What is the most important information I should know about goserelin? What should I discuss with my healthcare provider before receiving goserelin?

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1 1 of 5 6/10/2016 4:04 PM Generic Name: goserelin (implant) (GOE se REL in) Brand Name: Zoladex What is goserelin? 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. What is the most important information I should know about goserelin? Unless you are being treated for advanced breast cancer, you should not use a goserelin implant during pregnancy. What should I discuss with my healthcare provider before receiving goserelin? You should not use this implant if you are allergic to goserelin, or: if you are allergic to other hormone medications such as leuprolide (Lupron, Eligard, Viadur), nafarelin (Synarel), or ganirelix (Antagon). Unless you are being treated for advanced breast cancer, you should not use a goserelin implant during pregnancy. To make sure goserelin is safe for you, tell your doctor if you have: diabetes; heart disease or prior heart attack; a history of heart attack or stroke; risk factors for coronary artery disease (such as high blood pressure, high cholesterol, smoking, or being overweight); personal or family history of long QT syndrome; osteoporosis or low bone density; a condition affecting your spine;

2 2 of 5 6/10/2016 4:04 PM abnormal vaginal bleeding that has not been checked by a doctor; or if you take a blood thinner such as warfarin (Coumadin, Jantoven). Goserelin can decrease bone mineral density, which may increase your risk of developing osteoporosis. This risk may be greater if you smoke, drink alcohol frequently, have a family history of osteoporosis, or use certain drugs such as seizure medications or steroids. Talk to your doctor about your individual risk of bone loss. This medicine can harm an unborn baby or cause birth defects. However, goserelin is sometimes given to pregnant women being treated for advanced breast cancer. Unless you are being treated for advanced breast cancer, you should not use goserelin during pregnancy. You may need to have a negative pregnancy test before receiving the implant. Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Keep using birth control for at least 12 weeks after the implant is removed. It is not known whether goserelin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while the implant is in place. How is goserelin given? Goserelin implant is inserted through a needle into the skin of your upper stomach, once every 28 days. You will receive the implant in a clinic or doctor's office. Your dosing schedule may be different if you are also receiving chemotherapy. Follow your doctor's instructions. It is very important to receive your goserelin injections on time each month. You are not likely to be able to feel the implant through your skin, and it should not cause pain or discomfort. The implant will dissolve in your body over time. While your hormone levels are adjusting, you may notice new or worsening symptoms of your condition during the first few weeks of treatment. Tell your doctor if your symptoms do not improve after several weeks. If you are a premenopausal woman, you should stop having menstrual periods while the goserelin implant is in place. Call your doctor if you still have regular periods. Missing a dose can cause breakthrough bleeding. After you stop using goserelin, you should begin having regular periods within 12 weeks. Your blood sugar may need to be checked while using goserelin, even if you are not diabetic. You may need other blood tests at your doctor's office. Goserelin can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using goserelin. What happens if I miss a dose? Call your doctor for instructions if you miss an appointment for your goserelin implant injection. What happens if I overdose? Since the goserelin implant contains a specific amount of the medication, you are not likely to receive an overdose.

3 3 of 5 6/10/2016 4:04 PM What should I avoid while receiving goserelin? Avoid drinking alcohol. It can increase your risk of bone loss while you are being treated with goserelin. Avoid smoking, which can increase your risk of bone loss, stroke, or heart problems. This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry. Goserelin side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: painful or difficult urination; pain, bruising, swelling, redness, oozing, or bleeding where the implant was injected; high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; high calcium levels--nausea, vomiting, constipation, increased thirst or urination, muscle pain or weakness, bone pain, confusion, and feeling tired or restless; heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; nerve problems--back pain, muscle weakness, problems with balance or coordination, severe numbness or tingling in your legs or feet, loss of bladder or bowel control; or signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance. Common side effects may include: hot flashes, sweating; mood changes, increased or decreased interest in sex; changes in sexual function, fewer erections than normal; headache; swelling in your hands or feet; vaginal dryness, itching, or discharge; changes in breast size; or acne, mild skin rash or itching. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at FDA See also: Side effects (in more detail) Goserelin dosing information Usual Adult Dose for Prostate Cancer: For the palliative treatment of advanced carcinoma of the prostate: 3.6 mg or 10.8 mg subcutaneously into the upper abdominal wall once.

4 4 of 5 6/10/2016 4:04 PM The 10.8 mg dosage may be repeated every 12 weeks. Intended for long-term administration unless clinically inappropriate. For use in the treatment of Stage B2-C prostate cancer: When administered in combination with radiotherapy and flutamide for patients with Stage T2b-T4 (Stage B2-C) prostate cancer, treatment should be started 8 weeks prior to initiating radiotherapy and should continue during radiotherapy. Usual Adult Dose for Endometriosis: 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 recommended duration of therapy is 6 months. Usual Adult Dose for Breast Cancer--Palliative: For use in the palliative treatment of advanced breast cancer: 3.6 mg subcutaneously into the upper abdominal wall once. Intended for long-term administration unless clinically inappropriate. Usual Adult Dose for Bleeding: For use as an endometrial thinning agent prior to endometrial ablation for dysfunctional uterine bleeding: 1 or 2 of the 3.6 mg subcutaneous depot injections (with each depot given four weeks apart). When one depot is administered, surgery should be performed at 4 weeks. When two depots are administered, surgery should be performed within 2 to 4 weeks following administration of the second depot. What other drugs will affect goserelin? 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. Where can I get more information? Your doctor or pharmacist can provide more information about goserelin implant. 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. Disclaimer: 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

5 5 of 5 6/10/2016 4:04 PM 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. Copyright Cerner Multum, Inc. Version: Revision Date: , 9:55:01 AM.