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ZOLADEX is a brand name for Goserelin, supplied as a implant. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ........................................................................... 3 CONTRAINDICATIONS ................................................................................................. 4 WARNINGS AND PRECAUTIONS ............................................................................... 5…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview The adverse effects seen with ZOLADEX (goserelin acetate) are due primarily to its pharmacologic action of sex hormone suppression and may give rise to certain expected effects that vary by sex. Adverse events that have been observed at an equal frequency in both males and females follow.
Very common adverse events (≥ 10%) consist of: decreased libido, hot flush, and hyperhidrosis. These are pharmacological effects which seldom require withdrawal of therapy. Common adverse reactions (≥ 1% to <10%) are: paraesthesia, abnormal blood pressure, rash, weight increase, and decrease in bone density.
1% to <1). 1). Cases of pituitary tumours and psychotic disorder have also been occasionally reported during post-marketed use. As with other agents in this class, cases of pituitary hemorrhage have occasionally been reported following initial administration of ZOLADEX during post- marketed use.
Abnormal blood pressure, manifest as hypotension or hypertension are commonly observed in patients administered ZOLADEX. The changes are usually transient, resolving either during continued therapy or after cessation of therapy with ZOLADEX.
Such changes have rarely required medical intervention including withdrawal of ZOLADEX treatment. In males, erectile dysfunction was reported very commonly (≥ 10%). Commonly reported adverse reactions (≥ 1% to <10%) consist of: impaired glucose tolerance, spinal cord compression, bone pain, gynecomastia, mood swings, depression, cardiac failure and injection site reaction.
1% to <1) are: arthralgia, ureteric obstruction and breast tenderness. Alopecia, particularly the loss of body hair, is an expected effect of lowered androgen levels and has been reported in males at an unknown frequency. Heart failure was commonly reported (5%) in patients receiving ZOLADEX for prostate cancer treatment in clinical studies.
Serious myocardial infarction and heart failure were observed in a pharmaco-epidemiology study of LHRH agonists and anti-androgens used in the treatment of prostate cancer. The risks for these cardiovascular adverse events appear to be increased when LHRH agonists are used in combination with anti-androgens.
In females, very common adverse reactions (≥ 10%) consist of: vulvovaginal dryness, breast enlargement, injection site reaction and acne (in most cases, acne was reported within one month after the start of ZOLADEX). Common adverse reactions (≥ 1% to <10%) are: mood alteration including depression, headache, arthralgia and tumour flare/tumor pain.
General Injection site injury and vascular injury including pain, hematoma, hemorrhage and hemorrhagic shock, requiring blood transfusions and surgical intervention, have been reported with ZOLADEX. Monitor patients for signs or symptoms of abdominal hemorrhage.
5) or in patients who are fully anticoagulated (INR >2) due to the risk of vascular injury and subsequent bleeding during administration (see DOSAGE AND ADMINISTRATION). Initially, ZOLADEX transiently increases serum testosterone in males and serum estradiol concentrations in females and other gonadal hormones.
Although not necessarily related, isolated cases of short-term worsening of signs and symptoms have been reported during the first four weeks of therapy. Worsening of the clinical condition may occasionally require discontinuation of therapy and/or surgical intervention.
Effect on ability to drive a vehicle and use machinery:
There is no evidence that ZOLADEX results in impairment of ability to drive or operate machinery.
Tumour Flare Reaction Patients with genitourinary tract symptoms:
During the first month of therapy with ZOLADEX, patients at risk of developing ureteric obstruction should be closely Serious Warnings and Precautions ZOLADEX (goserelin acetate) should be prescribed by a qualified physician experienced in the use of hormonal therapy in cancer and endometriosis.
ZOLADEX should be administered by a healthcare professional experienced in administering deep subcutaneous injections and under the supervision of a physician. The following are clinically significant adverse events: Tumour flare reaction (see Tumour Flare Reaction, below) Osteoporosis (see Musculoskeletal, below) Injection site injuries and vascular injuries (see General, below) COPYRIGHT 2017 TERSERA THERAPEUTICS LLC Page 6 of 45 monitored.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1% to <1%). 1) cases of ovarian cyst have been reported. At the beginning of ZOLADEX treatment, COPYRIGHT 2017 TERSERA THERAPEUTICS LLC Page 12 of 45 abdominal pain, bleeding, loss of necrotic tissue and abdominal distension have been reported in patients with uterine fibroid at an unknown frequency.
Loss of head hair (alopecia) has been reported commonly in females, including in younger patients treated for benign conditions. This is usually mild but occasionally can be severe. Following the administration of ZOLADEX, skin rashes have been reported as generally mild, often regressing without discontinuation of therapy.
Initially, prostate cancer patients may experience a temporary increase in bone pain, which can be managed symptomatically. The use of LHRH agonists may cause a reduction in bone mineral density (see WARNINGS AND PRECAUTIONS). 06%) and post-market use of ZOLADEX.
Clinical Trial Adverse Drug Reactions Prostate Cancer Patients Five hundred and eighteen (518) patients with prostate cancer who had not been previously treated and who entered into 14 open multicentre studies were monitored for adverse reactions to ZOLADEX.
The mean duration of treatment in these patients was 23 weeks. 9%). Also in these clinical studies, an initial rise in mean serum testosterone levels occurred during the first few days of treatment with ZOLADEX. In a few instances, patients experienced a worsening of signs and symptoms, during the first month after initiation of therapy (see WARNINGS AND PRECAUTIONS).
2%) have also been reported during the initial four weeks of ZOLADEX therapy. The relationship of these observations to ZOLADEX is unknown. The potential for exacerbation of signs and symptoms during the first few weeks of treatment is a concern particularly in male patients with impending neurologic compromise and in patients with severe obstructive uropathy (see WARNINGS AND PRECAUTIONS).
The most frequently reported (greater than 5%) adverse experiences during treatment with a LHRH-agonist in combination with flutamide are listed in the table below. For comparison, adverse experiences seen with a LHRH-agonist and placebo are also listed in the following table.
COPYRIGHT 2017 TERSERA THERAPEUTICS LLC Page 13 of 45 Table 1 Adverse events (greater than 5%) reported during treatment with a LHRH-agonist in combination with flutamide (n=294) Flutamide + LHRH-agonist % All (n=285) Placebo + LHRH-agonist % All Hot Flush 61 57 Loss of Libido 36 31 Impotence 33 29 Diarrhea 12 4 Nausea/Vomiting 11 10 […]
Ureteric obstruction may develop in male patients with a history of obstructive uropathy.
Patients with vertebral metastases:
During the first month of therapy with ZOLADEX, patients with vertebral metastases who are thought to be at particular risk of spinal cord compression should be closely monitored. If spinal cord compression or renal impairment due to ureteric obstruction are present, or develop, treatment of these complications should be instituted according to current local clinical practice.
Cardiovascular Androgen deprivation therapy may increase cardiovascular risk in men with prostate cancer on the basis of its adverse impact on demonstrated cardiovascular risk factors, by increasing body weight, reducing insulin sensitivity, and/or resulting in dyslipidemia.
Heart failure was commonly reported in patients receiving ZOLADEX for prostate cancer treatment in clinical studies (see ADVERSE REACTIONS/Adverse Drug Reaction Overview). Assessment of cardiovascular risk and management according to local clinical practice and guidelines should be considered.
Androgen deprivation therapy has the potential to prolong QT/QTc interval on ECG. g. g. g. flecainide, propafenone) antiarrhythmic medications (see DRUG INTERACTIONS). In patients at risk of developing QT/QTc interval prolongation, periodic monitoring of ECG and serum electrolyte levels should be considered (see Monitoring and Laboratory Tests).
In a randomized, active-controlled trial comparing goserelin plus a nonsteroidal antiandrogen to a LHRH antagonist in 177 patients with prostate cancer, periodic electrocardiograms were performed and prospectively evaluated. A mean QTcF increase of 18 msec from baseline was reported for the combination cohort.
A total of 8% patients experienced QTcF change ≥ 60 msec from baseline and 3 patients were withdrawn for a QT prolongation to > 500 msec in the combination cohort. Dependence/Tolerance There have been no reports of drug dependence following the use of ZOLADEX.
Endocrine and Metabolism Males Induced hypogonadism:
Suppression of pituitary gonadotropins and gonadal hormone production will occur with continued administration of ZOLADEX. These changes have been COPYRIGHT 2017 TERSERA THERAPEUTICS LLC Page 7 of 45 observed to reverse on discontinuation of therapy.
However, whether the clinical symptoms of induced hypogonadism will reverse in all patients has not yet been established.
Metabolic:
Impaired glucose tolerance has been observed in males using LHRH agonists. This may manifest as diabetes or loss of glycaemic control in those with pre-existing diabetes mellitus. Consideration should therefore be given to monitoring blood glucose.
Hematologic Anemia is a known physiologic consequence of testosterone suppression. Assessment of anemia risk and management according to local clinical practice and guidelines should be considered. Immune Antibody formation has not been observed during administration of ZOLADEX.
Local reactions, such as mild bruising have been related to the trauma of the injection itself and not to the copolymer material of the depot or to the prolonged presence of ZOLADEX at the site of depot injection.
Musculoskeletal Changes in bone density:
The use of LHRH agonists may cause a reduction in bone mineral density. In men and women, some bone loss can be anticipated as part of the natural aging process. Androgen deprivation therapy is associated with increased risks of osteoporosis and skeletal bone fractures.
The risk of skeletal fracture increases with the duration of androgen deprivation therapy. Assessment of osteoporosis risk […]