GOSERELIN

COMMON BRAND NAME(S): Zoladex

GENERIC NAME(S): GOSERELIN ACETATE

 

Description: Goserelin is a potent inhibitor of pituitary gonadotrophin secretion. Initially, it causes an increase in the serum levels of FSH and LH but chronic admin will lead to sustained suppression of the pituitary gonadotrophin release causing regression of the sex organs.

Pharmacokinetics:

Absorption: Almost complete (SC).

Excretion: >90% excreted in urine (as unchanged drug and metabolites); 2-4 hr (elimination half-life).

Goserelin treats prostate cancer for men and certain breast cancers or a certain uterine disorder for women. It so thins the lining of the uterus (endometrium) in preparation for a procedure to treat abnormal uterine bleeding.

Goserelin to slows or stops the growth of certain cancer cells and uterine tissue that need hormones to grow and spread. It is similar to a natural hormone made by the body (luteinizing hormone releasing hormone-LHRH) that decreases testosterone hormones in men and estrogen hormones in women.

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

OTHER USES:

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

How to use goserelin 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.

Tell your doctor or pharmacist promptly if any of these effects persist or worse:

  • Hot flashes (flushing)
  • Dizziness
  • Headache
  • increased sweating
  • decreased sexual interest/ability
  • trouble sleeping
  • nausea
  • change in breast size
  • hair loss
  • mental/mood changes (such as depression, mood swings, hallucinations)
  • Pain, bruising, bleeding, redness, or swelling at the injection site
  • vaginal dryness

Tell your doctor right away if you have any serious side effects, including:

  • 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
  • stomach/abdominal pain or swelling
  • shortness of breath

This drug may infrequently make your blood sugar level rise, which can cause or worsen diabetes.

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

  • fast/irregular heartbeat
  • severe dizziness
  • fainting
  • 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. Get medical help right away 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 right away 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, 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.

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. 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.

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. 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. Discuss the use of reliable non-hormonal forms of birth control (such as condoms, diaphragm with spermicide) with your doctor. Continue using effective birth control until the return of the woman’s period or for at least 12 weeks after stopping this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

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

Hormonal birth control (e.g., pills, patch) and medications that can cause bone loss (e.g., corticosteroids such as prednisone) may interact with this drug.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately.

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.

 

Brands

Also marketed as

Zoladex/Zoladex LA [ AstraZeneca ]

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