Pregnyl

Pregnyl – drug with gonadotropic action.

Form of release and structure

Pregnyl is produced in the form of lyophilisate for preparation of solution for intramuscular and hypodermic introduction: white color; solvent – transparent, colourless (in colourless glass ampoules on 2 ml, on 1 or 3 ampoules in blister strip packagings or pallets, on 1 packaging or the pallet in a cardboard pack complete with solvent (3 ampoules)).

Is a part of 1 ampoule:

• Active agent: a chorionic human gonadotrophin (HGch) – 500, 1500 or 5000 IU (international units);
• Auxiliary components: Mannitolum, karmelloza of sodium, hydrosodium phosphate, dihydrosodium phosphate.

Solvent: 0,9% sodium chloride solution – 1 ml.

Indications to use

For women:

• The infertility caused by disturbance of maturing of follicles or anovulation (for induction of an ovulation);
• Maintenance of a phase of a yellow body;
• Programs of controlled hyper stimulation of ovaries (by preparation of follicles for a puncture).

For boys and men:

• Hypogonadotropic hypogonadism;
• The cryptorchism which is not connected with anatomic obstruction;
• Puberty delay which is caused by insufficiency of gonadotropic function of a hypophysis.

Contraindications

Absolute:

• Premature puberty (at boys);
• The established or suspected tumors dependent on sex hormones (women have ovary cancer, cancer of a uterus and a breast cancer; men have a prostate cancer, cancer of chest gland);
• The fibrous tumor of a uterus incompatible with pregnancy (at women);
• The wrong formation of generative organs incompatible with pregnancy (at women);
• Pregnancy and period of a lactation;
• Hypersensitivity to drug components.

Relative (Pregnyl is appointed with care):

• Women: risk factors of thrombosis – the instruction in the personal or family anamnesis, a thrombophilia, heavy obesity (with a body weight index> 30 ^kg/sq.m) that is connected with the increased risk of development of an arterial or venous thromboembolism in time or after treatment by gonadotrophins. Before purpose of drug such women need to estimate advantages of therapy of extracorporal fertilization (EKO) and possible risks. It is necessary to consider that pregnancy in itself is also followed by the increased risk of developing of thrombosis;
• Boys and men: arterial hypertension, latent or explicit heart failure, renal failures, migraine, epilepsy, including instructions in the anamnesis on these states (such patients need strict medical control as the exacerbation of a disease or a recurrence in certain cases can be observed at the raised products of androgens);
• Boys: prepubertatny age as HGch can lead to premature closing of an epiphysis or premature puberty. At purpose of Pregnyl it is necessary to exercise control of a skeletogeny regularly.

Route of administration and dosage

Pregnyl solution after recovery (addition to solvent lyophilisate) should be entered slowly subcutaneously or intramusculary.

The recommended dosing mode for women:

• The infertility caused by disturbance of maturing of follicles or anovulation (for induction of an ovulation), preparation of follicles for a puncture in programs of controlled hyper stimulation of ovaries for completion of treatment by drugs of follicle-stimulating hormone (FSG): 1 injection in a dose of 5000-10 000 ME;
• Maintenance of a phase of a yellow body: in addition 2-3 repeated injections for 9 days after an ovulation or transfer of an embryo (for example, for the 3, 6 and 9 day after induction of an ovulation) on 1000-3000 ME.

The recommended dosing mode for boys and men:

• Hypogonadotropic hypogonadism: 2-3 times a week on 1000-2000 ME. At infertility Pregnyl can be combined with additional drug with the content of follitropin (FSG) 2-3 times a week. Duration of a therapeutic course at which it is possible to expect any improvement of a spermatogenesis – not less than 3 months. For Pregnyl use replacement therapy by testosterone needs to be suspended. After achievement of improvement of a spermatogenesis, in certain cases for the purpose of its maintenance of rather isolated use of HGch;
• The puberty delay connected with insufficiency of gonadotropic function of a hypophysis: 2-3 times a week on 1500 ME. Duration of a therapeutic course – is not less than 6 months;
• The cryptorchism which is not connected with anatomic obstruction: up to 2 years – on 250 ME, up to 6 years – on 500-1000 ME, of 6 years – on 1500 ME; frequency rate of introduction – 2 times a week. Duration of a therapeutic course – 6 weeks. If necessary repetition of a course is possible.
• Immune system: in rare instances – fever or generalized rash;
• The general disturbances and reactions in an injection site: pain, bruise, reddening, itch, swelling; in certain cases – allergic reactions, as a rule, in the form of rash and/or pain in the place of an injection.

Side effects

At women:

• Alimentary system: the syndrome of hyper stimulation of ovaries (SHSO) in a moderate current in the form of an abdominal pain and gastrointestinal symptoms (nausea and diarrhea), SGYa in a heavy current in the form of ascites;
• Cardiovascular system: in rare instances – the thromboembolisms connected with therapy FSG/HGch which are, as a rule, associated with SGYa in a heavy current;
• Reproductive system and mammary glands: undesirable hyper stimulation of ovaries, SGYa in moderated (in the form of morbidity of mammary glands, small or average increase in ovaries and cysts of ovaries) or heavy (in the form of cysts of ovaries, big, inclined to a gap) a current;
• Others (respiratory, mediastinal and chest disturbances): SGYa complications in a heavy current in the form of a hydrothorax.

By results of a research development of increase in body weight was also noted (SGYa in a heavy current).

At boys and men:

• Metabolism and food: in some cases at administration of Pregnyl in high doses – a delay of sodium and water (presumably – because of excess formation of androgens);
• Reproductive system and chest glands: gynecomastia.

Special instructions

During use of Pregnyl it is necessary to consider:

• At women who used auxiliary reproductive technologies the frequency of loss of pregnancy is higher, than in usual population;
• Frequency of emergence of inborn malformations after use of the auxiliary reproductive technologies (ART) can be slightly higher, than as a result of spontaneous conceptions (presumably – because of features of parents (maternal age, the characteristic of sperm));
• There is an increased risk of polycarpous pregnancy in cases if pregnancy arose after induction of an ovulation Pregnyl;
• Against the background of disturbances of uterine tubes the frequency of emergence of ectopic pregnancies can increase. In these cases early carrying out ultrasonic confirmation that pregnancy intrauterine is important;
• It is necessary to exclude existence of extra gonadal uncontrollable endocrinopathies (for example, diseases of a thyroid gland, hypophysis or adrenal glands).

When carrying out combination therapy FSG/HGch concerning infertility which is caused by anovulation or disturbance of maturing of follicles use of drug with the maintenance of FSG can lead to undesirable hyper stimulation of ovaries. In this regard before FSG initiation of treatment, and also regularly in the course of treatment for assessment of development of follicles it is necessary to conduct ultrasonography and to determine oestradiol level. At development of undesirable hyper stimulation of ovaries it is necessary to interrupt immediately administration FSG-soderzhashchego of drug, to avoid pregnancy and to cancel Pregnyl. In particular it is important concerning patients with polycystic ovaries.

Morbidity of mammary glands, gastrointestinal disturbances (in the form of pain, nausea, diarrhea), increase in ovaries and cysts of ovaries from small to moderate degree belongs to clinical symptoms of moderate weight of SGYa. Also there are messages on the short deviations of results of tests of function of a liver connected with SGYa (confirms hepatic dysfunction which at a biopsy of a liver can be followed by morphological changes).

In some cases there is SGYa in heavy degree that can be threat of life. Treat clinical symptoms: increase in weight, ascites, cysts of ovaries, big, inclined to a gap.

It is not necessary to apply Pregnyl to weight reduction. HGch of influence on appetite, metabolism and distribution of fat does not render.

Medicinal interaction

It is impossible to exclude interaction of Pregnyl with other medicinal means / substances it (is not studied).

During therapy and for 10 days after its termination drug can influence values of immunoassays on the maintenance of HGch in urine/serum that can result in false positive test results on pregnancy.

Terms and storage conditions

To store in protected from light, the place, unavailable to children, at a temperature of 2-15 °C.

Period of validity – 3 years.