Generic Medicine Info
Undiagnosed vaginal bleeding. Pregnancy and lactation.
Special Precautions
Patient with congenital long QT syndrome, heart failure, frequent electrolyte abnormalities; hypertension, depression, predisposition to osteoporosis (e.g. family history of osteoporosis, chronic alcohol abusers, smokers, undergoing long-term treatment with anticonvulsants or corticosteroids), polycystic ovarian syndrome; diabetes mellitus. Patient receiving anticoagulant drugs. Obese and underweight (low BMI) patients. Male patient at risk of developing spinal cord compression or ureteric obstruction. Use of the 10.8 mg implant is not indicated for female patients. Monitoring Parameters Assess pregnancy status before use. Monitor blood glucose and HbA1c periodically; bone mineral density, cholesterol/lipids. Consider monitoring of ECG and electrolytes periodically. Monitor for tumour flare, weakness, paraesthesia, urinary tract obstruction, and spinal cord compression in the 1st few weeks of therapy (particularly in prostate cancer patients). Assess for signs and symptoms of abdominal haemorrhage after administration.
Adverse Reactions
Significant: Inj site injury including vascular injury, pain, haematoma, haemorrhage, haemorrhagic shock; tumour flare (during initial treatment), hypercalcaemia, hyperglycaemia, loss of glycaemic control, increased cervical resistance, decreased bone mineral density, hypersensitivity reactions, antibody formation; spinal cord compression, ureteric obstruction; MI, cardiac failure, QT/QTc interval prolongation, stroke; depression, vaginal bleeding. Rarely, pituitary apoplexy. Gastrointestinal disorders: Nausea, abdominal pain. General disorders and administration site conditions: Asthenia, voice alteration (in females). Hepatobiliary disorders: Hepatic dysfunction. Investigations: Abnormal blood pressure, changes in blood count; increased weight, increased serum cholesterol. Metabolism and nutrition disorders: Peripheral oedema. Musculoskeletal and connective tissue disorders: Bone pain, arthralgia, myalgia. Nervous system disorders: Headache, paraesthesia. Psychiatric disorders: Mood changes, insomnia, nervousness. Rarely, psychotic disorder. Reproductive system and breast disorders: Erectile dysfunction, vulvovaginal dryness, breast enlargement, gynaecomastia, breast tenderness, decreased libido, vaginitis, breast atrophy. Respiratory, thoracic and mediastinal disorders: Pulmonary embolism, interstitial pneumonia. Skin and subcutaneous tissue disorders: Acne, hyperhidrosis, rash, alopecia; dry skin, change of body hair (in females). Vascular disorders: Hot flush.
ROUTE(S) : SC: D In patients w/ advanced breast cancer
ROUTE(S) : SC: X In patients w/ endometriosis & endometrial thinning
Drug Interactions
May increase the risk of QT interval prolongation with drugs known to prolong QT interval or induce torsade de pointes (e.g. class Ia [e.g. quinidine, disopyramide] or class III [e.g. amiodarone, sotalol, dofetilide] antiarrhythmic agents; moxifloxacin, methadone, antipsychotics). Concomitant use with gonadotropins resulted in ovarian hyperstimulation syndrome.
CIMS Class
Hormonal Chemotherapy / Trophic Hormones & Related Synthetic Drugs
ATC Classification
L02AE03 - goserelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.
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