Posted on April 28th, 2009 by
Class: Colony stimulating factor, biologic response modifier
Generic Name: Darbepoetin Alfa (dar-be-POE-e-tin AL-fe)
Trade Name: Aranesp®
For which conditions is this drug approved? Aranesp® is FDA-approved for the treatment of anemia (low levels of red blood cells) caused by chemotherapy in patients with non-myeloid cancers. FDA-approval means that Aranesp® has been evaluated in several clinical trials involving patients with non-myeloid cancers, and has been demonstrated to be safe and effective for this indication. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Aranesp® belongs to a class of drugs called colony stimulating factors. Aranesp® alleviates anemia that can be caused by chemotherapy by increasing low levels of red blood cells to normal levels. Red blood cells transport necessary oxygen to tissues throughout the body and carry some waste products from cells. Aranesp® works by stimulating cells in the bone marrow to produce functioning red blood cells, ultimately providing sustained normal levels of red blood cells in the body.
How is Aranesp® typically given (administered)? Aranesp® may be given as a subcutaneous (under the skin) injection or rarely into a vein (intravenous). It is typically administered every two weeks, allowing patients to visit their physician less frequently and avoid unnecessary injections. Increased red blood cell levels in response to Aranesp® may take several weeks. The response time is different for every person. The dose and frequency of Aranesp® administration may vary, depending on how the patient responds, and may change over time while using Aranesp®.
How are patients typically monitored? Patients will usually have their blood levels monitored closely to assess their response to Aranesp® and to refine the dosage that will provide optimal results. Two important blood levels which will be reviewed are called hemoglobin and hematocrit. Hemoglobin is an iron-containing molecule inside every red blood cell that is responsible for the delivery of oxygen to tissues that have low levels of oxygen. Hematocrit is the proportion of red blood cells that are in blood. Blood draws will be continually taken throughout treatment with Aranesp® as needs may change in response to chemotherapy or a patient’s specific condition. Blood pressure will also be monitored frequently.
What are the common (occur in 30% or more of patients) side effects of treatment with Aranesp®?
There are no common side effects attributable to Aranesp® in cancer patients treated with chemotherapy. Common side effects experienced by patients being treated with chemotherapy and Aranesp® appear to be associated with chemotherapy.
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Aranesp®?
• Fluid retention
• Nausea or vomiting
• Headache, dizziness
• Changes in blood pressure
• Pain at injection site
• Muscle aches, joint pain
• Difficulty breathing
What are possible late side effects of treatment with Aranesp®? There are no known late side effects associated with the appropriate use of Aranesp®.
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Although the risk is small, blood clots may occur while taking Aranesp®. It is important that patients with high blood pressure monitor their blood pressure regularly and take all prescribed doses of blood pressure medication.
• Patients should speak with their physician about iron supplementation while taking Aranesp®, as it is recommended by the manufacturer. Only patients’ physicians can accurately advise patients about any type of supplementation.
• If patients are allowed to administer Aranesp® at home, they should be sure to understand proper storage and administration of Aranesp®, as well as the safe and proper way to handle and discard needles.
Are there any special precautions patients should be aware of before starting therapy with Aranesp®?
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician if they have hypertension or a history of seizures.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• Patients should tell their doctor if they had any reactions to prior therapy with Procrit® or Aranesp®.
When should patients notify their physician?
• Allergic reaction (hives, itching, tightness in chest, rash, difficulty breathing, swelling of tongue, throat or lips).
• Tremors or seizures
• Blurry vision
• Severe, sudden headache
• Chest pain
• Extreme fatigue (unable to carry on self-care activities)
• Swelling, redness and/or pain in one leg or arm and not the other.
• Joint pain
• Fluid retention, rapid weight gain
• Acute back pain
• Muscular tremors or seizure activity
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. Click here to view the package insert
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