Visanne tablets - treatment of uterine endometriosis, expert reviews

Pharmacodynamics

The active substance of Visanne, micronized dienogest, has antiandrogenic activity, which is approximately one third of the activity of cyproterone acetate. It binds to progesterone receptors in the uterus. Despite the 10% similarity with progesterone receptors, the substance is characterized by a powerful progestogenic effect in vivo. Dienogest micronized does not have significant androgenic, glucocorticoid or mineralocorticoid activity in vivo.

Visanne acts on endometriosis by suppressing the trophic effects of estrogens on ectopic and autotopic endometrium due to a decrease in the production of estrogens in the ovaries and a decrease in their amount in the plasma.

If you take Visanne for a long time, an initial decidualization of endometrial tissue appears. Subsequent atrophy of endometrioid lesions is possible. Dienogest has additional properties: antiangiogenic and immunological effects. They contribute to an inhibitory effect on cell proliferation.

Three months after starting Visanne, half of the patients reported a decrease in pelvic pain associated with endometriosis. With continued treatment for up to 15 months, a sustained reduction in pelvic pain was observed.

Preclinical data obtained during routine pharmacological safety, repeated dose toxicity, genotoxicity, carcinogenic potential and reproductive toxicity studies of Visanne do not indicate a specific risk to humans. However, it must be taken into account that sex hormones can stimulate the growth of a number of hormone-dependent tissues and tumors.

The drug Visanne is quickly and almost completely absorbed after oral administration. The maximum amount of the substance in the blood serum is observed 1.5 hours after application.

Dienogest binds to serum albumin. Visanne does not bind to corticosteroid binding globulin and sex hormone binding globulin.

Dienogest is almost completely metabolized to form inactive metabolites. Based on research, the main enzyme involved in metabolism is CYP3A4.

The concentration of the active substance in the blood plasma decreases in two phases. Metabolites are excreted through the kidneys and intestines. After oral administration, approximately 86% of the dose is eliminated within 6 days. The main part is excreted by the kidneys in the first 24 hours.

Analogs

Relative analogues of the drug Visanne include:

1. Duphaston. The active component of the drug is dydrogesterone in a dosage of 10 mg. The drug belongs to the gestagens. The drug is prescribed for endogenous progesterone deficiency and conditions such as endometriosis, dysmenorrhea, secondary amenorrhea, severe premenstrual syndrome, infertility associated with luteal phase deficiency, threatened miscarriage, dysfunctional uterine bleeding. The active component of the drug stimulates the onset of the secretion phase in the mucous membrane of the uterine cavity. The product does not have estrogen-like, antiandrogenic or anabolic properties.
2. Utrozhestan. The drug contains micronized progesterone in a dosage of 100 or 200 mg. The medication helps reduce the tone of the fallopian tubes and smooth muscles of the uterus. The drug is prescribed for fibrocystic mastopathy, threatened miscarriage, menstrual dysfunction and absence of ovulation, as well as for the treatment of infertility caused by the absence of the luteal phase. Also, Utrozhestan is prescribed as hormone replacement therapy during menopause.
3. Megays. The active component of the drug is megestrol acetate in dosages of 40 and 160 mg. The medication is prescribed for cachexia and anorexia in cancer patients, endometrial and breast cancer. The pharmacological effect is based on the suppression of the synthesis of androstenedione and estradiol in the adrenal glands.
4. Norkolut. The drug contains norethisterone in a dosage of 5 mg. When it enters the female body, the active component of the medication stimulates the transition from the proliferative phase of the ovarian-menstrual cycle to the secretory phase. The drug is prescribed for severe premenstrual syndrome, dysfunctional uterine bleeding, endometrial hyperplasia, mastalgia, uterine fibroids, as well as to stop lactation.

Contraindications

Tablets are contraindicated in case of hypersensitivity to the active substance or auxiliary components

The drug is not prescribed if you have the following diseases:

• cardiovascular or arterial diseases (for example, coronary heart disease, myocardial infarction);
• active form of venous thromboembolism;
• diabetes mellitus, accompanied by vascular damage;
• benign and malignant tumors in the liver;
• severe liver diseases (Visanne may be prescribed after function indicators return to normal);
• vaginal bleeding of unknown etiology;
• known or suspected sex hormone-dependent tumors.

If one of these diseases occurs during treatment with Visanne, the drug should be stopped immediately.

Tablets are prescribed with caution for: ectopic pregnancy, history of depression, diabetes mellitus without vascular complications, chronic heart failure, migraine with aura, arterial hypertension, history of deep vein thrombophlebitis.

In childhood

Treatment with hormonal drugs in persons under 18 years of age should be carried out only after a comprehensive study of the possible consequences of therapy and a careful balance of risks and benefits for the patient’s health. The effect of dienogest on an unformed organism has not been studied, relevant studies have not been conducted, therefore the drug Visanne is not used in pediatrics.

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Side effects

The most commonly reported side effects during treatment with the drug were headache, depressed mood, discomfort in the mammary glands, acne. The medicine also affects the pattern of menstrual bleeding in most women.

Depending on the organs and systems, the following side effects are distinguished:

• On the part of the heart - increased heartbeat, nonspecific circulatory disorders.
• From the side of blood vessels – arterial hypotension.
• From the lymphatic system – anemia.
• From the respiratory system – shortness of breath.
• From the nervous system – headache, migraine, impaired attention, impaired autonomic regulation.
• From the mental side - sleep disturbance, depressed mood, nervousness, mood changes, decreased libido, depression, anxiety.
• From the organs of hearing and vision - dry eyes, ringing in the ears.
• From the musculoskeletal system - pain in the back and limbs, muscle cramps, bone pain, a feeling of heaviness in the limbs.
• Skin: alopecia, acne, itching, dry skin, dermatitis, magnifying glass, hair growth disorder, pigmentation changes, hyperhidrosis, onychoclasia, photosensitivity reactions, hirsutism.
• Metabolism: increased or decreased body weight, increased appetite.
• From the gastrointestinal tract - abdominal pain, nausea, vomiting, bloating, flatulence, diarrhea, inflammation of the gastrointestinal tract, constipation, gingivitis.
• From the urinary system – urinary tract infection.
• From the reproductive system - vaginal or uterine bleeding, discomfort in the mammary glands, hot flashes, ovarian cysts, discharge from the genitals, vaginal candidiasis, enlarged mammary glands, pelvic pain, dryness of the vulva and vagina, osteofibrous diseases of the mammary glands, atrophic vulvovaginitis.

Side effects most often develop in the first months of using the medicine and disappear during treatment.

Common disorders that may occur during Visanne therapy include: irritability, asthenic conditions, edema. Hypersensitivity reactions, increased appetite, and persistence of follicles were also observed.

Negative sides

Among the negative aspects of treatment with Visanne, one can note its side effects. Some women report pain in the lower abdomen, as well as rashes on the face. Some patients experience weight gain, but after completion of treatment, body weight returns to normal.

Author of the article:

Lapikova Valentina Vladimirovna |
Gynecologist, reproductive specialist Education: Diploma in Obstetrics and Gynecology received from the Russian State Medical University of the Federal Agency for Health and Social Development (2010). In 2013, she completed her postgraduate studies at NIMU named after. N.I. Pirogova. Our authors

Compatibility with other drugs

Inducers and inhibitors of CYP3A4 can affect the metabolism of progestogen. Increasing the clearance of sex hormones through enzyme induction may reduce the therapeutic effect of the tablets and lead to undesirable changes (for example, changes in the pattern of menstrual bleeding).

Drugs that increase clearance include: barbiturates, felbamate, phenytoin, carbamazepine, primidone, rifampicin, topiramate, drugs that contain St. John's wort and others.

Reducing the clearance of sex hormones through enzyme inhibition can also reduce the therapeutic effect of the drug and lead to the development of adverse reactions.

To better understand the interaction of Visanne with other drugs, it is recommended to read the instructions for the drugs that were taken as concomitant therapy.

Price

The average price for this drug ranges from 2900 to 3100 rubles. You can find this drug in online stores at a lower price. But in order to avoid purchasing counterfeits, it is best to buy this medicine in pharmacies.

Visanne is a unique drug; it has no analogues. If a gynecologist prescribes this drug, then you need to listen to his advice, due to the fact that similar drugs of this pharmacological group have more serious side effects.

The big disadvantage of this medication is its price. To save money, you need to buy large packs containing 84 tablets.

If you have insufficient financial resources, you must inform your doctor, who will prescribe a cheaper medicine. Under no circumstances should you go and make a replacement without his knowledge, this can seriously affect the patient’s health.

Use of the drug

Visanne is prescribed for oral use.

You need to take one tablet a day at the same time without interruption in use. Visanne is prescribed for 6 months. The decision to continue therapy should be made by the attending physician depending on the clinical picture. The effectiveness and safety of the drug has been proven in treatment for up to 15 months.

Take the tablets with a small amount of liquid. The medicine is taken regardless of food intake.

Taking the pills is not affected by menstrual bleeding. Therapy can be started on any day of the menstrual cycle.

Before starting to use the drug, you must stop using any hormonal medications. If contraception is needed, non-hormonal methods should be additionally used.

If you miss a pill, you should take one Visanne pill as soon as the woman remembers. The next one should be taken at the usual time of administration.

If the tablet is not absorbed through vomiting or diarrhea, you need to replace it with another one.

Overdose

In the event that there is a violation of therapy with this medication, by taking it in excess, symptoms may appear that indicate an overdose.

The patient may develop nausea, vomiting, spotting, or bleeding from the vagina. These manifestations may be accompanied by increased body temperature and sweating.

There is no special antidote to eliminate these signs. To cope with them, symptomatic treatment is required. To do this, you need to do gastric and intestinal lavage. Take enterosorbent (Polysorb, Enterosgel, Sorbex, Activated carbon). If the clinical picture does not disappear, then it is better to discontinue this remedy.

Use during pregnancy and breastfeeding

Data on the use of Visanne by pregnant women are limited. Animal studies do not indicate direct or indirect risks of reproductive toxicity.

Visanne is not prescribed to pregnant women, since there is no need to treat endometriosis during pregnancy.

Therapy with Visanne during breastfeeding is not recommended, because there is no data on whether dienogest passes into breast milk. Animal studies have shown that the active substance passes into breast milk.

A breastfeeding woman needs to decide whether to stop taking the pills or stop breastfeeding.

Reviews from doctors

Expert opinion Borovikova Olga Visanna is a good drug that can reduce the manifestations of the disease. However, the best effect can be achieved only in combination with surgical treatment. Therefore, you cannot rely only on Vizanne when trying to cure endometriosis. One of the advantages is the relatively small chance of developing side symptoms.

Expert review Olga Borovikova The effectiveness of Visanne strongly depends on the individual characteristics of the body. In my clinical practice, I used to often prescribe this drug after surgical treatment, but I did not see the effect in all patients. In any case, the drug has no analogues, so for postoperative management of endometriosis it is necessary to take it. This will relieve the unpleasant manifestations of the disease.

special instructions

Before starting treatment, pregnancy must be excluded. While taking the medicine, patients are recommended to use non-hormonal methods of contraception, for example, barrier.

Since Visanne contains only a progestogen component, it can be assumed that precautions for the use of other drugs with a progestogen component apply to it.

When using Visanne, uterine bleeding may increase in women with leiomyoma or adenomyosis of the uterus. If it is severe and does not stop for a long time, it can lead to anemia. In this case, you should consider stopping treatment with the drug.

Women with hypertension may have an increased risk of stroke when treated with drugs that contain progestogen. Some studies also suggest an increased risk of venous thromboembolism. It is necessary to take into account the increased risk of thromboembolism in the postpartum period - the use of the drug should be preceded by consultation with a doctor.

In case of prolonged immobilization, it is recommended to discontinue Visanne therapy at least 4 weeks before elective surgery. It is recommended to start taking pills no earlier than 2 weeks after complete rehabilitation.

If symptoms of venous or arterial thrombotic diseases occur, treatment with the drug should be discontinued.

It is necessary to monitor the condition of patients with a history of depression. If severe symptoms develop, treatment with Visanne should be stopped.

Positive experience after Visanne

Patients taking the drug noted that after completing the course of treatment, the condition of the endometrium returned to normal, and long, painful menstruation disappeared.

Many patients felt a positive effect already in the middle of taking the medication.

A huge advantage of using the drug is the low percentage of side effects. Most patients were successfully treated with medication.

Price

The cost of the drug is high, but it is the only drug developed to treat endometriosis. You can purchase tablets in pharmacies and online stores in Moscow at the following prices:

Release form

Visanne is available in the form of white or white-gray tablets with the letter B engraved on the front side, the diameter of one tablet is 7 mm.

The tablets are in a green blister pack, there are 14 tablets in one blister pack, and the days of the week are marked on the back side opposite each tablet as a reminder of whether the tablet was taken today or not.

The pack contains 2.6 or 12 blister packs (28.84 or 168 tablets, respectively) with instructions in Russian.

Compound

One tablet contains 2 mg of dienogest - it is the main active ingredient. The remaining excipients are contained in small quantities, they are necessary for filling the tablets - these are potato starch, milk sugar (lactose monohydrate), microcrystalline cellulose, povidone K25, talc, crospovidone, magnesium stearate.