Zoladex 10.8 mg subcutaneous implant

Generic name:
Goserelin - implant

Pronunciation
(GOE-se-REL-in)

Brand name(s)
Zoladex

Goserelin is used to treat certain types of cancer (prostate and breast). It is also used to thin the lining of the uterus (endometrium) in preparation for a procedure to treat abnormal uterine bleeding. Goserelin is also used to treat a condition in which the tissue that normally lines the inside of the uterus also grows outside the uterus (endometriosis). 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 and estrogen hormones. This effect helps to slow or stop the growth of certain cancer cells and uterine tissue that need these hormones to grow and spread.

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.

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.

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 to 13 weeks. Follow the dosing schedule carefully to get the most benefit from it. To help you remember, mark your calendar with a reminder. Do not stop this medication without your doctor's approval.

The dosage is based on your medical condition and response to treatment.

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 may cause new or worsening symptoms (such as increased pain, increased difficulty urinating in men) for the first few weeks. Tell your doctor right away about these symptoms. See also Side Effects section.

In women, menstrual periods should 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 gets worse.

Hot flashes (flushing), dizziness, headache, increased sweating, decreased sexual interest/ability, trouble sleeping, nausea, change in breast size, vaginal dryness, or hair loss may occur. Pain, bruising, bleeding, redness, or swelling at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including:

• vaginal burning/pain
• 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
• signs of kidney problems (such as change in the amount of urine)
• mental/mood changes (such as depression, mood swings, hallucinations)
• signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Get medical help right away if you have any very serious side effects, including:

• symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)
• signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion)
• fast/irregular heartbeat
• severe dizziness
• 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 right away if you have 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, get medical help right away 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 or at www.fda.gov/medwatch.

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

Before using goserelin, tell your doctor or pharmacist if you are allergic to it; or to LHRH or LHRH-like hormones (such as 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)
• mental/mood problems (such as depression)

If you have diabetes, this drug may make it harder to control your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar (see Side Effects section). 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 rarely cause 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).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using goserelin. Goserelin may harm an unborn baby. Ask about reliable non-hormonal forms of birth control (such as condoms, diaphragm with spermicide) while using this medication and for 12 weeks after the last dose or until the return of your period. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

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.

This implant may be harmful if swallowed. If someone has swallowed it and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as blood sugar, hormone levels, cholesterol/triglyceride levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Sudden/unusual vaginal bleeding (breakthrough bleeding) may occur if a dose is missed.

Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. 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.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.