Zoladex

Generic Name: goserelin (Subcutaneous route)

goe-se-REL-in

Commonly used brand name(s)

In the U.S.

• Zoladex

Available Dosage Forms:

• Implant

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Luteinizing Hormone Releasing Hormone Agonist

Uses For Zoladex

Goserelin is a hormone similar to the one normally released from the hypothalamus gland in the brain. It is used to treat a number of medical problems. These include:

• Cancer of the prostate in men


• Cancer of the breast in women if it develops before or around the time of menopause


• Endometriosis, a painful condition caused by extra tissue growing inside or outside of the uterus, and


• Thinning of the lining of the uterus before surgery on the uterus.

When given regularly as an implant, goserelin works every day to decrease the amount of estrogen and testosterone in the blood.

Reducing the amount of estrogen in the body is one way of treating endometriosis and cancer of the breast, and can help thin the uterus lining before surgery. Goserelin prevents the growth of tissue associated with endometriosis in adult women during treatment and for up to 6 months after treatment is discontinued.

Reducing the amount of testosterone in the body is one way of treating cancer of the prostate.

Suppressing estrogen can thin the bones or slow their growth. This is a problem for adult women whose bones are no longer growing like the bones of children. This is why goserelin is used only for up to 6 months in adult women treated for endometriosis.

This medicine is to be given only by or under the supervision of your doctor.

Before Using Zoladex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of goserelin in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of goserelin in elderly men. However, safety and efficacy have not been established for elderly women.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse or


• Osteoporosis, family history of or


• Tobacco cigarette smoking—May increase risk for osteoporosis (thinning of the bones).

• Diabetes or


• Hypercalcemia (high calcium in the blood) or


• Hyperglycemia (high blood sugar)—Use with caution. May make these conditions worse.

• Nerve problems caused by bone lesions in the spine (in treatment of cancer of the prostate) or


• Problems in passing urine (in treatment of cancer of the prostate)—Conditions may get worse for a short time after goserelin treatment is started.

Proper Use of Zoladex

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin near your stomach. This medicine may be given once every 28 days or once every 3 months. Your schedule depends on the reason you are using this medicine. To stay on the right schedule with the medicine, make sure you keep all appointments.

It is very important that you continue to receive the medicine, even after you begin to feel better.

Precautions While Using Zoladex

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

For female patients: You should not receive this medicine if you are pregnant or may become pregnant. Using this medicine while you are pregnant can harm your unborn baby. Your birth control pills may not work as well while you are receiving this medicine. Use a nonhormonal form of birth control together with your pills to keep from getting pregnant while you are receiving this medicine and for at least 12 weeks after treatment. Nonhormonal birth control includes vaginal spermicides, condoms, diaphragms, and cervical caps. If you think you have become pregnant while using the medicine, tell your doctor right away.

For female patients: During the time you are receiving goserelin, your menstrual period may not be regular or you may not have a menstrual period at all. This is to be expected when being treated with this medicine. If regular menstrual periods continue during treatment or do not begin within 2 to 3 months after you stop using this medicine, check with your doctor.

For male patients: This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

When you first start using this medicine for cancer treatment, some of your symptoms might get worse for a short time. You might also have new symptoms. You might have bone pain, back pain, or trouble urinating. These symptoms should improve within a few weeks. Tell your doctor if you have any new symptoms or your symptoms get worse.

This medicine can cause decreases in bone mineral density, which may lead to osteoporosis or weakened bones. Talk with your doctor about how this risk will affect you.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Zoladex Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

For all adultsLess common

• Fast or irregular heartbeat

Rare

• Bone, muscle, or joint pain


• changes in skin color of the face


• fainting


• fast or irregular breathing


• numbness or tingling of the hands or feet


• puffiness or swelling of the eyelids or around the eyes


• shortness of breath


• skin rash, hives, or itching


• sudden, severe decrease in blood pressure and collapse


• tightness in the chest or wheezing


• troubled breathing

For females onlyRare

• Anxiety


• deepening of voice


• increased hair growth


• mental depression


• mood changes


• nervousness

For males onlyRare

• Pains in the chest


• pain in the groin or legs (especially in the calves of the legs)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For all adultsMore common

• Sudden sweating and feelings of warmth (also called hot flashes)

Less common

• Blurred vision


• burning, itching, redness, or swelling at the place of injection


• decreased interest in sexual intercourse


• dizziness


• headache


• nausea or vomiting


• swelling and increased tenderness of the breasts


• swelling of the feet or lower legs


• trouble with sleeping


• weight gain

For females onlyMore common

• Light, irregular vaginal bleeding


• stopping of menstrual periods

Less common

• Burning, dryness, or itching of the vagina


• pelvic pain

For males onlyLess common

• Bone pain


• constipation


• decreased size of the testicles


• inability to have or keep an erection

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Zoladex side effects (in more detail)

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More Zoladex resources

• Zoladex Side Effects (in more detail)
• Zoladex Use in Pregnancy & Breastfeeding
• Zoladex Drug Interactions
• Zoladex Support Group
• 8 Reviews for Zoladex - Add your own review/rating

• Zoladex Prescribing Information (FDA)


• Zoladex Monograph (AHFS DI)


• Zoladex MedFacts Consumer Leaflet (Wolters Kluwer)


• Zoladex Consumer Overview

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