The autoimmune diseases affect an average of 15% to 20% of the entire population, a fairly high number. There is a great diversity of types and characteristics of each one of them.
No autoimmune disease is curable, that is, treatments are performed to combat symptoms, control and prevent complications that may be caused by the disease.
Thinking about it, we will see more information about a drug used in the treatment of two of these diseases. Check out more information about the Entyvio remedy:
- 1 What is Entyvio?
- 2 What is the medicine Entyvio for?
- 3 What is the mechanism of action of the active ingredient Vedolizumab?
- 4 How does the package insert indicate using Entyvio?
- 5 What are the side effects?
- 6 Entyvio gets fat?
- 7 Price: what is the value of Entyvio 300mg?
- 8 Are you in SUS?
- 9 Are you generic or similar?
- 10 Is it approved by ANVISA?
- 11 How to budget?
What is Entyvio?
Entyvio is one of the trade names of the medicine whose active ingredient is Vedolizumab. It is classified as an immunosuppressant – that is, it acts by reducing the activity or efficiency of the immune system. Therefore, it is used to treat two autoimmune diseases ( Crohn’s disease and Ulcerative Colitis).
It is currently available and regulated in an injectable version.
What is the medicine Entyvio for?
The Entyvio drug is used to treat adult patients with Crohn’s autoimmune disease or Ulcerative Colitis. It is worth mentioning that these diseases have no cure , so treatments are carried out to treat symptoms and avoid other complications.
So, let’s see more about the two pathologies that this remedy can treat and what are their characteristics:
The Crohn’s disease is an inflammatory disease of the gastrointestinal tract and, at first, the treatment is performed with other medications. Symptoms include:
- Severe diarrhea ;
- Abdominal pain;
- Arthritis ;
- Inflamed eyes;
- Low fever ;
- Abdominal swelling;
- Nausea and vomiting.
Treatment with Entyvio is indicated for cases in which the disease is moderate or severe and is in its active phase. In addition, among the specifications, the package insert indicates that patients must have shown an inadequate response, loss of response or intolerance to more conventional treatments or with a TNF-α *.
TNF-α stands for tumor necrosis factor alpha antagonist . It is a group of cytokines (a type of protein) capable of causing the death of tumor cells and helping to control inflammation.
The Colitis Ulcerative is characterized by inflammation in the large intestine and is initially treated with other medications. Some of the symptoms of the disease include:
- Abdominal pain;
- Reduced appetite and weight loss;
- Extraintestinal manifestations – such as thrush , joint pain, itching or the appearance of lumps on the skin.
Treatment with Entyvio is indicated for moderate and severe cases of the disease. Patients must have presented an inadequate response, loss of response or intolerance to other conventional treatments or treatment with TNF-α ( tumor necrosis factor antagonist alpha ) .
What is the mechanism of action of the active ingredient Vedolizumab?
The active ingredient Vedolizumab belongs to a group of biological medicines called “monoclonal antibodies”.
Its action occurs as follows: it blocks the protein present on the surface of white blood cells (responsible for much of the body’s immune control).
This protein causes inflammation in Ulcerative Colitis and Crohn’s Disease. The block occurs mainly in the gastric mucosa, which makes the immunosuppressive effect more specific for these diseases.
Therefore, by blocking its action, Vedolizumbae reduces inflammation and – consequently – the symptoms of these pathologies.
How does the package insert indicate using Entyvio?
The drug Entyvio must be administered intravenously ( infusion into the vein ) and must be prepared and applied by specialized professionals, in a hospital environment.
The medicine is infused through a drip system into a vein in the arm (as if it were a serum). This process takes an average of 30 minutes.
In addition, the package insert highlights that patients need to be monitored during and after (approximately 1 hour) the administration of the medication.
As for the dosage, the package insert indicates that after the initial dose, the next one should occur after 2 weeks. Then, after 4 weeks, a new administration is indicated. Finally, maintenance of treatment and administration of a new dose should occur every 8 weeks.
However, it is worth mentioning that you must follow the guidelines of the doctor responsible for your case.
What are the side effects?
All medications can cause some side effect. However, since each organism reacts differently to the medication, some people may not have reactions and others may even have more than one.
There is also a list of common side effects (between 1% and 10% of patients):
- Pain in the extremities;
- Bronchitis ;
- Gastrointestinal inflammation;
- Respiratory infection in the upper airways (nose and throat), flu, sinusitis , sore throat;
- Tingling in the skin;
- High blood pressure ;
- Pain in the back of the mouth, stuffy nose, cough;
- Infection of the anus, ulcer in the anus;
- Nausea, heartburn, constipation, abdominal bloating, gas, hemorrhoids;
- Rash and redness of the skin, itching and eczema on the skin;
- Acne (pimples);
- Night sweats;
- Involuntary muscle contraction;
- Back pain, muscle weakness, tiredness, fever.
To learn more about rare or very rare adverse reactions, you can consult the doctor and read the package leaflet .
Entyvio gets fat?
The product leaflet does not indicate weight gain as a possible side effect. Therefore, there is no evidence that its use is fattening.
But it is worth mentioning that, as mentioned in the previous topic, among the possible adverse reactions, there are complications such as heartburn and nausea – factors that can alter the diet.
If you administer the medication and notice changes in your weight without apparent cause, inform the doctor responsible for your case. Thus, it will be possible for him / her to investigate and relate, or not, this factor to the medication.
Price: what is the value of Entyvio 300mg?
The price * of Entyvio 300mg may vary depending on your location and the availability of the medication.
But, in general, the box with 1 vial (with powder for solution for intravenous use) can cost almost R $ 18,000.
* Prices consulted in February 2020. Prices may change.
Are you in SUS?
No . The drug Entyvio is not present in the National List of Essential Medicines (RENAME) of 2020 and is not considered a drug of exceptional dispensation.
Therefore, it is currently not provided by the Unified Health System (SUS).
Are you generic or similar?
No . Entyvio is a biological medicine from the Takeda laboratory and there is no other version. Considering that it is a biological remedy, if an alternative version is created, it will also be biological.
It is worth mentioning that, in the same way as the reference drugs, biologicals have a patent time. This means that for that period, the developer laboratory will have the exclusive marketing right.
This time is provided due to the investments required during the creation of a new drug. Then, after the patent period, the formula can be made available.
The only difference is that it is easier to break the stipulated period. This is because biological remedies are generally developments for the treatment of very specific problems.
Therefore, it is good that different versions are produced, in order to enable different treatment options for the disease in question.
Is it approved by ANVISA?
-Yeah . The drug Entyvio is registered with ANVISA (National Health Surveillance Agency) under number 106390271. With this, it is marketed as a safe and effective drug – certified by quality tests.
In the registry, it is linked to the regulatory category of “Biologicals” and to the therapeutic class of “immunosuppressants”.
How to budget?
Even when the drug is not available via SUS, patients with a medical report can make a judicial request to receive the treatment paid for by the Unified Health System or Health Plan – if applicable.
Thus, it is necessary to open a process and follow the stipulated requests. Among them is the delivery of documents that include:
- Medical report;
- Standard requirement;
- Budget of 3 pharmacies .
To facilitate the last procedure, it is possible to count on the assistance of legal advice on the purchase of medicines, which provides a personalized quote for your case free of charge .
When accessing the link , make your registration informing some personal data and the medicine in question. Then, click on “request quotes” and wait for the return.
Ulcerative Colitis and Crohn’s Disease are diseases that affect more than 150 thousand people every year in Brazil. Therefore, medicines like Entyvio are increasingly needed to carry out treatments, in order to provide quality of life to people with these pathologies.
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