goserelin (Rx)

Brand and Other Names:Zoladex, Zoladex LA

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

subcutaneous implant

  • 3.6mg
  • 10.8mg

Prostate Cancer

Indications

  • Stage B2-C Prostatic carcinoma: Indicated combination with flutamide for management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate; initiate 8 weeks before starting radiation therapy and continue during radiation therapy
  • Advanced prostatic carcinoma: Indicated as palliative treatment for advanced prostate cancer

Dose

  • Monthly implant: 3.6 mg SC q28days
  • 3-months implant: 10.8 mg SC q12week
  • Stage B2-C: Total of 4 doses
  • Advanced prostate cancer: Treat long-term

Breast Cancer

Indicated for palliative treatment of advanced breast cancer in pre- and perimenopausal women; estrogen and progesterone receptor values may help to predict whether goserelin therapy is likely to be beneficial

3.6 mg implant SC q28days

Treat long-term

Endometriosis

Indicated for management of endometriosis, including pain relief and reduction ofendometriotic lesions for duration of therapy

3.6 mg implant SC q28days x 6 months

Endometrial Thinning

Indicated for use as an endometrial-thinning agent before endometrial ablation for dysfunctional uterine bleeding

3.8 mg SC q28days for 1 or 2 doses (with each depot give 4 weeks apart)

When 1 depot is administered, surgery should be performed at 4 weeks; if 2 depots are administered, surgery should be performed within 2-4 weeks after administration of 2nd depot

Dosage Modifications

Renal and hepatic impairment

  • Dose adjustment not necessary

Dosing Considerations

Confirm negative pregnancy test and use of effective nonhormonal contraception in all premenopausal women before initiating

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and goserelin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (30)

            • amiodarone

              goserelin increases toxicity of amiodarone by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • anagrelide

              goserelin increases toxicity of anagrelide by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • arsenic trioxide

              goserelin increases toxicity of arsenic trioxide by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • artemether

              goserelin increases toxicity of artemether by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • artemether/lumefantrine

              goserelin increases toxicity of artemether/lumefantrine by QTc interval. Contraindicated.

            • citalopram

              goserelin increases toxicity of citalopram by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • disopyramide

              goserelin increases toxicity of disopyramide by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • dofetilide

              goserelin increases toxicity of dofetilide by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • dronedarone

              goserelin increases toxicity of dronedarone by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • eliglustat

              goserelin increases toxicity of eliglustat by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • escitalopram

              goserelin increases toxicity of escitalopram by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • fluoxetine

              goserelin increases toxicity of fluoxetine by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • ibutilide

              goserelin increases toxicity of ibutilide by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • iloperidone

              goserelin increases toxicity of iloperidone by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • lopinavir

              goserelin increases toxicity of lopinavir by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • lumefantrine

              goserelin increases toxicity of lumefantrine by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • mifepristone

              goserelin increases toxicity of mifepristone by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • nilotinib

              goserelin increases toxicity of nilotinib by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • paliperidone

              goserelin increases toxicity of paliperidone by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • pimozide

              goserelin increases toxicity of pimozide by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • procainamide

              goserelin increases toxicity of procainamide by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • quetiapine

              goserelin increases toxicity of quetiapine by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • quinidine

              goserelin increases toxicity of quinidine by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • sotalol

              goserelin increases toxicity of sotalol by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • tetrabenazine

              goserelin increases toxicity of tetrabenazine by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • thioridazine

              goserelin increases toxicity of thioridazine by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • toremifene

              goserelin increases toxicity of toremifene by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • vandetanib

              goserelin increases toxicity of vandetanib by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • vemurafenib

              goserelin increases toxicity of vemurafenib by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • ziprasidone

              goserelin increases toxicity of ziprasidone by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            Serious - Use Alternative (23)

            • amisulpride

              amisulpride and goserelin both increase QTc interval. Avoid or Use Alternate Drug. ECG monitoring is recommended if coadministered.

            • asenapine

              asenapine and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            • asenapine transdermal

              asenapine transdermal and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            • buprenorphine

              buprenorphine and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            • buprenorphine buccal

              buprenorphine buccal and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            • buprenorphine subdermal implant

              buprenorphine subdermal implant and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            • buprenorphine transdermal

              buprenorphine transdermal and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            • buprenorphine, long-acting injection

              buprenorphine, long-acting injection and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            • desflurane

              desflurane and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            • encorafenib

              encorafenib and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            • entrectinib

              goserelin and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.

            • fexinidazole

              fexinidazole and goserelin both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.

            • glasdegib

              goserelin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • inotuzumab

              inotuzumab and goserelin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

            • isoflurane

              isoflurane and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            • lefamulin

              lefamulin and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            • lithium

              lithium and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            • olanzapine

              olanzapine and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            • oxaliplatin

              oxaliplatin and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            • panobinostat

              goserelin and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.

            • pitolisant

              goserelin and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.

            • sevoflurane

              sevoflurane and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            • siponimod

              siponimod and goserelin both increase QTc interval. Avoid or Use Alternate Drug.

            Monitor Closely (80)

            • albuterol

              albuterol and goserelin both increase QTc interval. Use Caution/Monitor.

            • alfuzosin

              goserelin and alfuzosin both increase QTc interval. Use Caution/Monitor.

            • apomorphine

              goserelin increases toxicity of apomorphine by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • arformoterol

              goserelin increases toxicity of arformoterol by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • aripiprazole

              aripiprazole and goserelin both increase QTc interval. Use Caution/Monitor.

            • atomoxetine

              atomoxetine and goserelin both increase QTc interval. Use Caution/Monitor.

            • azithromycin

              goserelin increases toxicity of azithromycin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • bedaquiline

              goserelin increases toxicity of bedaquiline by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • bosutinib

              bosutinib and goserelin both increase QTc interval. Use Caution/Monitor.

            • capecitabine

              capecitabine and goserelin both increase QTc interval. Use Caution/Monitor.

            • ceritinib

              goserelin increases toxicity of ceritinib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • chloroquine

              goserelin increases toxicity of chloroquine by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • chlorpromazine

              goserelin increases toxicity of chlorpromazine by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • cholera vaccine

              goserelin decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

            • ciprofloxacin

              goserelin increases toxicity of ciprofloxacin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • clarithromycin

              goserelin increases toxicity of clarithromycin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • clozapine

              goserelin increases toxicity of clozapine by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • crizotinib

              goserelin increases toxicity of crizotinib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • dasatinib

              dasatinib and goserelin both increase QTc interval. Use Caution/Monitor.

            • degarelix

              goserelin increases toxicity of degarelix by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • dengue vaccine

              goserelin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

            • desipramine

              desipramine and goserelin both increase QTc interval. Use Caution/Monitor.

            • deutetrabenazine

              deutetrabenazine and goserelin both increase QTc interval. Use Caution/Monitor. At the maximum recommended dose, deutetrabenazine does not prolong QT interval to a clinically relevant extent. Certain circumstances may increase risk of torsade de pointes and/or sudden death in association with drugs that prolong the QTc interval (eg, bradycardia, hypokalemia or hypomagnesemia, coadministration with other drugs that prolong QTc interval, presence of congenital QT prolongation).

            • dolasetron

              goserelin increases toxicity of dolasetron by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • donepezil

              donepezil and goserelin both increase QTc interval. Use Caution/Monitor.

            • doxepin

              doxepin and goserelin both increase QTc interval. Use Caution/Monitor.

            • droperidol

              goserelin increases toxicity of droperidol by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • efavirenz

              efavirenz and goserelin both increase QTc interval. Use Caution/Monitor.

            • eribulin

              goserelin increases toxicity of eribulin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • erythromycin base

              goserelin increases toxicity of erythromycin base by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • erythromycin ethylsuccinate

              goserelin increases toxicity of erythromycin ethylsuccinate by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • erythromycin lactobionate

              goserelin increases levels of erythromycin lactobionate by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • erythromycin stearate

              goserelin increases toxicity of erythromycin stearate by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • ezogabine

              goserelin increases levels of ezogabine by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • fingolimod

              goserelin increases toxicity of fingolimod by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • flecainide

              goserelin increases toxicity of flecainide by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • fluconazole

              goserelin increases toxicity of fluconazole by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • formoterol

              goserelin increases toxicity of formoterol by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • fostemsavir

              goserelin and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.

            • gallium Ga 68 PSMA-11

              goserelin will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.

            • gemifloxacin

              goserelin increases toxicity of gemifloxacin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • gemtuzumab

              goserelin and gemtuzumab both increase QTc interval. Use Caution/Monitor.

            • gilteritinib

              gilteritinib and goserelin both increase QTc interval. Use Caution/Monitor.

            • granisetron

              granisetron and goserelin both increase QTc interval. Use Caution/Monitor.

            • haloperidol

              goserelin increases toxicity of haloperidol by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • hydroxyzine

              hydroxyzine and goserelin both increase QTc interval. Use Caution/Monitor.

            • indacaterol, inhaled

              goserelin increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • itraconazole

              itraconazole and goserelin both increase QTc interval. Use Caution/Monitor.

            • lapatinib

              goserelin increases levels of lapatinib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • lenvatinib

              goserelin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.

            • levofloxacin

              goserelin increases toxicity of levofloxacin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • metformin

              goserelin decreases effects of metformin by pharmacodynamic antagonism. Use Caution/Monitor.

            • methadone

              goserelin increases toxicity of methadone by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • mirtazapine

              mirtazapine and goserelin both increase QTc interval. Use Caution/Monitor.

            • moxifloxacin

              goserelin increases toxicity of moxifloxacin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • ofloxacin

              goserelin increases toxicity of ofloxacin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • ondansetron

              goserelin increases toxicity of ondansetron by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • osilodrostat

              osilodrostat and goserelin both increase QTc interval. Use Caution/Monitor.

            • osimertinib

              goserelin increases toxicity of osimertinib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • oxaliplatin

              oxaliplatin will increase the level or effect of goserelin by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.

            • pasireotide

              goserelin increases toxicity of pasireotide by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • pazopanib

              goserelin increases toxicity of pazopanib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • pentamidine

              goserelin increases toxicity of pentamidine by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • perflutren

              goserelin increases toxicity of perflutren by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • primaquine

              primaquine and goserelin both increase QTc interval. Use Caution/Monitor.

            • propafenone

              goserelin increases toxicity of propafenone by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • ranolazine

              goserelin increases toxicity of ranolazine by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • romidepsin

              goserelin increases toxicity of romidepsin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • saquinavir

              goserelin increases toxicity of saquinavir by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • sertraline

              sertraline and goserelin both increase QTc interval. Use Caution/Monitor.

            • siponimod

              siponimod and goserelin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • solifenacin

              solifenacin and goserelin both increase QTc interval. Use Caution/Monitor.

            • sorafenib

              goserelin increases toxicity of sorafenib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • sunitinib

              goserelin increases toxicity of sunitinib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • tacrolimus

              tacrolimus and goserelin both increase QTc interval. Use Caution/Monitor.

            • telavancin

              goserelin increases toxicity of telavancin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • trazodone

              goserelin increases toxicity of trazodone by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • valbenazine

              valbenazine and goserelin both increase QTc interval. Use Caution/Monitor.

            • voriconazole

              goserelin increases toxicity of voriconazole by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • vorinostat

              vorinostat and goserelin both increase QTc interval. Use Caution/Monitor.

            Minor (2)

            • maitake

              maitake increases effects of goserelin by pharmacodynamic synergism. Minor/Significance Unknown. Maitake mushroom has anti-tumor effects (animal/in vitro research).

            • taurine

              goserelin decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown.

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            Adverse Effects

            >10%

            Prostate cancer

            • Hot flashes (62%)
            • Sexual dysfunction (21%)
            • Decreased erections 18%)
            • Lower urinary tract symptoms (13%)

            Endometriosis

            • Hot flushes (96%)
            • Vaginitis (75%)
            • Headache (75%)
            • Libido decreased (61%)
            • Emotional lability (60%)
            • Depression (54%)
            • Sweating (45%)
            • Acne (42%)
            • Breast atrophy (33%)
            • Seborrhea (26%)
            • Peripheral edema (21%)
            • Breast enlargement (18%)
            • Pelvic symptoms (18%)
            • Pain (17%)
            • Dyspareunia (14%)
            • Infection (13%)
            • Libido increased (12%)
            • Asthenia (11%)
            • Insomnia (11%)

            Endometrial thinning

            • Vasodilation (57%)
            • Headache (32%)
            • Sweating (16%)
            • Abdominal pain (11%)

            Breast cancer

            • Hot flashes (70%) Tumor flare (23%)
            • Nausea (11%)

            1-10%

            Prostate cancer

            • Lethargy (8%)
            • Pain (worsened first 30 days) (8%)
            • Edema (7%)
            • Upper respiratory tract infection (7%)
            • Rash (6%)
            • Sweating (6%)
            • Anorexia (5%)
            • COPD (5%)
            • CHF (5%)
            • Dizziness (5%)
            • Insomnia (5%)
            • Nausea (5%)

            Endometriosis

            • Nausea (8%)
            • Hirsutism (7%)
            • Breast pain (7%)
            • Abdominal pain (7%)
            • Back pain (7%)
            • Dizziness (6%)
            • Application site reactions (6%)
            • Flu syndrome (5%)
            • Pharyngitis (5%)
            • Hair disorders (4%)
            • Voice alterations (3%)
            • Myalgia (3%)
            • Nervousness (3%)
            • Weight gain (3%)
            • Leg cramps (2%)
            • Increased appetite (2%)
            • Pruritus (2%)
            • Hypertonia (1%)

            Endometrial thinning

            • Pelvic pain (9%)
            • Migraine (7%)
            • Dysmenorrhea (7%)
            • Hypertension (6%)
            • Uterine hemorrhage (6%)
            • Nausea (5%)
            • Nervousness (5%)
            • Vulvovaginitis (5%)
            • Back pain (4%)
            • Menorrhagia (4%)
            • Depression (3%)
            • Sinusitis (3%)
            • Vaginitis (1%)

            Breast cancer

            • Edema (5%)
            • Malaise/fatigue/lethargy (5%)
            • Vomiting (4%)

            Postmarketing Reports

            Bone mineral density: Osteoporosis, decreased bone mineral density, bony fracture in men

            Cardiovascular: DVT, PE, MI, stroke, TIA observed in women treated with GnRH agonists

            Ovarian cyst: Ovarian cyst formation and, in combination with gonadotropins, ovarian hyperstimulation syndrome

            Changes in blood pressure: Hypotension and hypertension

            Pituitary apoplexy and tumors: Pituitary apoplexy and pituitary adenoma

            Acne: Usually within 1 month of starting treatment

            Other: Psychotic disorders, convulsions, and mood swings, including depression; suicidal ideation and attempt in women

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            Warnings

            Contraindications

            Hypersensitivity to LHRH, LHRH-agonists, any component of product

            Pregnancy (for endometriosis), lactation, undiagnosed abnormal vaginal bleeding

            Cautions

            Hypersensitivity, antibody formation, and acute anaphylactic reactions reported with GnRH agonist analogues

            Hypercalcemia reported in some patients with prostate or breast cancer with bone metastases after starting treatment

            Pharmacologic action on the uterus and cervix may cause an increase in cervical resistance; care should be taken when dilating the cervix for endometrial ablation

            Women of childbearing potential and pregnancy

            • Before initiating, pregnancy must be excluded in females for benign gynecological conditions
            • Effective nonhormonal contraception must be used by all premenopausal females during therapy and for 12 weeks following discontinuation of therapy
            • When used every 28 days, goserelin usually inhibits ovulation and stops menstruation; however, pregnancy prevention is not ensured
            • Effects on reproductive function are expected to occur with chronic administration as a result of the drug’s anti-gonadotrophic properties
            • Based on mechanism of action in humans and findings of increased pregnancy loss in animal studies, can cause fetal harm when administered to a pregnant females
            • If used during pregnancy for palliative treatment of breast cancer, inform patient of potential hazard to fetus

            Tumor flare

            • Initially, like other GnRH agonists, causes transient increases in serum levels of testosterone in men with prostate cancer, and estrogen in females with breast cancer
            • Transient worsening of symptoms, or occurrence of additional signs and symptoms of prostate or breast cancer, may occasionally develop during the first few weeks of treatment
            • A few patients may experience a temporary increase in bone pain, which can be managed symptomatically
            • As with other GnRH agonists, isolated cases of ureteral obstruction and spinal cord compression observed in patients with prostate cancer
            • If spinal cord compression or renal impairment secondary to ureteral obstruction develops, initiate standard treatment for these complications
            • For extreme cases in prostate cancer patients, consider an immediate orchiectomy

            Hyperglycemia and diabetes

            • Hyperglycemia and increased risk of developing diabetes reported in men receiving GnRH agonists
            • Hyperglycemia may represent development of diabetes mellitus or worsening of glycemic control in patients with diabetes
            • Monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving a GnRH agonist and manage with current practice for treatment of hyperglycemia or diabetes

            Cardiovascular diseases

            • Increased risk of developing myocardial infarction, sudden cardiac death, and stroke reported in association with use of GnRH agonists in men
            • Risk appears low based on reported odds ratios, and should be evaluated carefully along with cardiovascular (CV) risk factors when determining a treatment for patients with prostate cancer
            • Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of CV disease and be managed according to current clinical practice

            QT/QTc interval prolongation

            • Androgen deprivation therapy may prolong the QT/QTc interval
            • Consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and coadministration of drugs known to prolong the QT interval
            • Correct electrolyte abnormalities before initiating
            • Consider periodic monitoring of electrolytes and performing ECG

            Injection site injury

            • Injection site injury and vascular injury including pain, hematoma, hemorrhage and hemorrhagic shock, requiring blood transfusions and surgical intervention, reported
            • Extra care should be taken when administering to patients with a low BMI and/or to patients receiving full dose anticoagulation

            Depression

            • Depression may occur or worsen in women during treatment with GnRH agonists including goserelin 3.6 mg
            • Carefully observe women for depression, especially those with history of depression and consider whether risks of continuing goserelin 3.6 mg outweigh benefits
            • Refer females with new or worsening depression to a mental health professional, as appropriate
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            Pregnancy & Lactation

            Pregnancy

            Contraindicated during pregnancy unless being used for palliative treatment of advanced breast cancer

            Based on mechanism of action in humans and findings of increased pregnancy loss in animal studies, goserelin can cause fetal harm when administered to pregnant females

            Lactation

            Unknown if excreted in human milk

            Goserelin is excreted in milk of lactating rats

            Because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants, a decision should be made to either discontinue nursing or discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Gonadotropin-releasing hormone (LHRH) analog; chronic stimulation of goserelin results in suppression of LH, FSH serum levels

            Pharmacokinetics

            Half-life: 2-4 hr

            Protein bound: 27%

            Time to peak: 12-15 days (male); 8-22 days (female)

            Vd: 44.1 L (Male); 20.3 L (female)

            Excretion: Urine (90%)

            Absorption

            • 3.6 mg: absorbed slowly during first 8 days, then more rapid continuous release
            • 10.8 mg: peak level within 24 hr, then decline until day 4, then concentrations stabilize
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            Images

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            Patient Handout

            Patient Education
            goserelin subcutaneous

            GOSERELIN - IMPLANT

            (GOE-se-REL-in)

            COMMON BRAND NAME(S): Zoladex

            USES: 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.

            HOW TO USE: 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 to keep track of when to receive the next dose. 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.

            SIDE EFFECTS: 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), stomach/abdominal pain or swelling, mental/mood changes (such as depression, mood swings, hallucinations).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.

            PRECAUTIONS: 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, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: 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.

            OVERDOSE: 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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

            MISSED DOSE: 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.

            STORAGE: 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.

            Information last revised March 2023. Copyright(c) 2023 First Databank, Inc.

            IMPORTANT: 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.

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.