Instruction for use: Decapeptyl depot

ATX Code L02AE04 Triptorelin

Active substance: Triptorelin

Pharmacological group

Hormones of the hypothalamus, pituitary gland, gonadotropins and their antagonists

Antineoplastic hormonal agents and hormone antagonists

Nosological classification (ICD-10)

C61 Malignant neoplasm of prostate

Adenocarcinoma of the prostate, Hormone-dependent prostate cancer, Hormone-Resistant Prostate Cancer, Malignant tumor of prostate, Malignant neoplasm of prostate, Carcinoma of the prostate, Locally-distributed non-metastatic prostate cancer, Locally advanced prostate cancer, Locally spread prostate cancer, Metastatic prostatic carcinoma, Metastatic prostate cancer, Metastatic hormone-resistant prostate cancer, Non-metastatic prostate cancer, Incompatible prostate cancer, Prostate Cancer, Prostate cancer, Common prostate cancer, Testosterone-Depot Prostate Cancer

D26 Other benign neoplasms of the uterus

Fibromyoma of the uterus, Myoma, Uterine fibroids, Fibromyoma, Myoma of the uterus, Fibrrios, Meigs syndrome, Tumors of the uterus

N80 Endometriosis

Endometrioid endometriosis

Z31.1 Artificial insemination

Fence of egg, ICSI (Intra Cytoplasmic Sperm Injection), Controlled ovarian stimulation, Controlled superovulation, Controlled superovulation in artificial insemination, Treatment of insemination, Fertilization artificial, Premature ovulation, The IVF program, The program of in vitro fertilization, Superovulation

Composition and form of release

Lyophilizate in the form of microcapsules for the preparation of solution for injection 172 mg

Triptorelin acetate 4.12 mg

(Corresponding to 3.75 mg of tryptorelin)

Auxiliary substances: polyglycolic acid and lactic acid (1: 1); Miglyol 840

Suspender 1 ml

Polysorbate 80; Dextran 70; sodium chloride; Phosphate buffer; Water for injection - up to 1 ml

In disposable syringes, complete with suspending agent (in disposable syringes 1 ml each), connecting element, needles for injections; In the box 1 set.

pharmachologic effect

Pharmacological action - antitumor, cytostatic, antigonadotropic.

It blocks the gonadotropic function of the pituitary gland and suppresses the liberation of LH and FSH, reduces the content of sexual hormones in the blood to the post-cystic level.

Clinical Pharmacology

Provides a gradual release of the active substance, which helps maintain a therapeutic concentration of triptorelin in the blood (200-500 ng / ml) for 30 days after a single injection.

Indications

IVF program (in vitro fertilization), endometriosis, uterine myoma, prostate cancer.

Contraindications

Hypersensitivity, pregnancy, breast-feeding.

pregnancy and lactation

Contraindicated. At the time of treatment should stop breastfeeding.

Side effects

They are associated with a decrease in the level of sex hormones in the blood: weakening of libido, mood lability, depression, tides, insignificant demineralization of bones (without increased fragility), local allergic reaction (hyperemia, itching at the injection site).

Dosing and Administration

P / to the anterior abdominal wall, IM, after preliminary mixing with the attached suspension, every 28 days. The injection site should be changed.

In men: symptomatic therapy of late stages of hormone-dependent prostate carcinoma; "Pharmacological orchiectomy" - as an alternative to surgical castration, as preparation for prostatectomy, postoperative treatment. The drug is administered for 3 months.

In women with endometriosis: in cases of infertility due to endometriosis, it seems reasonable to prescribe a course of therapy with Decapeptil Depot before the operation. Before the start of therapy, a laparoscopic and histological examination should be performed to confirm the diagnosis. With myoma of the uterus: the most appropriate combination of drugs with analogues of gonadotropin-releasing hormone with surgical treatment. The appointment of Decapeptil Depot leads to a significant decrease in the size of the myomatous uterus, which facilitates the technique of the operation. It is particularly advisable to conduct a course of drug therapy in young patients in order to maintain the reproductive function, when using laparoscopic technique can be performed organosaving operation. The duration of treatment for women with endometriosis or uterine myoma is no more than 6 months.

In vitro fertilization (IVF): appointed to stabilize the level of endogenous sex hormones, followed by the appointment of exogenous gonadotropins to stimulate the growth of follicles. The use of Decapeptal Depot helps to avoid premature spontaneous luteinization of stimulated follicles, which increases the effectiveness of the IVF program as a whole. In the schemes of stimulation of ovulation according to the IVF program is introduced once for 2-3 or on the 22nd day of the menstrual cycle.

If there is a violation of kidney function, there is no need to reduce the dose.

storage Conditions

In a dry place, at a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life

3 years. For microcapsules - 2 g, suspending agent - 3 g, for the prepared suspension - 3 min.

Do not use after the expiry date printed on the package.