Aranesp®

Class: Supportive Care

Generic Name: Darbepoetin Alfa (dar-be-POE-e-tin  AL-fe)
Trade Name: Aranesp®

For which conditions is this drug approved? Aranesp® is approved for the treatment of anemia (low levels of red blood cells) caused by chemotherapy in patients with non-myeloid cancers. This FDA approval means that Aranesp® has been compared to standard therapies or supportive care in several clinical trials involving patients with this condition, and has been demonstrated to be safe and effective for this indication. If your doctor has prescribed this drug for a different condition, keep in mind that doctors have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA, and you should discuss this issue with your doctor.

What is the mechanism of action? 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 doctor 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 your 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
• Diarrhea

What are possible late side effects of treatment with Aranesp®? There are no known late side effects associated with the appropriate use of Aranesp®.

What can patients do to alleviate or prevent discomfort and side effects?

• Although the risk is small, blood clots may occur while taking Aranesp®. Therefore, it is important that patients take all prescribed doses of blood pressure medication if they have high blood pressure.
• 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.
• Maintain adequate rest.
• Maintain good nutrition.
• Patients should speak to their healthcare provider about any side effects they are experiencing.
• 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 tell their physician if they are pregnant, breast feeding 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 regarding wanting 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 stones, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should let their physician know 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 tell their doctor if they had any reactions to prior therapy with Procrit®.

When should patients notify their physician?

• Tremors or seizures
• Difficulty breathing
• 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.
• Dizziness
• Diarrhea
• Fever
• Joint pain
• Rash
• Fluid retention

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. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Website: www.aranesp.com

Copyright © 2010 CancerConnect Last updated 01/05.

Disclaimer
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information.  Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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