Darbepoetin alfa Side Effects

Some side effects of darbepoetin alfa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to darbepoetin alfa: injectable solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking darbepoetin alfa: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Contact your doctor if you feel light-headed or unusually weak or tired. These may be signs that your body has stopped responding to darbepoetin alfa.

Darbepoetin alfa can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use darbepoetin alfa. Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• feeling short of breath, even with mild exertion;

• swelling, rapid weight gain;

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, confusion, problems with vision, speech, or balance; or

• pain, swelling, warmth, or redness in one or both legs.

Stop using darbepoetin alfa and call your doctor at once if you have other serious side effects such as:

• fever, chills, body aches, flu symptoms;

• feeling like you might pass out;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• seizure (black-out or convulsions); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects of darbepoetin alfa may include:

• stomach pain;

• mild cough;

• mild skin rash or redness; or

• pain, bruising, swelling, warmth, redness, oozing, or bleeding where the IV needle is placed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to darbepoetin alfa: injectable solution

Cardiovascular

Cardiovascular side effects have included hypertension (up to 23%), hypotension (up to 22%), cardiac arrhythmias/cardiac arrest (up to 10%), angina pectoris/cardiac chest pain (8%), congestive heart failure (up to 6%), thrombosis vascular access (6%), acute myocardial infarction (2%), and transient ischemic attack (1%).

Hematologic

Hematologic side effects including an increased incidence of thrombotic events have been observed in patients treated with erythropoietic agents. In patients with cancer who received darbepoetin alfa, pulmonary emboli, thrombophlebitis, and thrombosis occurred more frequently than in placebo controls.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 22%), constipation (up to 18%), vomiting (up to 15%), nausea (up to 14%), abdominal pain (up to 12%), and constipation (5%).

Musculoskeletal

Musculoskeletal side effects have included myalgia (up to 21%), muscle spasm (17%), arthralgia (up to 13%), limb pain (up to 10%), and back pain (up to 8%).

Nervous system

Nervous system side effects have included headache (up to 16%), dizziness (up to 8%), stroke (up to 2%), and seizure (1%).

General

General side effects reported have included fatigue (33%), edema (up to 21%), fever (up to 19%), peripheral edema (up to 11%), access hemorrhage (7%), death (up to 7%), fluid overload (6%), access infection (6%), influenza-like symptoms (6%), asthenia (5%), and dehydration (5%).

In general, some of the adverse effects reported are typically associated with chronic renal failure, or recognized complications of dialysis, and may not necessarily be the result of darbepoetin alfa therapy.

Dermatologic

Dermatologic side effects have included pruritus (up to 8%) and rash (7%).

Respiratory

Respiratory side effects have included upper respiratory infection (up to 27%), dyspnea (up to 12%), cough (up to 10%), and bronchitis (up to 6%).

Local

Local adverse effects have included pain at injection site (up to 7%).

Immunologic

Immunologic side effects including neutralizing antibodies to erythropoietin, in association with pure red cell aplasia (PRCA) or severe anemia (with or without cytopenias) have been reported. Infection (24%) has been reported.

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