Zoladex 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 implants are used to treat symptoms of prostate cancer in men.

The Zoladex implant is used in women to treat breast cancer or endometriosis. Zoladex is also used in women to prepare the lining of the uterus for endometrial ablation (a surgery to correct abnormal uterine bleeding).

Zoladex is sometimes used in combination with another cancer drug called flutamide.

Goserelin 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

Zoladex is given in a tiny implant inserted through a needle into the skin of your 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 implant 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.

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

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.

Prostate cancer, stage B2 to C (in combination with an antiandrogen and radiotherapy; begin 8 weeks prior to radiotherapy): Males: SubQ:
Combination 28-day/12-week implant: 3.6 mg implant, followed in 28 days by 10.8 mg implant
OR
28-day implant (alternate dosing): 3.6 mg; repeated every 28 days for a total of 4 doses (2 depots preceding and 2 during radiotherapy)

Uses:
-In combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment should start 8 weeks prior to radiation therapy and continue during radiation.
-For palliative treatment of advanced carcinoma of the prostate.

Usual Adult Dose for Endometriosis:

3.6 mg subcutaneously into the upper abdominal wall once; repeat every 28 days

The recommended duration of therapy is 6 months.

Use: For the management of endometriosis, including pain relief and reduction of endometriotic lesions.

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; repeat every 28 days

Intended for long-term administration unless clinically inappropriate.

Use: For the palliative treatment of advanced breast cancer in pre- and perimenopausal women

Usual Adult Dose for Bleeding:

1 or 2 of the 3.6 mg subcutaneous depot injections (with each depot given 4 weeks apart). When 1 depot is administered, surgery should be performed at 4 weeks. When 2 depots are administered, surgery should be performed within 2 to 4 weeks following administration of the second depot.

Use: For use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding.

You should not be treated with Zoladex implants if you are allergic to goserelin, or to similar hormone medications such as histrelin, leuprolide, nafarelin, or ganirelix.

This medicine can harm an unborn baby, but goserelin is sometimes used in pregnant women with 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 starting this treatment.

If you have not gone through menopause, you should use a nonhormonal form of birth control (condom, diaphragm, cervical cap, contraceptive sponge) to prevent pregnancy while the Zoladex implant is in place.

Keep using birth control for at least 12 weeks after the implant was removed. Even though the Zoladex implant can stop ovulation and menstrual periods, you could still become pregnant.

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

• diabetes;

• heart problems, heart attack, or stroke;

• bone cancer;

• long QT syndrome (in you or a family member);

• low bone mineral density (osteoporosis); or

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

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 medicine or steroids. Talk to your doctor about your individual risk.

You should not breastfeed while the implant is in place.

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

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

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.

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.

When you start treatment with Zoladex, your tumor symptoms may get worse for a short time. Worsening of a prostate tumor may increase pressure on your spinal cord or urinary tract. Tell your doctor right away if you have symptoms such as: back pain, painful or difficult urination, loss of movement in any part of your body, or loss of bowel or bladder control.

Call your doctor at once if you have:

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

• dizziness, trouble breathing, feeling light-headed (like you might pass out);

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;

• high calcium levels - confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss;

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

• signs of a blood clot - sudden numbness or weakness on one side of the body, chest pain, problems with vision or speech, pain or swelling in one leg.

Common Zoladex side effects may include:

• hot flashes, sweating;

• painful urination;

• 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.

Goserelin can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your other medicines, especially a blood thinner (warfarin, Coumadin, Jantoven).

Other drugs may interact with goserelin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.