诺雷得(Zoladex Depo)

【Function and Indications】
Indications:
Prostate cancer: This product is suitable for prostate cancer that can be treated with hormones.
Breast cancer: It is suitable for breast cancer in premenopausal and perimenopausal women who can be treated with hormones.
Endometriosis: Symptom relief includes pain relief and reduction in the size and number of endometrial lesions.

【Model and Specifications】
3.6mg/vial (in terms of goserelin).

【Usage and Dosage】
Adults: Subcutaneously inject this product 3.6mg vial in the anterior abdominal wall once every 28 days. No dose adjustment is required for patients with renal or hepatic insufficiency and the elderly.
The treatment of endometriosis should not exceed six months, because there is no clinical data on long-term treatment. Considering the problem of bone mineral loss, repeated courses should be avoided. In patients with endometriosis treated with this product. Adding hormone replacement therapy (daily administration of estrogen and progesterone preparations) can reduce bone mineral loss and vasomotor symptoms.
Use the medicine as directed by a physician. Make sure the packaging is not damaged when using it. Use immediately after opening the package. Discard the used syringe into a permitted sharps collection device.
For the correct use of this product, please refer to the medication instructions on the package.

[Clinical Research]
Mode of Action: This product (D-Ser(But)6AZGLY10LHRH) is a synthetic analogue of natural gonadotropin-releasing hormone. Long-term use of this product inhibits the secretion of pituitary gonadotropin, thereby causing a decrease in male serum testosterone and female serum estradiol. This effect is reversible after discontinuation of the drug. In the initial use of this product, like other LHRH agonists, it can temporarily increase the concentration of male serum testosterone and female serum estradiol.
About 21 days after the first injection of this drug, the testosterone concentration of male patients will reach the castration level, and this concentration will be maintained in every 28 days of treatment thereafter, which can cause the prostate tumor to regress and the symptoms to improve in most patients.
The serum estradiol concentration of female patients is suppressed about 21 days after the first dose, and is maintained at the postmenopausal level in every 28 days of treatment thereafter. This inhibition is associated with efficacy in hormone-dependent advanced breast cancer, uterine fibroids, and endometriosis, and inhibition of intrauterine follicular maturation. This can cause endometrial thinning and amenorrhea in most patients.
Menopause may occur during treatment with LHRH analogs, and a very small number of women do not resume menstruation after stopping treatment.
In anemic women with uterine fibroids, the combination of this product with iron can reduce the occurrence of amenorrhea and increase hemoglobin concentrations and related hematological parameters, which is 1g/dl higher than the average hemoglobin concentration obtained with iron treatment alone.
An increased incidence of benign pituitary tumors has been observed in male mice after long-term repeated injections of this product, a finding similar to that obtained after castration of male mice. No relevance to human use has been found.
In mice, long-term repeated use of several times the human dose produced changes in tissue structure in the digestive tract, manifested as benign hyperplasia and insulin cell proliferation in the pyloric region of the stomach (also reported as spontaneous lesions). The clinical relevance of these phenomena is unclear.

【Precautions】
This product should not be used in children because its safety and effectiveness in children have not been established.
Male:
This product should be used with caution in male patients who are at risk of developing ureteral obstruction or spinal cord compression, and patients should be closely monitored during the first month of treatment. Anti-androgen preparations may be considered when starting LHRH analog therapy (such as daily use 3 days before and 3 weeks after the start of treatment with this product), as it has been reported that this can prevent the consequences of increased serum testosterone. If spinal cord compression or renal damage or deterioration caused by ureteral obstruction exists or occurs, appropriate treatment should be given.
The use of LHRH agonists in male patients may cause a decrease in bone density. In male patients, preliminary data show that the combined use of bisphosphonates and LHRH agonists can improve the decrease in bone density.
Impaired glucose tolerance may be observed in male patients receiving LHRH agonists. In patients with pre-existing diabetes, this may manifest as poor control of diabetes or hyperglycemia. Therefore, blood sugar should be monitored.
Women:
Women’s use of LHRH agonists may cause a decrease in bone density. After 2 years of treatment for early breast cancer, the average bone density at the femoral neck and lumbar spine decreased by 6.2% and 11.5%, respectively. After 1 year of stopping treatment, it can be partially restored to only 3.4% and 6.4% lower than the baseline value (this result is based on limited data).
In patients with endometriosis treated with this product, the addition of hormone replacement therapy (daily administration of estrogen and progesterone preparations) can reduce bone mineral loss and vasomotor symptoms.
Caution should be taken when using this product for women with known abnormal bone metabolism.
The use of this product may cause increased cervical resistance, making it more difficult to dilate the cervix.
There is currently no clinical data on the use of this product for the treatment of benign gynecological diseases for more than six months.
Effects on the ability to drive or operate machinery: There is no evidence that this product has an effect on the above abilities.

[Adverse Reactions and Contraindications]
The frequency of the following categories of adverse drug reactions (ADRs) is calculated based on data from clinical studies and post-marketing reports of Norad.
Adverse drug reactions of Noradrena 3.6mg in different frequencies and system organ classes (SOC)

a These reactions are pharmacological effects and rarely require interruption of treatment

b Impaired glucose tolerance may be observed in male patients receiving LHRH agonists. For patients with diabetes, this may manifest as poorly controlled diabetes or hyperglycemia

c Abnormal blood pressure, manifested as hypotension or hypertension, is occasionally observed in patients treated with this product. These reactions are usually transient and recover during or after continued treatment, and rarely require medical intervention, including discontinuation of treatment.

d Most are mild and disappear without interruption of treatment.

e In the early stage of administration, patients with prostate cancer may have a temporary increase in bone pain, which should be treated symptomatically.

f This reaction was observed in a pharmacoepidemiological study of LHRH agonists for the treatment of prostate cancer. When used in combination with anti-androgenic therapy, the risk may be increased.

g Patients with early breast cancer treatment will have aggravated symptoms and should be treated symptomatically.

h Patients with breast cancer with bone metastases develop hypercalcemia in the early stage of treatment.
I Ovarian cysts have been reported after LHRH therapy. Most cysts are asymptomatic, non-functional, of varying sizes and reversible.
In the early stages of treatment with this product, some women experience vaginal bleeding of varying duration and severity, usually in the first month of treatment. This bleeding may be estrogen withdrawal bleeding and should stop on its own.
A very small number of women enter menopause during treatment with LHRH analogs and do not resume menstruation after stopping treatment. This may be simply a physiological change.

[Contraindications]
This product is contraindicated in patients with known allergies to the active ingredient of this product or other LHRH analogs, and any other excipients of this product. It is contraindicated in pregnant and lactating women.

[Pregnant women use]
This product is contraindicated in pregnant and lactating women.

[Children use]
This product is not recommended for children.

【Drug Interactions】
This product has almost complete bioavailability. It is taken once every four weeks and maintains effective blood drug concentration without tissue accumulation. This product has weak protein binding ability and serum elimination half-life is 2-4 hours under normal renal function. Its half-life will increase in patients with renal insufficiency. This change has little effect on monthly treatment, so there is no need to adjust the dose. There is no significant change in its pharmacokinetics in patients with hepatic insufficiency.

【Storage】
Store below 25℃.

【Manufacturer】
AstraZeneca UK Limited