goserelin

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

What is goserelin?

Goserelin is a man-made form of a hormone that regulates many processes in the body. Goserelin overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily.

Goserelin is used in men to treat symptoms of prostate cancer, and in women to treat breast cancer or endometriosis. Goserelin is also used in women to prepare the lining of the uterus for endometrial ablation (a surgery to correct abnormal uterine bleeding).

If you are receiving goserelin to treat prostate cancer, use any other medications your doctor has prescribed to best treat your condition. Goserelin treats only the symptoms of prostate cancer but does not treat the cancer itself.

Goserelin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about goserelin?

This medication can harm an unborn baby or cause birth defects and should not be used during pregnancy. Use effective non-hormonal (barrier) birth control during treatment and for at least 12 weeks after treatment ends. Tell your doctor right away if you become pregnant during treatment. Do not use goserelin if you are pregnant or breast-feeding. You should not use this medication if you are allergic to goserelin or to similar hormone medications such as leuprolide (Lupron, Eligard, Viadur), nafarelin (Synarel), or ganirelix (Antagon). Do not use goserelin if you are pregnant or breast-feeding.

Before you receive goserelin, tell your doctor if you have osteoporosis, diabetes, urination problems, a condition affecting your spine, or if you have abnormal bleeding that your doctor has not checked.

Goserelin can decrease bone mineral density, which may increase your risk of developing osteoporosis. This risk may be greater if you smoke, drink alcohol frequently, have a family history of osteoporosis, or use certain drugs such as seizure medications or steroids. Talk to your doctor about your individual risk of bone loss. Call your doctor at once if you have a serious side effect such as severe numbness or tingling in your legs or feet, muscle weakness, problems with balance or coordination, loss of bladder or bowel control, urinating more or less than usual, pain or burning when you urinate, feeling like you might pass out, pale skin, easy bruising, trouble breathing, chest pain or heavy feeling, or changes in heart rate.

If you are using goserelin to treat prostate cancer, use any other medications your doctor has prescribed to best treat your condition. Goserelin treats only the symptoms of prostate cancer but does not treat the cancer itself.

What should I discuss with my healthcare provider before receiving goserelin?

You should not receive this medication if you are allergic to goserelin or to similar hormone medications such as leuprolide (Lupron, Eligard, Viadur), nafarelin (Synarel), or ganirelix (Antagon). Do not use goserelin if you are pregnant or breast-feeding.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use goserelin:

• osteoporosis or low bone density;

• diabetes;

• painful or difficult urination;

• a condition affecting your spine; or

• if you have abnormal bleeding that your doctor has not checked.

Goserelin can harm an unborn baby or cause birth defects. Before receiving goserelin, you may need a pregnancy test to make sure you are not pregnant. Do not use goserelin if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication and for at least 12 weeks after your treatment ends. If you are a premenopausal woman, goserelin should cause your periods to stop during treatment. However, you must still use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective during your treatment with goserelin. After you stop using goserelin, you should begin having regular periods again. Call your doctor if your normal periods do not return within 12 weeks after your goserelin treatment ends. It is not known whether goserelin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Goserelin can decrease bone mineral density, which may increase your risk of developing osteoporosis. This risk may be greater if you smoke, drink alcohol frequently, have a family history of osteoporosis, or use certain drugs such as seizure medications or steroids. Talk to your doctor about your individual risk of bone loss.

How is goserelin given?

Goserelin is given in a tiny implant that is inserted through a needle injected under the skin of your upper stomach. You will receive this injection in a clinic or doctor's office.

You are not likely to be able to feel the implant through your skin, and it should not cause pain or discomfort. The implant will dissolve in your body over time.

A new goserelin implant is usually injected every 28 days, but the timing of your dose may be different if you are also receiving chemotherapy. Follow your doctor's instructions. It is very important to receive your goserelin injections on time each month.

If you are a premenopausal woman, you should stop having menstrual periods during treatment with goserelin. Call your doctor if you still have regular periods. Missing a dose can cause breakthrough bleeding.

While your homone levels are adjusting to goserelin, you may notice increased symptoms or new symptoms of your condition. This should be only temporary during the first few weeks of treatment. Tell your doctor if your symptoms do not improve after several weeks of using goserelin.

Your blood sugar may need to be checked while using goserelin, even if you are not diabetic. You may also need other blood tests at your doctor's office. Do not miss any appointments.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using goserelin.

What happens if I miss a dose?

It is important not to miss a dose of goserelin. Contact your doctor immediately if you miss a dose of this medication.

What happens if I overdose?

Since the goserelin implant contains a specific amount of the medication, you are not likely to receive an overdose.

What should I avoid while receiving goserelin?

Avoid drinking alcohol. It can increase your risk of bone loss while you are being treated with goserelin. Avoid smoking, which can also increase your risk of bone loss.

Goserelin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• back pain, severe numbness or tingling in your legs or feet;

• muscle weakness, problems with balance or coordination;

• loss of bladder or bowel control;

• urinating less than usual or not at all;

• pain or burning when you urinate;

• feeling like you might pass out;

• trouble breathing;

• pale skin, easy bruising;

• chest pain or heavy feeling, changes in heart rate; or

• nausea, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless.

Less serious side effects may include:

• hot flashes, sweating, headache, dizziness;

• mood changes, vaginal dryness, increased or decreased interest in sex;

• impotence, fewer erections than normal;

• breast swelling or tenderness;

• bone pain;

• nausea, vomiting, diarrhea, constipation;

• loss of appetite, nausea, or diarrhea;

• sleep problems (insomnia); or

• acne, mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Goserelin Dosing Information

Usual Adult Dose for Prostate Cancer:

For the palliative treatment of advanced carcinoma of the prostate:3.6 mg or 10.8 mg subcutaneously into the upper abdominal wall once. The 3.6 mg dosage may be repeated every 28 days. The 10.8 mg dosage may be repeated every 12 weeks.Intended for long-term administration unless clinically inappropriate.For use in the treatment of Stage B2-C prostate cancer: When administered in combination with radiotherapy and flutamide for patients with Stage T2b-T4 (Stage B2-C) prostate cancer, treatment should be started 8 weeks prior to initiating radiotherapy and should continue during radiotherapy.

Usual Adult Dose for Endometriosis:

For use in the management of endometriosis, including pain relief and reduction of endiometrotic lesions for the duration of therapy: 3.6 mg subcutaneously into the upper abdominal wall once. The 3.6 mg dosage may be repeated every 28 days.The recommended duration of therapy is 6 months.

Usual Adult Dose for Breast Cancer--Palliative:

For use in the palliative treatment of advanced breast cancer: 3.6 mg subcutaneously into the upper abdominal wall once. The 3.6 mg dosage may be repeated every 28 days.Intended for long-term administration unless clinically inappropriate.

Usual Adult Dose for Bleeding:

For use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding: 1 or 2 of the 3.6 mg subcutaneous depot injections (with each depot given four weeks apart). When one depot is administered, surgery should be performed at 4 weeks. When two depots are administered, surgery should be performed within 2 to 4 weeks following administration of the second depot.

What other drugs will affect goserelin?

There may be other drugs that can interact with goserelin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about goserelin.

• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 08/31/2009 3:50:38 PM.