Epoetin alfa?

Epoetin alfa may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Epoetin alfa?

Epoetin alfa may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Epoetin alfa?

Epoetin alfa may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Epoetin alfa.

What is the dose of Epoetin alfa for an adult?

Usual Adult Dose for Anemia Associated with Zidovudine

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

Use: Treatment of anemia due to zidovudine administered at 4200 mg/week or less in HIV-infected patients with endogenous serum erythropoietin levels of 500 milliunits/mL or less.

Usual Adult Dose for Anemia Associated with Chemotherapy

Initial dose: 150 units/kg subcutaneously 3 times a week or 40,000 units subcutaneously once a week

Duration of therapy: Until completion of chemotherapy course

Comments:

-Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned.

-Use the lowest dose necessary to avoid RBC transfusions.

Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.

Usual Adult Dose for Anemia Associated with Chronic Renal Failure

Chronic Kidney Disease (CKD) Patients Not on Dialysis:

Initial dose: 50 to 100 units/kg IV or subcutaneously 3 times a week

Comments:

-Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal.

CKD Patients on Dialysis:

Initial dose: 50 to 100 units/kg IV or subcutaneously 3 times a week

Comments:

-Initiate treatment when hemoglobin is less than 10 g/dL.

-IV route is recommended for patients on hemodialysis.

Usual Adult Dose for Anemia Prior to Surgery

300 units/kg subcutaneously once a day starting 10 days before surgery, on day of surgery, and 4 days after surgery (15 days total) or 600 units/kg subcutaneously on days 21, 14, and 7 before surgery and on day of surgery (4 doses total)

Comments: Deep venous thrombosis (DVT) prophylaxis is recommended during treatment with this drug.

Use: To reduce the need for allogeneic RBC transfusions in patients with perioperative hemoglobin greater than 10 and less than or equal to 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. This drug is not indicated for patients who are willing to donate autologous blood preoperatively.

Dose Adjustments

All chronic kidney disease (CKD) patients:

-May increase dose no more than every 4 weeks; may decrease dose more frequently. Avoid frequent dose adjustments.

-If hemoglobin increases by more than 1 g/dL in 2 weeks, reduce dose by 25% or more as needed to reduce rapid responses.

-If hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase dose by 25%.

-For patients who do not respond adequately over a 12 week escalation period, further dose increases are unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce need for RBC transfusions. Evaluate other causes of anemia. Discontinue if responsiveness does not improve.

CKD patients on dialysis:

-If hemoglobin approaches or exceeds 11 g/dL, reduce or interrupt the dose of this drug.

CKD patients not on dialysis:

-If hemoglobin exceeds 10 g/dL, reduce or interrupt the dose and use the lowest dose sufficient to reduce need for RBC transfusions.

Zidovudine treated patients:

-If hemoglobin does not increase in 8 weeks, increase dose by 50 to 100 units/kg at 4 to 8 week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 units/kg.

-If hemoglobin does not increase with 300 units/kg for 8 weeks, discontinue treatment.

-If hemoglobin exceeds 12 g/dL, withhold treatment until hemoglobin decreases to less than 11 g/dL and resume at a dose 25% below the previous dose.

All chemotherapy patients:

-If hemoglobin increases greater than 1 g/dL in 2 weeks or reaches a level needed to avoid RBC transfusion, reduce dose by 25%.

-If hemoglobin exceeds a level needed to avoid RBC transfusion, withhold dose until hemoglobin approaches a level where RBC transfusions may be required and reinitiate at a dose 25% below the previous dose.

-If hemoglobin increases by less than 1 g/dL and remains below 10 g/dL after 4 weeks of therapy, increase dose to 300 units/kg 3 times a week or 60,000 units once a week in adults or 900 units/kg (60,000 units maximum) once a week in children.

-If there is no response as measured by hemoglobin levels or if RBC transfusions are still required after 8 weeks of therapy, discontinue this drug.

Dialysis

ANEMIA ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD):

Adult:

Initial dose: 50 to 100 units/kg IV or subcutaneously 3 times a week

Comments:

-Initiate treatment when hemoglobin is less than 10 g/dL.

-IV route is recommended for patients on hemodialysis.

Pediatric (1 Month to 16 Years):

Initial dose: 50 units/kg IV or subcutaneously 3 times a week

Comments:

-Initiate treatment when hemoglobin is less than 10 g/dL.

-IV route is recommended for patients on hemodialysis.

Other Comments

Administration advice: The manufacturer product information should be consulted.

Storage requirements:

-Protect from light.

-Store (including unused portions of multidose vials) at 36 to 46F (2 to 8C). Do not freeze. Discard 21 days after initial entry.

Reconstitution/preparation techniques:

-Do not dilute.

-Do not shake. Do not use this drug if it has been shaken or frozen.

-Allow this drug to reach room temperature before injecting.

-Discard unused portions in preservative-free vials. Do not re-enter preservative-free vials.

IV compatibility: Do not mix with other drug solutions except for the following: Preservative-free single-use vials may be admixed in a syringe with bacteriostatic 0.9% sodium chloride injection, USP, with benzyl alcohol 0.9% (bacteriostatic saline) in a 1:1 ratio using aseptic technique at the time of administration. Risks are associated with benzyl alcohol in neonates, infants, pregnant women, and nursing mothers.

General:

-Women who become pregnant during treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN to enroll.

-Contact Amgen (1-800-AMGEN) OR Janssen (1-800-JANSSEN) to perform assays for binding and neutralizing antibodies.

Monitoring:

-Following treatment initiation and dose adjustments, monitor hemoglobin weekly until stable and sufficient to minimize need for RBC transfusion. Monitor at least monthly thereafter provided hemoglobin remains stable.

-Monitor patients closely for premonitory neurologic symptoms during the first several months following initiation of this drug.

-Monitor platelet count regularly during the first 8 weeks of therapy.

-Monitor serum electrolytes in chronic renal failure patients.

Patient advice:

-Inform cancer patients that they must sign the patient-healthcare provider acknowledgment form before the start of each treatment course with this drug.

-Inform patients of the increased risks of mortality, serious cardiovascular reactions, thromboembolic reactions, stroke, and tumor progression.

-Advise patients of the importance of regular blood pressure monitoring and compliance with concomitant antihypertensive therapy and dietary restrictions.

-Advise patients to seek medical attention for new/different neurologic symptoms.

-Inform patients of the need to have regular laboratory tests for hemoglobin.

What is the dose of Epoetin alfa for a child?

Usual Pediatric Dose for Anemia Associated with Chemotherapy

5 to 18 Years:

Initial dose: 600 units/kg IV once a week

Duration of therapy: Until completion of chemotherapy course

Comments:

-Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned.

-Use the lowest dose necessary to avoid RBC transfusions.

Usual Pediatric Dose for Anemia Associated with Chronic Renal Failure

CHRONIC KIDNEY DISEASE (CKD) PATIENTS ON DIALYSIS:

1 Month to 16 Years:

Initial dose: 50 units/kg IV or subcutaneously 3 times a week

Comments:

-Initiate treatment when hemoglobin is less than 10 g/dL.

-IV route is recommended for patients on hemodialysis.

Precautions

Safety and efficacy have not been established in CKD patients on dialysis younger than 1 month; this drug is indicated for pediatric patients 1 month to 16 years for treatment of anemia associated with CKD.

Safety and efficacy have not been established in cancer patients on chemotherapy younger than 5 years.

How is Epoetin alfa available?

Epoetin alfa is available in the following dosage forms and strengths:

  • Solution for Injection

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Epoetin alfa, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: January 25, 2018 | Last Modified: January 25, 2018

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