Goserelin

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Goserelin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Goserelin is a Gonadotropin Releasing Hormone (GnRH) agonist that is FDA approved for the treatment of locally confined carcinoma of the prostate, and palliative treatment of advanced carcinoma of the prostate. Common adverse reactions include hot flashes, sexual dysfunction, decreased erections and lower urinary tract symptoms.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

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
Dosage
  • 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 depot, should be administered.
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 implant administered every 12 weeks.
  • The automatic safety feature of the syringe aids in the prevention of needlestick injury.
Dosage
  • For the management of advanced prostate cancer, ZOLADEX is intended for long-term administration unless clinically inappropriate.
Renal or Hepatic Impairment
  • No dosage adjustment is necessary for patients with renal or hepatic impairment.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Goserelin in adult patients.

Non–Guideline-Supported Use

  • Breast cancer, Adjuvant treatment of hormone receptor-positive, axillary lymph node-positive disease in premenopausal women[1][2]
  • Dysfunctional uterine bleeding[3]
  • In vitro fertilization[4]
  • Precocious puberty[5]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Goserelin in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Goserelin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Goserelin in pediatric patients.

Contraindications

Hypersensitivity
  • Anaphylactic reactions to ZOLADEX have been reported in the medical literature. ZOLADEX is contraindicated in those patients who have a known hypersensitivity to GnRH, GnRH agonist analogues or any of the components in ZOLADEX.
Pregnancy
  • Expected hormonal changes that occur with ZOLADEX treatment increase the risk for pregnancy loss. ZOLADEX may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus

Warnings

Tumor Flare Phenomenon
  • Initially, ZOLADEX, like other GnRH 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 GnRH agonists, isolated cases of ureteral obstruction and spinal cord compression have been observed. If spinal cord compression or renal impairment secondary to ureteral obstruction develops, standard treatment of these complications should be instituted, and in extreme cases an immediate orchiectomy.
Hypersensitivity

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

  • Of 115 women worldwide treated with ZOLADEX 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.
Hyperglycemia and Diabetes
  • Hyperglycemia and an increased risk of developing diabetes have been 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 has been reported in association with use of GnRH agonists in men. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular 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 cardiovascular disease and be managed according to current clinical practice.

Effect on QT/QTc Interval

Androgen deprivation therapy may prolong the QT/QTc interval. Providers should 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 in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Goserelin in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Goserelin in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Goserelin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Goserelin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Goserelin with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Goserelin with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Goserelin with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Goserelin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Goserelin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Goserelin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Goserelin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Goserelin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Goserelin in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Goserelin in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Goserelin in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Goserelin in the drug label.

Pharmacology

There is limited information regarding Goserelin Pharmacology in the drug label.

Mechanism of Action

Structure

File:Goserelin01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Goserelin in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Goserelin in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Goserelin in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Goserelin in the drug label.

How Supplied

Storage

There is limited information regarding Goserelin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Goserelin in the drug label.

Precautions with Alcohol

  • Alcohol-Goserelin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Goel S, Sharma R, Hamilton A, Beith J (2009). "LHRH agonists for adjuvant therapy of early breast cancer in premenopausal women". Cochrane Database Syst Rev (4): CD004562. doi:10.1002/14651858.CD004562.pub4. PMID 19821328.
  2. ↑ Hackshaw A, Baum M, Fornander T, Nordenskjold B, Nicolucci A, Monson K; et al. (2009). "Long-term effectiveness of adjuvant goserelin in premenopausal women with early breast cancer". J Natl Cancer Inst. 101 (5): 341–9. doi:10.1093/jnci/djn498. PMC 2650713. PMID 19244174.
  3. ↑ Vercellini P, Fedele L, Maggi R, Vendola N, Bocciolone L, Colombo A (1993). "Gonadotropin releasing hormone agonist for chronic anovulatory uterine bleeding and severe anemia". J Reprod Med. 38 (2): 127–9. PMID 8445603.
  4. ↑ Tapanainen JS, Hovatta O (1994). "Pituitary down-regulation with goserelin (Zoladex) for in vitro fertilisation". Br J Obstet Gynaecol. 101 Suppl 10: 27–8. PMID 8199101.
  5. ↑ de Brito VN, Latronico AC, Arnhold IJ, Lo LS, Domenice S, Albano MC; et al. (1999). "Treatment of gonadotropin dependent precocious puberty due to hypothalamic hamartoma with gonadotropin releasing hormone agonist depot". Arch Dis Child. 80 (3): 231–4. PMC 1717869. PMID 10325702.
  6. ↑ Empty citation (help)
  7. ↑ "http://www.ismp.org". External link in |title= (help)

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