Goserelin implant

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.

Goserelin implant is used in men to treat symptoms of prostate cancer.

Goserelin implant 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).

Goserelin implant may also be used for purposes not listed in this medication guide.

Goserelin 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 goserelin implant.

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.

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.

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.

No dosing adjustment is necessary in patients with renal impairment.

No dosing adjustment is necessary in patients with hepatic impairment.

No dosing adjustment is necessary in patients with renal impairment.

The use of goserelin in patients at risk of developing ureteral obstruction or spinal cord compression should be considered carefully and the patient should be monitored closely during the first month of therapy. Patients with ureteral obstruction or spinal cord compression should have appropriate treatment prior to initiation of goserelin.

FDA has identified a potential increase in the risk of diabetes and certain cardiovascular diseases in men treated with GnRH agonists. Most of the studies reviewed reported small, but statistically significant increased risks of diabetes and/or cardiovascular events. The review is ongoing and no final conclusions on increased risk have been determined. The benefits and risks of GnRH agonists should be carefully weighed when determining treatment choices. Patients receiving GnRH agonists should be monitored for development of diabetes and cardiovascular disease. Patients should not stop their treatment with GnRH agonists unless told to do so by their healthcare professional.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Before starting treatment, pregnancy must be excluded. Goserelin 10.8 mg is not indicated in women as the data are insufficient to support reliable suppression of serum estradiol. When used every 28 days, goserelin 3.6 mg usually inhibits ovulation and stops menstruation. However, contraception is not ensured. During treatment, pregnancy must be avoided by use of nonhormonal methods of contraception. Following the last injection, nonhormonal methods of contraception must be continued until the return of menses or for at least twelve weeks. The drug may cause fetal harm when administered to pregnant women. Studies in rats and rabbits administered goserelin during the period of organogenesis have confirmed dose-related increased pregnancy loss. In rats, the incidence of umbilical hernia was significantly increased (at doses greater than one-half the recommended human dose on a mg/m2 basis). In studies on male rats (at approximately 30 to 60 times the recommended human dose), atrophic histological changes were observed in the testes, epididymis, seminal vesicle and prostate gland with complete suppression of spermatogenesis. In female rats (receiving approximately 3 to 60 times the recommended human dose), suppression of ovarian function led to decreased size and weight of ovaries and secondary sex organs; follicular development was arrested at the antral stage and the corpora lutea were reduced in size and number.

Goserelin has been assigned by the FDA to pregnancy category X for the treatment of endometriosis and pregnancy category D for the treatment of advanced breast cancer in pre- and perimenopausal women. Animal studies have revealed evidence of teratogenicity, embryotoxicity, fetotoxicity, and atrophic histological changes consistent with gonadal suppression in both male and female reproductive organs. There are no controlled data in human pregnancy. Goserelin use is considered contraindicated during pregnancy. If the drug is used during pregnancy in a patient with advanced breast cancer or the patient becomes pregnant while receiving the drug, the patient must be apprised of the potential risk for loss of the pregnancy due to possible hormonal imbalance as a result of the expected pharmacologic action of goserelin therapy.

This drug can interact with other medications, herbs, or vitamins you might be taking. Your healthcare provider will look out for interactions with your current medications. Always be sure to tell your doctor about all medications, herbs, or vitamins you’re taking.

People with heart conditions

This medication may cause the irregular heart rate known as QT prolongation. If you have a serious heart condition, your doctor may monitor your heart function closely while you take this drug. This drug may increase the risk of heart attack and stroke in men.

People with diabetes

This drug may increase your blood sugar levels. If you have diabetes, it may make blood sugar control more difficult. Your doctor will monitor your blood sugar levels, and may ask you to test your blood sugar at home.

People with liver problems

This drug may increase your liver enzymes. Your doctor may monitor your liver enzymes while on this medication.

People with bone thinning or weakness

This drug lowers estrogen in your body, which may cause your bones to become weak or thin. This could increase your risk of fractures. Your doctor may do a bone mineral density test before you start and during treatment to check for bone changes. Your doctor will monitor you more closely if you already have bone thinning or osteoporosis.

Pregnant women

When used to treat breast cancer:

This drug is a category D pregnancy drug. That means two things:

1. Research in humans has shown adverse effects to the fetus when the mother takes the drug.
2. This drug should only be used during pregnancy in serious cases where it's needed to treat a dangerous condition in the mother.

Talk to your doctor if you’re pregnant or planning to become pregnant. Ask your doctor to tell you about the specific harm that may be done to the fetus. This drug should be only used if the potential risk to the fetus is acceptable given the drug’s potential benefit.

When used to treat endometriosis:

This drug is a category X pregnancy drug. Category X drugs should never be used during pregnancy.

Women who are breast-feeding

It isn’t known if this drug goes into breast milk. If it does, it may cause serious effects in a breastfeeding child.

You and your doctor may need to decide if you’ll take this drug or breastfeed.

When to call the doctor

Call your doctor if you have certain symptoms:

• unexpected vaginal bleeding. Women on goserelin shouldn’t have a monthly period (menstruation). Call your doctor if you menstruate while on this drug. 
• an injection site injury. Receiving this medication can cause an injection site injury. This could lead to pain, serious bleeding, and shock.  Call your doctor if you have these symptoms:
  • stomach pain
  • bloated stomach
  • shortness of breath
  • dizziness
  • low heart rate
  • going in and out of consciousness