Darbepoetin Alfa Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 10, 2024.

Applies to darbepoetin alfa: injection solution.

Precautions

People with severe anemia usually feel very tired and sick. When darbepoetin alfa begins to work, usually in about 6 weeks, most people start to feel better. Some people are able to be more active. But darbepoetin alfa only corrects anemia. It has no effect on kidney disease, cancer, or any other medical problem that needs regular medical attention. Even if you are feeling much better, it is very important that you do not miss any appointments with your doctor or any dialysis treatments.

It is very important that your doctor check your blood regularly while you are using this medicine. You may also need to monitor your blood pressure at home. If you notice any changes to your normal blood pressure, call your doctor right away.

Darbepoetin alfa may cause a serious type of allergic reaction called anaphylaxis. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble with breathing, or chest pain after you receive the medicine.

This medicine may increase your risk of having blood clots. This is more likely in patients who use high doses of this medicine, or who use this medicine before major surgery. If you have chest pain, trouble breathing, or pain, redness, or swelling in your arms or legs while using this medicine, call your doctor right away. If you are getting kidney dialysis treatments, tell your doctor right away if you notice blood clots at your injection site. Your doctor may give you a blood thinner before surgery to help prevent blood clots.

This medicine may also increase your risk of having serious heart and blood vessel problems such as a heart attack, congestive heart failure, or stroke. Check with your doctor right away if you start having dizziness, fainting spells, severe tiredness, chest pain, trouble with breathing, sudden or severe headache, or problems with vision, speech, or walking.

When used in patients with certain types of cancer (eg, breast, cervix, lymphoid, lung, head, or neck cancer), this medicine has shortened survival time and worsened the tumor or cancer in some patients. If you are concerned about this, talk with your doctor.

Darbepoetin alfa sometimes causes convulsions (seizures), especially during the first few months of treatment. During this time, it is best to avoid driving, operating heavy machinery, or other activities that could cause a serious injury if a seizure occurs while you are performing them.

One form of darbepoetin alfa injection has an ingredient that comes from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

Many people with kidney problems need to be on a special diet. Also, people with high blood pressure (which may be caused by kidney disease or by darbepoetin alfa treatment) may need to be on a special diet or to take medicine to keep their blood pressure under control. After their anemia has been corrected, some people feel so much better that they want to eat more than before. To keep your kidney disease or your high blood pressure from getting worse, it is very important that you follow your special diet and take your medicines regularly, even if you are feeling better.

In addition to darbepoetin alfa, your body needs iron and vitamins to make red blood cells. Your doctor may direct you to take iron or vitamin supplements. Be sure to follow your doctor's orders carefully. Darbepoetin alfa will not work well if you do not have enough iron or vitamins in your body.

Serious side effects of darbepoetin alfa

Along with its needed effects, darbepoetin alfa may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking darbepoetin alfa:

Other side effects of darbepoetin alfa

Some side effects of darbepoetin alfa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to darbepoetin alfa: injectable solution.

General adverse events

The most common adverse reactions in patients with chronic kidney disease (CKD) were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. The most common adverse reactions in cancer patients receiving chemotherapy were abdominal pain, edema, and thrombovascular events.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 38%), vomiting (up to 27%), diarrhea (up to 20%), constipation (up to 19%), abdominal pain (up to 16%)
• Common (1% to 10%): Dyspepsia^[Ref]

Other

• Very common (10% or more): Fatigue (up to 32%), fever (up to 19%), peripheral edema (up to 17%), asthenia (up to 16%), edema (up to 12.8%), procedural hypotension (10%), chest pain (up to 10%)
• Common (1% to 10%): Death, influenza-like symptoms, fluid overload, fall, contusion, pain, arteriovenous graft thrombosis^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (up to 31%), hypotension (up to 22%)
• Common (1% to 10%): Myocardial infarction, thrombotic events, angina pectoris
• Frequency not reported: Arrhythmia, thromboembolism, thrombosis, thrombophlebitis^[Ref]

Musculoskeletal

• Very common (10% or more): Myalgia (up to 20%), back pain (14%), arthralgia (up to 13%), limb pain (up to 11%)
• Common (1% to 10%): Skeletal pain^[Ref]

Respiratory

• Very common (10% or more): Dyspnea (up to 20%), upper respiratory infection (up to 14%), cough (up to 12%), nasopharyngitis (11%)
• Common (1% to 10%): Bronchitis, sinusitis, sore throat, pulmonary embolism
• Frequency not reported: Epistaxis, allergic bronchospasm^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 16%), dizziness (up to 14%)
• Common (1% to 10%): Cerebrovascular accident/transient ischemic attack, convulsions, paresthesia, hypoesthesia, cerebrovascular disorders, stroke
• Frequency not reported: Somnolence^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection (15%)^[Ref]

Renal

• Very common (10% or more): Chronic renal failure (15%)^[Ref]

Metabolic

• Very common (10% or more): Hypoglycemia (14%)^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (11%)
• Common (1% to 10%): Depression, anxiety^[Ref]

Dermatologic

• Common (1% to 10%): Pruritus, cellulitis, rash, skin ulcer, alopecia
• Frequency not reported: Angioedema, urticaria
• Postmarketing reports: Severe cutaneous reaction^[Ref]

Local

• Common (1% to 10%): Injection site pain, access hemorrhage, access infection, vascular access thrombosis, vascular access complications^[Ref]

Hematologic

• Common (1% to 10%): Granulocytopenia
• Frequency not reported: Anemia, pure red cell aplasia associated with neutralizing antibodies to erythropoietin^[Ref]

Oncologic

• Common (1% to 10%): Metastatic neoplasm^[Ref]

Immunologic

• Frequency not reported: Serious allergic reaction, hypersensitivity reaction, anaphylactic reaction^[Ref]

See also:

Frequently asked questions

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Further information

Darbepoetin alfa side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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