Class: Hormonal therapy
Generic Name: Goserelin (GOE-se-re-lin)
Trade Name: Zoladex®
For which conditions is Zoladex approved for? Zoladex is FDA approved for the treatment of advanced prostate cancer or for the treatment of prostate cancer that has not spread to distant sites (stages B2-C) in combination with the hormone agent flutamide. It is also approved for the treatment of advanced breast cancer in pre and peri-menopausal women. 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? Zoladex is classified as a luteinizing hormone releasing hormone (LHRH) agonist. LHRH is a naturally occurring hormone in the body that is involved in stimulating the production of female and male hormones such as estrogen and testosterone. Zoladex inhibits the signaling of LHRH, so that the production of estrogen or testosterone is reduced. Certain cancers, such as breast or prostate cancer, are stimulated to grow from hormones such as estrogen or testosterone. The reduction in the production of growth-stimulatory hormones (estrogen or testosterone) reduces the growth of cancer cells.
How is Zoladex typically given (administered)? Zoladex is administered subcutaneously (injection under the skin) and the dose depends on several factors, including the condition being treated, the particular regimen being used and the overall health of the patient. Patients may have an allergic-type reaction to treatment with Zoladex; however, this is uncommon. If patients experience difficulty breathing, rapid heart rate, or lightheadedness, they should contact their healthcare provider.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Zoladex. Patients may undergo physical examinations, scans or other measures to assess side effects and response to therapy.
Patients will also be monitored for a phenomenon called “flare” in which levels of the hormones testosterone or estrogen may surge during initial therapy with Zoladex. The elevated levels of hormones can cause a sudden increase in symptoms, such as bone pain in patients with cancer spread to the bone, or the obstruction of the urinary system resulting in difficulty or the inability to urinate in patients with prostate cancer. Patients experiencing increased bone pain, particularly in the spine, or experiencing difficulty urinating should consult their healthcare provider immediately.
After 6 months of treatment, Zoladex has been shown to decrease bone mineral density. A decrease in bone mineral density can lead to osteoporosis and an increased risk of fractures. Patients may be monitored for changes in bone mineral density with DEXA scans.
What are the common (occur in 30% or more of patients) side effects of treatment with Zoladex?
• Hot flashes
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Zoladex?
• Reduced sex drive
• Erectile dysfunction
• Vaginal dryness
• Swelling or tenderness of breasts
• Bone pain
• Local discomfort at injection site
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 help 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.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• Patients who experience hot flashes may wish to wear light clothing, stay in a cool environment, and place cool cloths on their body or head to relieve their symptoms.
Are there any special precautions patients should be aware of before starting treatment?
• 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 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.
When should patients notify their physician?
• Increase in bone pain, particularly the spine
• Inability or difficulty in urinating
• Severe depression
• Chest pain
• Swelling, pain or redness in only one extremity
• Difficulty breathing
• Rapid heart rate
• Weakness, numbness or tingling in arms or legs
• Swelling of the ankles, hands or face
• Extreme and persistent fatigue
• Abnormal thinking
• Skin rash, hives, itching
• Unusual nausea or vomiting
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.
Important Limitations of Use
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