Darbepoetin Alpha Side Effects
Serious Adverse Side Effects
Darbepoetin Alpha has some very serious adverse side effects associated with it. These include:
- Cardiovascular side effects like congestive heart failure, disorders of the cardiovascular system, high blood pressure and acute heart attacks
- Hematological side effects like anemia, blockage of the arteries, blood clots in veins, anemia where the body doesn’t produce red blood cells, and thromboembolism
- Immunological side effects like antibody development and immune system reactions to the drug
- Neurological side effects like stroke, hypertensive encephalopathy (a disorder caused by malignant hypertension), seizures, and loss of blood flow to the brain
- Respiratory side effects like pulmonary embolism, or blockage of the arteries of the lungs
- Other side effects like tumor progression
Common Adverse Side Effects
This drug has more common and less severe adverse side effects to it, such as:
- Cardiovascular side effects like fluid accumulation (edema), chronic kidney disease and low blood pressure
- Gastrointestinal side effects like abdominal pain
- Respiratory side effects like cough and shortness of breath
Warnings & Recalls for Darbepoetin Alpha
Black Box Warning
Darbepoetin Alpha has a “black box” warning associated with it that says that erythropoiesis-stimulating agents have the potential to increase death, heart attacks, stroke and other serious cardiovascular events. Patients with chronic kidney failure at a heightened risk of death and serious ailments. It also conveys that the lowest possible dosage of this drug should be administered at all times and treatment with
Darbepoetin Alpha should be as minimal as possible.
Contraindications
The contraindications with
Darbepoetin Alpha are as follows:
- Serious allergic reactions to the drug
- Uncontrolled hypertension
- Hypersensitivity to Darbepoetin Alpha
- Pure red blood cell aplasia that began with treatment with Darbepoetin Alpha or any other erythropoietin protein drug
Who Should Not Take This Drug
The following preexisting conditions hinder a patient’s ability to take
Darbepoetin Alpha. These include:
- Cancer patients with anemia and who are receiving myelosuppressive chemotherapy when cure is the anticipated outcome
- Chronic kidney disease patients with Hb greater than 11g/dL
- Chronic kidney disease patients with insufficient Hb response to therapy
- History of cardiac events
- Failure to respond to or maintain a response
- Patients undergoing hemodialysis
- Hemoglobin increase in excess of 1g/dL within a 2 week period
- Patients with latex allergies
- Those who are taking lenalidomide
Pregnancy Warning
This drug has been given a pregnancy category rating of “C” by the FDA, implying that although it doesn’t pose that much of a risk to the fetus, it probably is advisable to discontinue this drug after conception.
Darbepoetin Alpha Treatment and Use
Darbepoetin Alpha is a synthetic form of erythropoietin, an essential hormone that controls red blood cell production. The brand name version of this drug is called Aranesp. This drug primarily treats anemia which is associated with chronic renal failure and chemotherapy. This drug was approved by the FDA on September of 2001 and comes in the form of an injection.
Darbepoetin Alpha is reproduced by using recombinant DNA technology by the modification of Chinese hamster ovary cells.
See the “Warnings and Recalls” tab to get more information about Darbepoetin Alpha’s “black box” warning.
How This Drug Works
Darbepoetin Alpha is known as an erythropoiesis stimulating protein produced solely by recombinant DNA technology. This drug is related to the hormone that controls red blood cell production known as erythropoietin and stimulates erythropoiesis by the same mechanism of action as both agents bind to stem cells, thereby stimulating the production of red blood cells.
Dosage Information
Recommended starting dose for chronic kidney disease patients on dialysis:
- 0.45 mcg/kg intravenously or subcutaneously weekly, or
- 0.75 mcg/kg intravenously or subcutaneously every 2 weeks
- Intravenous route is recommended for patients on hemodialysis
Recommended starting dose for patients with chronic kidney disease not on dialysis:
- 0.45 mcg/kg intravenously or subcutaneously at 4 week intervals
Recommended starting dose for cancer patients on chemotherapy:
- 2.25 mcg/kg subcutaneously weekly, or
- 500 mcg subcutaneously every 3 weeks
Other Names for Darbepoetin Alpha
Brand Names
Generic Name
Lawsuits & Legal Information for Darbepoetin Alpha