According to studies and rates published by fertilization centers, about 40% of cases in which there is difficulty or inability to become pregnant are due to changes in men’s health.
Since, in these cases, the majority is related to deficient sperm production. In relation to women, the problems that most affect reproductive capacity are related to tubal factors, ovarian factors, endometriosis , uterine factors, cervical and even psychological factors.
Many people may be referred to drug therapies, in order to stimulate or adjust hormonal production. Among the options is Gonal F, a medication based on the active substance alphapholitropine, indicated for specific cases of hormonal deficiency related to FSH.
Learn more about the medication and its indications for use:
- 1 What is Gonal F?
- 2 What is Gonal medicine for?
- 3 How old is Alfafolitropin?
- 4 How to apply Gonal with pen?
- 5 What are the side effects?
- 6 Gonal gets fat?
- 7 Does Gonal sleep?
- 8 How to store the medicine?
- 9 Price and where to buy?
- 10 Does SUS provide Alfafolitropin?
- 11 How to budget Gonal F?
What is Gonal F?
Gonal F is one of the drugs based on the active substance alphapholitropine, marketed by the pharmaceutical industry Merck.
The solution is injectable, available in pre-loaded pens, which after medical advice can be administered by self-application, or in vials with lyophilized powder. Both are applied subcutaneously.
Gonal F is the reference medication, approved by ANVISA, registered in the Gonadotrophic Hormone category.
These are hormones naturally produced by the body, more specifically in the pituitary gland. The brain region produces 3 types of hormones related to the activities of the gonads and sexual organs, which are FSH (follicle stimulating hormone), LH (luteinizing hormone) and LTH (prolactin hormone).
For many women, especially those who want to get pregnant or understand more about the menstrual cycle, these hormones are already familiar. This is because they are part of the regulation of the menstrual cycle as well, participating in the follicular phase, ovulation and, if there is fertilization, the development of pregnancy and lactation.
Specifically, FSH, in women, acts by promoting the proliferation of ovarian follicular cells and also by stimulating the secretion of another hormone called estrogen. In men, this hormone also has important functions, participating in spermatogenesis, that is, sperm production.
As the substance Alfafolitropina is a formulation of the human FSH hormone, produced in the laboratory by means of recombinant DNA technology, the use of the drug is, in general, to treat some conditions related to fertility, both in women and in men.
In the case of recombinant FSH, the preparation takes place by the expression of DNA and its codes, resulting in substances similar to those produced by the body, capable of simulating the hormonal action.
Thus, the treatment that uses mechanisms related to follicle stimulating hormone (FSH) has been used for a long time for ovarian stimulation or in vitro fertilization .
What is Gonal medicine for?
The drug Gonal F is used to treat some conditions related to the natural control of reproduction, and it can be indicated for women or men who want to have biological children, but have some dysfunction.
According to the package insert, the indicated tables are:
Women who are not ovulating
In women patients who are not ovulating (when there is no egg release) or who do not respond to treatment with clomiphene citrate (medication indicated for the treatment of woman’s infertility due to anovulation), Gonal F is used to stimulate ovulation.
Follicle production in assisted reproduction techniques
In assisted reproduction procedures, when there is an impossibility or problems for natural fertilization, Gonal F can be indicated for the production of several follicles.
The release of eggs depends on the follicles, which are structures that are stimulated by hormones and come off the ovary with each menstrual cycle. This process of follicular release is called ovulation. Therefore, the follicles are essential for fertilization to take place.
Assisted reproduction procedures can be, for example, in vitro fertilization (fertilization is carried out in the laboratory and the embryos are placed in the uterus), intra-gamma transfer of gametes (placement of gametes in the fallopian tubes) or intra-phalanx transfer of zygotes (placement of zygotes in the fallopian tubes).
Follicular stimulation in women with severe LH and FSH insufficiency
Gonal F can be indicated for stimulation of follicular development when the woman has no ovulation due to the low rate of follicle stimulating hormones (FSH) and luteinizing hormone (LH) by the pituitary gland.
In these cases, Gonal F is used in combination with another hormonal medicine called alfalutropine.
Sperm production in infertile men
Men can also be treated with Gonal F. In conditions where there is infertility due to low hormone production, the drug is used in combination with human chorionic Gonadotropin (hCG) to stimulate sperm production.
Under the same conditions, they can also be used for men diagnosed with congenital or acquired hypogonadotrophic hypogonadism. This condition, in men, is characterized by insufficient or inadequate production of hormones (testosterone) or sperm.
How old is Alfafolitropin?
The active substance alfafolitropina, after the application, is distributed in the extracellular space, being that after the repeated administration, it triples its accumulation in the organism and reaches a balance in, approximately, 3 to 4 days.
In general, the package insert indicates that, in women, the main action of the drug is the development of mature Graaf follicles (that is, that are in the last stage of maturation).
In men, treatment associated with hCG results in induction of spermatogenesis (sperm production).
How to apply Gonal with pen?
Patients undergoing treatment with Gonal F can receive guidance and medical training to use the medication at home, as, in general, daily applications are necessary.
The pen facilitates the administration of the subcutaneous solution, being manufactured to make the process more comfortable and safe.
However, only after receiving guidance from health professionals is it possible to carry out applications at home.
The package insert instructs that the dosage is always checked on the marker, making sure that the number of units is in accordance with the medical prescription. Only the professional can determine the dosage, time and frequency of application.
It is also very important to follow the guidelines as to the places of application, making the correct cleaning with alcohol before the procedure.
In general, after verifying that the dosage is correct and cleaning your hands and the application site, just make a skin fold with one hand and, holding the pen firmly with the other hand, insert the entire needle into the skin.
After that, it is necessary to press the entire dose adjustment button, causing the medication to be injected. Without releasing the button, it is necessary to keep the needle for another 10 seconds inserted in the skin and then it can be removed carefully.
To ensure that all the necessary medication has been applied, it is necessary to confirm on the dosage indicator that the marker is at “0” (zero).
The needle (which is disposable and easily replaced) must also be removed from the pen and discarded in an appropriate place. To do this, simply unscrew carefully.
In case of administration errors or any other doubts, the responsible medical team must advise on the necessary procedures.
What are the side effects?
Just like any other medication or treatment, the use of Gonal F can trigger bothersome or serious adverse effects.
The presence of any symptoms should always be reported to the professionals who accompany the treatment, as only medical analysis can assess the need to interrupt or continue the treatment.
The use of Gonal F can trigger serious adverse effects, although some are rare, both in men and women. Among them is the allergic reaction, manifested with rashes, red skin, hives, swelling on the face with difficulty breathing.
In addition to these, some serious reactions are reported only in women undergoing treatments, such as Ovarian Hyperstimulation Syndrome (OHSS). The condition causes pain in the lower abdomen that manifests with nausea or vomiting.
The occurrence is of common frequency and is due to large cysts that appear when there is an overreaction of the ovaries to the treatment.
OHSS can become severe with a marked increase in the volume of the ovaries, decreased urine production, weight gain, difficulty in breathing and / or possible accumulation of fluids in the abdomen or chest.
In rare cases, complications resulting from OHSS may occur, such as torsion of the ovaries or formation of blood clots, which can still result in thromboembolic events independent of OHSS.
In such cases, complications can cause chest pain , shortness of breath, stroke (stroke) or heart attack.
Common and very common adverse symptoms in women
Among the side effects listed in the package insert that can occur commonly are:
- Abdominal pain;
- Motion sickness;
- Abdominal cramps;
- Abdominal distension.
The very common adverse reactions listed on the package insert are:
- Fluid pockets in the ovaries (ovarian cysts);
- Injection site reactions such as pain, redness, bruises, swelling and / or irritation.
Common and very common adverse symptoms in men
The package insert highlights that some side effects are reported in a common and very common way in men. Very common ones include reactions at the injection site, such as pain, redness, bruises, swelling and / or irritation.
Gonal gets fat?
The package leaflet for the drug indicates that there may be an increase in weight as a side effect of treatment. Thus, due to Ovarian Hyperstimulation Syndrome (OHSS), women can gain weight – even quickly.
It is also possible that there is weight gain or loss due to factors secondary to the treatment, such as changes in appetite, anxiety or fluid retention.
It is worth mentioning that each organism can react differently to treatments and substances. Thus, any reaction or symptom that arises after the use, immediately or late, of Gonal F must be informed to the professional who accompanies the condition.
Does Gonal sleep?
In the package insert there is no mention of the drowsiness or lethargy caused by the use of Gonal F. However, it is important to pay attention to other factors that may be triggering excessive sleep.
How to store the medicine?
As indicated in the package insert, Gonal F should be stored refrigerated between 2 ° C and 8 ° C, protected from light. It is very important that the medicine is not frozen or exposed to very high temperatures.
Within the expiration date, the pen can be kept below 25ºC for up to 28 days, as long as it is protected from light, and discarded after that time.
After the date of manufacture, the substance is valid for 24 months. Therefore, before using Gonal F, it is essential to consult the batch (date of manufacture) that appears on the packaging.
Price and where to buy?
The Gonal F can vary in price according to the amount and dosage units. On average, its price varies from R $ 189 *.
The approximate value of each presentation is:
- Gonal f 75UI, box with 1 vial with powder for solution for subcutaneous use + syringe with 1mL of diluent : between R $ 189 to R $ 217 *;
- Gonal f 300UI, box with 1 applicator pen with 0.5 ml of solution for subcutaneous use : on average, R $ 780 *;
- Gonal f 450UI, box with 1 applicator pen with 0.75mL of solution for subcutaneous use : on average, R $ 1,165 *;
- Gonal f 900UI, box with 1 applicator pen with 1.5 ml of solution for subcutaneous use : on average, R $ 2,330 *.
Does SUS provide Alfafolitropin?
No. The Unified Health System offers some centers specialized in assisted human reproduction, in which it is necessary, in general, to register in the queue and wait for other referrals.
However, not all drugs indicated for treatment are provided by SUS, as is the case with Alfafolitropina.
However, just like any other high-cost medication, it is possible that the person with a medical indication for treatment will resort to legal means to try to pay for the treatment. In such cases, it is recommended that patients seek legal support to know the necessary procedures.
Among the requirements for the judicialization of medicines is the delivery of some documents, which include medical reports, prescriptions and the budget of 3 different pharmacies.
How to budget Gonal F?
Patients who are going to file a court order for Gonal F (alpha-olitropine), or other high-cost medications, can count on the assistance of the high-cost medication quotation advisory, from the Consulta Remedios group.
To do this, simply access the link and fill in the data. In a simple and personalized way, patients receive budgets for the conduct of the judicial process.
Changes in the reproductive system can lead to pregnancy difficulties, delaying or preventing men and women from having biological daughters or sons.
In such cases, the correct diagnosis is very important so that treatments can be properly recommended. Some medication options can be used, aiming to treat changes in women and men, which, finally, favors fertilization.
This is the case of Gonal F, an injectable drug based on the active substance Alfafolitropina, produced and marketed by the pharmaceutical industry Merck.
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