LUVERIS ® is a drug based on human recombinant Luteinizing Hormone
THERAPEUTIC GROUP: Gonadotropins and other ovulation stimulants
Indications 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 follicle stimulating hormone, LUVERIS ® can be used in the stimulation of follicular development and subsequent ovulation.
Mechanism of action LUVERIS ® Luteinizing hormone
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, which is essential in regulating gonadal activity.
In fact, in men it is able to stimulate the Leydig cells to produce testosterone, a key hormone in regulating the development of secondary sexual characteristics and in correctly supporting the spermatogenesis process, 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 for allowing 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 how the exogenous administration of this hormone can contribute to the maintenance of reproductive capacities.
Furthermore, the advent of innovative technologies such as those of 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 variations in structure-function.
Studies carried out and clinical efficacy
1. NEW THERAPEUTIC APPROACHES
Hum Reprod. 2008 Feb; 23: 421-6. Epub 2007 Dec 15.
Effects of recombinant LH treatment on folliculogenesis and responsiveness to FSH stimulation.
Durnerin CI, Erb K, Fleming R, Hillier H, Hillier SG, Howles CM, Hugues JN, Lass A, Lyall H, Rasmussen P, Thong J, Traynor I, Westergaard L, Yates R; Luveris Pretreatment Group.
Stimulation with LH before that with FSH resulted in an increase in small antral follicles, and a greater yield of both ovulated oocytes and the number of successful fertilizations obtained.
2. REAL NEED FOR STIMULATION WITH LH
Gynecol Obstet Fertil. 2002 Nov; 30: 890-5.
Ovarian stimulation: is exogenous LH necessary in all patients ?.
Loumaye E.
Study that tries to discriminate cases of real need for LH intake from potentially avoidable ones, given some side effects that seem to occur following hormonal inductions at high concentrations.
3. THE EFFECTIVENESS OF COMBINED THERAPY
Reprod Biomed Online. 2004 Feb; 8: 175-82.
Randomized trial to compare the effect of recombinant human FSH (follitropin alfa) with or without recombinant human LH in women undergoing assisted reproduction treatment.
Marrs R, Meldrum D, Muasher S, Schoolcraft W, Werlin L, Kelly E.
This study demonstrates how the combination of luteinizing hormone with the stimulating follicle can guarantee significant benefits in women with anovularity, resulting in an increase in ovulated oocytes and in the fertilization rate.
Method of use and dosage
LUVERIS ®
Powder and solvent for solution for injection subcutaneously 75 IU / ml:
the treatment, which often makes use of the simultaneous intake of follicle stimulating hormone, requires medical supervision both in the dosage definition phases 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 dosage 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 essential before starting any cycle of ovarian stimulation.
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 occurrence of side effects, primarily ovarian hyperstimulation syndrome.
Excessive cycles of ovarian stimulation could also lead to the onset of pathologies affecting the genital system, an increase in the risk of thromboembolic events and the possible aggravation of existing 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 termination.
PREGNANCY AND BREASTFEEDING
LUVERIS ® should not be administered during pregnancy or in the subsequent lactation period, given the absence of therapeutic indications and studies capable of characterizing the safety profile of the luteinizing hormone on the fetus, when taken during pregnancy.
Interactions
At the moment it is not possible to define pharmacological interactions capable of significantly altering 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, whose concomitant intake does not seem to determine changes in the activity or stability of both hormones.
Contraindications LUVERIS ® Luteinizing Hormone
LUVERIS ® is contraindicated in the case of precocious puberty, pituitary, ovarian and mammary neoplastic pathologies, genital haemorrhages of unknown etiology, premature menopause, endocrine pathologies, absence of the uterus, 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 described adverse reactions were: headache, abdominal pain, vomiting, nausea, diarrhea, cramps, abdominal distension, ovarian cysts, acne and weight gain.
On the other hand, ovarian hyperstimulation syndrome, which is associated with intense pain in the pelvic and abdominal area, and the increased risk of thromboembolism are of greater concern.
It is also quite common to observe mild to moderate irritation at the injection site.
Note
LUVERIS ® can only be sold under medical prescription.
The use of LUVERIS ® outside the medical prescription, before and during a sports competition is prohibited as it constitutes a doping practice.
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