zoladex

Zoladex (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.

Zoladex is used in men to treat symptoms of prostate cancer.

Zoladex is used 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).

Important information

Zoladex can harm an unborn baby or cause birth defects. Unless you are being treated for advanced breast cancer, you should not use Zoladex 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. You should not breast-feed while you are using Zoladex.

You should not use Zoladex if you are allergic to goserelin or to similar hormone medications such as leuprolide (Lupron, Eligard, Viadur), nafarelin (Synarel), or ganirelix (Antagon).

Before you receive Zoladex, tell your doctor if you have osteoporosis, diabetes, urination problems, a condition affecting your spine, a history of heart attack or stroke, risk factors for coronary artery disease (such as high blood pressure, high cholesterol, smoking, or being overweight), or if you have abnormal bleeding that your doctor has not checked.

Zoladex 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 while using Zoladex, 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 less than usual, pain or burning when you urinate, blood in your urine or stools, easy bruising, increased thirst or urination, fruity breath odor, trouble breathing, sudden numbness or weakness, sudden severe headache, confusion, problems with vision or speech, or chest pain spreading to the arm or shoulder.

Before taking this medicine

You should not use Zoladex if you are allergic to goserelin, or:

• if you are allergic to other hormone medications such as leuprolide (Lupron, Eligard, Viadur), nafarelin (Synarel), or ganirelix (Antagon).

Unless you are being treated for advanced breast cancer, you should not use a Zoladex implant during pregnancy.

To make sure Zoladex is safe for you, tell your doctor if you have:

• diabetes;

• heart disease or prior heart attack;

• a history of heart attack or stroke;

• risk factors for coronary artery disease (such as high blood pressure, high cholesterol, smoking, or being overweight);

• personal or family history of long QT syndrome;

• osteoporosis or low bone density;

• a condition affecting your spine;

• abnormal vaginal bleeding that has not been checked by a doctor; or

• if you take a blood thinner such as warfarin (Coumadin, Jantoven).

Zoladex 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.

This medicine can harm an unborn baby or cause birth defects. However, Zoladex is sometimes given to pregnant women being treated for advanced breast cancer. Unless you are being treated for advanced breast cancer, you should not use Zoladex during pregnancy.

You may need to have a negative pregnancy test before receiving the implant.

Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Keep using birth control for at least 12 weeks after the Zoladex implant is removed.

It is not known whether goserelin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while the Zoladex implant is in place.

How is Zoladex given?

Zoladex implant is inserted through a needle into the skin of your upper stomach, once every 28 days. You will receive the implant in a clinic or doctor"s office.

Your dosing schedule may be different if you are also receiving chemotherapy. Follow your doctor"s instructions. It is very important to receive your Zoladex injections on time each month.

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.

While your hormone levels are adjusting, you may notice new or worsening symptoms of your condition during the first few weeks of treatment. Tell your doctor if your symptoms do not improve after several weeks.

If you are a premenopausal woman, you should stop having menstrual periods while the Zoladex implant is in place. Call your doctor if you still have regular periods. Missing a dose can cause breakthrough bleeding. After you stop using Zoladex, you should begin having regular periods within 12 weeks.

Your blood sugar may need to be checked while using Zoladex, even if you are not diabetic. You may need other blood tests at your doctor"s office.

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

Zoladex dosing information

Usual Adult Dose of Zoladex 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 endometriotic 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 happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Zoladex implant injection.

What happens if I overdose?

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

What should I avoid while receiving Zoladex?

Avoid drinking alcohol. It can increase your risk of bone loss while you are being treated with Zoladex.

Avoid smoking, which can increase your risk of bone loss, stroke, or heart problems.

This medicine can pass into body fluids (including urine, feces, vomit). Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Zoladex side effects

Get emergency medical help if you have signs of an allergic reaction to Zoladex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• painful or difficult urination;

• pain, bruising, swelling, redness, oozing, or bleeding where the implant was injected;

• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;

• high calcium levels - nausea, vomiting, constipation, increased thirst or urination, muscle pain or weakness, bone pain, confusion, and feeling tired or restless;

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• nerve problems - back pain, muscle weakness, problems with balance or coordination, severe numbness or tingling in your legs or feet, loss of bladder or bowel control; or

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common Zoladex side effects may include:

• hot flashes, sweating;

• mood changes, increased or decreased interest in sex;

• changes in sexual function, fewer erections than normal;

• headache;

• swelling in your hands or feet;

• vaginal dryness, itching, or discharge;

• changes in breast size; or

• acne, mild skin rash or itching.

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.

See also: Side effects (in more detail)

What other drugs will affect Zoladex?

Zoladex can cause a serious heart rhythm problem, especially if you use certain medicines at the same time, including antibiotics, antidepressants, heart rhythm medicine, antipsychotic medicines, and medicines to treat cancer, malaria, HIV or AIDS. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Zoladex.

This list is not complete. Other drugs may interact with goserelin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.