GONAL-F ® Follicle stimulating hormone

GONAL-F ® is a drug based on recombinant human follicle stimulating hormone

THERAPEUTIC GROUP: Gonadotropins and other ovulation stimulants

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

Indications GONAL-F ® Follicle stimulating hormone

GONAL-F ® is used in the induction of ovulation in case of anovulation in patients not responsive to therapy with clomiphene citrate, during medically assisted procreation techniques and in patients with low gonadotropin levels.

In humans, this medicine is indicated in the induction of spermatogenesis in patients with hypogonadotrophic hypogonadism.

Mode of action GONAL-F ® Follicle stimulating hormone

GONAL-F ® is a drug based on recombinant human stimulating follicle hormone, obtained through genetic engineering techniques, and therefore free from the potential contamination possible in hormones of extractive origin.

The stimulating follicle hormone, also known as follitropin, is normally produced by the adenohypophysis cells under the stimulus of the hypothalamic hormone GnRH, and acts at the gonadal level determining:

In women: the correct follicular maturation until the appearance of the dominant follicle;
In humans: spermatogenesis, interacting with specific receptors expressed on the surface of Sertoli cells, and allowing these supporting cells to both provide for the synthesis of androgen-binding proteins and to support the different stages of male gametogenesis.

It is therefore clear that its use in the therapeutic field is strongly oriented towards supporting both male and female fertility, acting selectively in the gonadal microenvironment.

Studies carried out and clinical efficacy

1. THE BIOLOGICAL COMPLEXITY OF FOLLITROPINE THERAPY

The complexity of medical therapy with follitropin and the need for specialized medical supervision is confirmed by this study which defines a new algorithm useful for identifying the optimal dose for each individual patient.

2. THE MOLECULAR ASPECTS OF HORMONAL STIMULATION

Molecules study that suggests how ovarian stimulation with FSH or with FSH and LH at the same time can have a different effect on maturation and oocyte competence, through a different induction of gene expression.

3. THE EFFICACY OF FSH IN THE TREATMENT OF AZOSPERMIA

Long-term treatment with recombinant human follitropin, of azospermia in patients with hypogonadotropic hypogonadism, has been shown to be effective in stimulating spermatogenesis with the appearance of tolerable side effects, such as acne.

Method of use and dosage

GONAL-F ®

Powder and solvent for solution for injection subcutaneously 75 IU / ml or

pens of 300 IU / 0.5 ml, 450 IU / 0.75 ml and 900 IU / 1.5 ml:

The dosage and dosage schedule required for the intake of human stimulating follicle hormone must be defined by a physician specialized in human reproductive medicine, given the wide range and the innumerable administration schemes provided for this drug.

The physio-pathological conditions of the patient, the clinical picture and the therapeutic goals will guide the doctor towards the formulation of the effective dosage.

Warnings GONAL-F ® Follicle stimulating hormone

The intake of GONAL-F ® should be preceded by a careful specialist medical examination useful for evaluating the causes of infertility and any prescriptive appropriateness.

Women undergoing treatment should be supervised by medical personnel throughout the therapeutic process, in order to avoid the incidence of unpleasant side effects such as ovarian hyperstimulation syndrome, the occurrence of which could push the doctor to stop treatment.

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.

Studies show that the incidence of twin pregnancies is statistically higher in women undergoing stimulation treatments with gonadotropins and analogues.

In humans, on the other hand, the efficacy of the treatment should be monitored with spermiograms repeated every four months.

PREGNANCY AND BREASTFEEDING

The absence of data on the safety of the crazy tropin on the health of the fetus when taken during pregnancy and above all the absence of therapeutic indications, discourages the use of GONAL-F ® during pregnancy.

Interactions

The possible interactions documented in the literature refer to the simultaneous use of other ovulation stimulants, which could lead to an excessive strengthening of the follicular response with an increased risk of ovarian hyperstimulation.

Contraindications GONAL-F ® Follicle stimulating hormone

GONAL-F ® is contraindicated in cases of precocious puberty, hypophyseal, ovarian, prostatic and testicular neoplastic diseases, 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

Several clinical trials and careful post-marketing monitoring have shown that treatment with follitropin can cause side effects such as: headache, abdominal pain, vomiting, nausea, diarrhea, cramps, abdominal distention, ovarian cysts, acne, weight gain, gynecomastia in men and ovarian hyperstimulation syndrome in women.

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