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Goserelin SubQ

Important Note

GOSERELIN - INJECTION

Pronunciation: (go-SIR-eh-lin)

Brand Name(s): Zoladex

Warnings
Uses
Side Effects
Precautions
Interactions
Overdose
Goserelin SubQ 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.

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.

How to use Goserelin SubQ

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. Follow all preparation and usage instructions. If you have any questions, consult your doctor or pharmacist.

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.

Goserelin SubQ Side Effects

Hot flashes (flushing), dizziness, headache, increased sweating, decreased sexual interest/ability, trouble sleeping, nausea, change in breast size, 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, fast/irregular heartbeat, 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.

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, fainting.

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.

Goserelin SubQ 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 medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: unexplained abnormal vaginal bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, long-term alcohol use, smoking, personal or family history of bone loss (osteoporosis), high cholesterol/triglyceride levels, 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.

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.

Goserelin SubQ Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: hormonal birth control (e.g., pills, patch), medications that can cause bone loss (e.g., corticosteroids such as prednisone).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Goserelin SubQ Overdose

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

NOTES:

Do not share this medication with others.

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:

If you miss an appointment to receive your next dose, reschedule the appointment as soon as you remember.

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

STORAGE:

Store the US product at room temperature below 77 degrees F (25 degrees C) away from light and moisture. Keep syringe in foil pack until ready for use. Do not store in the bathroom. Keep all medicines away from children and pets.

Store the Canadian product between 36-77 degrees F (2-25 degrees C).

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 for more details about how to safely discard your product.

Information last revised October 2009 Copyright(c) 2009 First DataBank, Inc.

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