Generic Name: goserelin (GOE-se-REL-in)
Brand Name: Zoladex

Zoladex is used for:

Treating prostate cancer. It is also used to treat endometriosis, to cause endometrial thinning before endometrial ablation, and to treat symptoms of advanced breast cancer in certain women. It may also be used for other conditions as determined by your doctor.

Zoladex is a synthetic analog of gonadotropin-releasing hormone (GnRH). It works by decreasing the production of certain hormones by the testes or ovaries.

Do NOT use Zoladex if:

  • you are allergic to any ingredient in Zoladex, GnRH, or another GnRH agonist (eg, histrelin)
  • you are pregnant, may become pregnant, or are breast-feeding
  • you have vaginal bleeding of unknown cause

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Zoladex:

Some medical conditions may interact with Zoladex. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of urinary problems (eg, blockage of the bladder or ureters), spinal cord problems, abnormal growths on or near the spine or spinal cord, mental or mood problems (eg, depression), diabetes or high blood sugar, heart problems (eg, irregular heartbeat), blood vessel problems, a stroke, or high blood calcium levels
  • if you have bone problems (eg, weak bones, osteoporosis) or if a family member has had bone problems
  • if a family member has had a certain type of irregular heartbeat (long QT syndrome)
  • if you are overweight
  • if you have a history of alcohol abuse or regular tobacco use
  • if you are taking medicines that can weaken the bones, such as anticonvulsants (eg, phenytoin) or corticosteroids (eg, prednisone)

Some MEDICINES MAY INTERACT with Zoladex. However, no specific interactions with Zoladex are known at this time.

Ask your health care provider if Zoladex may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zoladex:

Use Zoladex as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Zoladex is usually given as an injection at your doctor's office, hospital, or clinic.
  • If you miss a dose of Zoladex, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Zoladex.

Important safety information:

  • Zoladex may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Zoladex with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Certain hormone levels may increase during the first few weeks of treatment with Zoladex. This may cause you to experience worsening symptoms or onset of new symptoms (eg, bone pain; blood in the urine; difficulty urinating; burning, numbness, or tingling) during the first few weeks of treatment. Patients with growths on or near the spine or spinal cord, or blockage of the bladder or ureters may be at greater risk of developing serious and sometimes fatal complications. Contact your doctor if any new or worsened symptoms occur while using Zoladex.
  • Zoladex lowers the amount of certain hormones in your body. This may cause certain expected side effects to occur, such as breast enlargement, soreness, or tenderness; testicular changes, pain, or soreness; decreased sexual ability; hot flashes; or night sweats. Contact your doctor if you have questions or concerns or if you experience any of these side effects.
  • Zoladex should stop regular menstrual bleeding. If you continue to have menstrual bleeding while using Zoladex, contact your health care provider.
  • Women must avoid becoming pregnant while using Zoladex and for at least 12 weeks after stopping Zoladex. Talk with your doctor about using effective, nonhormonal methods of birth control (eg, condoms).
  • Some women may not experience a return to their regular menstrual cycle right away after stopping Zoladex. This effect does not ensure pregnancy prevention. Rarely, some women may experience a persistent lack of menstrual period after stopping Zoladex. Discuss any questions or concerns with your doctor.
  • Zoladex may cause your bones to weaken or become more prone to fractures, especially if you use Zoladex for long periods of time. Contact your doctor if you experience bone pain or if you have concerns regarding changes in bone density. Discuss any questions or concerns with your doctor.
  • A slight increase in the risk of stroke or serious and sometimes fatal heart problems has been reported with the use of GnRH agonists in men. Although the risk appears to be low, seek immediate medical attention if you experience chest, jaw, or left arm pain; confusion; fainting; numbness of an arm or leg; one-sided weakness; slurred speech; sudden, severe headache or vomiting; or vision changes. Discuss any questions or concerns with your doctor.
  • Zoladex may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Rarely, a serious pituitary gland problem (pituitary apoplexy) may occur after you use Zoladex. This serious problem usually occurs shortly after you begin to use Zoladex. Contact your doctor immediately if you experience a sudden headache, vomiting, fainting, eye weakness, inability to move your eyes, mental status changes, or vision changes.
  • Zoladex may interfere with certain lab tests, including certain hormonal tests and pituitary gland function tests. Be sure your doctor and lab personnel know you are using Zoladex.
  • Lab tests, including bone density, prostate-specific antigen (PSA) or testosterone levels, hemoglobin A1c, estradiol levels, and blood glucose, may be performed while you use Zoladex. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Zoladex should be used with extreme caution in CHILDREN; safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Zoladex may cause harm to the fetus. Avoid becoming pregnant while taking Zoladex. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zoladex while you are pregnant. It is not known if Zoladex is found in breast milk. Do not breast-feed while taking Zoladex.

Possible side effects of Zoladex:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; change in breast size; decreased sexual desire or ability; diarrhea; dizziness; headache; hot flashes; loss of appetite; mood swings; nausea; sweating; tiredness or weakness; trouble sleeping; vaginal dryness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back or stomach pain; blood in the urine or dark urine; bloody vomit; bone pain; breast pain; burning, numbness, or tingling; fainting; fast or irregular heartbeat; fever, chills, or sore throat; mood or mental changes (eg, depression); painful urination; reaction at the injection site; severe or persistent headache or dizziness; shortness of breath; sudden, unusual weight gain; swelling of the arms or legs; symptoms of a heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); trouble urinating or inability to urinate; unusual tiredness or weakness; vaginal irritation or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Zoladex:

Zoladex is usually handled and stored by a health care provider. If you are using Zoladex at home, store Zoladex as directed by your pharmacist or health care provider. Keep Zoladex out of the reach of children and away from pets.

General information:

  • If you have any questions about Zoladex, please talk with your doctor, pharmacist, or other health care provider.
  • Zoladex is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Zoladex or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Zoladex. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Zoladex. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Zoladex.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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