Zoladex

— THERAPEUTIC CATEGORIES —
  • Breast cancer
  • Endometriosis
  • Prostate and other male cancers
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Zoladex Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Goserelin (as acetate) 3.6mg; SC implant.

    Pharmacological Class

    GnRH agonist.

    See Also

      How Supplied

      Implant (in syringe)—1

      Manufacturer

      TerSera Therapeutics

      Mechanism of Action

      Zoladex is a synthetic decapeptide analogue of GnRH. It acts as an inhibitor of pituitary gonadotropin secretion when administered in the biodegradable formulation.

      Zoladex Indications

      Indications

      Palliative treatment of advanced breast cancer in pre- and perimenopausal women.

      Zoladex Dosage and Administration

      Adult

      Implant SC into anterior abdominal wall. One 3.6mg implant every 28 days.

      Children

      Not established.

      Zoladex Contraindications

      Not Applicable

      Zoladex Boxed Warnings

      Not Applicable

      Zoladex Warnings/Precautions

      Warnings/Precautions

      Males: increased risk of diabetes, MI, sudden cardiac death, stroke; monitor blood glucose and for signs/symptoms of CVD during therapy. Risk of ureteral obstruction or spinal cord compression; monitor during 1st month of therapy. Females: nondiagnosed abnormal vaginal bleeding: not recommended. Risk factors for decreased bone mineral density (eg, chronic alcohol, tobacco, anticonvulsants, corticosteroids). Premenopausal women: use nonhormonal contraception during and for 12 weeks after discontinuation of therapy. Risk of QT prolongation in congenital long QT syndrome, CHF, electrolyte abnormalities; monitor EKG and correct electrolyte abnormalities if needed. Risk of inj site injury in patients with low BMI and/or receiving full dose anticoagulation. History of depression. Pregnancy. Nursing mothers: not recommended.

      Zoladex Pharmacokinetics

      Distribution

      Plasma protein bound: 27.3%.

      Metabolism

      Hepatic.

      Elimination

      Renal (>90%). Half-life: 4–5 hours.

      Zoladex Interactions

      Interactions

      Avoid concomitant drugs known to prolong the QT interval. May affect tests of pituitary-gonadotropic and gonadal functions.

      Zoladex Adverse Reactions

      Adverse Reactions

      Females: hypoestrogenism (eg, hot flashes, headache, sweating, acne, emotional lability, depression, decreased libido, vaginitis, breast atrophy, seborrhea, peripheral edema). Males: decreased testosterone levels (eg, hot flashes, sexual dysfunction, decreased erections, gynecomastia), lower urinary tract symptoms. Both: transient worsening of symptoms (eg, bone pain), tumor flare, diarrhea, nausea, edema, malaise, hyperglycemia, hypercalcemia, decreased bone mineral density, QT prolongation.

      Zoladex Clinical Trials

      See Literature

      Zoladex Note

      Not Applicable

      Zoladex Patient Counseling

      See Literature

      Zoladex Generic Name & Formulations

      Legal Class

      Rx

      General Description

      Goserelin (as acetate) 3.6mg; SC implant.

      Pharmacological Class

      GnRH agonist.

      See Also

        How Supplied

        Implant (in syringe)—1

        Manufacturer

        TerSera Therapeutics

        Mechanism of Action

        Zoladex is a synthetic decapeptide analogue of GnRH. It acts as an inhibitor of pituitary gonadotropin secretion when administered in the biodegradable formulation.

        Zoladex Indications

        Indications

        Management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. Endometrial thinning prior to endometrial ablation for dysfunctional uterine bleeding.

        Zoladex Dosage and Administration

        Adult

        Implant SC into anterior abdominal wall. ≥18yrs: Endometriosis: one 3.6mg implant every 28 days, for up to 6 months. Retreatment: not recommended. Endometrial thinning: one 3.6mg implant, do surgery at 4 weeks. Or, may give a second 3.6mg implant 4 weeks after the first, and do surgery within 2–4 weeks after the second implant.

        Children

        <18yrs: not established.

        Zoladex Contraindications

        Contraindications

        Pregnancy.

        Zoladex Boxed Warnings

        Not Applicable

        Zoladex Warnings/Precautions

        Warnings/Precautions

        Nondiagnosed abnormal vaginal bleeding: not recommended. Use nonhormonal contraception during and for 12 weeks after discontinuation of therapy. Risk factors for decreased bone mineral density (eg, chronic alcohol, tobacco, anticonvulsants, corticosteroids). Risk of QT prolongation in congenital long QT syndrome, CHF, electrolyte abnormalities; monitor EKG and correct electrolyte abnormalities if needed. Risk of inj site injury in patients with low BMI and/or receiving full dose anticoagulation. Hyperlipidemia. History of depression. Nursing mothers: not recommended.

        Zoladex Pharmacokinetics

        Distribution

        Plasma protein bound: 27.3%.

        Metabolism

        Hepatic.

        Elimination

        Renal (>90%). Half-life: 4–5 hours.

        Zoladex Interactions

        Interactions

        Avoid concomitant drugs known to prolong the QT interval. May affect tests of pituitary-gonadotropic and gonadal functions.

        Zoladex Adverse Reactions

        Adverse Reactions

        Endometriosis: hot flushes, headache, sweating, acne, emotional lability, depression, decreased libido, vaginitis, breast atrophy, seborrhea, peripheral edema. Endometrial thinning: headache, hot flushes, hypertension, vasodilatation, sweating, vulvovaginitis, increased cervical resistance. Hyperglycemia, decreased bone mineral density, elevated liver enzymes and lipids, QT prolongation.

        Zoladex Clinical Trials

        See Literature

        Zoladex Note

        Not Applicable

        Zoladex Patient Counseling

        See Literature

        Zoladex Generic Name & Formulations

        Legal Class

        Rx

        General Description

        Goserelin (as acetate) 3.6mg; SC implant.

        Pharmacological Class

        GnRH agonist.

        See Also

        How Supplied

        Implant (in syringe)—1

        Manufacturer

        TerSera Therapeutics

        Mechanism of Action

        Zoladex is a synthetic decapeptide analogue of GnRH. It acts as an inhibitor of pituitary gonadotropin secretion when administered in the biodegradable formulation.

        Zoladex Indications

        Indications

        Palliative treatment of advanced prostate carcinoma. In combination with flutamide for management of locally confined Stage T2b-T4 (Stage B2-C) prostate carcinoma.

        Zoladex Dosage and Administration

        Adult

        Implant SC into anterior abdominal wall. Prostate cancer: one 3.6mg implant every 28 days or one 10.8mg implant every 12 weeks. Stage B2-C prostatic carcinoma (in combination with flutamide): Treat 8 weeks prior to and during radiotherapy. Initially one 3.6mg implant, followed in 28 days by one 10.8mg implant; or may use one 3.6mg implant every 28 days (two before and two during radiotherapy).

        Children

        Not established.

        Zoladex Contraindications

        Contraindications

        Pregnancy.

        Zoladex Boxed Warnings

        Not Applicable

        Zoladex Warnings/Precautions

        Warnings/Precautions

        Increased risk of diabetes, MI, sudden cardiac death, stroke; monitor blood glucose and for signs/symptoms of CVD during therapy. Risk of ureteral obstruction or spinal cord compression; monitor during 1st month of therapy. Risk factors for decreased bone mineral density (eg, chronic alcohol, tobacco, anticonvulsants, corticosteroids). Risk of QT prolongation in congenital long QT syndrome, CHF, electrolyte abnormalities; monitor EKG and correct electrolyte abnormalities if needed. Risk of inj site injury in patients with low BMI and/or receiving full dose anticoagulation. Obesity; monitor testosterone if no clinical response. Nursing mothers: not recommended.

        Zoladex Pharmacokinetics

        Distribution

        Plasma protein bound: 27.3%.

        Metabolism

        Hepatic.

        Elimination

        Renal (>90%). Half-life: 4–5 hours.

        Zoladex Interactions

        Interactions

        Avoid concomitant drugs known to prolong the QT interval. May affect tests of pituitary-gonadotropic and gonadal functions.

        Zoladex Adverse Reactions

        Adverse Reactions

        Decreased testosterone levels (eg, hot flashes, sexual dysfunction, decreased erections, gynecomastia), lower urinary tract symptoms, transient worsening of symptoms (eg, bone pain), tumor flare, diarrhea, nausea, edema, malaise, hyperglycemia, hypercalcemia, decreased bone mineral density, QT prolongation.

        Zoladex Clinical Trials

        See Literature

        Zoladex Note

        Not Applicable

        Zoladex Patient Counseling

        See Literature

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