Buserelin

Brand Nativa

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Clinical Pharmacology

Antiandrogenic, antigonadropic, antiestrogenic.

Pharmacodynamics

Buserelin is a synthetic analogue of the endogenous gonadotropin-releasing hormone (GnRH). Competitively binds to receptors of the cells of the anterior pituitary gland and causes a short-term increase in the level of sex hormones in the blood plasma. Further use of therapeutic doses of the drug (an average of 12-14 days) leads to a complete blockade of the pituitary gonadotropic function and reduces the secretion of luteinizing (LH) and follicle-stimulating hormone (FSH). As a result, suppression of the synthesis of sex hormones in the ovary and a decrease in the concentration of estradiol (E2) in the blood plasma to post-menopausal values are observed.

Pharmacokinetics

With intranasal administration, buserelin is completely absorbed through the nasal mucosa. The half-life is about 3 hours. In small quantities, the drug is excreted in breast milk.

Indications

Hormone-dependent pathology of the reproductive system, caused by absolute or relative hyperestrogenism: endometriosis (pre- and postoperative periods); uterine fibroids; endometrial hyperplastic processes; infertility treatment (with in vitro fertilization program (IVF)).

Composition

Spray nasal dosed as a colorless transparent liquid without foreign inclusions.

	1 dose	1 fl.
buserelin acetate	150 mcg	2.1 mg

Excipients: benzalkonium chloride - 0.1 mg, water d / and - up to 1 ml.

Buserelin is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Buserelin	Nativa	Russia	spray
Buserelin long	Nativa	Russia	lyophilisate
Buserelin Depot	Farm Synthesis	Russia	lyophilisate

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Dosage and administration

With hormone-dependent prostate cancer, Buserelin-Long is administered at a dose of 3.75 mg (1 injection) intramuscularly (IM) every 4 weeks. In the treatment of endometriosis, endometrial hyperplastic processes, the drug is administered at a dose of 3.75 mg / m once every 4 weeks. Treatment should be started in the first five days of the menstrual cycle. Duration of treatment is 4-6 months. In the treatment of uterine fibroids, Buserelin-Long is administered at a dose of 3.75 mg IM once every 4 weeks. Treatment should be started in the first five days of the menstrual cycle. Duration of treatment - 3 months before surgery, in other cases - 6 months; 2 In the treatment of infertility by in vitro fertilization (IVF), Buserelin-Long is administered at a dose of 3.75 mg (1 injection) intramuscularly at the beginning of the follicular (on the 2nd day of the menstrual cycle) or in the middle of the luteal phase (21-24 days ) menstrual cycle prior to stimulation. After blockade of the pituitary function, confirmed by a decrease in the concentration of estrogens in the blood serum by at least 50% of the initial level (usually determined 12-15 days after Buserelin-Long injection), in the absence of ovarian cysts (according to ultrasound), the thickness of the endometrium is not more than 5 mm, stimulation of superovulation with gonadotropic hormones begins under ultrasound monitoring and control of the level of estradiol in the blood serum.

Adverse effects

Allergic reactions: urticaria, flushing of the skin, rarely - angioedema. From the side of the central nervous system: frequent mood swings, sleep disturbances, depression, headache. On the part of the musculoskeletal system: with prolonged use - demineralization of bones, which is a risk of osteoporosis. In women, headache, depression, sweating and changes in libido, dryness of the vaginal mucosa, pain in the lower abdomen, rarely menstrual bleeding (during the first weeks of treatment). In men, in the treatment of prostate cancer - during the first 2 - 3 weeks after the first injection, buserelin can cause exacerbation and progression of the underlying disease (associated with stimulation of the synthesis of gonadotropins and, accordingly, testosterone), gynecomastia, "hot flashes", increased sweating and decreased potency (rarely requires discontinuation of therapy), transient increase in the concentration of androgens in the blood, urinary retention, "renal edema" - swelling of the face, eyelids, legs; muscle weakness in the lower limbs. At the beginning of treatment, patients with prostate cancer may experience a temporary increase in bone pain; in this case, symptomatic therapy should be carried out. There were isolated cases of ureteral obstruction and spinal cord compression. Others: in isolated cases (cause-and-effect relationship is not clearly established) - pulmonary embolism, dyspeptic disorders.