Autoimmune diseases are those in which the immune system attacks healthy cells in the body itself, where the body cannot distinguish between normal body cells and invading cells.
To combat and relieve the symptoms caused by some of these diseases, there are specific medications and, among them, MabThera.
Continue reading and learn more about the medicine:
Contents
What is the medicine MabThera?
MabThera is one of the trade names for the active ingredient Rituximab, a monoclonal antibody, that is, produced in the laboratory.
It is a medicament used in the treatment of certain diseases caused by the abnormal growth of B lymphocytes (immune system cells), such as leukemia chronic lymphocytic and rheumatoid arthritis .
Its administration is via intravenous infusion and is manufactured by Roche, a pharmaceutical company.
It can be used alone, that is, as monotherapy, or combined with other medications, according to the clinical condition and medical prescription.
What is MabThera treatment for?
MabThera is used to treat diseases caused by the abnormal growth of some cells of the immune system, called B lymphocytes. It acts in diseases such as non-Hodgkin’s lymphoma, rheumatoid arthritis, chronic lymphoid leukemia, granulomatosis and pemphigus vulgaris. Specifically, the drug is used to:
Non-Hodgkin’s lymphoma
Non-Hodgkin’s lymphoma is a type of cancer that originates in the cells of the lymphatic system. It happens when a healthy cell becomes cancerous.
The lymphatic system is part of the immune system and has cells spread throughout the body. Therefore, the problem can occur in any region.
MabThera works on patients with:
- Recurrent non-Hodgkin’s B-cell lymphoma (reappearing after a period of healing) or chemotherapy-resistant;
- Diffuse non-Hodgkin’s lymphoma of large B cells, when combined with chemotherapy;
- Non-Hodgkin’s lymphoma not previously treated, when combined with chemotherapy.
- Follicular lymphoma, as maintenance therapy.
Rheumatoid arthritis
Rheumatoid arthritis is a chronic autoimmune disease that consists of inflammation of the body’s joints, causing pain, swelling and redness.
It occurs when the body attacks some healthy cells in the body and is therefore called autoimmune.
MabThera is indicated for adults with active rheumatoid arthritis who have had an inadequate response or intolerance to other tumor necrosis factor (TNF) inhibition therapies, when combined with the drug Methotrexate.
Chronic lymphoid leukemia
Chronic lymphoid leukemia is a rare disease, caused by an abnormal increase in the number of white cells – of defense – in the blood.
It occurs when the bone marrow produces an excess of cells that later turn into white blood cells (lymphocytes), however, with ineffective functioning.
These abnormal blood cells multiply exaggeratedly, causing some organs to malfunction and even interfering with the production of healthy cells.
In the case of chronic lymphoid leukemia, Mabthera is indicated for patients who:
- They have not been previously treated;
- They had a refractory condition to treatment (with no expected results).
Granulomatosis with polyangiitis
Granulomatosis with polyangiitis – also called Wegener’s granulomatosis – is a rare disease that causes inflammation of blood vessels.
Inflammation causes a reduction in blood flow, generally affecting small and medium vessels and also tissues in the nose, lungs and kidneys. Despite this, it can harm any organ.
Mabthera is used to treat this problem when combined with glucocorticoids – steroid hormones.
Microscopic polyangiitis
Like granulomatosis, microscopic polyangiitis is a disease that causes inflammation of blood vessels and can harm any organ in the body.
It is an autoimmune disease, in which the body causes its own cells to attack the blood vessel wall.
In the case of microscopic polyangiitis, MabThera is used for treatment when combined with glucocorticoids.
Pemphigus vulgaris
Pemphigus vulgaris is a serious autoimmune disease, in which there are blisters on the skin and mucous membranes.
It occurs when the immune system mistakenly triggers defense reactions against skin tissues, which causes the formation of lesions.
Mabthera is used together with corticosteroids for patients suffering from moderate to severe pemphigus vulgaris.
How does the active ingredient Rituximab act according to the package leaflet?
The active ingredient Rituximab is a monoclonal antibody, that is, produced in the laboratory, which acts against specific cells in the human organism.
It binds to B lymphocyte receptors, stimulating the destruction of these cells, which are part of the development of some diseases fought by MabThera.
What is the difference between MabThera and MabThera SC?
Both MabThera and MabThera SC are drugs used to treat some diseases that are related to the immune system. Despite this, both have some differences between them.
The first is in relation to the form of administration: while MabThera is used via intravenous infusion, MabThera SC is administered subcutaneously.
Another divergence is in relation to the indication, since MabThera works to combat different diseases and MabThera SC is indicated only for the treatment of one, non-Hodgkin’s lymphoma.
In addition, the concentration of the drug also varies. Because MabThera has two dosages: 100mg / 10mL and 500mg / 50mL. In the case of MabThera SC, the concentration is 1.440mg / 11.7mL.
How MabThera is applied
The administration of the medicine MabThera needs to be carried out in an appropriate environment and under medical supervision. There are some steps for the application, which can be divided into:
Pre-medication
Before performing the intravenous infusion, it is recommended to administer a pre-medication to the patient, made up of analgesics (reduces pain perception) and antipyretics (prevents or reduces fever ), together with an antihistamine (anti-allergic) ).
Glucocorticoid medications, that is, steroid hormones, should also be administered before application.
In addition, there are different drugs to be used according to the clinical picture of each person.
Chronic Lymphoid Leukemia
In cases of patients with Chronic Lymphoid Leukemia, it is recommended to apply uricostatic drugs (decrease uric acid levels in the body) 48 hours before starting treatment with MabThera.
This is to reduce the risk of developing Tumor Lysis Syndrome, when complications related to the treatment of the tumor occur.
In some cases, the medical team may recommend the use of Prednisone 30 minutes before the infusion, to reduce the reactions in the infusion.
Read more: Low uric acid: what can it be? What are the symptoms?
Rheumatoid Arthritis and Pemphigus Vulgaris
For patients suffering from Rheumatoid Arthritis or Pemphigus Vulgaris, the administration of the drug Methylprednisolone IV is indicated, 30 minutes before the application of MabThera.
The goal is to decrease the chances of infusion-related reactions.
Granulomatosis with polyangiitis and microscopic polyangiitis
People who have granulomatosis with polyangiitis or microscopic polyangiitis, the package insert indicates the use of some drugs in parallel to the treatment with MabThera.
The recommendations are:
Administration of Methylprednisolone IV between 1 and 3 days from the beginning of treatment. After that, the use of Prednisone during and after treatment with MabThera.
Infusion
For the first administration, the package insert recommends making the infusion at a speed of 50mg every 1 hour. In subsequent infusions, it is possible to start them at a speed of 100mg per hour.
The speed can be increased progressively, according to medical advice.
For application, it is necessary that the healthcare professional dilute the recommended dose of MabThera in saline or glycoside and make the administration slowly into the bloodstream.
The dose for each patient varies according to their clinical condition and physical characteristics, such as weight and height.
Is MabThera chemotherapy?
No. MabThera is not chemotherapy.
The classification of Mabthera is that of immunotherapeutic medication.
Immunotherapeutic drugs are those that work by helping the body’s immune system to identify disease-causing cells.
This is because some tumors can develop mechanisms to go unnoticed by the human immune system.
In this way, immunotherapy helps the body to identify these diseased cells.
What are the side effects of MabThera?
Like other medicines, MabThera can cause side effects in some people.
It is worth remembering that each patient reacts differently to the use of medication, thus, not everyone will have side effects.
The reactions can be divided according to the disease treated:
Non-Hodgkin’s lymphoma and chronic lymphoid leukemia
For cases of non-Hodgkin’s lymphoma and chronic lymphoid leukemia, the most common reactions are:
- Bronchitis;
- Infections caused by bacteria;
- Infections caused by viruses;
- Decrease in the number of white blood cells in the blood;
- Swelling of the tongue;
- Swelling of the throat;
- Nausea;
- Itch;
- Rash;
- Loss of hair;
- Fever;
- Chills;
- Weakness;
- Headache;
- Reduction in IgG (antibody) levels.
Common symptoms are:
- Severe general infection (sepsis);
- Pneumonia;
- Respiratory tract infection;
- Sinusitis;
- Hepatite B;
- Reduction of all blood cells;
- Reduction of granulocytes in the blood (defense cells);
- Hypersensitivity;
- Increase in blood sugar levels;
- Weight reduction;
- Edema and face;
- High LDH (bad cholesterol);
- Decrease in blood calcium levels;
- Loss or decrease in sensitivity in part of the body;
- Conjunctivitis;
- Lacrimation disorder;
- Ringing in the ear;
- Earache;
- Heart attack;
- Change in heart rate;
- Hypertension;
- Hypotension;
- Decreased bronchial caliber (bronchospasm);
- Chest pain;
- Lack of air;
- Increased cough;
- Rhinitis;
- Vomiting;
- Diarrhea;
- Abdominal pain;
- Difficulty swallowing;
- Inflammation in the mouth (stomatitis);
- Constipation;
- Difficulty in digestion;
- Anorexia;
- Throat irritation;
- Urticaria;
- Sweating;
- Increased muscle stiffness;
- Muscle pain;
- Fatigue;
- Multiple organ failure.
Among the unusual ones are:
- Aplastic anemia (insufficient production of blood cells);
- Hemolytic anemia (destruction of red blood cells);
- Depression;
- Nervousness;
- Change in taste;
- Tachycardia;
- Myocardial ischemia (decreased heart irrigation);
- Asthma;
- Abdominal augmentation;
- Pain at the application site.
Rheumatoid arthritis
For patients suffering from rheumatoid arthritis, the very common side effects are:
- Respiratory tract infections;
- Infections in the urinary tract;
- Hypertension;
- Nausea;
- Rash;
- Fever;
- Itch;
- Skin irritations;
- Throat irritation;
- Hypotension;
- Tremors;
- Tachycardia;
- Fatigue;
- Headache;
- Reduced levels of IgM (antibody);
- Peripheral edema (swelling of lower limbs).
Common reactions are:
- Bronchitis;
- Sinusitis;
- Athlete’s foot (fungal infection in the feet);
- Gastroenteritis (stomach infection);
- Reduction of white blood cells in the blood;
- High cholesterol;
- Altered sensitivity in a region of the body;
- Migraine;
- Dizziness;
- Loss of hair;
- Depression;
- Anxiety;
- Diarrhea;
- Reflux;
- Oral ulcer;
- Abdominal pain;
- Osteoarthritis (degenerative disease of the joints);
- Bursitis (inflammation of the joints);
- Reduction in IgG (antibody) levels.
The unusual reactions , which can occur, are:
- Generalized edema;
- Bronchospasm (decrease in the caliber of the bronchi);
- Edema in the larynx;
- Generalized itching;
- Generalized edema;
- Anaphylactoid reaction (allergic reaction).
Granulomatosis with polyangiitis and microscopic polyangiitis
In the case of patients who use the drug for the treatment of granulomatosis with polyangiitis and microscopic polyangiitis, the reactions that can occur are:
- Reduction of platelets in the blood;
- Diarrhea;
- Dyspepsia (difficulty in digestion);
- Constipation;
- Peripheral edema (swelling of the lower limbs);
- Cytokine release syndrome;
- Urinary tract infection;
- Bronchitis;
- Herpes zoster (disease that causes skin rashes);
- Infection of the nose and throat;
- Reduction in hemoglobin levels;
- High level of potassium in the blood;
- Muscle spasms;
- Arthralgia (joint pain);
- Muscle weakness;
- Dizziness;
- Tremors;
- Insomnia;
- Cough;
- Lack of air;
- Bleeding from the nose;
- Nasal congestion;
- Acne;
- Hypertension.
Pemphigus vulgaris
In cases of Pemphigus vulgaris, the reactions that can occur in some patients are:
- Loss of hair;
- Itch;
- Urticaria;
- Skin disorder;
- Recurrent depressive disorder;
- Irritability;
- Herpes virus infection;
- Conjunctivitis;
- Fatigue;
- Fever;
- Dizziness;
- Abdominal pain;
- Tachycardia;
- Musculoskeletal pain;
- Skin papilloma (benign skin tumor).
Value: what is the price of MabThera and where to buy cheaper?
The price of MabThera may vary according to the geographic region and establishment of purchase.
It can be found in physical and online pharmacies and its price is approximately *:
- MabThera — R$3.160;
- MabThera SC — R$9.780.
If there is a need to compare prices, it is possible to use the website of Consulta Remédios , which indicates the values of medicines in different pharmacies in each region.
* Prices consulted in March 2020. Prices may change.
Are you generic?
No . The active ingredient Rituximab does not have generic drugs.
Medicines currently registered with Anvisa that use Rituximab as an active ingredient do not receive the reference and generic nomenclature. These are names used for synthetic drugs.
Rituximab medicines, including MabThera, are characterized as biological.
Biological drugs are those produced from living cells, using biotechnology resources.
These resources allow the action of the substance to be more specific and directed to molecules that are related to the development of diseases.
Because they are produced from living organisms, there is no way to perform the identical production between one medicine and another, as occurs with the reference and the generic.
Despite this, copies can be legally produced, provided the similarity in efficacy, quality and safety is proven.
These copies are named as biosimilar medicines.
Rituximabe tem no SUS?
-Yeah . The active ingredient Rituximab is part of the National List of Essential Medicines (Rename), that is, the list of medicines distributed by SUS.
For cases in which, for some reason, the medication cannot be passed on and the patient is unable to afford the costs of treatment, it is possible to request coverage by the State.
For that, it is necessary to open a judicial process, presenting some documents such as the medical report and budget in 3 different pharmacies.
Is it approved by ANVISA?
-Yeah . MabThera was registered with the National Health Surveillance Agency (ANVISA) in 1998.
The drug is part of the therapeutic class of anti-neoplastic CD20 monoclonal antibodies, that is, its purpose is to inhibit the growth and spread of malignant tumors.
How to budget MabThera?
For cases in which SUS does not provide medication, there is the possibility to request treatment coverage by the State, through a lawsuit.
In that case, it is necessary to present some documents. Between them:
- Medical report;
- Exams;
- Standard requirement;
- Budget in 3 different pharmacies.
For the realization of the budget, it is possible to obtain assistance in advising on the quotation of high-cost drugs, which makes a personalized quote.
Just access the link , fill in the necessary data and wait for the return.
Autoimmune diseases originate from a failure in the functioning of the immune system, which results in defense responses against the body itself.
To combat and alleviate the symptoms of some types of this problem, there are medications like MabThera.
Want to know more about medicines and treatments? The Healthy Minute has complete contents of the subject for you! Read more and stay informed!
