Summary
Commonly reported side effects of darbepoetin alfa include: hypertension and peripheral edema. Other side effects include: congestive heart failure and hypervolemia. Continue reading for a comprehensive list of adverse effects.
Applies to darbepoetin alfa: injection solution.
Warning
Injection route (Solution)
Erythropoiesis-stimulating agents (ESAs) increase the risk for death, myocardial infarction, stroke, and other serious cardiovascular events. Patients with chronic kidney disease (CKD) were at a greater risk for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target Hb levels of greater than 11 g/dL in clinical studies. No trial has identified a Hb target level, ESA dose, or dosing strategy that does not increase these risks. In CKD patients, use the lowest sufficient dose to reduce the need for RBC transfusions. In cancer patients with certain tumor types (ie, breast, non-small cell lung, head and neck, lymphoid, cervical), ESAs shortened overall survival and increased the risk of tumor progression or recurrence in clinical studies. In cancer patients, use the lowest dose needed to avoid RBC transfusions to reduce these risks and the risk of serious cardiovascular and thromboembolic reactions. Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy, and discontinue following the completion of a chemotherapy course. Patients receiving myelosuppressive therapy when the anticipated outcome is cure should not be treated with ESAs.
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:
More common
- Accumulation of pus
- arm, back, or jaw pain
- blurred vision
- breathing problems (irregular, noisy, or trouble when resting)
- chest pain, discomfort, tightness, or heaviness
- chills
- confusion
- cough producing mucus
- decrease in the amount of urine
- diarrhea
- dilated neck veins
- dizziness, fainting, or lightheadedness
- dry mouth
- fast, slow, or irregular heartbeat
- fatigue or tiredness (extreme or unusual)
- fever
- headache
- nausea
- pain, tenderness, swelling, or warmth over the injection site
- pounding in the ears
- rapid breathing
- rapid or pounding pulse
- skin discoloration at the injection site
- stomach pain
- sunken eyes
- sweating
- swelling of the ankles, face, fingers, feet, hands, or lower legs
- thirst
- trouble with breathing
- unconsciousness
- vomiting
- weight gain
- wrinkled skin
Less common
- Anxiety
- difficulty with speaking (slow speech or unable to speak)
- double vision
- seizures
- trouble with thinking
- trouble with walking
- unable to move the arms, legs, or face muscles (including numbness and tingling)
Rare
- Fever
- hives, itching, skin rash
- pale skin
- sore throat
Incidence not known
- Blistering, peeling, or loosening of the skin
- cough
- joint or muscle pain
- red, irritated eyes
- red skin lesions, often with a purple center
- sores, ulcers, or white spots in mouth or on the lips
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:
More common
- Constipation
- general feeling of discomfort or illness
- lack or loss of strength
- loss of appetite
- muscle aches, pains, or stiffness
- runny nose
- shivering
- sneezing
- trouble with sleeping
For Healthcare Professionals
Applies to darbepoetin alfa: injectable solution.
General
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]
