In the U.S.—

In Canada—

• Gonadotropin-releasing hormone analog
• Antiendometriotic agent
• Antineoplastic
• Gonadotropin inhibitor

Goserelin (GOE-se-rel-in) 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.

Goserelin is to be given only by or under the supervision of your doctor. It is injected under the skin and is available in the following dosage form:

Parenteral
• Implants (U.S. and Canada)

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 goserelin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to goserelin, buserelin, gonadorelin, histrelin, leuprolide, or nafarelin.

Fertility

During use of goserelin, and usually for a short time after discontinuing it, the medicine decreases fertility in men by reducing sperm counts and in many women by suppressing egg development. Be sure you have discussed this with your doctor before receiving the medicine.

Pregnancy—Goserelin is not recommended for use during pregnancy. This medicine may cause birth defects if taken by a woman during pregnancy or may cause a miscarriage to occur. Use of a nonhormonal contraceptive is recommended for women who are taking goserelin. Although the chance of becoming pregnant is decreased while you are taking this medicine, a pregnancy can still occur. Tell your doctor immediately if you think you have become pregnant.

Breast-feeding—It is not known whether goserelin passes into breast milk. However, use of goserelin is not recommended during breast-feeding because it may cause unwanted effects in nursing babies.

Children—Studies of this medicine have been done only in adult patients, and there is no specific information comparing use of goserelin in children younger than 18 years of age with use in other age groups. Endometriosis is not likely to occur before puberty.

Older adults—Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of goserelin in the elderly to use in other age groups, it has been used mostly in elderly patients and is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two 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 doctor and pharmacist if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Changes in vaginal bleeding from an unknown cause—Gonadorelin may delay diagnosis or worsen condition. The reason for the bleeding should be determined before goserelin is used

• Conditions that increase the chances of developing thinning bones or
• Osteoporosis (brittle bones), history of, or family history of—It is important that your doctor know if you already have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, alcohol abuse, and a family history of osteoporosis or easily broken bones. Some medicines, such as corticosteroids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones when used for a long time

• 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

Goserelin sometimes causes unwanted effects such as hot flashes or decreased sexual ability. However, it is very important that you continue to receive the medicine, even after you begin to feel better. Do not stop treatment with this medicine without first checking with your doctor.

Dosing—

The dose of goserelin will be different for different patients. Goserelin implants are usually given by a doctor in the office or hospital. The following information includes only the average dose of goserelin:

• For implants dosage form:
  • For treating cancer of the breast:
    • Adults—3.6 milligrams (mg) (one implant) injected under the skin of the upper abdomen every twenty-eight days.
    • Children up to 18 years of age—Use and dose must be determined by the doctor.
  • For treating cancer of the prostate:
    • Adults—3.6 milligrams (mg) (one implant) injected under the skin of the upper abdomen every twenty-eight days or 10.8 mg (one implant) injected under the skin of the upper abdomen every twelve weeks.
    • Children up to 18 years of age—Use and dose must be determined by the doctor.
  • For treating endometriosis:
    • Adults—3.6 milligrams (mg) (one implant) injected under the skin of the upper abdomen every twenty-eight days for six months.
    • Children up to 18 years of age—Use must be determined by the doctor.
  • For thinning the uterus before surgery of the uterus:
    • Adults—3.6 milligrams (mg) (one implant) injected under the skin of the upper abdomen every twenty-eight days for two doses.
    • Children up to 18 years of age—Use and dose must be determined by the doctor.

Missed dose—

If you miss getting a dose of this medicine, receive it as soon as possible.

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 women—

• 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 health care professional.
• To prevent pregnancy if you are sexually active and able to become pregnant, you should use birth control methods that do not contain hormones, such as vaginal spermicides with condoms, a diaphragm, or a cervical cap. If you have any questions about this, check with your health care professional.
• If you suspect you are pregnant, check with your doctor immediately. There is a chance goserelin could cause problems to the unborn baby if taken during a pregnancy.

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.

Get emergency help immediately if any of the following side effects occur:

• For adults
  • Less common
    • Fast or irregular heartbeat 
    
    
  • Rare
    • Bone, muscle, or joint pain;  changes in skin color of face;  fainting;  fast or irregular breathing;  numbness or tingling of hands or feet;  puffiness or swelling of the eyelids or around the eyes;  shortness of breath;  skin rash, hives, and/or itching;  sudden, severe decrease in blood pressure and collapse;  tightness in chest or wheezing;  troubled breathing  
    
    

• For males only
  • Rare
    • Pains in chest;  pain in groin or legs (especially in calves of legs) 
    
    

Check with your doctor as soon as possible if any of the following side effects occur:

• For females only
  • Rare
    • Anxiety;  deepening of voice;  increased hair growth;  mental depression ;  mood changes;  nervousness  
    
    

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• For females and males
  • More common
    • Sudden sweating and feelings of warmth (also called hot flashes)  
    
    
  • Less common
    • Blurred vision;  burning, itching, redness, or swelling at place of injection;  decreased interest in sexual intercourse;  dizziness;  headache;  nausea or vomiting;  swelling and increased tenderness of breasts;  swelling of feet or lower legs;  trouble in sleeping;  weight gain 
    
    

• For females only
  • More common
    • Light, irregular vaginal bleeding;  stopping of menstrual periods 
    
    
  • Less common
    • Burning, dryness, or itching of vagina;  pelvic pain 
    
    

• For males only
  • Less common
    • Bone pain;  constipation;  decreased size of testicles;  inability to have or keep an erection 
    
    

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