The composition of the drug MabThera is rituximab, which is the main active ingredient, and a number of auxiliary components: sodium citrate, polysorbate 80, sodium chloride, water d / and, hydrochloric acid or sodium hydroxide - up to pH 6.5.
MabThera drug is made in the form of a concentrate for the preparation of a solution for intravenous infusion. The liquid is either completely transparent or has a pale yellow tint.
- 10 ml - glass bottles (2) - cardboard boxes;
- 50 ml - glass bottles (1) - cardboard boxes.
MabThera is a antitumor and immunomodulatory high drug rituximaba - chimeric recombinant monoclonal antibodies that have a certain effect on body cells. Antibodies specifically bind to the CD20 transmembrane antigen located on pre-B lymphocytes and mature B cells. The peculiarity of the CD20 transmembrane antigen is its absence on cells that move in a small amount through the bloodstream (hematopoietic). On early progenitors (precursors) of white nucleated cells in bone marrow and plasma cells without pathological disorders, as well as in cells of other tissues, this antigen is also absent.
The active substance MabThera stimulates the development of immunological reactions after binding to the CD20 antigen on B-lymphocytes, which stimulates the process of lysis of white nucleated cells.
During the initial infusion of this drug, the patient may experience a decrease in the level of white nucleated blood cells. This effect disappears after half a year of treatment using the drug and the level of white nucleated blood cells in the peripheral blood returns to normal. Final recovery is observed after about 9 months of using MabThera.
Pharmacodynamics and Pharmacokinetics
Rituximab, which is part of MabThera, is an antibody that is produced by immune cells belonging to a single cell clone. This means that the antibody is produced from a single plasma progenitor cell. This type of protein was designed to recognize and attach to a specific structure (the so-called antigen) that is found in certain cells of the body.
Rituximab attaches to the antigen, which leads to cell death. It helps in healing lymphomas and CLL (chronic lymphocytic leukemia), since cancerous B-lymphocytes are destroyed by the action of the active substance of the drug. At rheumatoid arthritisB cells are destroyed in the joints, which helps to reduce inflammation. At chronic lymphocytic leukemia destruction of B-lymphocytes, reduces the productivity of antineutrophilic cytoplasmic antibodies.
In people who received rituximab intravenously in quantities of 125 mg / m2 (m2 - the value of the measurement of the body surface), 250 mg / m2 or 375 mg / m2 every week for one month, an increase in the number of antibodies in the blood serum was observed depending on the increase in the dose of the active substance.
In patients who received MabThera at a dosage of 375 mg / m2, the average T1 / 2 of the active ingredient of the drug was 68.1 hours. This reaction was observed immediately after the initial administration of the drug. In patients, Cmax was 238.7 μg / ml. The average plasma clearance was equal to 0.0459 l / h. The analysis carried out after the fourth instillation by MabThera showed: 189.9 h, 480.7 μg / ml and 0.0145 l / h.
Indications for use
MabThera drug is prescribed for adults according to the following indications:
- Non-Hodgkin lymphoma - MabThera is indicated for the treatment of patients with AH-III-IV follicular lymphoma in combination with chemotherapy. A prerequisite is that you can use the drug only in case of previously not conducted therapeutic procedures for the treatment of this disease.
- Maintenance therapy using this medication is indicated for treatment. follicular lymphoma in conjunction with induction therapy.
- Monotherapy using this drug is indicated for the treatment of patients with stage III-IV. follicular lymphomaduring a second or regular relapse after a course of chemotherapy.
- The drug is indicated for the treatment of people in whom it has been confirmed CD20-positive diffuse large cell B-cell non-Hodgkin lymphoma. This drug is used in combination with CDVP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
- Chronic lymphocytic leukemia - MabThera in combination with chemotherapy is indicated for the treatment of patients in whom the disease was first detected and patients with relapses chronic lymphocytic leukemia.
- Rheumatoid arthritis - MabThera is prescribed for the treatment of adult patients with a diagnosis severe severe rheumatoid arthritis. The drug is used along with Methotrexateotherwise treatment will not bring the expected effect.
Mabter's medicine is prescribed with caution:
- People who have a large number of cancer cells circulating in the blood or with a high tumor burden.
- People with lung cancer.
- People with any form of lung disease.
- People with different shapes CCC diseases.
- To people who were previously exposed chemotherapy. In this case, the likelihood of side effects on CVS is high.
- Low people neutrophils and platelet count in blood.
- People whose immune system has a reduced ability to fight infections and diseases.
- People with a history of recurring or chronic infections.
- People who have suffered hepatitis.
Prescribing treatment using MabThera is strictly contraindicated:
- People with an active form of severe infections.
- People with a poorly functioning immune system, for example, due to previous courses chemotherapy or radiation therapy.
- To people who have allergies on mouse protein.
- In the treatment rheumatoid arthritisthis medicine should not be prescribed to people with severe heart failure or others heart disease.
- For children.
- This medicine should not be used in case of a possible manifestation of an allergic reaction due to exposure to one of the components of the drug.
Pregnancy and lactation
Such drugs are prescribed with great caution for the treatment of women who are pregnant or breastfeeding. But, if experts believe that using the drug will bring benefits to the mother outweighing the risks to the health of the unborn child, then its use is advisable.
Experts have not established whether rituximab affect reproductive ability or harm the fetus when the drug is administered during pregnancy. However, since rituximab it can potentially penetrate the placenta and attack the B cells of a developing child; the drug is not prescribed for pregnant women. The only exception is when the apparent benefit is several times greater than the likely risk to the health of the carrying baby.
Also, this drug is not prescribed for the treatment of women who are breastfeeding. Since MabThera is administered intravenously, some of the drug passes into breast milk, which may not affect the baby’s health in the best way. Therefore, women who have been treated with this medicine should not breast-feed at least one year after the last infusion.
Medications have an individual effect on the body of each person, therefore, in patients treated with MabThera, in some cases, various side effects were observed, the list of which is given below.
Please note: despite the fact that there are a lot of side effects, this does not mean that with treatment with this drug they can be observed in all patients. In some cases, treatment can take place without showing side effects of the drug.
Likely side effects:
- fever (hyperthermia) or chills;
- weakness or loss of coordination;
- a decrease in blood levels of white and red blood cells;
- increased susceptibility to infections;
- rash and itching;
- hair loss;
- intestinal disorders (abdominal pain, indigestion, diarrhea, constipation etc);
- runny or itchy nose;
- severe swelling of the lips, face, or tongue (Quincke's edema);
- decrease or increase in blood pressure;
- numbness of the limbs;
- sleep disturbance (insomnia);
- anxiety, agitation, nervousness, or depression;
- sensation of ringing or other tinnitus;
- breathing problems due to narrowing of the airways (bronchospasm) or other lung problems;
- throat irritation;
- muscle, joint, back, or neck pain;
- high blood sugar (hyperglycemia);
- swollen ankles due to fluid retention;
- heart problems such as abnormal heart contractions (arrhythmias)heart failure, chest pain, or heart attack.
Instructions for use Mabtera
The instruction for MabThera is to some extent complicated, therefore, before using the drug, you must carefully familiarize yourself with it.
Treatment with MabThera should be carried out under the close supervision of an experienced healthcare professional. Ideally, the introduction of the drug should be carried out in the presence of all conditions for resuscitation of patients in case of serious adverse reactions. When a drug is used in conjunction with chemotherapy, injections are given cyclically on the first day of each stage of treatment. Previously, the patient must be given an antihistamine (to prevent the occurrence of allergic reactions) and an antipyretic.
In the treatment non-Hodgkin lymphoma, the usual dose of MabThera when administered intravenously is 375 mg per unit surface area of the body (calculated by patient height and weight). The frequency of infusions and their number depends on the type of lymphoma to be treated. Some patients who receive one full dose as an intravenous infusion may receive subsequent doses as a subcutaneous injection. The recommended dose for subcutaneous injection is 1400 mg. Here, body area is not taken into account when dosing the injection.
For treatment Hll, the drug is infused six times intravenously: the first dose is 375 mg / m 2, and then 500 mg / m 2 for all other doses. To avoid the side effects caused by the destruction of cancerous lymphocytes, patients should take medications in parallel that help stabilize uric acid levels.
For treatment rheumatoid arthritis, this drug is prescribed in the form of two intravenous infusions of 1000 mg. The interval between infusions should be at least 14 days. Patients usually respond to treatment from 16 to 24 weeks after the initial treatment. After 24 weeks, treatment can be repeated depending on the patient's response.
Mabthera overdose cases are currently unknown, as single doses rituximabaexceeding 1000 mg / m2 have not been thoroughly studied.
Interaction with other drugs
Rituximab can cause a decrease in blood pressure and reduce the effectiveness of drugs that stabilize it. For this reason, if a patient is taking medication to lower blood pressure, the specialist should make sure that he stops taking this medication at least 12 hours before the infusion of MabThera.
If this medicine is prescribed for the treatment of rheumatoid arthritis, the patient must inform his doctor about vaccinations made the day before, for example, before visiting exotic countries. Since this medicine attacks B cells, which are part of the immune system, rituximab may decrease antibody performance. This means that vaccines can be potentially less effective during treatment, as well as provoke the development of serious infections. For this reason, if any vaccinations have been given to the patient, MabThera infusions should be prescribed at least four weeks after the last vaccination.
Using this medication in combination with other medications to treat the active form rheumatoid arthritis not studied (except Methotrexate).
Terms of sale
MabThera drug is dispensed in pharmacies strictly according to the prescription.
The drug should be stored in a place inaccessible to children at a temperature of at least 2 and not more than 8 degrees Celsius.
The shelf life of the drug is 30 months.
MabThera AnalogsMatches for ATX Level 4 code:ErbituxAvastinHerceptin
Analogs by ATX code, composition of active substances and release form:
- Reditux - a preparation in the form of a concentrate for a solution of d / inf., 10 mg / ml, 10 ml (100 mg) and 50 (500 mg) in a bottle;
- Rituxim - a preparation in the form of a concentrate for a solution of d / inf., 10 mg / ml, 10 ml (100 mg) and 50 (500 mg) in a bottle No. 1 and No. 2.
Analogs for ATX code level 4:
- Avastin - a preparation in the form of a concentrate for a solution of d / inf. 100 mg / 4 ml and 400 mg / 16 ml in a vial;
- Acetris - a preparation in the form of powder for conc. for solution d / inf. 50 mg per vial;
- Vectibix - a preparation in the form of a concentrate for a solution of d / inf., 20 mg / ml of 20 ml and 5 ml in a bottle;
- Herceptin - lyophilisate d / conc. for solution d / inf. 150 mg and 440 mg per bottle;
- Cadzil - a preparation in the form of powder for conc. for solution d / inf. 100 mg and 160 mg per bottle.
- Trastumab - a drug in the form of a lyoph powder. d / prg. conc. d / inf. 150 mg per vial;
- Erbitux - the drug in the form of a solution d / inf. 5 mg / ml in 100 ml and 5 mg / ml in 20 ml in a bottle.
Reviews about MabThera on the forums are different. Positive reviews about the drug indicate its effectiveness, and negative ones are caused by a large number of contraindications and side effects. There are no neutral reviews on the Internet about the drug MabThera.
You can buy MabThera in Moscow only at pharmacies and with a prescription from your doctor. The price in Russia of this drug varies from 21 to 45 thousand rubles:
- MabThera solution for infusion 100mg 10ml No. 2 - the price is from 21300 rubles. up to 30550 rub.
- MabThera solution for infusion 500mg 50ml No. 1- the price is approximately 44500 rubles.
The price of MabThera in Ukraine differs in a wider range:
- MabThera infusion solution 100mg 10ml No. 2 - the price is from 6383.52 hryvnias to 7744.70 hryvnias.
- MabThera infusion solution 500mg 50ml No. 1- price from 12,767.04 hryvnias to 20,460.66 hryvnias.
- Online pharmacies in UkraineUkraine
- MabThera 100 mg / 10 ml N2 bottle concentrate Hoffman-La Roche Ltd, Swiss15297 UAH.order
- MabThera 500mg / 50ml 50ml No. 1 concentrate for solution for infusion 38401 UAH
- MabThera infusion MabThera concentrate for solution for infusion bottle 100mg / 10ml №2 Switzerland, Roche 12863 UAH order
- MabThera infusion MabThera bottle 500mg / 50ml No. 1 Switzerland, Roche 31886 UAH.