Goserelin acetate

What is Goserelin Acetate?

Goserelin Acetate (Zoladex) is a Gonadotropin Releasing Hormone (GnRH) agonist used:

• in combination with flutamide for the management of locally confined carcinoma of the prostate
• Palliative treatment of advanced carcinoma of the prostate
• The management of endometriosis
• Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding
• Use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women

Goserelin

Goserelin ball-and-stick

What are the uses of this medicine?

Goserelin Acetate (Zoladex) is used:

• in combination with flutamide for the management of locally confined carcinoma of the prostate
• Palliative treatment of advanced carcinoma of the prostate
• in the management of endometriosis
• as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding
• in the palliative treatment of advanced breast cancer in pre- and perimenopausal women

How does this medicine work?

• Zoladex keeps the body from making the hormones luteinizing hormone-releasing hormone (LHRH) and luteinizing hormone (LH).
• This causes the testicles to stop making testosterone (a male hormone) in men, and the ovaries to stop making estradiol (a form of the hormone estrogen) in women.
• Zoladex may stop the growth of cancer cells that need testosterone or estrogen to grow.
• It is a type of LHRH agonist.
• Also called goserelin acetate and ZDX.
• ZOLADEX is a synthetic decapeptide analogue of GnRH.
• ZOLADEX acts as an inhibitor of pituitary gonadotropin secretion when administered in the biodegradable formulation.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have a known hypersensitivity to GnRH, GnRH agonist analogues or any of the components in ZOLADEX.
• are pregnant unless ZOLADEX is being used for palliative treatment of advanced [[breast cancer.

What drug interactions can this medicine cause?

• No formal drug-drug interaction studies have been performed.
• No confirmed interactions have been reported between ZOLADEX and other drugs.

Is this medicine FDA approved?

• It was patented in 1976 and approved for medical use in 1987.

How should this medicine be used?

Recommended dosage:

• ZOLADEX 3.6 mg should be administered subcutaneously every 28 days.
• For the management of endometriosis, the recommended duration of administration is 6 months for women 18 years of age and older.

Administration:

• ZOLADEX, at a dose of 3.6 mg, should be administered subcutaneously every 28 days into the anterior abdominal wall below the navel line using an aseptic technique under the supervision of a physician.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Implant 3.6 mg

This medicine is available in fallowing brand namesː

• ZOLADEX

What side effects can this medication cause?

The most common side effects of this medicine include: In men:

• hot flashes
• sexual dysfunction
• decreased erections
• lower urinary tract symptoms

In women:

• hot flushes
• headache
• sweating
• acne
• emotional lability
• depression
• decreased libido
• vaginitis
• breast atrophy
• seborrhea
• peripheral edema

• Tumor flare can occur on the initiation of ZOLADEX for both men and women being treated for cancer.

What special precautions should I follow?

• Before starting treatment with ZOLADEX, pregnancy must be excluded for women using ZOLADEX for benign gynecological conditions. Women of childbearing potential should be advised to avoid becoming pregnant.
• Initially, ZOLADEX, like other GnRH agonists, causes transient increases in serum levels of testosterone in men with prostate cancer, and estrogen in women with breast cancer. Transient worsening of symptoms, or the occurrence of additional signs and symptoms of prostate or breast cancer, may occasionally develop during the first few weeks of ZOLADEX treatment. Monitor patients at risk for complications of tumor flare.
• Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor blood glucose level and manage according to current clinical practice.
• Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. Monitor for cardiovascular disease and manage according to current clinical practice.
• As with other GnRH agonists or hormonal therapies (antiestrogens, estrogens, etc.), hypercalcemia has been reported in some prostate and breast cancer patients with bone metastases after starting treatment with ZOLADEX. If hypercalcemia does occur, appropriate treatment measures should be initiated.
• Hypersensitivity, antibody formation and acute anaphylactic reactions have been reported with GnRH agonist analogues. Monitor and manage appropriately.
• Increase in cervical resistance may occur. Caution is recommended when dilating the cervix for endometrial ablation. Caution is recommended when dilating the cervix for endometrial ablation.
• Androgen deprivation therapy may prolong the QT/QTc interval. Consider risks and benefits.
• Injection site injury and vascular injury including pain, hematoma, hemorrhage and hemorrhagic shock, requiring blood transfusions and surgical intervention, have been reported with ZOLADEX. Extra care should be taken when administering ZOLADEX to patients with a low BMI and/or to patients receiving full dose anticoagulation.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There is no experience of overdosage from clinical trials.

Management of overdosage:

• If overdosage occurs, it should be managed symptomatically.

Can this medicine be used in pregnancy?

• ZOLADEX is contraindicated during pregnancy unless ZOLADEX is being used for palliative treatment of advanced breast cancer.
• There are no adequate and well-controlled studies in pregnant women using ZOLADEX.
• Based on mechanism of action in humans and findings of increased pregnancy loss in animal studies, ZOLADEX can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• GOSERELIN ACETATE

Inactive ingredients:

• Glycolic Acid
• Lactic Acid, DL

Who manufactures and distributes this medicine?

Distributed by: TerSera Therapeutics LLC, Deerfield, IL

What should I know about storage and disposal of this medication?

• Dailymed label info on Goserelin acetate
• FDA Goserelin acetate

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