VAGIFEM ® - Estradiol

VAGIFEM ® is a drug based on Estradiol hemihydrate

THERAPEUTIC GROUP: Natural estrogens

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

Indications VAGIFEM ® - Estradiol

VAGIFEM ® is a drug based on estradiol useful for the treatment of vaginal symptoms associated with estrogen deficiency typical of menopause.

Mechanism of action VAGIFEM ® - Estradiol

17 Beta Estradiol is a hormone fundamental for the correct development of the organism since it intervenes during adolescence in guaranteeing the maturation of the secondary female sexual organs, and in the fertile period in facilitating development and endometrial regeneration.

Its production is guaranteed during the reproductive age by the activity of the granulosa cells, which gradually decreases until it disappears completely during the menopause.

The estrogenic deficiency that characterizes this period is generally accompanied by the development of a particularly complex symptomatology, characterized by neurological symptoms such as panic attacks, anxiety and difficulty in falling asleep; vasomotor symptoms, and more precisely instability; local effects concentrated at the vaginal level with relative atrophy and chronic and progressive pathologies such as osteoporosis.

Replacement therapy with VAGIFEM ® is therefore indicated to alleviate the aforementioned symptomatic condition, preventing at the same time the development of more serious and progressive pathologies such as osteoporosis.

The estradiol hemihydrate taken by vaginal route, skips the first-pass metabolism, thus maintaining an excellent systemic bioavailability.

The vaginal assumption allows the estradiol contained in VAGIFEM ® to carry out its effect mainly at the local level.

Studies carried out and clinical efficacy

1. SAFETY OF THE VAGINAL THERAPY WITH ESTRADIOLO

Study demonstrating that the vaginal administration of estradiol at 10 mg for 12 months, besides being effective in the treatment of vaginal atrophy, is well tolerated and without particularly serious side effects.

2. VAGIFEM AND BREAST CANCER

The high systemic concentrations of estradiol that are observed following the use of estradiol in tablets or vaginal tablets, could reverse the effects of the aromatase inhibitors used in the treatment of breast cancer, and therefore be contraindicated

3. EFFECTIVENESS OF THERAPY WITH VAGIFEM

An interesting study that shows that taking VAGIFEM in just 12 weeks of treatment can guarantee a significant improvement in the symptoms associated with vaginal atrophy in over 60% of the patients treated.

Method of use and dosage

VAGIFEM ® vaginal tablets coated with 25 mcg of estradiol hemihydrate :

the recommended and most clinically used dosage is that of one tablet a day for the first two weeks, followed by a maintenance phase characterized by taking one tablet twice a week.

Despite the standardized protocol, the dosage may be subject to variations, for which medical supervision is necessary both in the initial phases of the treatment and in the continuation.

Warnings VAGIFEM ® - Estradiol

The particular biological "complexity" of estrogen hormone replacement therapy requires careful medical supervision both during the initial stages of therapy and during the subsequent maintenance period.

A careful initial clinical examination, useful for ascertaining the presence of predisposing factors such as endometriosis, history or familiarity for dependent thromboembolic or estrogen diseases, hypertension, liver disease, diabetes, migraine and autoimmune diseases, asthma and osteosclerosis is essential to correctly set the therapy, minimizing the risk of heart and coronary, vascular and neoplastic diseases.

PREGNANCY AND BREASTFEEDING

Taking VAGIFEM ® is strictly contraindicated during pregnancy and the subsequent period of breastfeeding, despite the absence of a direct mutagenic or teratogenic effect on the fetus.

Interactions

Taking vaginal estradiol completely reduces the presence of clinically relevant drug interactions

Contraindications VAGIFEM ® - Estradiol

The use of VAGIFEM ® is contraindicated during pregnancy and lactation, in patients with estorgeno-dependent carcinomas, breast carcinoma, acute thrombophlebitis, recent embolic thrombus disease, history of thrombus embolism, liver disease, porphyria, untreated endometrial hyperplasia, undiagnosed vaginal discharge and of course in case of hypersensitivity to the active ingredient or to one of its excipients.

Undesirable effects - Side effects

Different clinical trials have tested the safety and tolerability of VAGIFEM ® intake by observing the presence of particularly frequent side effects.

The most commonly reported adverse reactions include: headache, nausea, abdominal pain, vomiting, flatulence, breast edema and increased breast tenderness, peripheral edema, bleeding and vaginal infections.

On the contrary, the presence of hives and dermatological reactions, ulcerations, insomnia and depression has been observed more rarely.

The increase in the risk of breast and endometrial carcinoma observed following prolonged therapies is particularly important.