Zoladex (Goserelin Acetate)

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Zoladex (Goserelin Acetate)

ZOLADEX (Goserelin Acetate) is used in men to treat symptoms of prostate cancer.  ZOLADEX  is used in women to treat breast cancer or endometriosis. ZOLADEX is also used in women to prepare the lining of the uterus for endometrial ablation (a surgery to correct abnormal uterine bleeding).

Warnings and Precautions

Serious Warnings and Precautions

ZOLADEX should be prescribed and managed by a doctor experienced with using this type of drug.

ZOLADEX should be administered by a healthcare professional experienced in administering deep subcutaneous injections and under the supervision of a physician.

ZOLADEX may cause:

  • Worsening of symptoms of prostate cancer at the beginning of the treatment (risk of spinal cord compression, or increased difficulty in urinating)

  • Bone thinning (osteoporosis)

  • Injection site injury (including damage to blood vessels in the abdomen) has been reported following injection of ZOLADEX. In rare cases this has caused severe bleeding (with some cases requiring surgical treatment).

 If you go into hospital, let the medical staff know you are receiving ZOLADEX.

In women, there are no clinical data on the effect of treating endometriosis with ZOLADEX for periods in excess of 6 months.

ZOLADEX is not recommended for use in children.

ZOLADEX is not recommended for use in very thin patients and/or those on blood thinners.

ZOLADEX is unlikely to affect your ability to drive a car or to operate machinery.

Before you use ZOLADEX, talk to your doctor or pharmacist if any of the following applies to you:

  • Have or have had any problems passing urine.

  • Family history of severe osteoporosis (thinning of the bones with fractures).

  • Have low bone mineral density (BMD).

  • Taking other medicines that cause thinning of the bones.

  • Have a low red blood cell count (anemia).

  • Have heart or blood vessel disease, have had an abnormal heart rhythm (QT prolongation), have a heart condition called ‘long QT syndrome’, a family history of this heart condition, or are being treated with medicines for these conditions. ZOLADEX may increase the risk of having an abnormal heart rhythm (QT prolongation).

  • Have diabetes.

  • Are pregnant or planning to become pregnant. ZOLADEX should not be used during pregnancy, therefore, effective non-hormonal contraceptive methods should be used to prevent pregnancy during the treatment and until the return of menses after the last injection with ZOLADEX. After stopping ZOLADEX it may take longer for some women to experience menses. Rarely, some women may enter menopause. If 8 weeks have passed after the last ZOLADEX injection and you do not experience menses, talk to your doctor.

  • Taking blood thinners.

Side Effects

As with all medicines, side effects are sometimes experienced with ZOLADEX.

Contact your doctor or pharmacist if you experience any of these problems:

  • Tingling in your fingers or toes.

  • Psychiatric problems such as hallucinations, disordered thoughts or personality change. These have occasionally been reported.

  • Injection site injury (including damage to blood vessels in the abdomen) has been reported following injection of ZOLADEX. This can cause severe bleeding. Contact your doctor immediately if you experience any of the following symptoms: bleeding underneath the skin or bruising, abdominal pain, abdominal distension, swelling at the injection site, shortness of breath, dizziness, low blood pressure and/or any altered levels of consciousness.

  • There have been occasional reports of side effects with pituitary tumours. You may develop a tumour of the pituitary gland in your head or, if you have an existing tumour of the pituitary gland, ZOLADEX may cause it to bleed or collapse. Pituitary tumours may cause headaches, vomiting, loss of eyesight and unconsciousness.

  • A local skin reaction may occur at the injection site such as pain, bruising, bleeding, itching, redness, burning and swelling. These reactions generally are mild and disappear after a few days. If they get worse or do not go away, tell your doctor.

  • Cancer patients: Contact your doctor immediately if you develop: severe increased pain, numbness or weakness of the limbs, or persistent difficulty in urinating (prostate cancer).

Use of ZOLADEX in Men:

  • When you first start receiving ZOLADEX you may feel some pain in your bones. If this happens tell your doctor and you may be given something for this.

  • Very occasionally you may have trouble passing urine or experience lower back pain. If this happens, tell your doctor and you may be given something for this.

  • You may experience hair loss, particularly the loss of body hair.

Use of ZOLADEX in Women:

  • For pre-menopausal women: menstruation stops with the monthly depot of ZOLADEX. If regular menstruation persists, notify your doctor. If a monthly ZOLADEX depot is missed, breakthrough menstrual bleeding may occur.

  • Vaginal bleeding may occur. At the beginning of treatment, if you have fibroids a slight increase in symptoms, such as pain, may occur. These effects are usually short-lived and discontinue on continuation of treatment. If symptoms persist or you are uncomfortable, contact your doctor.

  • Occasionally some women may enter menopause early, so when ZOLADEX treatment is stopped, menstruation will not start again.

  • ZOLADEX has been associated with the formation of ovarian cysts, which may cause pain for some women.

  • If you experience excessive nausea, vomiting or thirst, you should tell your doctor. This may indicate possible changes in the amount of calcium in your blood and your doctor may have to do certain blood tests.

  • Often, acne is reported within one month after starting ZOLADEX.

Interactions with this medication

Check with your doctor or pharmacist before taking any other drugs, including non-prescription drugs (for colds, nausea, etc.). ZOLADEXmight interfere with some medicines used to treat heart rhythm problems or might increase the risk of heart rhythm problems when used with some other drugs that can cause heart rhythm abnormalities.

Proper Use of this medication

Usual dose:

  • ZOLADEX is given as an injection under the skin of the abdomen by a trained health care professional, such as a doctor or nurse.

  • Prostate or breast cancer: one injection every 28 days.

  • Endometriosis: one injection every 28 days.

  • It is very important your doctor checks your progress at regular medical visits. Consult your doctor before you decide to change your treatment.

  • If you need more information, ask your doctor.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you missed your scheduled dose, contact your doctor for advice.

Other related products

The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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