Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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.
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
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
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.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
Images
Patient Handout
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.
Formulary
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