Several conditions require drug treatment. Sometimes, the drugs are indicated to fight diseases, other times, they serve to keep the body functioning properly and reduce the risk of problems.
It may seem curious, but there are substances that can be indicated for both situations, depending only on the dosage adjustment.
This is the case of the active ingredient Everolimo, which can be indicated for some specific cases of cancer and also for the treatment of people undergoing organ transplantation, to avoid organ rejection.
Learn more about the indications and effects of the drug:
- 1 What is Everolimo?
- 2 Is Everolimo immunosuppressive or antineoplastic?
- 3 What is Everolimo used for?
- 4 What does the label say about side effects?
- 5 How to take Everolimo?
- 6 Does SUS provide Everolimo?
- 7 Price: How much does Everolimo cost?
- 8 How to budget Everolimo?
What is Everolimo?
The active substance Everolimo is marketed in tablets. The drug belongs to the category of rapamycin analogues and has a high affinity for specific receptors. This causes its action to prevent binding of the mTor pathway (involved in cell reproduction), which is why it is considered a selective mTor inhibitor.
The drug is registered and approved by Anvisa in two categories, that of antineoplastic and immunosuppressant.
As its action results in the inhibition of cell proliferation, the active ingredient can be administered for the treatment of some types of cancer and also to prevent organ rejection in transplanted people. What will vary, for each condition, is the dosage administered.
It is worth emphasizing that only doctors or specialist doctors can advise on the brand, dosage and form of use of Everolimo.
Is Everolimo immunosuppressive or antineoplastic?
Everolimo is an active substance registered and released by Anvisa, with current records for two drug categories, which are the immunosuppressive and the antineoplastic.
According to the CONITEC report, the drug is a synthetic derivative of the substance sirolimus. This, in turn, is derived from rapamycin.
Both rapamycin and Everolimo have an antiproliferative and immunosuppressive action, resulting in inhibition of the proliferation of fibroblasts (cells that make up connective tissue) and smooth muscle cells.
In addition, the substances interfere with the growth factor of lymphocytes (cells of the immune system) and fibroblasts.
Therefore, Everolimo is classified in both categories, both immunosuppressive and antineoplastic substances. Its action is determined according to the dosage administered.
Indication as immunosuppressive medication
The immune system is responsible for protecting the body from invaders and foreign agents. Therefore, when white blood cells detect foreign bodies, they attack it and inhibit possible damage to the body.
Although an immune system is fundamental to the health and integrity of the body, in some specific cases it can be exactly the cause of the problem.
For example, after organ transplantation. Even if the new organ is functioning well, the body recognizes it as a foreign agent, attacking it as a protective mechanism.
In general, people who have received transplants need treatment with immunosuppressive substances indefinitely. These substances reduce the immune action, making the defense cells not recognize these foreign agents.
Therefore, Everolimo is indicated as an immunosuppressive agent to, in general, prevent rejection of transplanted organs.
Indication as antineoplastic medication
The substance Everolimo can be indicated for the treatment of some types of cancer and also some types of benign tumors. That’s because it has the ability to block the growth of some cells.
According to the Oncoguia Institute, the drug acts by blocking the cell protein called mTor, which is related to cell growth and division.
As cancer is generally characterized by the accelerated proliferation of diseased or abnormal cells, inhibition of replication can be effective for the treatment of the disease.
What is Everolimo used for?
The medication Everolimo can be indicated as an antineoplastic or immunosuppressive agent, depending on the dosage. Therefore, the inserts of each brand can bring different indications. Check out:
Afinitor — Novartis
Everolimo from the Afinitor brand, a reference drug, produced by the pharmaceutical industry Novartis, is classified as antineoplastic by ANVISA, and can be found in the presentations of tablets with 2.5mg, 5mg and 10mg.
According to the package insert, the drug is indicated for the treatment of:
- Women who have already had menopause (last menstruation) and are diagnosed with advanced breast cancer, positive hormone receptor, being used in combination with an aromatase inhibitor, after previous endocrine therapy;
- Advanced neuroendocrine tumors (NET) located in the stomach and intestine, lung and pancreas;
- Advanced kidney or kidney cancer – a condition called advanced renal cell carcinoma, when the disease has progressed during treatment with VEGFR – TKI, chemotherapy or immunotherapy;
- Renal angiomyolipoma (kidney tumor) associated with Tuberous Sclerosis Complex (TSC) that is not indicated for immediate surgery (in patients over 18 years old);
- Giant cell subependymal astrocytoma (SEGA, a specific brain tumor) associated with the Tuberous Sclerosis Complex (TSC).
Certican — Novartis
Certican is one of the reference brands of Everolimo, from the Novartis laboratory. In Anvisa’s records, the drug is in the immunosuppressant category.
According to the package insert, it is indicated to prevent rejection of transplanted organs, being the kidney, heart and liver. Its use is made in conjunction with other immunosuppressive medications, such as cyclosporine or tacrolimus, or even corticosteroids.
Everolimo Natcofarma – Natcofarma do Brasil
Everolimo from the pharmaceutical industry Netcofarma is a generic medicine, based on the active substance Everolimo. At Anvisa, the product is part of the antineoplastic category, registered in the presentations of 5mg and 10mg tablets.
Its indications are as an antineoplastic agent, for cancer / tumor treatment.
Everolimo FURP — FURP
At Anvisa, Everolimo produced by the Foundation for Popular Remedy is listed as an antineoplastic agent and also an immunosuppressant. However, all registrations are currently canceled.
Osys — Libbs
The pharmaceutical industry Libbs produces the drug Osys, an interchangeable product based on the active substance Everolimo. At Anvisa, the product is listed as an immunosuppressive agent, and can be found in presentations of 0.5mg, 0.75mg and 1mg tablets, with 60 tablets each.
According to the package insert, its use is indicated to prevent kidney, heart and liver rejection in transplanted people.
What does the label say about side effects?
Like other substances, the use of Everolimo can trigger adverse reactions. They will not necessarily occur, but when they manifest they may have different intensities and duration for each patient.
Among the common and most common reactions reported by the package inserts are:
Very common reactions
The use of Everolimo as an immunosuppressive agent can trigger, in a very common way, the following manifestations:
- Infections (viral, bacterial and fungal);
- Infections of the lower respiratory tract, such as lung infections and pneumonia;
- Infections of the upper respiratory tract, such as inflammation of the pharynx and the common cold;
- Infections in the urinary tract;
- Anemia (reduced red blood cell count);
- Reduced platelet count in the blood, which can lead to bleeding and / or bruising under the skin;
- Very high levels of some fats (lipids, cholesterol and triglycerides) in the blood;
- Reduced levels of potassium in the blood;
- Low levels of white blood cells (increased risk of infections);
- Problems sleeping (insomnia);
- Accumulation of fluid in the bag around the heart, which, when severe, can decrease the heart’s ability to pump blood;
- Venous thrombosis (blockage of a main vein by a blood clot);
- Fluid accumulation in the pulmonary / thoracic cavity, which, when severe, can lead to shortness of breath;
- Lack of air;
- Onset of diabetes (high blood sugar);
- High blood pressure;
- Abdominal pain;
- Generalized pain;
- Edema (accumulation of fluid in the tissues);
- Abnormal wound healing;
The most common adverse reactions described on the label of Everolimo when used as an antineoplastic agent are:
(occurs in more than 10% of patients using this medication)
- Signs of infection such as increased temperature or chills;
- Fatigue, loss of appetite, nausea, jaundice (yellowing of the skin), or pain in the upper right part of the
- abdomen, pale stools or dark urine (may also be a sign of reactivation of hepatitis B);
- Fever, cough, difficulty breathing, wheezing, signs of inflammation of the lung (pneumonitis).
When used as an immunosuppressant, Everolimo can commonly cause the following reactions:
- Wound infection;
- Benign tumors and cancers;
- Cancer of the lymphatic tissue (lymphoma, post-transplant lymphoproliferative disorder);
- Fast heartbeat;
- Joint pain;
- Muscle pain;
- Pain in the oral cavity, such as the throat;
- Renal graft thrombosis (sudden obstruction of the blood vessels that nourish the transplanted kidney that can result in graft loss);
- Simultaneous reduction of white and red blood cells and platelets (symptoms may include weakness, bruising and frequent infections);
- Cysts containing lymphatic fluid;
- Swelling of the face, lips, mouth, tongue or throat usually associated with rash and itching;
- Inflammation of the pancreas (symptoms may include severe pain in the upper stomach, vomiting and loss of appetite);
- Mouth sores;
- Protein in the urine;
- Kidney disorder;
- Hernia at the surgery site;
- Abnormal liver test results;
- Rash (rash).
The most common manifestations related to the use of Everolimo as an antineoplastic agent are:
- Excessive thirst, large volume of urine, increased appetite with weight loss, tiredness (diabetes);
- Bleeding (hemorrhage), for example, in the intestinal wall;
- Severe decrease in urine production, signs of kidney failure (kidney failure).
How to take Everolimo?
The way of taking it, the quantity of pills and the general guidelines on the time and form of ingestion must always be indicated by professionals who accompany each patient.
In general, the package insert indicates that the tablets should be taken at the same time, so that the concentration of the active substance Everolimo is always present and constant in the body.
Although the package insert also instructs that the medication can be taken with or without food, it is important that there is no change in the choice.
That is, if the first dose is taken with food, all others should always be taken in the same way. Or, if the first ingestion is made without the accompaniment of food, all the others should be as well.
Does SUS provide Everolimo?
Yes. Everolimo appears in RENAME, National List of Essential Medicines, in the 0.5mg, 0.75mg and 1mg presentations.
It is worth mentioning that even when present at RENAME, the drug is only supplied if the dispensing criteria are met, based on the indications adopted by the CONITEC reports.
Price: How much does Everolimo cost?
The price of Everolimo may vary depending on the dosage and the laboratory. To evaluate and compare prices, it is possible to perform a search in online comparators or pharmacies for special medicines.
On average, the drug can be found in the following price ranges *:
* Average prices consulted in January 2020. Prices may change.
The everolimus Afinitor 5mg tablets in box 30 , Novartis manufacturer, can be found for prices of approximately US $ 5,394 to $ 6,930.
Novartis also produces Certican 0.5mg, box of 60 pills, with values ranging from R $ 1,369 to R $ 1,771.
Everolimo is also available in the dosage of 0.75mg, from Certican (Novartis) , in the box with 60 tablets. The price is, on average, from R $ 2,179.52, reaching R $ 2,532.
The Certican 1mg box with 60 tablets , Novartis pharmaceutical may be found at the dosage of 1mg between approximately US $ 2,906 to $ 3,517.
The everolimus Natcofarma Brazil with 5mg, in the box with 28 tablets , can be found with price of approximately R $ 3,709 to R $ 4,168.
Novartis produces Everolimo Afinitor in a 10mg dose , in boxes of 30 tablets . On average, the values are between R $ 10,869 to R $ 13,860.
Natcofarma also offers the drug Everolimo in presentation with 10mg, in boxes with 28 pills . The price ranges from R $ 7,758 to R $ 8,201.
How to budget Everolimo?
People who receive medical advice for treatment with Everolimo can obtain the drug free of charge from SUS.
In 2015, CONITEC indicated that the substance would become part of the list of drugs provided by SUS for patients undergoing organ transplantation. However, for cancer cases, Everolimo has no indication of distribution.
For those who have health insurance, having access to the use of Everolimo as an antineoplastic agent can be simpler, since the drug is part of the ANS List, which is a list of minimum mandatory coverage.
However, even so, getting access to therapy, whether it is immunosuppressive or antineoplastic, free of charge is not always possible. A number of conditions can lead to a negative SUS or health plan for the cost of treatment.
Thus, it is necessary to resort to judicial means, in an attempt to obtain medication.
For this, patients can count on groups of legal guidance, present in hospitals and health associations, in addition to the guidance of the medical team itself.
A number of documents are fundamental to the opening of the judicial process. In addition to medical reports, exams and medical prescriptions, patients must also submit a budget for 3 different pharmacies.
This can be a task that makes it difficult to open the process. So, in order to facilitate the organization of documentation, the Consulta Remédios group provides a quote advisory service for high-cost drugs.
Just fill out the forms and the substance quotation will be sent quickly and in a personalized way.
Studies have found and developed products and treatments capable of improving the health and well-being of several people.
Often, the same substance can be indicated for different therapies, such as Everolimo, which can treat some types of cancer and also be used as an immunosuppressive agent for transplanted people.
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