Pregnyl ® Chorionic gonadotropin

PREGNYL ® is a drug based on chorionic gonadotropin

THERAPEUTIC GROUP: Gonadotropins and other ovulation stimulants

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications Pregnyl ® Chorionic Gonadotropin

PREGNYL ® is a drug that is used in the treatment of male and female pathologies, being successfully used both in the treatment of male hypogonadotropic hypogonadism, in puberal delay and in cryptorchidism than in female infertility associated with anovulation or insufficient lutein.

Mode of action Pregnyl ® Chorionic gonadotropin

PREGNYL ® is a medicine based on chorionic gonadotropin, a hormone of extractive origin, obtained through purification protocols from the urine of pregnant women.

Normally produced by the placenta during pregnancy, useful to guarantee the correct endometrial changes necessary to preserve the correct growth of the embryo, this hormone is used in the therapeutic field above all for its lutein-like activity capable of:

Increase endogenous testosterone secretion from Leydig cells in humans, contributing to both sexual maturation in cases of puberal delay and improvement of semen quality in hypogonadotropic hypogonadism;
Induce ovulation by solving cases of female infertility due to anovulation.

The chorionic gonadotropin, administered parenterally by injection (intramuscular) reaches the maximum plasma concentrations in about 6 hours, persisting in the body for 48 hours before an intense renal metabolism with subsequent urinary elimination.

Studies carried out and clinical efficacy

1. OVARIAN STIMULATION IN WOMEN WITH A SINGLE OVA

Study demonstrating how ovarian stimulation followed by in vitro fertilization in women with only one ovary can guarantee pregnancy rates comparable to those with two ovaries.

2. CORIONIC GONADOTROPINA IN PREGNANCY

First studies that try to evaluate the effects of chorionic gonadotropin therapy on fetal health when taken in the first trimester of pregnancy (when the embryo is most susceptible to pharmacological insult). The scientific community looks forward to these results.

3. CORIONIC GONADOTROPINE AND WAYS OF ADMINISTRATION

Study that evaluates the effectiveness of chorionic gonadotropin when taken intramuscularly or subcutaneously. Although the pharmacokinetic characteristics tend to be used for intramuscular use, the ease of administration that characterizes the subcutaneous route could increase the acceptability of the therapy.

Method of use and dosage

PREGNYL ®

Powder and solvent for solution for injection for intramuscular use from 1500 to 5000 IU of human chorionic gonadotropin:

the different therapeutic indications concerning the use of chorionic gonadotropin do not allow to define standard and replicable dosages between different patients.

The specialist doctor must therefore evaluate the correct dosing schedule for each patient, based on the physiopathological conditions, the clinical picture and the therapeutic goals.

Warnings Pregnyl ® Chorionic Gonadotropin

The prescription of PREGNYL ® should be made by a specialist doctor after carefully assessing the patient's state of health and having ascertained the therapeutic compatibility of the chorionic gonadotropin.

Patients suffering from renal, cardiac, nervous, hepatic and metabolic disorders should undergo periodic checks necessary to assess the maintenance of the state of health and the effectiveness of the therapy, by contacting their doctor at the onset of the first side effects.

Ovarian hyperstimulation syndrome is the main cause of discontinuation of PREGNYL ® therapy in women, while the risk of early sexual development and premature epiphyseal welding is the greatest risk in prepubescent male patients.

The induction of ovulation with chorionic gonadotropin was statistically associated with a higher incidence of twin pregnancies.

PREGNANCY AND BREASTFEEDING

Although there are currently no studies able to characterize the safety profile of chorionic gonadotropin on the fetus, when taken during pregnancy, the use of PREGNYL ® in this period is contraindicated given the absence of therapeutic indications in this regard.

Interactions

At the moment there are no studies able to demonstrate relevant drug interactions.

However, it is important to consider that taking PREGNYL ® could result in a false positive pregnancy test.

Contraindications Pregnyl ® Chorionic gonadotropin

PREGNYL ® contraindicated in cases of precocious puberty, hypophyseal, ovarian, prostatic and testicular neoplastic diseases, early menopause, endocrine pathologies, absence of the uterus, thrombophlebitis and hypersensitivity to the active ingredient or one of its excipients.

Undesirable effects - Side effects

The side effects observed during therapy with chorionic gonadotropin were observed with greater frequency and clinical severity during prolonged therapeutic cycles.

Headache, asthenia, nausea, diarrhea, water and sodium retention, weight gain, increased ovarian volume or cysts present are the most frequently described adverse reactions, although the most clinically relevant ones involve the ovary with ovarian hyperstimulation syndrome and cardiovascular system with increased risk of thromboembolism.