Pregnil
Pregnil: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Pregnyl
ATX code: G03GA01
Active ingredient: Human chorionic gonadotropin (Human Chorionic Gonadotropin)
Producer: Organon (Netherlands)
Description and photo update: 2019-12-08
Pregnil is a drug with gonadotropic action.
Release form and composition
Pregnyl is produced in the form of a lyophilisate for the preparation of a solution for intramuscular and subcutaneous administration: white; solvent - transparent, colorless (in colorless glass ampoules of 2 ml, 1 or 3 ampoules in blisters or pallets, 1 package or pallet in a cardboard box complete with solvent (3 ampoules)).
The composition of 1 ampoule includes:
- Active substance: human chorionic gonadotropin (hCG) - 500, 1500 or 5000 IU (international units);
- Auxiliary components: mannitol, sodium carmellose, sodium hydrogen phosphate, sodium dihydrogen phosphate.
Solvent: 0.9% sodium chloride solution - 1 ml.
Pharmacological properties
Pharmacodynamics
The active ingredient of Pregnil is hCG, which has a biological activity similar to that of luteinizing hormone. Luteinizing hormone is essential for the formation of female and male sex hormones, as well as the growth and maturation of reproductive cells in women and men.
In women, Pregnyl is used to replace the release of endogenous luteinizing hormone in the middle of the cycle. This effect induces the final stage of follicular maturation, leading to ovulation. The drug is also used during the luteal phase as a substitute for luteinizing hormone.
In boys and men, Pregnyl is used to stimulate testosterone-producing Leydig cells.
Pharmacokinetics
In men, the maximum plasma concentration of hCG is reached after 6-16 hours after a single subcutaneous or intramuscular injection of the drug, in women - after about 20 hours. The differences in the rate of absorption of Pregnil in men and women after intramuscular administration of the drug are probably due to a thicker layer of subcutaneous fat in women.
HCG is approximately 80% metabolized in the kidneys. A single subcutaneous or intramuscular injection of hCG is bioequivalent with respect to the duration of absorption and the value of the apparent half-life, which is 33 hours. Cumulation of the drug is not observed.
Indications for use
For women:
- Infertility due to impaired follicular maturation or anovulation (to induce ovulation);
- Maintaining the phase of the corpus luteum;
- Controlled ovarian hyperstimulation programs (when preparing follicles for puncture).
For boys and men:
- Hypogonadotropic hypogonadism;
- Cryptorchidism not associated with anatomical obstruction;
- Delayed puberty, which is due to the insufficiency of the gonadotropic function of the pituitary gland.
Contraindications
Absolute:
- Premature puberty (in boys);
- Established or suspected tumors dependent on sex hormones (in women - ovarian cancer, uterine cancer and breast cancer; in men - prostate cancer, breast cancer);
- Fibrous tumor of the uterus, incompatible with pregnancy (in women);
- Incorrect formation of the genitals, incompatible with pregnancy (in women);
- Pregnancy and lactation;
- Hypersensitivity to drug components.
Relative (Pregnyl is prescribed with caution):
- Women: risk factors for thrombosis - indications in a personal or family history, thrombophilia, severe obesity (with a body mass index> 30 kg / m 2), which is associated with an increased risk of arterial or venous thromboembolism during or after treatment with gonadotropins. Before prescribing the drug, such women need to evaluate the benefits of in vitro fertilization (IVF) therapy and the possible risks. It should be borne in mind that pregnancy itself is also accompanied by an increased risk of thrombosis;
- Boys and men: arterial hypertension, latent or overt heart failure, impaired renal function, migraine, epilepsy, including indications of a history of these conditions (such patients need strict medical supervision, since exacerbation of the disease or relapse in some cases can be observed with increased production androgens);
- Boys: prepubertal because hCG can lead to premature epiphyseal closure or premature puberty. With the appointment of Pregnil, it is necessary to regularly monitor the development of the skeleton.
Instructions for use of Pregnil: method and dosage
After reconstitution (adding solvent to the lyophilisate), Pregnyl solution should be injected slowly subcutaneously or intramuscularly.
Recommended dosage regimen for women:
- Infertility due to impaired follicular maturation or anovulation (for the induction of ovulation): 1 injection of Pregnil 5000-10 000 ME;
- Preparation of follicles for puncture in programs of controlled ovarian hyperstimulation to complete treatment with follicle-stimulating hormone (FSH) preparations: 1 injection of Pregnil 5000-10,000 ME;
- Maintaining the corpus luteum phase: additionally 2-3 repeated injections within 9 days after ovulation or embryo transfer (for example, on days 3, 6 and 9 after ovulation induction) 1000-3000 IU.
Recommended dosing regimen for boys and men:
- Hypogonadotropic hypogonadism: 2-3 times a week, 1000-2000 ME. For infertility, Pregnyl can be combined with an additional drug containing follitropin (FSH) 2-3 times a week. The duration of a therapeutic course in which any improvement in spermatogenesis can be expected is at least 3 months. For the period of using Pregnyl, testosterone replacement therapy should be suspended. After achieving an improvement in spermatogenesis, in some cases, in order to maintain it, the isolated use of hCG is sufficient;
- Delayed puberty associated with insufficiency of the gonadotropic function of the pituitary gland: Pregnyl 1500 ME 2-3 times a week. The duration of the therapeutic course is at least 6 months;
- Cryptorchidism not associated with anatomical obstruction: from 6 years - Pregnyl 1500 ME, 2-6 years - 500-1000 ME, up to 2 years - 250 ME. The frequency of administration is 2 times a week. The duration of the therapeutic course is 6 weeks. If necessary, it is possible to repeat the course.
Side effects
- Immune system: in rare cases, fever or generalized rash;
- General disorders and reactions at the injection site: pain, bruising, redness, itching, swelling; in some cases, allergic reactions, usually in the form of a rash and / or pain at the injection site.
Among women:
- Digestive system: ovarian hyperstimulation syndrome (OHSS) in moderate course in the form of abdominal pain and gastrointestinal symptoms (nausea and diarrhea), severe OHSS in the form of ascites;
- Cardiovascular system: in rare cases - thromboembolism associated with FSH / HCG therapy, which is usually associated with severe OHSS;
- Reproductive system and mammary glands: unwanted ovarian hyperstimulation, OHSS in moderate (in the form of breast tenderness, slight or moderate enlargement of the ovaries and ovarian cysts) or severe (in the form of large, prone to rupture of ovarian cysts) course;
- Others (respiratory, mediastinal and chest disorders): complications of OHSS in severe course in the form of hydrothorax.
According to the results of the study, the development of an increase in body weight (OHSS in severe course) was also noted.
In boys and men:
- Metabolism and nutrition: in some cases, with the introduction of Pregnyl in high doses, sodium and water retention (presumably due to the excessive formation of androgens);
- Reproductive System and Breasts: Gynecomastia.
Overdose
The acute toxicity of urine-derived chorionic gonadotropin is extremely low. However, too high doses of hCG can cause ovarian hyperstimulation syndrome.
special instructions
During the use of Pregnyl, it is necessary to consider:
- Women who have used assisted reproductive technologies have a higher incidence of pregnancy loss than the general population;
- The incidence of congenital malformations after the use of assisted reproductive technologies (ART) may be slightly higher than as a result of spontaneous conception (presumably due to the characteristics of the parents (maternal age, sperm characteristics));
- There is an increased risk of multiple pregnancies if the pregnancy occurs after the induction of ovulation by Pregnil;
- Against the background of violations of the fallopian tubes, the incidence of ectopic pregnancies may increase. In these cases, early ultrasound confirmation that the pregnancy is intrauterine is important;
- It is necessary to exclude the presence of extragonadal uncontrolled endocrinopathies (for example, diseases of the thyroid gland, pituitary gland, or adrenal glands).
When conducting a combination therapy of FSH / hCG for infertility, which is caused by anovulation or impaired maturation of follicles, the use of a drug containing FSH can lead to unwanted ovarian hyperstimulation. In this regard, before starting treatment with FSH, as well as regularly during treatment, to assess the development of follicles, it is necessary to conduct ultrasound and determine the level of estradiol. With the development of unwanted ovarian hyperstimulation, you must immediately interrupt the administration of the FSH-containing drug, avoid pregnancy and cancel Pregnyl. This is especially important for patients with polycystic ovaries.
The clinical symptoms of moderate OHSS severity include breast tenderness, gastrointestinal disturbances (in the form of pain, nausea, diarrhea), small to moderate enlargement of the ovaries and ovarian cysts. There are also reports of short-term abnormalities in liver function test results associated with OHSS (indicative of hepatic dysfunction, which may be accompanied by morphological changes in liver biopsy).
In some cases, severe OHSS occurs, which can be life threatening. Clinical symptoms include: weight gain, ascites, large, ruptured ovarian cysts.
Pregnyl should not be used for weight loss. HCG has no effect on appetite, metabolism and fat distribution.
Application during pregnancy and lactation
According to the instructions, Pregnyl is contraindicated for use by pregnant and lactating women.
Pediatric use
In children, the use of Pregnil is possible according to indications.
With premature puberty in boys, the use of Pregnil is contraindicated.
HCG is prescribed with caution to boys in the prepubertal period, since premature puberty and closure of the pineal glands are possible. Regular monitoring of skeletal development is required.
With impaired renal function
In case of impaired renal function (including with a history of similar conditions), patients should be closely monitored by a physician, since a relapse or exacerbation of the disease in some cases may be due to increased production of androgens.
Drug interactions
Interaction of Pregnil with other drugs / substances cannot be excluded (not studied).
During the period of therapy and for 10 days after its termination, the drug may affect the values of immunological tests for the hCG content in urine / serum, which can lead to false positive results of a pregnancy test.
Analogs
The analogues of Pregnil are: Ovitrel, Horagon, Chorionic Gonadotropin, Choral, Profazi, Ecostimulin.
Terms and conditions of storage
Store in a dark place, out of reach of children, at a temperature of 2-15 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Pregnil
Reviews about Pregnil are most often left by women who use the drug to combat infertility in order to stimulate the process of follicular formation. The action of the drug is individual in each case, however, its use, as a rule, is painless. Side effects and discomfort from treatment are very rare.
Men share their reviews of the drug much less often, but even from the few reports available, it can be concluded that the use of Pregnil in men is also effective and painless.
Price for Pregnyl in pharmacies
In pharmacies, the average prices for Pregnyl are as follows:
- lyophilisate for the preparation of a solution for intramuscular and subcutaneous administration of 1500 IU (1 pc.) - 423 rubles;
- lyophilisate for the preparation of a solution for intramuscular and subcutaneous administration of 1500 IU (3 pcs.) - 1271 rubles.
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
