Pregnyl^® (Lyophilisate) Instructions for Use

ATC Code

G03GA01 (Chorionic gonadotrophin)

Active Substance

Chorionic gonadotrophin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Recombinant human chorionic gonadotropin

Pharmacotherapeutic Group

Luteinizing agent

Pharmacological Action

A gonadotropic hormone. It is produced by the human placenta and excreted into the urine, from which it can be extracted and purified. It stimulates the production of progesterone by the corpus luteum and supports placental development. It has a gonadotropic action, primarily luteinizing.

In women, the drug induces ovulation and stimulates the synthesis of estrogens and progesterone. In men, it stimulates spermatogenesis and the production of sex steroids.

Pharmacokinetics

After intramuscular administration, it is well absorbed. The half-life (T_1/2) is 8 hours.

It is believed that chorionic gonadotropin is modified in the body before being excreted in the urine, as its half-life measured by an immunological method significantly exceeds that determined by biological activity.

Indications

For women: ovarian dysfunction (anovulatory), amenorrhea; induction of ovulation in infertility caused by anovulation or impaired follicle maturation; support of the luteal phase; preparation of follicles for puncture in controlled ovarian hyperstimulation programs (for assisted reproductive technologies).

For boys and men: delayed puberty due to insufficient gonadotropic function of the pituitary gland; cryptorchidism not caused by anatomical obstruction; insufficiency of spermatogenesis, oligoasthenospermia, azoospermia; when conducting a differential diagnostic test for anorchia and cryptorchidism in boys; when conducting a Leydig cell functional test to assess testicular function in hypogonadotropic hypogonadism before starting long-term stimulating treatment.

ICD codes

Dosage Regimen

Administer the lyophilisate by intramuscular injection after reconstitution with the supplied solvent.

For anovulatory infertility in women, administer 5,000 to 10,000 IU as a single dose to trigger final follicular maturation and ovulation after adequate follicular development with gonadotropins.

For luteal phase support, administer 1,500 to 5,000 IU on the day of ovulation induction and then every 2 to 3 days for at least 2 weeks following a confirmed pregnancy.

In assisted reproductive technology cycles, administer a single dose of 5,000 to 10,000 IU to induce final oocyte maturation prior to follicle puncture.

For prepubertal cryptorchidism in boys, administer 500 to 1,500 IUtwo to three times per week for a period of up to 6 weeks.

For hypogonadotropic hypogonadism in men, administer 1,000 to 2,000 IUtwo to three times per week for a period of at least 3 months to stimulate spermatogenesis and testosterone production.

For the Leydig cell function test, administer a single dose of 5,000 IU and measure serum testosterone levels after 72 to 96 hours.

Adjust the dosage and duration of treatment individually based on the clinical indication, patient response, and tolerability.

Discontinue treatment immediately and do not administer the ovulatory trigger dose if ovarian hyperstimulation syndrome is suspected or if an excessive number of mature follicles develop.

Adverse Reactions

From the endocrine system in women, the development of ovarian hyperstimulation syndrome is possible, accompanied by the development of ovarian cysts with a risk of their rupture, ascites, hydrothorax, and a risk of thromboembolism.

From the endocrine system in boys and men, temporary reversible enlargement of the mammary glands, prostate gland, fluid and electrolyte retention, acne vulgaris are possible; in boys, behavioral changes similar to those observed during the first phase of puberty are possible, which disappear after the end of treatment.

Contraindications

Hormone-dependent malignant tumors of the genital organs and mammary gland (ovarian cancer, uterine cancer, breast cancer in women); androgen-dependent tumors (prostate cancer, breast cancer, testicular tumor); presence of cysts or enlargement of the ovaries not associated with polycystic ovary syndrome; bleeding or bloody discharge from the vagina of unclear etiology; history of ectopic pregnancy (within 3 months before the start of treatment); primary ovarian insufficiency; abnormalities in the development of the female genital organs incompatible with the normal course of pregnancy; uterine fibroids incompatible with pregnancy; menopause; conditions associated with non-descent of the testicle into the scrotum (inguinal hernia, surgical operations in the groin area, testicular ectopia); organic lesions of the CNS (including tumors of the pituitary gland, hypothalamus); deep vein thrombophlebitis; hypothyroidism; adrenal insufficiency; hyperprolactinemia; pregnancy, breastfeeding period; children under 3 years of age.

With caution

Coronary artery disease, chronic heart failure, epilepsy, migraine (including in the anamnesis), chronic renal failure, arterial hypertension, in women with risk factors for thrombosis; in boys in the prepubertal period.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Renal Impairment

Use with caution in case of impaired renal function.

Pediatric Use

Contraindicated for use in children under 3 years of age.

Geriatric Use

Contraindicated for use during menopause.

Special Precautions

Long-term use is not recommended due to the possible formation of antibodies that reduce the effectiveness of treatment.

In case of development of ovarian hyperstimulation syndrome, use should be discontinued.

Storage Conditions

Store at 2°C (36°F) to 15°C (59°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.