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Drugs & Medications

Zoladex subcutaneous

GENERIC NAME(S): GOSERELIN ACETATE

Uses

Goserelin is used in men to treat prostate cancer. It is used in women to treat certain breast cancers or a certain uterus disorder (endometriosis). It is also used in women to thin the lining of the uterus (endometrium) in preparation for a procedure to treat abnormal uterine bleeding. Talk to your doctor about the risks and benefits of treatment.

Goserelin is similar to a natural hormone made by the body (luteinizing hormone releasing hormone-LHRH). It works by decreasing testosterone hormones in men and estrogen hormones in women. This effect helps to slow or stop the growth of certain cancer cells and uterine tissue that need these hormones to grow and spread.

The 10.8-milligram syringe should not be used in women.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to stop early puberty in children.

How to use Zoladex subcutaneous

Read the Patient Information Leaflet if available from your pharmacist before you start using goserelin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is an implant that slowly releases hormone into your body. It is placed by a health care professional by injection under the skin of the lower abdomen below the navel. The implant itself will be completely absorbed into the body over weeks or months.

Dosage is based on your medical condition and response to therapy.

Receive this medication as directed by your doctor. The 3.6-milligram syringe is usually injected every 4 weeks. The 10.8-milligram syringe is usually injected every 12 weeks. Follow the dosing schedule carefully to get the most benefit from the drug. To help you remember, mark your calendar to keep track of when to receive the next dose. Do not stop this medication without your doctor's approval.

During the first few weeks of treatment, your hormone levels will actually increase before they decrease. This is a normal response by your body to this drug. This effect may result in new symptoms or worsening of symptoms (e.g., pain, tumor size) for the first few weeks.

In women, it is expected that menstrual periods will stop when this medication is used regularly. Tell your doctor promptly if regular periods continue after 2 months of treatment with goserelin.

Usually, this medication will not need to be removed because the implant will be slowly and completely absorbed by your body. However, in the unlikely event that you have serious side effects or other problems, your doctor may remove this medication.

Tell your doctor if your condition persists or worsens.

Side Effects

Hot flashes (flushing), dizziness, headache, increased sweating, decreased sexual interest/ability, trouble sleeping, nausea, change in breast size, hair loss, or mental/mood changes (such as depression, mood swings, hallucinations) may occur. Pain, bruising, bleeding, redness, or swelling at the injection site may also occur. In women, vaginal dryness may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vaginal burning/pain (in women), pain during sex (in women), breast pain/tenderness, new/worsening bone pain, new broken bone, burning feeling in feet/toes, swelling of the ankles/feet, unusual tiredness, change in the amount of urine.

This drug may infrequently make your blood sugar level rise, which can cause or worsen diabetes. High blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar, such as unusual increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly.

Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest/jaw/left arm pain, trouble breathing, confusion, vision changes, slurred speech, weakness on one side of the body.

Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first dose of this medication. Seek immediate medical attention if any of these very serious side effects occur: sudden severe headache, mental/mood changes (e.g., confusion), vision changes, vomiting.

In men using this medication for prostate cancer, a rare but very serious urinary blockage problem or spinal cord problem (compression) can occur, especially during the first month of treatment. Tell your doctor immediately if you experience any of the following serious side effects: severe back pain, numbness/tingling/weakness of the arms/legs, inability to move, painful/difficult urination, blood in the urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using goserelin, tell your doctor or pharmacist if you are allergic to it; or to LHRH or LHRH-like hormones (e.g., triptorelin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: unexplained abnormal vaginal bleeding, diabetes, long-term alcohol use, smoking, personal or family history of bone loss (osteoporosis), heart disease (such as heart attack), high cholesterol/triglyceride levels, stroke, urinary blockage problem (in men), spinal cord problem (in men).

If you have diabetes, this drug may make it harder to control your blood sugar levels. Monitor your blood sugar levels regularly and tell your doctor of the results. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Goserelin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using goserelin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using goserelin safely.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Women of child-bearing age must make sure they are not pregnant before starting this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately. Consult your doctor for more details and to discuss reliable forms of birth control. For women, this medication should stop the release of an egg (ovulation) and your periods, but this should not be used as a reliable method of birth control. It is recommended that men and women using this medication use 2 effective forms of nonhormonal birth control (e.g., condoms and diaphragm with spermicide) while taking this medication. Continue using effective birth control until the return of the woman's period or for at least 12 weeks after stopping this medication.

It is not known whether this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: hormonal birth control (e.g., pills, patch), medications that can cause bone loss (e.g., corticosteroids such as prednisone).

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Laboratory and/or medical tests (such as blood sugar, hormone levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

In women, sudden/unusual vaginal bleeding (breakthrough bleeding) may occur if a dose is missed.

Storage

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised July 2013. Copyright(c) 2013 First Databank, Inc.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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