Darbepoetin Alfa

By Medically reviewed by hellodoktor

Generic Name: Darbepoetin Alfa Brand Name(s): Darbepoetin Alfa. Avability: Rx Pregnancy Category: C

Uses

What is Darbepoetin Alfa used for?

Darbepoetin Alfa is used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic kidney failure) and people receiving chemotherapy for some types of cancer (cancer that does not involve the bone marrow or blood cells). Darbepoetin alfa also helps to reduce the need for blood transfusions. It 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 Darbepoetin Alfa?

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

Do not shake this medication and do not mix it with other drugs or IV solutions.

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 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 Darbepoetin Alfa?

Store in the refrigerator and protect from light. Do not freeze darbepoetin alfa, and throw away the medication if it has become frozen.

Do not shake the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Each single-use vial (bottle) or prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

There may be different brands of Darbepoetin 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 Darbepoetin 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 Darbepoetin Alfa?

Before using darbepoetin 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 epoetin alfa); or if you have any other allergies. This product may contain inactive ingredients (such as polysorbate, latex), 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).

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 Darbepoetin Alfa during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Darbepoetin Alfa. Darbepoetin 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 Darbepoetin Alfa?

Headache, body aches, diarrhea, cough, stomach/abdominal pain, or injection site 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.

Darbepoetin 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).

Tell your doctor right away if you have any serious side effects, including: symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).

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 Darbepoetin Alfa?

Darbepoetin 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 Darbepoetin Alfa?

Darbepoetin 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 Darbepoetin Alfa?

Darbepoetin 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 Darbepoetin Alfa.

What is the dose of Darbepoetin Alfa for an adult?

Usual Adult Dose for Anemia Associated with Chronic Renal Failure

Chronic Kidney Disease (CKD) Patients Not on Dialysis:

Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate

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: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate

Comments:

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

-IV route is recommended for patients on hemodialysis.

Usual Adult Dose for Anemia Associated with Chemotherapy

Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks

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.

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.

Pediatric CKD patients:

-If hemoglobin approaches or exceeds 12 g/dL, reduce or interrupt the dose of this drug.

Conversion from epoetin alfa to this drug in CKD patients on dialysis:

-Maintain the route of administration when converting.

-Administer this drug once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly; administer once every 2 weeks in patients who were receiving epoetin alfa once weekly.

-Previous weekly epoetin alfa dose (units/week): Darbepoetin alfa dose (mcg/week)

–Less than 1500: Adults: 6.25; Pediatric: Unknown

–1500 to 2499: Adults: 6.25; Pediatric: 6.25

–2500 to 4999: Adults: 12.5; Pediatric: 10

–5000 to 10999: Adults: 25; Pediatric: 20

–11000 to 17999: Adults: 40; Pediatric: 40

–18000 to 33999: Adults: 60; Pediatric: 60

–34000 to 89999: Adults: 100; Pediatric: 100

–90000 or greater: Adults: 200; Pediatric: 200

Conversion from epoetin alfa to this drug in CKD patients not on dialysis:

-Refer to doses for CKD patients on dialysis. Dose conversion does not accurately estimate the once monthly dose of this drug.

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 40%.

-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 40% below the previous dose.

-If hemoglobin increases by less than 1 g/dL and remains below 10 g/dL after 6 weeks of therapy, increase dose to 4.5 mcg/kg/week, if on the weekly dosing schedule. If on the every 3 week dosing schedule, no dose adjustment is recommended.

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

Dialysis

ANEMIA ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD):

Adult:

Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate

Comments:

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

-The intravenous route is recommended for patients on hemodialysis.

What is the dose of Darbepoetin Alfa for a child?

Usual Pediatric Dose for Anemia Associated with Chronic Renal Failure

Less than 18 Years:

Initial dose:

-Chronic Kidney Disease (CKD) Patients Not on Dialysis: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks

-CKD Patients on Dialysis: 0.45 mcg/kg IV or subcutaneously once a week

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

Dialysis

Pediatric (Less than 18 Years):

Initial dose: 0.45 mcg/kg IV or subcutaneously once a week

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

How is Darbepoetin Alfa available?

Darbepoetin Alfa is available in the following dosage forms and strengths:

  • Injectable solution.

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 Darbepoetin 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: August 29, 2018 | Last Modified: September 12, 2019

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