Zoladex is a brand of goserelin, which is a GnRH agonist presented as an acetate salt. It is available as a subcutaneous implant containing 3.8 mg of goserelin acetate for a 28-day continuous release. The implant includes D,L-lactic and glycolic acids copolymer and other inactive ingredients. This formulation is packaged in a SafeSystem Syringe for subcutaneous administration.

How should I use this medication?

This medication is injected under the skin. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in the amount of urine
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• High calcium level—increased thirst or amount of urine, nausea, vomiting, confusion, unusual weakness or fatigue, bone pain
• Pain, redness, irritation, or bruising at the injection site
• Severe back pain, numbness or weakness of the hands, arms, legs, or feet, loss of coordination, loss of bowel or bladder control
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Swelling and pain of the tumor site or lymph nodes
• Trouble passing urine

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in sex drive or performance
• Headache
• Hot flashes
• Rapid or extreme change in emotion or mood
• Sweating
• Swelling of the ankles, hands, or feet
• Unusual vaginal discharge, itching, or odor

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bone problems
• Diabetes
• Heart disease
• History of irregular heartbeat or rhythm
• An unusual or allergic reaction to goserelin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Other medications that cause heart rhythm changes

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Your symptoms may appear to get worse during the first weeks of this therapy. Tell your care team if your symptoms do not start to get better or if they get worse after this time.

Using this medication for a long time may weaken your bones. If you smoke or frequently drink alcohol you may increase your risk of bone loss. A family history of osteoporosis, chronic use of medications for seizures (convulsions), or corticosteroids can also increase your risk of bone loss. The risk of bone fractures may be increased. Talk to your care team about your bone health.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

This medication should stop regular monthly menstruation in women. Tell your care team if you continue to menstruate.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for 12 weeks after stopping treatment. Talk to your care team about reliable forms of contraception.

Do not breastfeed while taking this medication.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.