Zoladex 3.6 mg, syringe applicator implant

• Hypersensitivity to goserelin or other GnRH analogues
• Pregnancy and lactation
• Childhood

CAREFULLY

Males at particular risk of ureteral obstruction or spinal cord compression. In vitro fertilization in patients with polycystic ovary syndrome. Combined use with drugs that can prolong the QT interval or cause ventricular tachysystolic arrhythmia of the “pirouette” type. With the introduction of the drug, especially in patients with a low body mass index and / or receiving anticoagulants in a full dose.

The frequency of occurrence of undesirable effects is presented as follows:

Often (> 1/100, < 1/10); Uncommon (> 1/1000, < 1/100); Rare (> 1/10000, < 1/1000); Very rare (< 1/10000), including isolated reports.

Neoplasms:

Very rare: pituitary tumor.

Unspecified frequency: degeneration of fibromatous nodes in women with uterine fibroids.

From the immune system:

Uncommon: hypersensitivity reactions. Rare: anaphylactic reactions.

From the endocrine system:

Very rare: hemorrhage in the pituitary gland.

Metabolic disorders:

Often: impaired glucose tolerance. In men treated with GnRH agonists, a decrease in glucose tolerance was observed. A decrease in glucose tolerance was manifested by the development of diabetes mellitus or deterioration in the control of blood glucose concentration in patients with a history of diabetes mellitus.

Uncommon: hypercalcemia (in women).

From the nervous system and mental sphere:

Very often: a decrease in libido associated with the pharmacological action of the drug and, in rare cases, leading to its withdrawal.

Common: mood changes (in women), depression (in women), mood swings (in men), paresthesia, spinal cord compression (in men), headache (in women).

Very rare: psychotic disorder.

From the side of the cardiovascular system:

Very common: “hot flashes” associated with the pharmacological action of the drug and, in rare cases, leading to its withdrawal.

Often: myocardial infarction (in men); heart failure (in men), the risk of which increases with the simultaneous use of antiandrogenic drugs. Changes in blood pressure, manifested by a decrease in blood pressure or an increase in blood pressure. These changes are usually transient and resolve either during therapy with Zoladex® or after its termination. In rare cases, these changes required medical intervention, including the withdrawal of Zoladex®.

Unspecified frequency: prolongation of the QT interval (see sections “Interaction with other drugs and other forms of drug interaction” and “Special Instructions”).

From the skin and subcutaneous tissue:

Very often: excessive sweating associated with the pharmacological action of the drug and, in rare cases, leading to its cancellation; acne (in women), in most cases occurs within 1 month after the start of therapy with Zoladex®.

Often: alopecia (in women), as a rule, is slightly pronounced, including in young patients with benign neoplasms; the rash is mostly mild and often resolves with continued therapy.

Unspecified frequency: alopecia (in men), which manifested itself as hair loss throughout the body due to a decrease in the concentration of androgens.

From the musculoskeletal system:

Often: arthralgia (in women), bone pain (in men). At the beginning of treatment, patients with prostate cancer can often experience a temporary increase in bone pain, which is treated symptomatically.

Uncommon: arthralgia (in men).

From the genitourinary system:

Very common: erectile dysfunction (in men), dryness of the vaginal mucosa and enlargement of the mammary glands (in women).

Often: gynecomastia (in men).

Infrequently: soreness of the mammary glands (in men), obstruction of the ureters (in men).

Rare: ovarian cyst (in women), ovarian hyperstimulation syndrome (in women, when used together with gonadotropins).

Unspecified frequency: vaginal bleeding (in women).

Others:

Very often: reaction at the injection site (in women).

Often: reaction at the injection site (in men); temporary increase in symptoms of the disease in patients with breast cancer at the beginning of therapy.

Laboratory research:

Often: decrease in bone mineral density, increase in body weight.

Post-marketing application

Against the background of the use of the drug Zoladex®, isolated cases of changes in blood test parameters, abnormal liver function, pulmonary embolism and interstitial pneumonia were noted.

Care should be taken when administering Zoladex into the anterior abdominal wall due to the proximity of the inferior epigastric artery and its branches.

Zoladex should be administered with extreme caution to patients with a low body mass index and/or receiving full dose anticoagulants (see section

“Special instructions”).

Detailed instructions for administering Zoladex® are given on the annotation flag movably attached to the envelope.

The drug Zoladex® 3.6 mg Adults

Zoladex® 3.6 mg is injected subcutaneously into the anterior abdominal wall every 28 days.

• with malignant neoplasms for a long time
• with benign gynecological diseases no more than 6 months
• to thin the endometrium, two injections are given 4 weeks apart, with uterine ablation recommended in the first two weeks after the 2nd dose.

in vitro fertilization

The drug Zoladex® 3.6 mg is used to desensitize the pituitary gland. Desensitization is determined by the concentration of estradiol in the blood serum. As a rule, the required level of estradiol, which corresponds to that in the early follicular phase of the cycle (approximately 150 pmol / l), is reached between 7 and 21 days. When desensitization occurs, stimulation of superovulation (controlled ovarian stimulation) with gonadotropin begins.

Induced pituitary desensitization with a depot GnRH agonist may be more persistent, which may lead to an increased need for gonadotropin. At the appropriate stage of follicle development, the administration of gonadotropin is stopped and then human chorionic gonadotropin is administered to induce ovulation. Treatment supervision, oocyte retrieval and fertilization procedures are carried out in accordance with the established practice of this medical institution.

• When using the drug Zoladex®, reactions at the injection site were reported, including pain, hematoma, bleeding and vascular damage. In these cases, it is necessary to observe the patient in order to identify possible signs or symptoms of intra-abdominal bleeding. In very rare cases, an error in the administration of the drug led to damage to the vessel and hemorrhagic shock, requiring blood transfusion and surgical intervention. Zoladex® should be administered with extreme caution to patients with a low body mass index and/or receiving full dose anticoagulants.
• Zoladex should be used with caution in males at particular risk of ureteral obstruction or spinal cord compression. These patients should be carefully monitored during the first month of therapy. In the event that compression of the spinal cord or renal failure due to ureteral obstruction occurs or develops, standard treatment for these complications should be prescribed.

• In women, Zoladex® 10.8 mg is indicated only for the treatment of endometriosis and uterine fibroids. For women requiring goserelin treatment for other indications, Zoladex® 3.6 mg is used.
• When using the drug Zoladex® in women, non-hormonal methods of contraception should be used until the restoration of menstruation.
• As with other GnRH analogues, rare cases of ovarian hyperstimulation syndrome (OHSS) have been reported with Zoladex 3.6 mg in combination with gonadotropin. It is assumed that the desensitization caused by the use of the drug Zoladex® 3.6 mg may lead in some cases to an increase in the required dose of gonadotropin. Cycle stimulation should be carefully monitored to identify patients at risk of developing OHSS, since the severity and frequency of the syndrome may depend on the dose regimen of gonadotropin. The introduction of human chorionic gonadotropin should be discontinued if required.
• The use of GnRH agonists in women may cause a decrease in bone mineral density. After the end of treatment, most women recover bone mineral density. In patients treated with Zoladex® 3.6 mg for the treatment of endometriosis, the addition of hormone replacement therapy (estrogen and progestogen daily) reduced bone mineral density loss and vasomotor symptoms. Currently, there is no experience with the use of hormone replacement therapy in the treatment of Zoladex® 10.8 mg.
• The resumption of menstruation after the end of treatment with Zoladex may be delayed in some patients. In rare cases, some women may experience menopause during treatment with GnRH analogues without resuming menstruation after the end of therapy.
• The use of the drug Zoladex® can lead to an increase in cervical resistance, care must be taken when dilating the cervix.

• There are no data on the efficacy and safety of therapy with Zoladex® for benign gynecological diseases lasting more than 6 months.
• Androgen deprivation may prolong the QT interval, although a causal relationship with Zoladex has not been established. In patients with a history of prolongation of the QT interval or risk factors for its development, as well as in patients taking concomitant drugs that can prolong the QT interval (see the section “Interaction with other medicinal products and other types of drug interactions”), before starting the use of the drug Zoladex ® should evaluate the ratio of expected benefits and potential risks, including the possibility of developing ventricular tachysystolic arrhythmia of the “pirouette” type.
• The drug Zoladex® 3.6 mg should be used in in vitro fertilization only under the supervision of a specialist with experience in this field.
• It is recommended to use Zoladex® 3.6 mg with caution in in vitro fertilization in patients with polycystic ovary syndrome, since stimulation of a large number of follicles is possible.
• Preliminary data indicate that the use of a bisphosphonate in combination with GnRH agonists in men reduces the loss of bone mineral density. In connection with the possibility of developing a decrease in glucose tolerance while taking GnRH agonists in men, it is recommended to periodically monitor blood glucose levels.

EFFECT ON ABILITY TO DRIVE AND OTHER MECHANISMS

There is no evidence that the drug Zoladex® leads to a deterioration in these activities.