Buserelin-long, lyophilizate 3.75mg

Pharmacotherapeutic group: antitumor drug, gonadotropin-releasing hormone (GnRH) analogue.

Indications

Active ingredient

Composition

Lyophilisate for preparation of a suspension for intramuscular injection of prolonged action,

containing 3.75 mg of buserelin.

How to take, the dosage

In hormone-dependent prostate cancer, Buserelin-Long is administered in a dose of 3.75 mg (1 injection) intramuscularly (i.m.) every 4 weeks. In treatment of endometriosis, endometrial hyperplastic processes, the drug is administered in a dose of 3.75 mg intramuscularly once every 4 weeks. The treatment should be started in the first five days of the menstrual cycle.

The duration of treatment is 4 to 6 months. In the treatment of uterine myoma, Buserelin-long is administered in a dose of 3.75 mg once every 4 weeks in m/m. Treatment should be started in the first five days of the menstrual cycle.

The duration of treatment is 3 months before surgery and 6 months in other cases; 2 In case of infertility treatment by the method of in vitro fertilization (IVF) Buserelin-long is administered in a dose of 3.75 mg (1 injection) once a month at the beginning of the folliculin phase (on the 2nd day of the menstrual cycle) or in the middle of the luteal phase (21-24 days) of the menstrual cycle prior to stimulation.

. After a blockade of pituitary function confirmed by a decrease in the concentration of estrogen in the blood serum by at least 50% of the initial level (usually determined 12-15 days after the injection of Buserelin-long), in the absence of ovarian cysts (according to ultrasound data) and with the endometrium thickness not exceeding 5 mm, the stimulation of super ovulation is started using gonadotropic hormones under ultrasound monitoring and control of the estradiol level in the blood serum.

Interaction

The simultaneous use of Buserelin-long with drugs containing sex hormones (for example, in the mode of ovulation induction) may contribute to the occurrence of ovarian hyperstimulation syndrome.

In concomitant use of Buserelin-long may decrease the effectiveness of hypoglycemic agents.

Special Instructions

In women Patients with any form of depression should be under close medical supervision during treatment with the drug. Ovulation induction should be performed under close medical supervision. At the initial stage of treatment with the drug, ovarian cysts may develop. 5 Before the start of treatment it is recommended to exclude pregnancy and stop taking hormonal contraceptives, but other (non-hormonal) contraceptive methods should be used during the first two months of using the drug.

After discontinuation of treatment, ovarian function is restored. The first menstruation resumes after 3 months.

In men In order to effectively prevent possible side effects in the first phase of the drug it is necessary to use antiandrogens two weeks before the first injection of Buserelin-long and for two weeks after the first injection.

Impact on the ability to drive a motor vehicle and other machines

Patient care should be taken when prescribing the drug to patients engaged in potentially hazardous activities requiring increased attention and mental and motor reaction speed.

Contraindications

Side effects

Allergic reactions: urticaria, skin hyperemia, rarely – angioedema.

CNS disorders: frequent mood swings, sleep disorders, depression, headache.

Muscular system disorders: with long-term use – bone demineralization which is a risk of osteoporosis development.

In women – headache, depression, sweating and libido changes, dry mucous membrane of the vagina, 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 of buserelin may cause exacerbation and progression of the underlying disease (associated with the stimulation of gonadotropin synthesis and, consequently, testosterone), gynecomastia, possible “hot flashes”, increased sweating and reduced potency (rarely requires cancellation 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 extremities.

At the beginning of treatment of patients with prostate cancer, a temporary increase in bone pain may occur; in this case, symptomatic therapy should be given. There have been individual cases of ureteral obstruction and spinal cord compression.

Others: in single cases (cause-effect relationship is not clearly defined) – pulmonary embolism, dyspeptic disorders.

Overdose

No cases of overdose have been reported at this time.