According to information from Hospital Sírio Libanês, hormone therapy (use of medications or treatments that interfere with hormone production) is one of the ways that can be used in the treatment of breast cancer .
Its use, in general, tends to have more effective effects in patients who have already gone through menopause , which is the last menstruation (either natural or artificially induced).
In cases where the diagnosis identifies that the cancer is stimulated by the action of hormones, medications such as Fulvestranto can be effective, as long as the patient meets the criteria for use.
Do you want to know more about the medication and its effects? I see the text below.
- 1 What is Fulvestranto?
- 2 What is hormone therapy?
- 3 What is the medicine for?
- 4 How to use intramuscular fulvestranto according to the package insert?
- 5 What side effects can Fulvestranto cause?
- 6 Does the medication have contraindications?
- 7 Fulvestranto fattening?
- 8 Generic fulvestranto and reference: which one to choose?
- 9 What is the price of Fulvestranto?
- 10 Does SUS provide?
- 11 How to make a budget of Fulvestranto?
What is Fulvestranto?
Fulvestranto is the active ingredient of some intramuscular injectable drugs, indicated for women with post-menopausal breast cancer under specific conditions.
The substance is part of the hormone therapy category and can be used alone or in conjunction with another medication called palbocyclib. According to the package insert, its action is to block the growth of estrogen-sensitive breast cancer, which is the hormone involved in the development of many breast tumors.
According to Oncoguia, the drug works by blocking estrogen receptors, causing them to be temporarily eliminated from the body.
Treatment with Fulvestranto can be indicated in metastatic conditions (which have spread throughout the body) or not (locally advanced), in women who have already undergone previous therapies.
Despite the good results, as well as other hormonotherapies, it can cease to be effective, requiring a medical reassessment and, possibly, the exchange of the medication.
What is hormone therapy?
Among the options available to treat cancers is hormone therapy. This category refers to the set of medications that act by blocking or interfering with hormone production.
Hormones are molecules that act in coordinating the development and functioning of various systems in the body. They are produced by several glands and neurons, triggering actions and done throughout the body.
Estrogen is the hormone produced primarily by the ovaries and which are involved in the development of female sexual organs and menstrual regulation. However, some cases of breast cancer can be affected by estrogen.
Thus, hormone therapy is only indicated when the diagnosis indicates that the body’s own hormones are part of tumor growth.
Therefore, one of the ways to control or treat the disease is by inhibiting or eliminating the production of hormones. In general, there are two mechanisms for this, which are by reducing the concentration of hormones or by blocking their action in cells, encouraging them to proliferate.
There are several drugs that can be used, the choice of which depends on clinical analysis and medical history.
Even with good results at the beginning, Oncoguia points out that, in most cases, hormone therapy stops taking effect, even though it may take many years. When it occurs, normally, the option is to change the medication, which may lead to chemotherapy.
What is the medicine for?
According to the package leaflet, Fulvestranto is indicated to treat women of any age with some specific conditions of breast cancer.
Patients diagnosed with locally advanced or metastatic breast cancer, who have already gone through menopause and have been previously treated with an antiestrogen can receive the medication.
That is, women who have already completed their reproductive phase (had their last menstruation), which can be naturally or induced, and who have received previous treatment with estrogen inhibitors or blockers.
In addition, the substance can be combined with palbobiblib when the patient is diagnosed with a disease that is positive for the hormone receptor (RH) and negative for the receptor for human epidermal growth factor 2 (HER-2) and that has already received endocrine treatment.
How to use intramuscular fulvestranto according to the package insert?
Fulvestranto is an injectable medication, applied intramuscularly. It is marketed in syringes of normally 5mL of solution for injection, containing 250mg of the active substance Fulvestranto.
The instructions guide that its use must be made in the region of the buttocks, always administered by people of the health area, properly trained, and in an adequate environment. This is because the substance needs to follow the guidelines for the application of large intramuscular injection.
The package insert also advises that, if it is impossible for the person being treated to receive the application on the scheduled date, the use can be made flexible up to 3 days before or after the date.
Regarding the dosage, in general, the package insert states that the recommended dose is 500mg of Fulvestranto with 1 monthly application, and 2 weeks after the first administration, a booster dose should be done, according to medical advice and supervision.
It is also advised that the total amount of substance should be applied in two injections, each in one buttock.
The interval between administrations, dosage and all other care and guidance should be clarified with the health team that assists patients.
If the patient is going to undergo combined treatment with Fulvestranto and palbocyclib, it is necessary to observe the instructions for use of this medication, being attentive to medical guidelines regarding therapeutic specifications.
What side effects can Fulvestranto cause?
The use of medications can cause side effects, although they will not necessarily occur. In any case, when they occur, it is important to emphasize that the frequency and intensity of the manifestations can vary in each case.
In the package insert, it is possible to find the adverse reactions reported and notified with the administration of the drug. Among them are:
Very common reactions
Common reactions are listed based on adverse events that occur in 10% or more of the people monitored who use the drug. The following reactions are listed:
- Reactions at the injection site, which may include a more severe sciatic reaction such as neuralgia (pain in one or more nerves);
- Peripheral neuropathic pain (pain that occurs due to disease or nerve damage) related to the injection site;
- Astenia (weakness);
- Elevation of liver enzymes observed in blood tests (ALT, AST, ALP);
- Hypersensitivity reactions (allergic reactions);
- Arthralgia (joint pain);
- Musculoskeletal pain, which may include back pain (back pain), myalgia (muscle pain) and pain in the extremities;
- Rash (skin lesions with redness);
- Heat waves.
Common reactions are those that have been reported between 1% and 10% of people who received treatment with the drug. The package insert indicates the following reactions:
- Headache (headache);
- Increased bilirubin (pigment produced by the liver);
- Reduced platelet count (blood cells responsible for clotting);
- Diarrhea ;
- Anorexia (loss of appetite);
- Urinary tract infections.
Does the medication have contraindications?
Yes. Fulvestranto is not indicated for women with known hypersensitivity to the active substance or to any excipient present in the formulation. In addition, pregnant patients who are breastfeeding or have severe hepatic impairment should inform their doctor of these conditions before starting treatment.
According to the package leaflet, these pictures represent special conditions and deserve attention regarding the therapeutic evaluation.
There is no indication or mention in the package insert about weight gain. Although not directly, what can occur is weight reduction, as among the reported adverse effects are nausea and loss of appetite.
In such cases, it is possible that the treatment interferes with the patient’s normal diet, causing weight reduction by secondary factors.
However, it is possible that there is a change in diet or lifestyle during treatment (for example, reduced physical activity or anxiety ), which can lead to weight gain.
Generic fulvestranto and reference: which one to choose?
The reference brand of the active substance Fulvestranto is Falsodex, from Astrazeneca. In addition to this, there are generic and similar interchangeable options.
It is worth mentioning that the choice or change of medication should only be made with medical guidance, after assessing the risks and benefits, also considering the clinical condition of each patient. Therefore, only the medical team can determine the best option.
Learn more about some of the options available:
The pharmaceutical company Doctor Reddy’s markets Fulvestranto Doctor Reddy’s, which is one of the generic options of the drug. It was registered in April 2018, in the antineoplastic category.
The brand also markets the Eranful, registered in August 2018, in the category of interchangeable similar.
Eurofarma produces and markets the Seletiv brand, a similar interchangeable product of Faslodex (reference medicine, from the Astrazeneca brand). The product was registered in May 2015.
In addition, there is also a generic version, which is the Fulvestranto Eurofarma.
One of the similar drug options interchangeable with Faslodex is Supreniq, from the company Teva, registered with ANVISA in January 2018.
Libbs sells one of the similar interchangeable versions of Faslodex, which is Poemmy, a drug registered with ANVISA in June 2018.
Sandoz markets one of the generic options for Faslodex, which is Fulvestranto Sandoz. The drug was registered in August 2018 with ANVISA.
What is the price of Fulvestranto?
The substance Fulvestranto can be found or consulted in physical pharmacies or online specialized dispensing of special drugs. On average, prices are from:
- Faslodex 250mg/5mL: R$4.051 a R$7.875*;
- Fulvestranto Doctor Reddy’s 250mg: R$1.405 a R$3.957*;
- Seletiv 50mg / mL, box with 5mL of solution : R $ 2,300 to R $ 2,800 *;
- Supreniq 50mg / mL, box with 5mL of solution : R $ 2,898 to R $ 4,800 *;
- Vequile 50mg / mL, with 5mL : R $ 2,050 to R $ 2,802 *.
* Prices consulted in January 2020. Prices may change.
Does SUS provide?
No. The active substance Fulvestranto is not yet part of the list of drugs distributed by the Unified Health System (SUS) for the treatment of cancer.
However, if there is a medical prescription for the use of this medication, and proof that the patient cannot afford the treatment costs, it is possible that the Justice will be called upon to try to pay for it by the State.
In such cases, it is recommended that there be assistance from lawyers or legal support centers to initiate the judicial process. In addition, the medical team itself must provide guidance on protocols and referrals to patients.
In general, the guideline is that an application be made at the Health Department, within the state or municipality, requesting the medication. If there is a denial on the part of the body, it is possible to appeal to the Legal Power.
It is necessary to find out if there are specific criteria or requests for opening the health application, according to the state or municipality in which the process is taking place. However, according to Oncoguia, the documents that are generally needed include:
- Proof of address.
- SUS card.
- Examination reports that prove the existence of the disease.
- Medical report containing the identification of the disease, with the specification of the ICD (International Classification of Diseases);
- Proof that the patient tried to obtain the drugs through administrative means or news published in the press that the medication is missing.
- Budget of the prescribed treatment. This helps the Judiciary to determine, in case of non-compliance with any decision, the sequestration of necessary funds.
How to make a budget of Fulvestranto?
The budget for 3 different pharmacies must be submitted with the rest of the documentation. This process can be carried out through consultations with special pharmacies or, to facilitate the search, through the consultation of quotations on high-cost medicines, from the Consulta Remédios group.
To do so, simply access the link and complete the registration. In a short time, a personalized quote from Fulvestranto or any other high-cost medication will be sent.
Treatments have increasingly evolved and provided better results in well-being and quality of life. Even so, the disease has major impacts on the health of the population.
Treatments called hormone therapy are advances made possible by a correct diagnosis, which identifies specific markers to some types of the disease, such as those that are sensitive to hormones.
The drug Fulvestrate is an example of an option for women who fall into this group.
Do you want to know more about cancer care, treatments and guidelines, women’s health and general health? Keep an eye on the Healthy Minute!