Drugs Details

Drugs Info of Zoladex
Drugs Details
  • Drugs Type  : FDA
  • Date : 28th Jan 2015 03:37 am
  • Brand Name : Zoladex
  • Generic Name : goserelin (Pronunciation: GOE se REL in)
Descriptions

ZOLADEX® (goserelin acetate implant), contains a potent synthetic decapeptide analogue of luteinizing hormone-releasing hormone (LHRH), also known as a gonadotropin releasing hormone (GnRH) agonist analogue. Goserelin acetate is chemically described as an acetate salt of [D-Ser(But)6,Azgly10]LHRH. Its chemical structure is pyro-Glu-His-Trp-Ser-Tyr-D-Ser(But)-Leu-Arg-Pro-Azgly-NH2 acetate [C59H84N18O14 • (C2H4O2)x where x = 1 to 2.4].

Goserelin acetate is an off-white powder with a molecular weight of 1269 Daltons (free base). It is freely soluble in glacial acetic acid. It is soluble in water, 0.1M hydrochloric acid, 0.1M sodium hydroxide, dimethylformamide and dimethyl sulfoxide. Goserelin acetate is practically insoluble in acetone, chloroform and ether.

ZOLADEX 10.8 mg (goserelin acetate implant) implant is supplied as a sterile, biodegradable product containing goserelin acetate equivalent to 10.8 mg of goserelin. ZOLADEX is designed for subcutaneous implantation with continuous release over a 12-week period. Goserelin acetate is dispersed in a matrix of D,L-lactic and glycolic acids copolymer (12.82-14.76 mg/dose) containing less than 2% acetic acid and up to 10% goserelin-related substances and presented as a sterile, white to cream colored 1.5 mm diameter cylinder, preloaded in a special single-use syringe with a 14-gauge x 36 +/- 0.5 mm siliconized needle with protective needle sleeve (SafeSystem™ Syringe) in a sealed, light- and moisture-proof, aluminum foil laminate pouch containing a desiccant capsule.

Studies of the D,L-lactic and glycolic acids copolymer have indicated that it is completely biodegradable and has no demonstrable antigenic potential.

ZOLADEX is also supplied as a sterile, biodegradable product containing goserelin acetate equivalent to 3.6 mg of goserelin designed for administration every 28 days.

What are the possible side effects of goserelin (Zoladex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • back pain, severe numbness or tingling in your legs or feet;
  • muscle weakness, problems with balance or coordination;
  • loss of bladder or bowel control;
  • urinating less than usual or not at all;
  • pain or burning when you urinate;
  • blood in your urine or stools;
  • feeling like you might pass...

Read All Potential Side Effects and See Pictures of Zoladex 10.8 mg »

What are the precautions when taking goserelin acetate implant (Zoladex 10.8 mg)?

Before using goserelin, tell your doctor or pharmacist if you are allergic to it; or to LHRH or LHRH-like hormones (e.g., 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).

If you have diabetes, this drug may make it harder to control your blood sugar...

Read All Potential Precautions of Zoladex 10.8 mg »


This monograph has been modified to include the generic and brand name in many instances.

Indications

Prostatic Carcinoma

ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate.

In controlled studies of patients with advanced prostatic cancer comparing ZOLADEX 3.6 mg to orchiectomy, the long-term endocrine responses and objective responses were similar between the two treatment arms. Additionally, duration of survival was similar between the two treatment arms in a major comparative trial.

In controlled studies of patients with advanced prostatic cancer, ZOLADEX 10.8 mg implant produced pharmacodynamically similar effect in terms of suppression of serum testosterone to that achieved with ZOLADEX 3.6 mg implant. Clinical outcome similar to that produced with the use of the ZOLADEX 3.6 mg implant administered every 28 days is predicted with the ZOLADEX 10.8 mg (goserelin acetate implant) implant administered every 12 weeks.

Stage B2-C Prostatic Carcinoma

ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.

The automatic safety feature of the syringe aids in the prevention of needlestick injury.

Dosage Administration

ZOLADEX, at a dose of 10.8 mg, should be administered subcutaneously every 12 weeks into the anterior abdominal wall below the navel line using an aseptic technique under the supervision of a physician.

While a delay of a few days is permissible, every effort should be made to adhere to the 12-week schedule.

Prostatic Carcinoma

For the management of advanced prostate cancer, ZOLADEX is intended for long-term administration unless clinically inappropriate.

Stage B2-C Prostatic Carcinoma

When ZOLADEX is given in combination with radiotherapy and flutamide for patients with Stage T2b-T4 (Stage B2-C) prostatic carcinoma, treatment should be started 8 weeks prior to initiating radiotherapy and should continue during radiation therapy. A treatment regimen using one ZOLADEX 3.6 mg depot, followed in 28 days by one ZOLADEX 10.8 mg (goserelin acetate implant) depot, should be administered.

Renal or Hepatic Impairment

No dosage adjustment is necessary for patients with renal or hepatic impairment.

Females

ZOLADEX 10.8 mg (goserelin acetate implant) implant is not indicated in women as the data are insufficient to support reliable suppression of serum estradiol. For female patients requiring treatment with goserelin, refer to the prescribing information for ZOLADEX 3.6 mg implant.

Administration Technique

The proper method of administration of ZOLADEX is described in the instructions that follow.

  1. Put the patient in a comfortable position with the upper part of the body slightly raised. Prepare an area of the anterior abdominal wall below the navel line with an alcohol swab.
  2. Examine the foil pouch and syringe for damage. Remove the syringe from the opened foil pouch and hold the syringe at a slight angle to the light. Check that at least part of the ZOLADEX implant is visible.
  3. Grasp the blue plastic safety tab and pull away from the syringe and discard. Remove needle cover. Unlike liquid injections, there is no need to remove air bubbles as attempts to do so may displace the ZOLADEX implant.
  4. Holding the syringe around the protective sleeve, using an aseptic technique, pinch the skin of the patient's anterior abdominal wall below the navel line. With the bevel of the needle facing up, insert the needle at a 30 to 45 degree angle to the skin in one continuous deliberate motion until the protective sleeve touches the patient's skin. NOTE: The ZOLADEX syringe cannot be used for aspiration. If the hypodermic needle penetrates a large vessel, blood will be seen instantly in the syringe chamber. If a vessel is penetrated, withdraw the needle and inject with a new syringe elsewhere.
  5. Do not penetrate into muscle or peritoneum.
  6. To administer the ZOLADEX implant and to activate the protective sleeve, grasp the barrel at the finger grip and depress the plunger until you cannot depress it any further. If the plunger is not depressed fully the protective sleeve will NOT activate. When the protective sleeve ‘clicks', the protective sleeve will automatically begin to slide to cover the needle. NOTE: The needle does not retract.
  7. Withdraw the needle and allow protective sleeve to slide and cover needle. Dispose of the syringe in an approved sharps collector. NOTE: In the unlikely event of the need to surgically remove ZOLADEX, it may be localized by ultrasound.

How Supplied

ZOLADEX 10.8 mg (goserelin acetate implant) implant is supplied as a sterile and totally biodegradable D,L-lactic and glycolic acids copolymer (12.82-14.76 mg/dose) impregnated with goserelin acetate equivalent to 10.8 mg of goserelin in a disposable syringe device fitted with a 14-gauge x 36 +/- 0.5 mm siliconized hypodermic needle with protective sleeve (SafeSystem™ Syringe) (NDC 0310-0951-30). The unit is sterile and comes in a sealed, light- and moisture-proof, aluminum foil laminate pouch containing a desiccant capsule. Store at room temperature (do not exceed 25°C [77°F]).

Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 By: AstraZeneca UK Limited, Macclesfield, England. Made in the United Kingdom. Rev 11/08.


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

General

Rarely, hypersensitivity reactions (including urticaria and anaphylaxis) have been reported in patients receiving ZOLADEX.

As with other endocrine therapies, hypercalcemia (increased calcium) has rarely been reported in cancer patients with bone metastases following initiation of treatment with ZOLADEX or other LHRH agonists.

ZOLADEX has been found to be generally well tolerated in clinical trials. Adverse reactions reported in these trials were rarely severe enough to result in the patients' withdrawal from ZOLADEX treatment. As seen with other hormonal therapies, the most commonly observed adverse events during ZOLADEX therapy were due to the expected physiological effects from decreased testosterone levels. These included hot flashes, sexual dysfunction and decreased erections.

Initially, ZOLADEX, like other LHRH agonists, causes transient increases in serum levels of testosterone. A small percentage of patients experienced a temporary worsening of signs and symptoms (see WARNINGS section), usually manifested by an increase in cancer-related pain which was managed symptomatically. Isolated cases of exacerbation of disease symptoms, either ureteral obstruction or spinal cord compression, occurred at similar rates in controlled clinical trials with both ZOLADEX and orchiectomy. The relationship of these events to therapy is uncertain.

There have been post-marketing reports of osteoporosis, decreased bone mineral density and bony fracture in men treated with ZOLADEX for prostate cancer.

Changes in blood pressure, manifest as hypotension or hypertension, have been occasionally observed in patients administered ZOLADEX. The changes are usually transient, resolving either during continued therapy or after cessation of therapy with ZOLADEX. Rarely, such changes have been sufficient to require medical intervention including withdrawal of treatment from ZOLADEX.

Prostatic Carcinoma

Two controlled clinical trials using ZOLADEX 10.8 mg (goserelin acetate implant) versus ZOLADEX 3.6 mg were conducted. During a comparative phase, patients were randomized to receive either a single 10.8 mg implant or three consecutive 3.6 mg implants every 4 weeks over weeks 0-12. During this phase, the only adverse event reported in greater than 5% of patients was hot flashes, with an incidence of 47% in the ZOLADEX 10.8 mg (goserelin acetate implant) group and 48% in the ZOLADEX 3.6 mg group.

From weeks 12-48 all patients were treated with a 10.8 mg implant every 12 weeks. During this noncomparative phase, the following adverse events were reported in greater than 5% of patients:

 

Adverse Event ZOLADEX 10.8 mg (n = 157 ) %
Hot Flashes 64
Pain (General) 14
Gynecomastia 8
Pelvic Pain 6
Bone Pain 6
Asthenia 5

The following adverse events were reported in greater than 1%, but less than 5% of patients treated with ZOLADEX 10.8 mg (goserelin acetate implant) implant every 12 weeks. Some of these are commonly reported in elderly patients.

WHOLE BODY - Abdominal pain, Back pain, Flu syndrome, Headache, Sepsis, Aggravation reaction

CARDIOVASCULAR - Angina pectoris, Cerebral ischemia, Cerebrovascular accident, Heart failure, Pulmonary embolus, Varicose veins

DIGESTIVE - Diarrhea, Hematemesis

ENDOCRINE - Diabetes mellitus

HEMATOLOGIC - Anemia

METABOLIC - Peripheral edema

NERVOUS SYSTEM - Dizziness, Paresthesia, Urinary retention

RESPIRATORY - Cough increased, Dyspnea, Pneumonia SKIN - Herpes simplex, Pruritus

UROGENITAL - Bladder neoplasm, Breast pain, Hematuria, Impotence, Urinary frequency, Urinary incontinence, Urinary tract disorder, Urinary tract infection, Urination impaired.

The following adverse events not already listed above were reported in patients receiving ZOLADEX 3.6 mg in other clinical trials. Inclusion does not necessarily represent a causal relationship to ZOLADEX 10.8 mg (goserelin acetate implant) .

WHOLE BODY - Allergic reaction, Chills, Fever, Infection, Injection site reaction, Lethargy, Malaise

CARDIOVASCULAR - Arrhythmia, Chest pain, Hemorrhage, Hypertension, Migraine, Myocardial infarction, Palpitations, Peripheral vascular disorder, Tachycardia

DIGESTIVE - Anorexia, Constipation, Dry mouth, Dyspepsia, Flatulence, Increased appetite, Nausea, Ulcer, Vomiting

HEMATOLOGIC - Ecchymosis

METABOLIC - Edema, Gout, Hyperglycemia, Weight increase

MUSCULOSKELETAL - Arthralgia, Hypertonia, Joint disorder, Leg cramps, Myalgia, Osteoporosis

NERVOUS SYSTEM - Anxiety, Depression, Emotional lability, Headache, Insomnia, Nervousness, Somnolence, Thinking abnormal

RESPIRATORY - Bronchitis, Chronic obstructive pulmonary disease, Epistaxis, Rhinitis, Sinusitis, Upper respiratory infection, Voice alterations

SKIN - Acne, Alopecia, Dry skin, Hair disorders, Rash, Seborrhea, Skin discoloration, Sweating

SPECIAL SENSES - Amblyopia, Dry eyes

UROGENITAL - Breast tenderness, Decreased erections, Renal insufficiency, Sexual dysfunction, Urinary obstruction

Stage B2-C Prostatic Carcinoma

Treatment with ZOLADEX and flutamide did not add substantially to the toxicity of radiation treatment alone. The following adverse experiences were reported during a multicenter clinical trial comparing ZOLADEX + flutamide + radiation versus radiation alone. The most frequently reported (greater than 5%) adverse experiences are listed below:

ADVERSE EVENTS DURING ACUTE RADIATION THERAPY (within first 90 days of radiation therapy)

  (n=231)
flutamide +
ZOLADEX +
Radiation
% All
(n=235)
Radiation Only
% All
Rectum/Large Bowel 80 76
Bladder 58 60
Skin 37 37

ADVERSE EVENTS DURING LATE RADIATION PHASE (after 90 days of radiation therapy)

  (n=231)
flutamide +
ZOLADEX +
Radiation
% All
(n=235)
Radiation Only
% All
Diarrhea 36 40
Cystitis 16 16
Rectal Bleeding 14 20
Proctitis 8 8
Hematuria 7 12

Additional adverse event data was collected for the combination therapy with radiation group over both the hormonal treatment and hormonal treatment plus radiation phases of the study. Adverse experiences occurring in more than 5% of patients in this group, over both parts of the study, were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%).

Changes in Laboratory Values During Treatment

Plasma Enzymes

Elevation of liver enzymes (AST, ALT) have been reported in female patients exposed to ZOLADEX 3.6 mg (representing less than 1% of all patients). There was no other evidence of abnormal liver function. Causality between these changes and ZOLADEX have not been established.

Lipids

In a controlled trial in females, ZOLADEX 3.6 mg implant therapy resulted in a minor, but statistically significant effect on serum lipids (ie, increases in LDL cholesterol of 21.3 mg/dL; increases in HDL cholesterol of 2.7 mg/dL; and triglycerides increased by 8.0 mg/dL).

Post-marketing

Pituitary Apoplexy

During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed. Most of the pituitary apoplexy cases occurred within 2 weeks of the first dose, and some occurred within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.

Reduction in glucose tolerance, manifesting as diabetes or a loss of glycemic control in those with pre-existing diabetes, has been reported during treatment with LHRH agonists, including ZOLADEX. The following adverse reactions have occurred very rarely in post-marketing experience with ZOLADEX: psychotic disorders and pituitary tumors.

Read the Zoladex 10.8 mg (goserelin acetate implant) Side Effects Center for a complete guide to possible side effects

Interactions

No drug interaction studies with other drugs have been conducted with ZOLADEX. No confirmed interactions have been reported between ZOLADEX and other drugs.

Drug/Laboratory Test Interactions

Administration of ZOLADEX in therapeutic doses results in suppression of the pituitary-gonadal system. Because of this suppression, diagnostic tests of pituitary-gonadotropic and gonadal functions conducted during treatment may show results which are misleading.

Read the Zoladex 10.8 mg Drug Interactions Center for a complete guide to possible interactions

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This monograph has been modified to include the generic and brand name in many instances.

Warnings

Initially, ZOLADEX, like other LHRH agonists, causes transient increases in serum levels of testosterone. Transient worsening of symptoms, or the occurrence of additional signs and symptoms of prostatic cancer, may occasionally develop during the first few weeks of ZOLADEX treatment. A small number of patients may experience a temporary increase in bone pain, which can be managed symptomatically. As with other LHRH agonists, isolated cases of ureteral obstruction and spinal cord compression have been observed. If spinal cord compression or renal impairment develops, standard treatment of these complications should be instituted, and in extreme cases an immediate orchiectomy considered.

Precautions

General

Hypersensitivity, antibody formation and acute anaphylactic reactions have been reported with LHRH agonist analogues. Of 115 women worldwide treated with ZOLADEX 3.6 mg and tested for development of binding to goserelin following treatment with ZOLADEX, one patient showed low-titer binding to goserelin. On further testing of this patient's plasma obtained following treatment, her goserelin binding component was found not to be precipitated with rabbit antihuman immunoglobulin polyvalent sera. These findings suggest the possibility of antibody formation.

Glucose Tolerance

A reduction in glucose tolerance has been observed in males receiving LHRH agonists, including ZOLADEX. This may manifest as diabetes or loss of glycemic control in those with pre-existing diabetes. Consideration should therefore be given to monitoring blood glucose in patients receiving ZOLADEX.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Subcutaneous implant of ZOLADEX in male and female rats once every 4 weeks for 1 year and recovery for 23 weeks at doses of about 80 and 150 μg/kg (males) and 50 and 100 μg/kg (females) daily (about 3 to 9 times the recommended human dose on a mg/m²basis) resulted in an increased incidence of pituitary adenomas. An increased incidence of pituitary adenomas was also observed following subcutaneous implant of ZOLADEX in rats at similar dose levels for a period of 72 weeks in males and 101 weeks in females. The relevance of the rat pituitary adenomas to humans has not been established. Subcutaneous implants of ZOLADEX every 3 weeks for 2 years delivered to mice at doses of up to 2400 μg/kg/day (about 70 times the recommended human dose on a mg/m²basis) resulted in an increased incidence of histiocytic sarcoma of the vertebral column and femur.

Mutagenicity tests using bacterial and mammalian systems for point mutations and cytogenetic effects have provided no evidence for mutagenic potential.

Administration of goserelin led to changes that were consistent with gonadal suppression in both male and female rats as a result of its endocrine action. In male rats administered 500-1000 μg/kg/day (about 30-60 times the recommended human dose on a mg/m²basis), a decrease in weight and atrophic histological changes were observed in the testes, epididymis, seminal vesicle and prostate gland with complete suppression of spermatogenesis. In female rats administered 50-1000 μg/kg/day (about 3-60 times the recommended daily human dose on a mg/m²basis), suppression of ovarian function led to decreased size and weight of ovaries and secondary sex organs; follicular development was arrested at the antral stage and the corpora lutea were reduced in size and number. Except for the testes, almost complete histologic reversal of these effects in males and females was observed several weeks after dosing was stopped; however, fertility and general reproductive performance were reduced in those that became pregnant after goserelin was discontinued. Fertile matings occurred within 2 weeks after cessation of dosing, even though total recovery of reproductive function may not have occurred before mating took place; and, the ovulation rate, the corresponding implantation rate, and number of live fetuses were reduced.

Based on histological examination, drug effects on reproductive organs seem to be completely reversible in male and female dogs when drug treatment was stopped after continuous administration for 1 year at 100 times the recommended monthly dose.

Pregnancy

Teratogenic Effects
Pregnancy Category X

See CONTRAINDICATIONS section. ZOLADEX 10.8 mg is not indicated in women as the data are insufficient to support reliable suppression of serum estradiol. Studies in both rats and rabbits at doses of 2, 10, 20, and 50 μg/kg/day and 20, 250, and 1,000 μg/kg/day, respectively (about 1/10 to 3 times and 2 to 100 times the daily maximum recommended human dose, respectively, on a mg/m²basis), administered during the period of organogenesis, have confirmed that ZOLADEX will increase pregnancy loss in a dose-related manner. While there was no evidence that ZOLADEX possessed the potential to cause teratogenicity in rabbits, in rats the incidence of umbilical hernia was significantly increased at doses greater than 10 mg/kg/day (about ½ the recommended dose on a mg/m²basis).

Nursing Mothers

It is not known if this drug is excreted in human milk. Many drugs are excreted in human milk and there is a potential for serious adverse reactions in nursing infants of mothers receiving ZOLADEX (See CONTRAINDICATIONS).

Pediatric Use

Safety and efficacy of ZOLADEX in pediatric patients have not been established.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

The pharmacologic properties of ZOLADEX and its mode of administration make accidental or intentional overdosage unlikely. There is no experience of overdosage from clinical trials. Animal studies indicate that no increased pharmacologic effect occurred at higher doses or more frequent administration. Subcutaneous doses of the drug as high as 1 mg/kg/day in rats and dogs did not produce any nonendocrine related sequelae; this dose is greater than 400 times that proposed for human use. If overdosage occurs, it should be managed symptomatically.

ContrainDications

A report of an anaphylactic reaction to synthetic GnRH (Factrel) has been reported in the medical literature. ZOLADEX is contraindicated in those patients who have a known hypersensitivity to LHRH, LHRH agonist analogues or any of the components in ZOLADEX.

ZOLADEX 10.8 mg (goserelin acetate implant) implant is not indicated in women as the data are insufficient to support reliable suppression of serum estradiol. For female patients requiring treatment with goserelin, refer to the prescribing information for ZOLADEX 3.6 mg implant.

ZOLADEX is contraindicated in women who are or may become pregnant while receiving the drug. In studies in rats and rabbits, ZOLADEX increased preimplantation loss, resorptions, and abortions (see Pregnancy section). In rats and dogs, ZOLADEX suppressed ovarian function, decreased ovarian weight and size, and led to atrophic changes in secondary sex organs. Further evidence suggests that fertility was reduced in female rats that became pregnant after ZOLADEX was stopped. These effects are an expected consequence of the hormonal alterations produced by ZOLADEX in humans. If a patient becomes pregnant during treatment, the drug must be discontinued and the patient must be apprised of the potential risk for loss of the pregnancy due to possible hormonal imbalance as a result of the expected pharmacologic action of ZOLADEX treatment. In animal studies, there was no evidence that ZOLADEX possessed the potential to cause teratogenicity in rabbits; however, in rats the incidence of umbilical hernia was significantly increased with treatment. (See Pregnancy, Teratogenic Effects.)


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism of Action

ZOLADEX is a synthetic decapeptide analogue of LHRH. ZOLADEX acts as a potent inhibitor of pituitary gonadotropin secretion when administered in the biodegradable formulation.

Following initial administration, ZOLADEX causes an initial increase in serum-luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels with subsequent increases in serum levels of testosterone. Chronic administration of ZOLADEX leads to sustained suppression of pituitary gonadotropins, and serum levels of testosterone consequently fall into the range normally seen in surgically castrated men approximately 21 days after initiation of therapy. This leads to accessory sex organ regression.

In animal and in in vitro studies, administration of goserelin resulted in the regression or inhibition of growth of the hormonally sensitive dimethylbenzanthracene (DMBA)-induced rat mammary tumor and Dunning R3327 prostate tumor.

In clinical trials using ZOLADEX 3.6 mg with follow-up of more than 2 years, suppression of serum testosterone to castrate levels has been maintained for the duration of therapy.

Pharmacokinetics

Absorption

The pharmacokinetics of goserelin have been determined in healthy male volunteers and patients. In healthy males, radiolabeled goserelin was administered as a single 250 μg (aqueous solution) dose by the subcutaneous route. The absorption of radiolabeled drug was rapid, and the peak blood radioactivity levels occurred between 0.5 and 1.0 hour after dosing.

The overall pharmacokinetic profile of goserelin following administration of a ZOLADEX 10.8 mg (goserelin acetate implant) depot to patients with prostate cancer was determined. The initial release of goserelin from the depot was relatively rapid resulting in a peak concentration at 2 hours after dosing. From Day 4 until the end of the 12-week dosing interval, the sustained release of goserelin from the depot produced reasonably stable systemic exposure. Mean (Standard Deviation) pharmacokinetic data are presented in Table 1. There is no clinically significant accumulation of goserelin following administration of four depots administered at 12-week intervals. Pharmacokinetic data were obtained using an RIA method, which has been shown to be specific for goserelin in the presence of its metabolites.

Table 1 — Goserelin pharmacokinetic parameters for the 10.8 mg depot

Parameter n Mean (SD) 95% CI
Lower Upper
Systemic clearance (mL/min) 41 121 (42.4) 108 134
Cmax (ng/mL) 41 8.85 (2.83) 7.96 9.74
Tmax (h) 41 1.80 (0.34) 1.70 1.92
Cmin (ng/mL) 44 0.37 (0.21) 0.30 0.43
Elimination Half-life (h) ¶ 7 4.16 (1.12) 3.12 5.20
¶ = determined after subcutaneous administration of 250 μg aqueous solution of goserelin.
SD = standard deviation 95%
CI = 95% confidence interval

Serum goserelin concentrations in prostate cancer patients administered three 3.6 mg depots followed by one 10.8 mg depot are displayed in Figure 1. The profiles for both formulations are primarily dependent upon the rate of drug release from the depots. For the 3.6 mg depot, mean concentrations gradually rise to reach a peak of about 3 ng/mL at around 15 days after administration and then decline to approximately 0.5 ng/mL by the end of the treatment period. For the 10.8 mg depot, mean concentrations increase to reach a peak of about 8 ng/mL within the first 24 hours and then decline rapidly up to Day 4. Thereafter, mean concentrations remain relatively stable in the range of about 0.3 to 1 ng/mL up to the end of the treatment period.

Figure 1: Goserelin serum concentrations during dosing three ZOLADEX 3.6 mg depots (0, 28, 56 days) then one ZOLADEX 10.8 mg (goserelin acetate implant) depot (84 days) to prostate cancer patients.

View Enlarged Table

Administration of four ZOLADEX 10.8 mg (goserelin acetate implant) depots to patients with prostate cancer resulted in testosterone levels that were suppressed to and maintained within the range normally observed in surgically castrated men (0-1.73 nmol/L or 0-50 ng/dL), over the dosing interval in approximately 91% (145/160) of patients studied. In 6 of 15 patients that escaped from castrate range, serum testosterone levels were maintained below 2.0 nmol/L (58 ng/dL) and in only one of the 15 patients did the depot completely fail to maintain serum testosterone levels to within the castrate range over a 336-day period (4 depot injections). In the 8 additional patients, a transient escape was followed 14 days later by a level within the castrate range.

Distribution

The apparent volume of distribution determined after subcutaneous administration of 250 μg aqueous solution of goserelin was 44.1 ± 13.6 liters for healthy males. The plasma protein binding of goserelin was found to be 27%.

Metabolism

Metabolism of goserelin, by hydrolysis of the C-terminal amino acids, is the major clearance mechanism. The major circulating component in serum appeared to be 1-7 fragment, and the major component present in urine of one healthy male volunteer was 5-10 fragment. The metabolism of goserelin in humans yields a similar but narrow profile of metabolites to that found in other species. All metabolites found in humans have also been found in toxicology species.

Excretion

Clearance of goserelin following subcutaneous administration of a radiolabeled solution of goserelin was very rapid and occurred via a combination of hepatic and urinary excretion. More than 90% of a subcutaneous radiolabeled solution formulation dose of goserelin was excreted in urine. Approximately 20% of the dose recovered in urine was accounted for by unchanged goserelin.

Special Populations

Renal Insufficiency

In clinical trials with the solution formulation of goserelin, subjects with impaired renal function (creatinine clearance less than 20 mL/min) had a serum elimination half-life of 12.1 hours compared to 4.2 hours for subjects with normal renal function (creatinine clearance greater than 70 mL/min). However, there was no evidence for any accumulation of goserelin on multiple dosing of the ZOLADEX 10.8 mg (goserelin acetate implant) depot to subjects with impaired renal function. There was no evidence for any increase in incidence of adverse events in renally impaired patients administered the 10.8 mg depot. These data indicate that there is no need for any dosage adjustment when administering ZOLADEX 10.8 mg (goserelin acetate implant) to subjects with impaired renal function.

Hepatic Insufficiency

The clearance and half-life of goserelin administered as an aqueous solution are not affected by hepatic impairment. These data indicate that there is no need for any dosage adjustment when administering ZOLADEX 10.8 mg (goserelin acetate implant) to subjects with impaired hepatic function.

Geriatric

There is no need for any dosage adjustment when administering ZOLADEX 10.8 mg to geriatric patients.

Body Weight

A decline of approximately 1 to 2.5% in the AUC after administration of a 10.8 mg depot was observed with a kilogram increase in body weight. In obese patients who have not responded clinically, testosterone levels should be monitored closely.

Drug-Drug Interactions

No formal drug-drug interaction studies have been performed.

Clinical Studies - Prostatic Carcinoma

In two controlled clinical trials, 160 patients with advanced prostate cancer were randomized to receive either one 3.6 mg ZOLADEX implant every four weeks or a single 10.8 mg ZOLADEX implant every 12 weeks. Mean serum testosterone suppression was similar between the two arms. PSA falls at three months were 94% in patients who received the 10.8 mg implant and 92.5% in patients that received three 3.6 mg implants.

Periodic monitoring of serum testosterone levels should be considered if the anticipated clinical or biochemical response to treatment has not been achieved. A clinical outcome similar to that produced with the use of the 3.6 mg implant administered every 28 days is predicted with ZOLADEX 10.8 mg (goserelin acetate implant) implant administered every 12 weeks (84 days). Total testosterone was measured by the DPC Coat-A-Count radioimmunoassay method which, as defined by the manufacturers, is highly specific and accurate. Acceptable variability of approximately 20% at low testosterone levels has been demonstrated in the clinical studies performed with the ZOLADEX 10.8 mg depot.

Clinical Studies - Stage B2-C Prostatic Carcinoma

The effects of hormonal treatment combined with radiation were studied in 466 patients (231 ZOLADEX + flutamide + radiation, 235 radiation alone) with bulky primary tumors confined to the prostate (stage B2) or extending beyond the capsule (stage C), with or without pelvic node involvement.

In this multicentered, controlled trial, administration of ZOLADEX (3.6 mg depot) and flutamide capsules (250 mg t.i.d.) prior to and during radiation was associated with a significantly lower rate of local failure compared to radiation alone (16% vs 33% at 4 years, P < 0.001). The combination therapy also resulted in a trend toward reduction in the incidence of distant metastases (27% vs 36% at 4 years, P=0.058). Median disease-free survival was significantly increased in patients who received complete hormonal therapy combined with radiation as compared to those patients who received radiation alone (4.4 vs 2.6 years, P < 0.001). Inclusion of normal PSA level as a criterion for disease-free survival also resulted in significantly increased median disease-free survival in patients receiving the combination therapy (2.7 vs 1.5 years, P < 0.001).


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients should be informed that diabetes, or loss of glycemic control in patients with pre-existing diabetes has been reported during treatment with LHRH agonists, including ZOLADEX. Consideration should therefore be given to monitoring blood glucose in patients receiving ZOLADEX.

The use of ZOLADEX in patients at particular risk of developing ureteral obstruction or spinal cord compression should be considered carefully and the patients monitored closely during the first month of therapy. Patients with ureteral obstruction or spinal cord compression should have appropriate treatment prior to initiation of ZOLADEX therapy.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

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.

 

GOSERELIN - IMPLANT

 

(GOE-se-REL-in)

 

COMMON BRAND NAME(S): Zoladex

 

USES: Goserelin is used in men to treat prostate cancer. It is used in women to treat certain breast cancers or a certain uterus disorder (endometriosis). It is also used in women to thin the lining of the uterus (endometrium) in preparation for a procedure to treat abnormal uterine bleeding. 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 in men and estrogen hormones in women. This effect helps to slow or stop the growth of certain cancer cells and uterine tissue that need these hormones to grow and spread.

The 10.8-milligram syringe should not be used in women.

 

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to stop early puberty in children.

 

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.

Dosage is based on your medical condition and response to therapy.

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 weeks. Follow the dosing schedule carefully to get the most benefit from the drug. 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.

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 effect may result in new symptoms or worsening of symptoms (e.g., pain, tumor size) for the first few weeks.

In women, it is expected that menstrual periods will 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 persists or worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Hot flashes (flushing), dizziness, headache, increased sweating, decreased sexual interest/ability, trouble sleeping, nausea, change in breast size, hair loss, or mental/mood changes (such as depression, mood swings, hallucinations) may occur. Pain, bruising, bleeding, redness, or swelling at the injection site may also occur. In women, vaginal dryness may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: vaginal burning/pain (in women), 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, change in the amount of urine.

This drug may infrequently make your blood sugar level rise, which can cause or worsen diabetes. High blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar, such as unusual increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly.

Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest/jaw/left arm pain, trouble breathing, confusion, vision changes, slurred speech, weakness on one side of the body.

Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first dose of this medication. Seek immediate medical attention if any of these very serious side effects occur: sudden severe headache, mental/mood changes (e.g., confusion), vision changes, vomiting.

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 immediately if you experience 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, seek immediate medical attention 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Zoladex 10.8 mg (goserelin acetate implant) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using goserelin, tell your doctor or pharmacist if you are allergic to it; or to LHRH or LHRH-like hormones (e.g., 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).

If you have diabetes, this drug may make it harder to control your blood sugar levels. Monitor your blood sugar levels regularly and tell your doctor of the results. 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 infrequently result in 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).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Women of child-bearing age must make sure they are not pregnant before starting this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately. Consult your doctor for more details and to discuss reliable forms of birth control. For women, this medication should stop the release of an egg (ovulation) and your periods, but this should not be used as a reliable method of birth control. It is recommended that men and women using this medication use 2 effective forms of nonhormonal birth control (e.g., condoms and diaphragm with spermicide) while taking this medication. Continue using effective birth control until the return of the woman's period or for at least 12 weeks after stopping this medication.

It is not known whether 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.

Consumer Overview Missed Dose

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.

Some products that may interact with this drug include: hormonal birth control (e.g., pills, patch), medications that can cause bone loss (e.g., corticosteroids such as prednisone).

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Laboratory and/or medical tests (such as blood sugar, hormone levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

In women, sudden/unusual vaginal bleeding (breakthrough bleeding) may occur if a dose is missed.

 

STORAGE: Consult the product instructions and your pharmacist for storage details. 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 July 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Zoladex

Generic Name: goserelin (Pronunciation: GOE se REL in)

  • What is goserelin (Zoladex 10.8 mg)?
  • What are the possible side effects of goserelin (Zoladex 10.8 mg)?
  • What is the most important information I should know about goserelin (Zoladex 10.8 mg)?
  • What should I discuss with my healthcare provider before receiving goserelin (Zoladex 10.8 mg)?
  • How is goserelin given (Zoladex 10.8 mg)?
  • What happens if I miss a dose (Zoladex 10.8 mg)?
  • What happens if I overdose (Zoladex 10.8 mg)?
  • What should I avoid while receiving goserelin (Zoladex 10.8 mg)?
  • What other drugs will affect goserelin (Zoladex 10.8 mg)?
  • Where can I get more information?

What is goserelin (Zoladex 10.8 mg)?

Goserelin is a man-made form of a hormone that regulates many processes in the body. Goserelin overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily.

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

If you are receiving goserelin to treat prostate cancer, use any other medications your doctor has prescribed to best treat your condition. Goserelin treats only the symptoms of prostate cancer but does not treat the cancer itself.

Goserelin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of goserelin (Zoladex 10.8 mg)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • back pain, severe numbness or tingling in your legs or feet;
  • muscle weakness, problems with balance or coordination;
  • loss of bladder or bowel control;
  • urinating less than usual or not at all;
  • pain or burning when you urinate;
  • blood in your urine or stools;
  • feeling like you might pass out;
  • trouble breathing;
  • pale skin, easy bruising;
  • nausea, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless;
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
  • sudden numbness or weakness, sudden severe headache, confusion, problems with vision or speech; or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

  • hot flashes, sweating, headache, dizziness;
  • mood changes, increased or decreased interest in sex;
  • vaginal dryness, itching, or discharge;
  • impotence, fewer erections than normal;
  • breast swelling or tenderness;
  • bone pain;
  • diarrhea, constipation;
  • sleep problems (insomnia); or
  • acne, mild skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Zoladex 10.8 mg (goserelin acetate implant) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about goserelin (Zoladex 10.8 mg)?

Goserelin can harm an unborn baby or cause birth defects. Unless you are being treated for advanced breast cancer, you should not use goserelin during pregnancy. Use effective non-hormonal (barrier) birth control during treatment and for at least 12 weeks after treatment ends. Tell your doctor right away if you become pregnant during treatment.

You should not breast-feed while you are using goserelin.

You should not use this medication if you are allergic to goserelin or to similar hormone medications such as leuprolide (Lupron, Eligard, Viadur), nafarelin (Synarel), or ganirelix (Antagon).

Before you receive goserelin, tell your doctor if you have osteoporosis, diabetes, urination problems, a condition affecting your spine, a history of heart attack or stroke, risk factors for coronary artery disease (such as high blood pressure, high cholesterol, smoking, or being overweight), or if you have abnormal bleeding that your doctor has not checked.

Goserelin can decrease bone mineral density, which may increase your risk of developing osteoporosis. This risk may be greater if you smoke, drink alcohol frequently, have a family history of osteoporosis, or use certain drugs such as seizure medications or steroids. Talk to your doctor about your individual risk of bone loss.

Call your doctor at once if you have a serious side effect such as severe numbness or tingling in your legs or feet, muscle weakness, problems with balance or coordination, loss of bladder or bowel control, urinating less than usual, pain or burning when you urinate, blood in your urine or stools, easy bruising, increased thirst or urination, fruity breath odor, trouble breathing, sudden numbness or weakness, sudden severe headache, confusion, problems with vision or speech, or chest pain spreading to the arm or shoulder.

Side Effects Centers
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Patient Detailed How Take

What should I discuss with my healthcare provider before receiving goserelin (Zoladex 10.8 mg)?

You should not receive this medication if you are allergic to goserelin or to similar hormone medications such as leuprolide (Lupron, Eligard, Viadur), nafarelin (Synarel), or ganirelix (Antagon). Do not use goserelin if you are pregnant or breast-feeding.

To make sure you can safely use goserelin, tell your doctor if you have any of these other conditions:

  • osteoporosis or low bone density;
  • diabetes;
  • a history of heart attack or stroke;
  • risk factors for coronary artery disease (such as high blood pressure, high cholesterol, smoking, or being overweight);
  • urination problems;
  • a condition affecting your spine; or
  • if you have abnormal bleeding that your doctor has not checked.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. However, goserelin is sometimes given to pregnant women being treated for advanced breast cancer. Unless you are being treated for advanced breast cancer, you should not use goserelin during pregnancy.

Before receiving goserelin, you may need a pregnancy test to make sure you are not pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication and for at least 12 weeks after your treatment ends.

If you are a premenopausal woman, goserelin should cause your periods to stop during treatment. However, you must still use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective during your treatment with goserelin.

After you stop using goserelin, you should begin having regular periods again. Call your doctor if your normal periods do not return within 12 weeks after your goserelin treatment ends.

It is not known whether goserelin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using goserelin.

Goserelin can decrease bone mineral density, which may increase your risk of developing osteoporosis. This risk may be greater if you smoke, drink alcohol frequently, have a family history of osteoporosis, or use certain drugs such as seizure medications or steroids. Talk to your doctor about your individual risk of bone loss.

How is goserelin given (Zoladex 10.8 mg)?

Goserelin is given in a tiny implant that is inserted through a needle injected under the skin of your upper stomach. You will receive this injection in a clinic or doctor's office.

You are not likely to be able to feel the implant through your skin, and it should not cause pain or discomfort. The implant will dissolve in your body over time.

A new goserelin implant is usually injected every 28 days, but the timing of your dose may be different if you are also receiving chemotherapy. Follow your doctor's instructions. It is very important to receive your goserelin injections on time each month.

If you are a premenopausal woman, you should stop having menstrual periods during treatment with goserelin. Call your doctor if you still have regular periods. Missing a dose can cause breakthrough bleeding.

While your hormone levels are adjusting to goserelin, you may notice increased symptoms or new symptoms of your condition. This should be only temporary during the first few weeks of treatment. Tell your doctor if your symptoms do not improve after several weeks of using goserelin.

Your blood sugar may need to be checked while using goserelin, even if you are not diabetic. You may need other blood tests at your doctor's office. Visit your doctor regularly.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using goserelin.

Side Effects Centers
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Patient Detailed Avoid Taking

What happens if I miss a dose (Zoladex 10.8 mg)?

Call your doctor for instructions if you miss an appointment for your goserelin injection.

What happens if I overdose (Zoladex 10.8 mg)?

Since the goserelin implant contains a specific amount of the medication, you are not likely to receive an overdose.

What should I avoid while receiving goserelin (Zoladex 10.8 mg)?

Avoid drinking alcohol. It can increase your risk of bone loss while you are being treated with goserelin.

Avoid smoking, which can increase your risk of bone loss, stroke, or heart problems.

What other drugs will affect goserelin (Zoladex 10.8 mg)?

There may be other drugs that can interact with goserelin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about goserelin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 5.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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