Myelodysplastic Syndrome is a condition that has a high impact on the routine, health and well-being of patients.
Although treatment options are growing, so that they provide more quality of life to patients after diagnosis, the picture is quite complex and needs to involve an individual analysis, carried out by specialist hematologists and oncologists.
Only in this way is it possible to lead patients to the correct treatment.
There are some therapeutic categories chosen according to the treatment status and progress. Among the options are bone marrow transplantation, blood transfusion, chemotherapy and biological therapies.
Remembering that they are not necessarily exclusive. Therefore, many people can be guided to the combination of treatments.
Vidaza is a medicine belonging to the biological therapy group. According to the Brazilian Association of Lymphoma and Leukemia , this type of treatment differs from chemotherapy in that it acts and affects cells in another way.
Learn more about Vidaza and its action on the body:
- 1 What is Vidaza?
- 2 What is Vidaza for?
- 3 How is the application of Vidaza subcutaneous?
- 4 How does azacitidine age?
- 5 What are the side effects on the package insert?
- 6 Is there any contraindication for use?
- 7 At what temperature should I keep Vidaza?
- 8 What is Vidaza 100mg price?
- 9 Is Vidaza generic?
- 10 Does SUS provide Azacitidine?
- 11 How to make a budget of Vidaza?
What is Vidaza?
Vidaza is an injectable drug of the cytotoxic class, for subcutaneous use, based on the active substance azacytidine. Its use is indicated for the treatment of myelodysplastic syndrome, under specific conditions.
According to the Instituto Oncoguia, the active ingredient azacitidine is a hypomethylating agent, which acts to control and decrease the activity of genes that promote cell growth. In addition, it also acts by destroying cells that exhibit abnormal behavior and divide in an accelerated way.
The result of the treatment, according to Oncoguia, is an improvement in blood count (normalization of the rate of blood cells), reducing the risks associated with the worsening of the disease and being able to prolong the life of patients.
Some diagnosed people need to have a blood transfusion as part of the treatment. However, with the use of Vidaza, if the increase in the rate of red blood cells is sufficient, there may be a reduction in the need for blood transfusions.
In addition, its action tends not to significantly affect normal, or non-proliferative, cells in the body. This means that the symptoms and side effects may be much less compared to other therapies.
However, like any medication, there can be adverse effects, but in general, they tend to be less intense.
The treatment is done, initially, with subcutaneous applications daily, for 7 days, as indicated by the doctor and the package insert. This time corresponds to a treatment cycle.
As a general protocol, at least between 4 and 6 cycles are indicated, and after completing the 7 days of application, it is necessary to wait 4 weeks to start another one.
The continuity of treatment must be assessed by the medical team, who can continue it as long as there are health benefits for the person being treated.
What is Vidaza for?
Vidaza is indicated to treat patients with subtypes of Myelodysplastic Syndrome (MS), a set of hematological malignancies, which start due to changes in the bone marrow. Thus, blood components begin to show changes in production and maturation, affecting other functions of the body.
Bone marrow is a tissue, also known as marrow, that is located inside the bones. Its function is the production of cells and blood components.
The main functions of each component are:
- White blood cells : responsible for the defense of the organism;
- Red blood cells : responsible for the transport of oxygen;
- Platelets : responsible for blood clotting.
Under normal conditions, the bone marrow produces healthy cells and, after they mature, releases them into the bloodstream. That is, to perform their functions correctly, cells must be adults.
However, with a cellular alteration, the bone marrow presents irregular and very young cells (called blasts), which are unable to perform their functions correctly.
Currently, the classification of myelodysplastic syndromes is made based on the formulated and updated system of the World Health Organization (WHO). Since 2008, the date of the last update, 7 categories have been distinguished, which consider immunophenotyping, genetic, clinical, cytomorphological and cytochemical findings.
However, not everyone is indicated for treatment with Vidaza. According to the package leaflet, the types oriented to the use of Vidaza are:
Refractory anemia SM with excess blasts or AREB
In the case of refractory anemia with excess of blasts (immature cells), one or more types of cells have reduced concentration in the blood and appear abnormal in the bone marrow, which can vary between 5% to 20%.
According to the new WHO classification, adopted in 2001 and updated in 2008, between 5% and 10% of blasts in the bone marrow, the condition is considered as AREB-1. Between 10% and 20%, AREB-2 is considered.
Patients with acute myeloid leukemia, with 20 to 30% of bone marrow blasts with multilineage dysplasia, may be referred for treatment with Vidaza.
Acute myeloid leukemia (AML) is characterized by a high production of blasts, which in this case are immature white cells. According to ABRALE, this means that they are unable to perform their functions correctly and leave the body susceptible to infections.
As they begin to accumulate in the bone marrow, blasts prevent other cells from being produced correctly.
Chronic myelomonocytic leukemia
According to Oncoguia, Chronic Myelomonocytic Leukemia (LMMC) is a cancer that originates in the bone marrow, more specifically in the cells that form blood components.
In such cases, there is a high concentration of monocytes (a type of white blood cell) in the blood. There is usually the presence of abnormal cells in the bone marrow, but the amount of blasts (which are immature cells) in the bone marrow is limited to 20%.
How is the application of Vidaza subcutaneous?
Vidaza is an injectable medicine, which must be applied subcutaneously. The administration sites, according to the package insert, include the arm, thigh or abdomen. It is worth remembering that, normally, each treatment cycle includes a daily injection, for 7 consecutive days. Therefore, it is important to rotate, avoiding application in the same places.
Therefore, a distance of 2.5 cm from the last injection must be respected. In addition, the medication should not be injected if there is pain, bruising (purple spots), redness or hardening in the area.
The application must always be made by health professionals, in appropriate environments, duly qualified for them.
How does azacitidine age?
The package insert indicates that azacitidine has antineoplastic action through multiple effects, which include cytotoxic action (destruction of diseased or abnormal cells) and hypomethylation (reduced ability to replicate genes). Thus, the substance favors the reorganization of tumor suppressor functions in cancer cells.
In general, the treatment has been shown to increase patient survival, in addition to reducing the effects and symptoms triggered by myelodysplasias.
In patients undergoing blood transfusion, which meet the indications for using the substance, azacitidine can reduce the need or frequency of the procedure.
What are the side effects on the package insert?
During treatment with azacitidine, it is important that patients undergo periodic examinations and have medical follow-up, as it is possible for conditions to occur:
- Neutropenia (reduced concentration of neutrophils, a type of white blood cell);
- Thrombocytopenia (reduced concentration of platelets, responsible for blood clotting);
- Anemia (reduced hemoglobin concentration, responsible for the transport of oxygen).
The package insert also informs which are the most common and common adverse reactions, listed in clinical studies and also after the drug has been commercialized. Are they:
Very common adverse reactions
- Febrile neutropenia (febrile conditions in people with reduced neutrophils);
- Neutropenia (low concentration of neutrophils in the blood);
- Leukopenia (reduction in the rate of leukocytes in the blood);
- Thrombocytopenia (reduction in the rate of platelets in the blood);
- Anorexia or decreased appetite;
- Hypokalemia ;
- Headache ( headache );
- Dyspnea (shortness of breath);
- Epistaxis (nosebleed);
- Diarrhea ;
- Abdominal pain;
- Rash (reddish patches or patches on the skin);
- Itching (itchy skin);
- Arthralgia (joint pain);
- Musculoskeletal pain;
- Weight decrease.
There may also be reactions at the application site, such as pain, bruising (purple spots on the skin) and localized reaction.
Frequent adverse reactions
- Sepsis , including bacterial, viral and fungal (generalized infection);
- Because neutropenia;
- Respiratory tract infection (includes upper respiratory tract and bronchitis);
- Infection of the urinary tract;
- Cellulite ;
- Diverticulitis ;
- Oral fungal infection;
- Sinusitis ;
- Herpes simplex;
- Skin infection;
- Pancytopenia (decrease in all elements of the blood);
- Bone marrow failure;
- Anxiety and confusion;
- Syncope (fainting);
- Ocular or conjunctival hemorrhage;
- Pericardial effusion;
- Hypertension or hypotension;
- Pleural effusion;
- Dyspnea on exertion;
- Pharyngolaryngeal pain;
- Dyspepsia ;
- Purple (spots on the skin);
- Erythema (vasodilation that causes redness of the skin);
- Macular cutaneous rash;
- Muscle spasms;
- Myalgia (muscle pain);
- Renal insufficiency;
- Elevated serum creatinine .
Reactions may also occur at the application site, such as the appearance of purple spots (bruises), induration, itching (itching), inflammation, discoloration and lump.
Is there any contraindication for use?
Yes. Vidaza is contraindicated for patients with hypersensitivity, or allergy , known as azacytidine or mannitol.
People with advanced malignant liver tumors are also contraindicated to use.
At what temperature should I keep Vidaza?
The package insert indicates that un reconstituted vials (ie, closed containers of Vidaza) should be stored at room temperature, between 15ºC and 30ºC.
The substance, after being opened and reconstituted with water for injections for subcutaneous administration, can be stored, immediately after preparation, for up to 1 hour at 25ºC or for up to 22 hours between 2ºC and 8ºC.
It is worth remembering that the handling, preparation and other care must be done by responsible persons, duly qualified to handle and apply medications.
What is Vidaza 100mg price?
The price of Vidaza can be consulted in online search engines or in special pharmacies, focused on the supply of high-cost drugs.
On average, the value of Vidaza 100mg / 200mg, box with 1 vial with 200mg of powder for solution for subcutaneous use is between R $ 1,755 and R $ 2,127 *, and a generic version Azacitidine.
* Average price consulted in January 2020. Prices may change.
Is Vidaza generic?
No. Vidaza, from the manufacturer United Medical, is the reference medicine, according to the 2019 Anvisa list.
But the active substance has a generic version, which is from the same laboratory. The Azacitidine United Medical has approximately R $ 1,490 *.
In addition, the manufacturer Doctor Reddy’s sells the similar drug, Winduza , with prices starting at approximately R $ 1,510 *.
* Prices consulted in January 2020. Prices may change.
Does SUS provide Azacitidine?
No. The drug is approved by Anvisa, but it is not distributed by the Unified Health System. However, people who have a medical indication for use can resort to legal means to have the treatment paid for, either by the SUS itself or by health plans. .
For this, it is necessary that the doctor who assists the person provides the necessary guidance, referring him to the proper procedures.
It is also important to have legal assistance, which will indicate which documents are necessary for the process. Among them are the medical report, medical prescription, corroborative exams and the medication budget.
It is worth mentioning that the opening of the legal process does not guarantee the cost of treatment.
How to make a budget of Vidaza?
People who are going to apply for Vidaza in court, whether applying for SUS or health insurance, need to present a budget with the price of the drug in 3 different pharmacies.
For that, it is possible to request the value in special pharmacies or – to assist in the procedure – count on the advice of quotation of high-cost medicines, from the Consultation Remedies Group.
Just access the link and fill out the form. Simply, the responsible team will send the personalized quote.
Vidaza is a drug indicated for the treatment of specific myelodysplastic syndrome. Its administration is by subcutaneous injection, which must always be done by trained people and in appropriate environments.
Myelodysplastic syndromes are currently the most prevalent hematological neoplasia. According to the Brazilian Society of Geriatrics and Gerontology, in the USA alone, about 30 thousand to 40 thousand new cases occur each year in people over 70 years of age.
The pathophysiological mechanisms of the disease are still poorly understood, but the picture in general involves cytogenetic changes and / or genetic mutations.
After diagnosis, not all diagnosed people need treatment, and some cases are only followed up and monitored with periodic examinations.
Thus, generally, only when there are observable symptoms or aggravated changes in blood cells do treatments begin.
Among the drug options is Vidaza, a drug based on Azacitidine, which has shown improvements in the quality of life and well-being of patients undergoing treatment.
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