Class: Hormonal therapy
Generic Name: Abarelix
Trade Name: Plenaxis™
For which conditions is this drug approved? Abarelix is FDA approved for the treatment of advanced prostate cancer in patients who are not eligible for a type of hormonal therapy utilizing luteinizing hormone releasing hormone (LHRH) agonists, and who elect not to undergo the surgical removal of the testicles (orchiectomy). Patients must also have one or more of the following: severe pain caused by bone metastasis, blockage of the urinary tract, a high risk for developing neurologic complications from cancer.
Abarelix is approved for use with restrictions for safety reasons; abarelix may cause an allergic-type reaction. Only physicians enrolled in a special plenaxis PLUS program may prescribe this drug. Patients will be asked to sign a form indicating that the risks and benefits of treatment have been explained prior to initiation of treatment.
What is the mechanism of action? Abarelix is referred to as a gonadotropin releasing-hormone (GnRH) antagonist. Gonadotropin releasing hormone is produced by the hypothalamus and stimulates the production of testosterone, a male hormone that is associated with the growth of prostate cancer. Abarelix reduces the ability of GnRH to bind properly to cells, and therefore inhibits the production of testosterone stimulated by GnRH.
How is abarelix typically given (administered)? Abarelix is administered into a muscle (intramuscular).
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with abarelix. Typically, blood will be drawn to check levels of testosterone and prostate specific antigen (PSA) before and during therapy and to monitor functions of some organ systems, such as the liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.
Patients are also monitored for an allergic-type reaction that may be caused by abarelix. Patients may be monitored for at least 30 minutes following administration of abarelix for low blood pressure, hives, rash, or signs of fainting. Patients experiencing difficulty breathing, dizziness, a noticeable change in heart rate or rhythm, extreme lethargy, hives or rash should tell their healthcare provider immediately.
What are the common (occur in 30% or more of patients) side effects of treatment with abarelix?
• Hot flushes
• Sleep disturbances
• Breast enlargement
What are the less common (occur in 10% to 29% of patients) side effects of treatment with abarelix?
• Breast pain
• Nipple tenderness
• Back pain
• Swelling of the hands and/or feet
• Upper respiratory infection
• Urinary tract infection
• Inability to urinate, low urine volume, frequent urination, painful urination
What are the potential long-term side effects of treatment with abarelix?
• Decrease in bone mineral density (osteoporosis)
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 regimen, 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 help alleviate or prevent discomfort and side effects?
• Patients should inform their doctors of any side effects.
• Wear sunscreen and protective clothing; try to minimize sun exposure.
• Drink plenty of fluid. Patients should ask their physician about the amount of liquid to consume during a day.
• Maintain adequate rest and nutrition.
• Eat small meals frequently to help alleviate nausea
• If experiencing hot flushes, patients may wish to dress cool and remain in a cool environment if possible
Are there any special precautions patients should be aware of before starting treatment?
• Patients should tell 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. Abarelix is not indicated for use in women.
• It is important that patients inform their physician of any pre-existing condition (chicken pox, infection, heart disease, kidney disease, liver disease, lung disease, etc.), as they may worsen with this drug or can affect the doses administered.
• 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. It is important for patients to inform their physician of any medications they are taking for a heart condition.
• 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.
When should patients notify their physician?
• Signs of an allergic reaction – hives, rash, itching, difficulty breathing, tightness of chest, extreme lethargy, fainting,
• Noticeable change in heart rate or rhythm
• Inability to urinate, pain or burning upon urination, increased frequency of urination, and/or low volumes of urine output
• Swelling of hands or feet, or facial features
• Yellowing of the skin or eyes
• Right upper abdominal pain
• Swelling of the feet and ankles accompanied by sudden weight gain
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.
Copyright © 2010 CancerConnect Last updated 07/10.
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Tags: A, Hormonal Therapy