What is the most important information I should know about goserelin?

Goserelin may cause decreased bone mineral density with prolonged use. Smoking, frequent alcohol use, family history of osteoporosis, and the use of certain medications may increase the risk of bone loss. Talk to your doctor about the risk of decreased bone mineral density.

Initially, goserelin may cause symptoms of your condition to worsen temporarily. Contact your doctor if symptoms do not improve within several weeks of starting treatment.

If you are a pre-menopausal female, notify your doctor if your menstrual period continues to occur. Goserelin usually stops menstruation. Delayed or missed doses of goserelin may cause ovulation or menstrual bleeding. Following treatment with goserelin, there may be a delay before the return of regular menstrual periods. Check with your doctor if your period does not restart within a few months of ending treatment.

Do not take goserelin if you are pregnant or could become pregnant during treatment. Goserelin is known to be harmful to an unborn baby. A nonhormonal method of birth control must be used during treatment with goserelin to ensure prevention of pregnancy. Although goserelin may stop ovulation and menstruation, a nonhormonal method of birth control must also be used. If a dose of goserelin is missed or delayed, ovulation and/or breakthrough bleeding may occur. A nonhormonal method of birth control must also be used until the return of menstruation or for at least 12 weeks following treatment with goserelin.

What is goserelin?

Goserelin is a man-made protein that is like a hormone in the body called gonadotropin-releasing hormone (GnRH). Goserelin decreases levels of testosterone in men and estrogen in women.

Goserelin is used in the treatment of endometriosis, to thin the endometrial layer (lining of the uterus) prior to surgery for abnormal uterine bleeding, and some types of prostate and breast cancer.

Goserelin may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking goserelin?

Do not use goserelin without first talking to your doctor if you have

• osteoporosis or low bone density;
• pain or difficulty passing urine; or
• spinal cord injury.

You may not be able to take goserelin, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Do not take goserelin if you are pregnant or could become pregnant during treatment. Goserelin is known to be harmful to an unborn baby. A nonhormonal method of birth control must be used during treatment with goserelin to ensure prevention of pregnancy. Although goserelin may stop ovulation and menstruation, a nonhormonal method of birth control must also be used. If a dose of goserelin is missed or delayed, ovulation and/or breakthrough bleeding may occur. A nonhormonal method of birth control must also be used until the return of menstruation or for at least 12 weeks following treatment with goserelin.

It is not known whether goserelin passes into breast milk. Do not take goserelin without first talking to your doctor if you are breast-feeding a baby.

How should I take goserelin?

Goserelin is administered by a healthcare professional as a subcutaneous (under the skin) injection into the abdomen (stomach). If goserelin is being administered at home, your healthcare provider will give you detailed instructions regarding how to administer the injection.

Goserelin is administered every 28 days or every 12 weeks, depending upon the formulation being used and the condition being treated. Your doctor will tell you how often you will need an injection. It is very important to receive each injection at the scheduled time, to maintain effectiveness of the medication.

Initially, goserelin may cause symptoms of your condition to worsen temporarily. Contact your doctor if symptoms do not improve within several weeks of starting treatment.

Your doctor may want you to have blood tests or other medical evaluations during treatment with goserelin to monitor progress and side effects.

Your healthcare provider will store goserelin as directed by the manufacturer. If you are storing goserelin at home, your healthcare provider will provide storage instructions.

What happens if I miss a dose?

It is important not to miss a dose of goserelin. Contact your doctor immediately if you miss a dose of this medication.

What happens if I overdose?

An overdose of goserelin is unlikely to threaten life. Notify your doctor immediately or call an emergency room or poison control center for advice if an overdose is suspected.

Symptoms of a goserelin overdose are not known.

What should I avoid while taking goserelin?

Avoid activities such as smoking and frequent alcohol use that may increase the risk of bone loss. Goserelin may cause decreased bone mineral density with prolonged use. Talk to your doctor about the risk of decreased bone mineral density.

What are the possible side effects of goserelin?

Goserelin may cause decreased bone mineral density with prolonged use. Smoking, frequent alcohol use, family history of osteoporosis, and the use of certain medications may increase the risk of bone loss. Talk to your doctor about the risk of decreased bone mineral density.

Initially, goserelin may cause symptoms of your condition to worsen temporarily. Contact your doctor if symptoms do not improve within several weeks of starting treatment.

If you are a pre-menopausal female, notify your doctor if your menstrual period continues to occur. Goserelin usually stops menstruation. Delayed or missed doses of goserelin may cause ovulation or menstrual bleeding. Following treatment with goserelin, there may be a delay before the return of regular menstrual periods. Check with your doctor if your period does not restart within a few months of ending treatment.

Seek emergency medical attention or notify your doctor immediately if you experience any of the following serious side effects:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
• menstrual bleeding or breakthrough bleeding;
• difficulty passing urine; or
• pain, redness, or irritation at the injection site.

Other side effects may also occur. Notify your doctor if you experience

• decreased sexual desire or ability (impotence);
• dizziness or drowsiness;
• depression or mood changes;
• headache;
• hot flushes or sweating;
• decreased appetite, nausea, or diarrhea;
• breast swelling or tenderness, or decrease in breast size;
• vaginal dryness;
• insomnia; or
• skin rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect goserelin?

It is not known whether other medications will interact with goserelin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products during treatment with goserelin.

Where can I get more information?

Your pharmacist has additional information about goserelin written for health professionals that you may read.

What does my medication look like?

Goserelin is available with a prescription under the brand name Zoladex. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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