LUVERIS ® Luteinizing Hormone

LUVERIS ® is a recombinant human luteinizing hormone drug

THERAPEUTIC GROUP: Gonadotropins and other ovulation stimulants

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

Directions LUVERIS ® Luteinizing Hormone

LUVERIS ® is used for the treatment of anovulatory infertility associated with hypopitituarism and in particular with low blood concentrations of luteinizing hormone.

In association with the stimulating follicle hormone, LUVERIS ® can be used to stimulate follicular development and subsequent ovulation.

Mechanism of action LUVERIS ® Luteinizing Hormone

The luteotropin (luteinizing hormone) active ingredient of LUVERIS, is a hormone produced in physiological conditions by the adenohypophysis under the induction of the hypothalamic hormone GnRH, fundamental in the regulation of gonadal activity.

In fact, in humans it is able to stimulate Leydig cells to produce testosterone, a key hormone in the regulation of the development of secondary sexual traits and in correctly supporting the process of spermatogenesis, while in women it plays a crucial role in inducing ovulation and at the same time in preserving the corpus luteum from atresia, allowing the latter to acquire an endocrine function useful to allow the implantation of the embryo in the uterine mucosa preceding the placenta in this activity.

In light of the aforementioned biological role, it is evident that the exogenous administration of this hormone may contribute to the maintenance of reproductive capacity.

Furthermore, the advent of innovative technologies such as recombinant DNA have made it possible to obtain hormones of synthetic origin capable of eliminating all the potential risks associated with products of extractive origin, such as contamination or structure-function variations.

Studies carried out and clinical efficacy

1. NEW THERAPEUTIC APPROACHES

Stimulation with LH before FSH stimulation resulted in an increase in small antral follicles, and a greater yield in both ovulated oocytes and the number of fertilizations successfully completed.

2. REAL NEED FOR STIMULATION WITH LH

Study that seeks to discriminate cases of real need for LH intake from those potentially avoidable, given some side effects that seem to be realized following hormonal induction at high concentrations.

3. THE EFFECTIVENESS OF COMBINED THERAPY

Study demonstrating how the combination of luteinizing hormone with stimulating follicle can guarantee significant advantages in women with anovulatory age, leading to an increase in ovulated oocytes and the rate of fertilization.

Method of use and dosage

LUVERIS ®

Powder and solvent for 75 UI / ml subcutaneous injection solution:

the treatment, which often takes advantage of the simultaneous intake of follicle stimulating hormone, requires medical supervision both in the definition phase of the dosage and in the entire follicular maturation cycle.

The goal in women is to induce follicular maturation until the appearance of an ovulatory follicle and subsequent ovulation.

The dosing schedule, the methods of administration and all the necessary precautions should be defined by the specialist doctor.

Warnings LUVERIS ® Luteinizing Hormone

a careful specialist medical examination, which ascertains the causes of infertility and the state of health of the woman, is fundamental before starting any ovarian stimulation cycle.

Patients subjected to these medical practices should be monitored throughout the therapeutic process in order to evaluate the efficacy of the therapy and the possible appearance of side effects, primarily the ovarian hyperstimulation syndrome.

Excessive ovarian stimulation cycles could also lead to the appearance of pathologies affecting the genital tract, an increase in the risk of thromboembolic events and the possible aggravation of ongoing morbid conditions.

Epidemiological studies show that the frequency of twin pregnancies is significantly higher among women subjected to stimulation as well as unfortunately the risk of pregnancy interruptions.

PREGNANCY AND BREASTFEEDING

LUVERIS ® should not be administered during pregnancy or in the subsequent period of breastfeeding, given the absence of therapeutic indications and studies able to characterize the safety profile of the luteinizing hormone on the fetus, when taken during pregnancy.

Interactions

It is not possible at the moment to define drug interactions able to significantly alter the pharmacokinetic and pharmacodynamic profile of the luteinizing hormone.

However, it would be advisable to avoid mixing different medicinal products in the same syringe, with the exception of follitropin, which does not appear to cause changes in the activity or stability of both hormones.

Contraindications LUVERIS ® Luteinizing Hormone

LUVERIS ® is contraindicated in case of precocious puberty, hypophyseal, ovarian and mammary neoplastic diseases, genital haemorrhages of unknown aetiology, early menopause, endocrine pathologies, uterus absence, thrombophlebitis and hypersensitivity to the active ingredient or to one of its excipients.

Undesirable effects - Side effects

The combined therapy between luteinizing hormone and stimulating follicle, does not allow to discriminate between the side effects induced by luteotropin or follitropin.

However the most frequently reported adverse reactions were: headache, abdominal pain, vomiting, nausea, diarrhea, cramps, abdominal distention, ovarian cysts, acne and weight gain.

On the other hand, the ovarian hyperstimulation syndrome, which is associated with intense pain in the pelvic and abdominal area, and the increased risk of thromboembolism are more worrying.

It is also quite common to observe mild or moderate irritation at the injection site.