Goserelin Implant

Generic name: Goserelin (implant)
Brand names: Zoladex
Dosage form: subcutaneous implant (10.8 mg; 3.6 mg)

Usage of Goserelin Implant

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

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

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

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

Goserelin Implant side effects

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

When you start treatment with goserelin, 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 goserelin 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.

Before taking Goserelin Implant

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

Goserelin can harm an unborn baby, but this medicine is sometimes used in pregnant women with advanced breast cancer. Unless you are being treated for advanced breast cancer, you should not use goserelin 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 goserelin implant is in place.

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

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

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.

How to use Goserelin Implant

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.

Warnings

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

Goserelin can harm an unborn baby or cause birth defects. Unless you are being treated for advanced breast cancer, you should not use goserelin 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 this medicine.

You should not use this medicine 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 goserelin, 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.

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 while using goserelin, 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

What other drugs will affect Goserelin Implant

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.

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