Blood is made up of cells that are important for maintaining organic function. Among them are platelets, a colorless component that participates in blood clotting.
This means that regular rates of platelets (or thrombocytes) are critical to prevent bleeding and bleeding.
Not always, when there is a low platelet count, the person has symptoms or health problems, but very high levels of thrombocytopenia (low platelet count) can trigger problems and need treatment.
Some conditions that cause this change can be controlled with the use of the medicine Revolade. Learn more about the indications and how to use it:
Contents
What is Revolade Novartis?
Revolade is an oral medication based on the active substance eltrombopague olamine, marketed by the pharmaceutical industry Novartis. The product is registered by ANVISA and can be found in coated tablets of 50mg and 25mg.
It is a thrombopoietin receptor agonist used to treat thrombocytopenia, which is the very low rate of platelets in the blood.
Its use is indicated for specific cases of adults or children over 6 years with idiopathic thrombocytopenic purpura of immune origin.
In addition, adult people with low blood cell counts due to acquired Severe Aplastic Anemia (ASA) may also receive guidance on how to receive the medication, according to their medical history and responses to previous treatments.
What is the medicine Revolade for?
According to the package insert, Revolade is used to stimulate the production of platelets, increasing their concentration in the blood. Thus, the drug is indicated in specific cases of the following conditions:
Idiopathic thrombocytopenic purpura of immune origin
The drug is indicated for adults or children over 6 years of age who suffer from idiopathic thrombocytopenic purpura of immune origin and who have received previous treatment with corticosteroids, immunoglobulins or who have had their spleen removed, but still have not responded to treatment and are at increased risk of bleeding and bleeding.
This condition is characterized by a low platelet count, also called thrombocytes. They are blood cells produced in the bone marrow and that participate in blood clotting.
In general, people who suffer from immune thrombocytopenia have skin with red spots (petechiae) or purple. In addition, there are bruises and a higher occurrence of bleeding, including mucous membranes, such as the mouth and nose.
Low blood cell counts caused by severe Aplastic Anemia (ASA) acquired
In adults, Revolade can be indicated when there are low blood cell counts due to Acquired Severe Aplastic Anemia (ASA), under specific conditions.
Are they:
- As long as there has been no response to previous immunosuppressive therapy;
- When the person has received many treatments and are not eligible for bone marrow transplantation (hematopoietic stem cell transplantation).
Aplastic anemia is a disease characterized by reduced blood cell production, which can be all of them (global) or just one type (selective).
In some cases, the condition is due to genetic factors, but this condition is more rare. Generally, the causes of aplastic anemia are exposure to chemical agents or infections.
How does the package insert indicate using Revolade?
Depending on the package insert, Revolade should be taken at least 2 hours before or 4 hours after any other product, be it food or other medications. For example:
- Antacids (medicines for digestion / stomach);
- Mineral supplements, containing polyvalent cations (aluminum, calcium, iron, magnesium, selenium and zinc);
- Dairy products (milk, cheese, butter).
However, the drug can be taken with foods that contain little (less than 50mg) or, preferably, no calcium.
The dosage, time and any other recommendation regarding the form of use must be guided by the professional who accompanies the picture.
In general, for the treatment of idiopathic thrombocytopenic purpura, the maximum daily dosage should not exceed 75mg. For the treatments of Severe Aplastic Anemia, the maximum dosage should not exceed 150mg per day.
What are the side effects?
Like any other medication, the use of Revolade can trigger undesirable adverse reactions. This does not mean that all people undergoing treatment will be affected, but it is always necessary to inform the medical team if they occur, as they can sometimes be serious.
The most reported side effects vary depending on the conditions treated:
Adverse reactions in the treatment of idiopathic thrombocytopenic purpura
According to the package insert, the collateral symptom reported in studies of people with idiopathic thrombocytopenic purpura in a very common form is back pain .
The Commons include:
- Blood clots (thromboembolic events);
- Feeling sick (nausea);
- Diarrhea ;
- Opaque lens in the eyes (cataract);
- Dry eyes;
- Unusual hair loss or thinning;
- Spots on the skin;
- Itch;
- Muscle pain, muscle spasms;
- Bone pain;
- Tingling or numbness in the hands or feet;
- Intense menstrual cycle or period;
- Sores ( thrush ) in the mouth.
In addition, when doing blood tests (which are usually needed during treatment), it is common for the following changes in results to be observed:
- Increase in liver enzymes (aspartate and alanine transaminases);
- Increased levels of bilirubin (a substance produced by the liver);
- Increased levels of some proteins.
Adverse reactions in the treatment of Severe Aplastic Anemia (ASA)
Below are the adverse reactions reported in the treatment of severe aplastic anemia. Very common symptoms include:
- Insomnia;
- Headache , dizziness;
- Cough, dyspnoea (difficulty breathing), oropharyngeal pain, rhinorrhea (excessive runny nose);
- Abdominal pain, diarrhea, nausea;
- Increase in transaminases;
- Bruise (purple spots on the skin);
- Arthralgia, muscle spasms, pain in the extremities;
- Fatigue, febrile neutropenia, pyrexia (fever).
Among the adverse symptoms that occur in common frequency are:
- Neutropenia, infarction of the spleen;
- Iron overload, decreased appetite, hypoglycemia, increased appetite;
- Anxiety, depression;
- Syncope (fainting);
- Dry eye, itchy (itchy) eye, cataract, eye jaundice, blurred vision, visual impairment, vitreous flakes;
- Epistaxis (bleeding or nosebleed);
- Gingival bleeding, blisters on the mucosa, oral pain;
- Vomiting, abdominal discomfort, abdominal pain, constipation, bloating, dysphagia, discolouration of stools;
- Swelling on the tongue;
- Disturbance of gastrointestinal motility, flatulence;
- Increased serum bilirubin (hyperbilirubinemia), jaundice (yellow skin and eyes);
- Petechiae (bleeding under the skin that causes small reddish spots), rash, itching, hives, rash, macular rash;
- Back pain, myalgia, bone pain;
- Chromaturia (change in urine color);
- Asthenia (reduced strength), peripheral edema, chills, malaise;
- Increased blood creatine phosphokinase.
Is Revolade approved by ANVISA?
Yea! Novartis’ Revolade has been registered and approved in Brazil by ANVISA since February 2017. The drug is in the therapeutic class of Thrombopoietin Agonists, in dosages of 25mg and 50mg.
What is the price of Revolade 25mg and 50mg?
Revolade can be found in two different dosages. The price may vary according to the city or pharmacy that provides the medication, but the approximate value is:
- Revolade 25mg , box with 14 coated tablets: R $ 2,068 to R $ 2,422;
- Revolade 50mg , box with 14 coated tablets: R $ 4,259 to R $ 4,845.
* Prices consulted in May 2020. Prices may change.
Does Revolade have generic?
No. Revolade is a drug based on the active substance eltrombopague olamine which, until now, has only been produced and marketed by the pharmaceutical industry Novartis.
Eltrombopague Olamina tem no SUS?
Revolade was evaluated by the CONITEC Report, which guided the incorporation of the substance in the Unified Health System, in December 2018, for the treatment of idiopathic thrombocytopenic purpura, in patients who meet the criteria stipulated by the therapeutic protocol.
Patients who have a medical indication for the use of the medication, but for some reason do not have access to the medication due to a SUS refusal, may resort to judicial means to try to obtain the cost of treatment through the State.
For this, it is necessary to seek assistance services in the judicialization of medicines. In general, it is necessary to present a series of documents, such as the medical report, exams and the budget of 3 different pharmacies.
How to get Revolade for health insurance?
As in the SUS, people with a medical indication for the use of Revolade can file a lawsuit to try to pay for the treatment by the health plan, when they are clients of one.
The procedure is basically the same, requiring the assistance of legal advisors for the correct conduct of the process.
However, it is worth remembering that the drug is not part of the ANS’s mandatory minimum coverage list and, therefore, the process will be judged, with or without granting the person the right to receive free treatment by the health plan.
How to budget Revolade?
People who have received a medical indication for treatment with Revolade and who do not meet the protocol criteria or are not receiving from SUS, may resort to legal channels to try to pay for the treatment.
Both in the case of the Public Health System and in health plans (private companies), it is possible to seek legal assistance. In these cases, a series of documents must be delivered at the opening of the process, including Revolade’s budget in 3 different pharmacies.
In order to facilitate the process of obtaining this information, the Consulta Remédios group provides advice on the quotation of high-cost medications, a simple and fast service, specialized in quotations for drug judicialization processes.
Just access the link and fill out the registration with your data and the desired medicine. In a short time, a budget in the necessary standard will be sent.
Various conditions can cause changes in blood cell counts, such as those due to immune changes or even infections. The decrease in platelet count does not always require treatment, as it can be a limited condition and without damage to health.
However, at other times, it is necessary to resort to drug therapy to restore normal blood cell rates, avoiding risks of bleeding and bleeding.
Among the options that can be used for idiopathic thrombocytopenic purpura and low blood cell counts due to severe aplastic anemia is Revolade, an oral medication.
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