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Indications & Uses
Pharmacology
Goserelin is a synthetic decapeptide analogue of GnRH. When it's given in its biodegradable formulation, it acts as an inhibitor of pituitary gonadotropin secretion. In animal and in vitro studies, goserelin caused regression or inhibited the growth of two hormonally sensitive tumours: the dimethylbenzanthracene (DMBA)-induced rat mammary tumour and the Dunning R3327 prostate tumour.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Goserelin 3.6 mg is given under the skin (subcutaneously) every 28 days, into the front wall of the abdomen below the navel line. A doctor should supervise it, and an aseptic technique must be used. A delay of a few days is allowed, but every effort should be made to keep to the 28-day schedule.
Stage B2-C Prostatic Carcinoma
When Goserelin is given together with radiotherapy and flutamide for patients with Stage T2b-T4 (Stage B2-C) prostatic carcinoma, treatment should start 8 weeks before radiotherapy begins and carry on during the radiation therapy. One option is a Goserelin 3.6 mg depot 8 weeks before radiotherapy, followed 28 days later by the Goserelin 10.8 mg depot. The other option is four injections of the 3.6 mg depot at 28-day intervals, with two depots before radiotherapy and two during it.
Prostatic Carcinoma
For advanced prostate cancer, Goserelin is meant for long-term use unless it is clinically inappropriate.
Endometriosis
For endometriosis, the recommended duration of treatment is 6 months. There are no clinical data on treating benign gynecological conditions with Goserelin for longer than 6 months. Retreatment cannot be recommended for endometriosis, because no safety data for retreatment are available. If symptoms come back after a course of therapy and further Goserelin treatment is being considered, bone mineral density should be monitored.
Clinical studies suggest that adding Hormone Replacement Therapy (estrogens and/or progestins) to Goserelin reduces the bone mineral loss that happens with Goserelin alone. It does this without reducing how well Goserelin relieves the symptoms of endometriosis. Hormone Replacement Therapy may also reduce vasomotor symptoms and vaginal dryness linked to hypoestrogenism. The best drugs, dose and duration of this treatment have not been established.
Endometrial Thinning
When Goserelin is used to thin the endometrium before endometrial ablation, the recommended dose is one or two depots, given four weeks apart. If one depot is given, surgery should be done at four weeks. If two depots are given, surgery should be done within two to four weeks after the second depot.
Breast Cancer
For advanced breast cancer, Goserelin is meant for long-term use unless it is clinically inappropriate.
Renal or Hepatic Impairment
No dose adjustment is needed for patients with renal or hepatic impairment.
Goserelin 10.8 mg is given under the skin (subcutaneously) every 12 weeks, into the front wall of the abdomen below the navel line. A doctor should supervise it, and an aseptic technique must be used. A delay of a few days is allowed, but every effort should be made to keep to the 12-week schedule.
Stage B2-C Prostatic Carcinoma
When Goserelin is given together with radiotherapy and flutamide for patients with Stage T2b-T4 (Stage B2-C) prostatic carcinoma, treatment should start 8 weeks before radiotherapy begins and carry on during the radiation therapy. The regimen is one Goserelin 3.6 mg depot, followed 28 days later by one Goserelin 10.8 mg depot.
Prostatic Carcinoma
For advanced prostate cancer, Goserelin is meant for long-term use unless it is clinically inappropriate.
Renal or Hepatic Impairment
No dose adjustment is needed for patients with renal or hepatic impairment.
Women
Goserelin 10.8 mg implant is not indicated in women, because the data are not enough to support reliable suppression of serum estradiol. Female patients who need goserelin should be treated according to the prescribing information for the Goserelin 3.6 mg implant.
Side Effects
In men, the most common side effects of Goserelin, seen in more than 10%, are hot flashes, sexual dysfunction, decreased erections and lower urinary tract symptoms. Women treated for breast cancer, dysfunctional uterine bleeding or endometriosis had a similar pattern. In them, these effects were seen in more than 20%: hot flushes, headache, sweating, acne, emotional lability, depression, decreased libido, vaginitis, breast atrophy, seborrhea and peripheral edema. Tumor flare can occur when Goserelin is started, in both men and women who are being treated for cancer.
Cautions & Contraindications
Warnings & Precautions
Women of Childbearing Potential and Pregnancy: When Goserelin is used for benign gynecological conditions, pregnancy must be excluded. Women should avoid pregnancy. Tumor Flare Phenomenon: Tumor symptoms may get worse for a short time during the first few weeks of treatment with Goserelin. This may include ureteral obstruction and spinal cord compression. Monitor patients at risk for complications of tumor flare. Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. Cardiovascular Diseases: An increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in men using GnRH analogs. Monitor for cardiovascular disease and manage according to current clinical practice. Hypercalcemia: Hypercalcemia has been reported in patients with bone metastases treated with Goserelin. Monitor and manage appropriately. Hypersensitivity: Systemic hypersensitivity has been reported in patients receiving Goserelin/ Goserelin implants. Cervical Resistance: Cervical resistance may increase. Be careful when dilating the cervix for endometrial ablation. Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT interval. Consider the risks and benefits. Injection Site Injury: Injection site injury and vascular injury have been reported during administration of Goserelin. Depression: Depression may occur or worsen in women receiving GnRH agonists. Monitor and manage appropriately.
Contraindications
Hypersensitivity Anaphylactic reactions to Goserelin have been reported in the medical literature. ZOLADEX must not be given to patients who are known to be hypersensitive to GnRH, to GnRH agonist analogues, or to any of the components in Goserelin. Pregnancy Goserelin must not be used during pregnancy, with one exception: when it is given as palliative treatment of advanced breast cancer. Goserelin can cause fetal harm when given to a pregnant woman. If the drug is used during pregnancy, the patient should be told about the possible hazard to the fetus. The risk of pregnancy loss is higher because of the hormone changes that are expected with Goserelin treatment.
Pregnancy & Breastfeeding
Goserelin should not be used during pregnancy, with one exception: palliative treatment of advanced breast cancer. There are no adequate and well-controlled studies of goserelin in pregnant women. But based on how it works in humans, and on the increased pregnancy loss seen in animal studies, goserelin can harm the baby when given to a pregnant woman. If it is used during pregnancy, the patient should be told about the possible danger to the baby. The hormone changes expected with goserelin treatment also raise the risk of pregnancy loss.
In rats and rabbits, goserelin crosses the placenta after subcutaneous administration. When pregnant rats and rabbits were given goserelin during organogenesis, there was more preimplantation loss and more resorptions. Pregnant rats that received goserelin throughout gestation and lactation had more umbilical hernia in their offspring, and the increase was related to the dose. Other reproduction studies in rats showed that goserelin lowered the survival of fetuses and pups. The animal data available were not enough to calculate human dose or exposure multiples.
It is not known whether goserelin passes into human milk. It does pass into the milk of lactating rats. Many drugs are excreted in human milk, and goserelin could cause serious adverse reactions in nursing infants. So a decision should be made either to stop nursing or to stop the drug, taking into account how important the drug is to the mother.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Store Goserelin away from light and moisture. Keep it out of the reach of children.
Common questions about Golexin 10.8 mg
What is Golexin 10.8 mg SC Injection?
Golexin 10.8 mg SC Injection is a medicine that contains Goserelin. It is made by CuRx.
What is Golexin used for?
Golexin is used for: Pain, Cancer.
What are the side effects of Golexin?
In men, the most common side effects of Goserelin, seen in more than 10%, are hot flashes, sexual dysfunction, decreased erections and lower urinary tract symptoms. Women treated for breast cancer, dysfunctional uterine bleeding or endometriosis had a similar pattern.
Can I take Golexin during pregnancy or while breastfeeding?
Goserelin should not be used during pregnancy, with one exception: palliative treatment of advanced breast cancer. There are no adequate and well-controlled studies of goserelin in pregnant women. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Golexin?
Store Goserelin away from light and moisture. Keep it out of the reach of children.
Do I need a prescription for Golexin?
Golexin is a prescription (Rx) medicine. Take it as your doctor advises.