MabThera - instructions for use, analogs, reviews and release forms (injections in ampoules for injections and infusions of 100 mg and 500 mg) of a drug for the treatment of rheumatoid arthritis, lymphoma and lymphocytic leukemia in adults, children and pregnancy

In this article, you can read the instructions for using the drug MabThera. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of medical experts on the use of MabThera in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of MabThera in the presence of existing structural analogues. Use for the treatment of rheumatoid arthritis, lymphoma and lymphocytic leukemia in adults, children, as well as during pregnancy and lactation.

MabThera a chimeric mouse / human monoclonal antibody that specifically binds to the transmembrane CD20 antigen. This antigen is located on pre-B lymphocytes and mature B lymphocytes, but is absent on stem hemopoietic cells, pro-B cells, normal plasma cells, cells of other tissues and is expressed in more than 95% of cases with B-cell non-Hodgkin's lymphomas. The CD20 expressed on the cell after binding to the antibody is not internalized and ceases to flow from the cell membrane to the extracellular space. CD20 does not circulate in the plasma as a free antigen, and therefore does not compete for binding to the antibody.

Rituximab (the active substance of MabThera's preparation) binds to the CD20 antigen on B lymphocytes and initiates immunological reactions mediating lysis of B cells. Possible mechanisms of cell lysis include complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and induction of apoptosis. MabThera increases the sensitivity of human B-cell lymphoma lines to the cytotoxic effect of certain chemotherapeutic drugs.

The number of B cells in the peripheral blood after the first administration of the drug is lower than normal and begins to recover in patients with hematologic malignancies after 6 months, reaching normal values 12 months after the completion of therapy, however, in some cases, the duration of the recovery period of the number of B cells can be more. In patients with rheumatoid arthritis, the duration of a decrease in the number of B-cells varies, most patients are prescribed subsequent therapy until their number is completely restored. In patients with granulomatosis with polyangiitis and microscopic polyangiitis, a decrease in the number of CD19-positive B cells to less than 10 cells / μl occurs after the first two infusions of rituximab, and most patients remain at this level for 6 months.

Antichymeric antibodies were detected in 1.1% of the examined patients with non-Hodgkin's lymphoma and 10% with rheumatoid arthritis. Antimony antibodies in the examined patients were not identified.

Composition

Rituximab + excipients.

Pharmacokinetics

Traces of rituximab can be found in the body for 3-6 months after the last infusion. The pharmacokinetic profile of rituximab (6 infusions of 375 mg / m2) in combination with 6 cycles of CHOR chemotherapy was almost the same as with monotherapy. When carrying out a repeated course of treatment, the pharmacokinetic parameters of rituximab are comparable with the first course of treatment. The pharmacokinetic parameters of rituximab in granulomatosis with polyangiitis and microscopic polyangiitis were almost the same as in rheumatoid arthritis.

Indications

Non-Hodgkin's Lymphoma:

relapsing or chemically resistant B cell, CD20-positive non-Hodgkin's low-grade lymphoma or follicular;
follicular lymphoma of 3-4 stages in combination with chemotherapy in previously untreated patients;
follicular lymphoma as maintenance therapy after responding to induction therapy;
CD20-positive diffuse B-large-cell non-Hodgkin's lymphoma in combination with CHOP chemotherapy.

Chronic lymphocytic leukemia:

chronic lymphocytic leukemia in combination with chemotherapy in patients who had not previously received standard therapy;
relapsing or chemo-resistant chronic lymphocytic leukemia in combination with chemotherapy.

Rheumatoid arthritis:

moderate and severe rheumatoid arthritis (active form) in adults in combination with methotrexate with intolerance or inadequate response to current regimens of therapy, including one or more tumor necrosis factor (TNF-alpha) inhibitors, incl. for inhibition of radiologically proven destruction of the joints.

Granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic polyangiitis

severe forms of active granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic polyangiitis in combination with glucocorticosteroids (GCS).

Forms of release

Concentrate for the preparation of a solution for infusions (injections in ampoules for injection) 100 mg and 500 mg.

Instructions for use and the scheme of administration

Rules for the preparation and storage of a solution

The necessary amount of the drug is taken under aseptic conditions and diluted to the estimated concentration (1-4 mg / ml) in the infusion bottle (package) with 0.9% sodium chloride solution for infusions or 5% Dextrose solution (solutions must be sterile and pyrogen-free).For mixing, gently invert the vial (packet) to avoid foaming. Before administration, it is necessary to inspect the solution for any foreign matter or discoloration.

The doctor is responsible for the preparation, conditions and time of storage of the prepared solution prior to its use.

Since the drug MabThera does not contain preservatives, the prepared solution must be used immediately.

The prepared infusion solution of MabThera's preparation is physically and chemically stable for 12 hours at room temperature or for not more than 24 hours at a temperature of 2 ° to 8 ° C.

The drug MabThera is administered only in / in the drip, through a separate catheter! Enter the drug intravenously struyno or bolusno not!

The recommended initial speed of the first infusion is 50 mg / h, then it can be increased by 50 mg / h every 30 minutes, bringing to a maximum speed of 400 mg / h.

Subsequent infusions can be started at a rate of 100 mg / h and increased by 100 mg / h every 30 minutes to a maximum rate of 400 mg / h.

Correction of dose during therapy

It is not recommended to reduce the dose of rituximab. If MabThera is administered in combination with chemotherapy, a reduction in the dose of chemotherapeutic drugs is carried out in accordance with standard recommendations.

Standard dosing regimen

Non-Hodgkin's lymphoma of low grade or follicular

Before each infusion of MabThera drug, it is necessary to perform a premedication (analgesic / antipyretic, for example, paracetamol; antihistamine, eg, diphenhydramine). If MabThera is not used in combination with chemotherapy containing glucocorticosteroids, then SCS is also included in the premedication.

Initial therapy:

1) monotherapy of adult patients: 375 mg / m2 once a week, for 4 weeks;

2) in combination with chemotherapy under any scheme: 375 mg / m2 on the first day of the chemotherapy cycle after intravenous administration of GCS as a component of therapy, during:

8 cycles (cycle: 21 days) with the R-CVP scheme (rituximab, cyclophosphamide, vincristine, prednisolone);
8 cycles (cycle: 28 days) with the R-MCP scheme (rituximab, mitoxantrone, chlorambucil, prednisolone);
8 cycles (cycle: 21 days) with the R-CHOP scheme (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisolone); If complete remission is achieved after 4 cycles, it is possible to limit to 6 cycles;
6 cycles (cycle: 21 days) with the R-CHVP-Interferon scheme (rituximab, cyclophosphamide, doxorubicin, teniposide, prednisolone + interferon).

Repeated use in case of relapse (in patients who responded to the first course of therapy): 375 mg / m2 once a week, for 4 weeks.

Supportive therapy (after responding to induction therapy):

in previously untreated patients: 375 mg / m2 once in 2 months, not more than 2 years (12 infusions). If there is evidence of progression of the disease, MabThera should be discontinued;
with relapsing or chemo-resistant lymphoma: 375 mg / m2 every 3 months, no more than 2 years. If there is evidence of progression of the disease, MabThera should be discontinued.

Diffuse B-large-cell non-Hodgkin's lymphoma

In combination with CHOP chemotherapy: 375 mg / m2 on the first day of each chemotherapy cycle after iv glucocorticosteroid administration, 8 cycles. Other components of the CHOP scheme (cyclophosphamide, doxorubicin and vincristine) are administered after the administration of MabThera.

Chronic lymphatic leukemia

In combination with chemotherapy (in patients who had not previously received standard therapy and with relapsing / chemo-resistant lymphocytic leukemia): 375 mg / m2 on the first day of the first cycle, then 500 mg / m2 on the first day of each subsequent cycle, 6 cycles. Chemotherapy is carried out after the administration of MabThera.

To reduce the risk of developing tumor lysis syndrome, preventive maintenance of adequate hydration and the introduction of uricostatics 48 hours before the start of therapy are recommended. In patients with chronic lymphocytic leukemia and lymphocyte count> 25 000 / μL, intravenous prednisone / Prednisolone 100 mg / hour prior to MabThera infusion is recommended to reduce the incidence and severity of acute infusion reactions and / or cytokine release syndrome.

Rheumatoid arthritis

Before each infusion of MabThera drug, it is necessary to perform a premedication (analgesic / antipyretic, for example, paracetamol; antihistamine, eg, diphenhydramine).In addition, pre-medication of SCS should be performed to reduce the frequency and severity of infusion reactions. Patients should receive 100 mg of methylprednisolone IV within 30 minutes before each infusion of MabThera's drug.

Initial therapy: 1000 mg IV drip, slowly, 1 every 2 weeks, course - 2 infusions.

Repeated use: the need for repeated courses of therapy is recommended to be evaluated 24 weeks after the previous course. The repeated application is carried out in the case of residual activity of the disease or an increase in the activity of the disease more than 2.6 according to DAS28-COE (disease activity index for 28 joints and erythrocyte sedimentation rate). Repeated courses can be scheduled no earlier than 16 weeks after the previous course.

Recommended dosage regimen for repeated use: 1000 mg once every 2 weeks, course - 2 infusions.

Granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic polyangiitis

Before each infusion of MabThera drug, it is necessary to perform a premedication (analgesic / antipyretic, for example, paracetamol; antihistamine, eg, diphenhydramine).

Recommended dosing regimen:

it is recommended to start SCS therapy within 2 weeks before the first MabThera infusion or on the day of the first infusion of MabThera: methylprednisolone (iv) 1000 mg / day for 1 to 3 days, then oral prednisolone at a dose of 1 mg / kg / day (but not more than 80 mg / day) with a gradual reduction in the dose of the latter until complete elimination (the rate of dose reduction is determined by the specific clinical situation). Oral glucocorticosteroid therapy can be continued during and after the completion of MabThera;
MabThera is 375 mg / m2 once a week, for 4 weeks.

During and after the completion of MabThera therapy in patients with granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic polyangiitis, it is recommended that pneumocystis pneumonia (caused by Pneumocystis jiroveci) be prevented.

Dosing in special cases

In patients older than 65 years, no dose adjustment is required.

Side effect

bacterial and viral infections;
respiratory tract infections;
pneumonia;
sepsis;
herpes zoster;
fungal infections;
infection of unknown etiology;
leukopenia, neutropenia, thrombocytopenia, anemia;
lymphadenopathy;
impaired blood clotting;
transient partial aplastic anemia;
hemolytic anemia;
coryza;
bronchospasm;
cough;
dyspnea;
pain in the chest;
bronchiolitis obliterans;
bronchial asthma;
angioedema;
decreased body weight;
peripheral edema;
swelling of the face;
headache;
fever;
chills;
asthenia;
pain in the foci of the tumor;
influenza-like syndrome;
tides;
weakness;
pain at the injection site;
nausea, vomiting;
diarrhea;
dyspepsia;
lack of appetite;
stomatitis;
constipation;
stomach ache;
sore throat;
abdominal enlargement;
lowering blood pressure or increasing blood pressure;
orthostatic hypotension;
tachycardia;
arrhythmia;
atrial fibrillation;
bradycardia;
myocardial ischemia;
angina pectoris;
dizziness;
sleep disturbance;
sense of anxiety;
perversion of taste;
nervousness;
depression;
myalgia, arthralgia;
back pain;
itching;
rash;
hives;
sweating;
alopecia;
conjunctivitis;
pain and noise in the ears.

Contraindications

acute infectious diseases;
severe primary or secondary immunodeficiency;
severe heart failure (Class 4 according to the classification of the New York Heart Association (NYHA)) with rheumatoid arthritis;
children under 18 years of age (efficacy and safety not established);
pregnancy;
the period of breastfeeding;
hypersensitivity to rituximab, any component of the drug or mouse proteins.

Application in pregnancy and lactation

Immunoglobulins G (IgG) are able to penetrate the placental barrier.

The level of B cells in newborns with the appointment of MabThera in women during pregnancy has not been studied.

Some newborns whose mothers received rituximab during pregnancy experienced a temporary depletion of the B-cell pool and lymphocytopenia. In this regard, MabThera should not be given to pregnant women, unless the possible benefits of therapy do not exceed the potential risk.

During the treatment period and within 12 months after the end of MabThera treatment, women of childbearing age should use effective methods of contraception.

It is not known whether rituximab is excreted in breast milk.Given that IgG immunoglobulins circulating in the mother's blood are excreted in breast milk, MabThera should not be used during breastfeeding.

Application in elderly patients

When prescribed for the treatment of rheumatoid arthritis, patients over 65 years of age are not required to adjust the dose.

Use in children

Contraindicated in children and adolescents under the age of 18 years (efficacy and safety not established).

When MabThera was used in children, hypogammaglobulinemia was observed, in some cases in severe form, requiring prolonged replacement therapy with immunoglobulins. The consequences of depletion of the B-cell pool in children are unknown.

special instructions

In the patient's medical records, the trade name of the drug (MabThera) should be indicated. Replacement of the drug with any other biological medicinal product requires agreement with the attending physician. The information provided in this manual applies only to the preparation of MabThera.

MabThera is administered under close supervision of an oncologist, hematologist or rheumatologist, provided there are necessary conditions for resuscitation.

Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

Infusion reactions. The development of infusion reactions may be due to the release of cytokines and / or other mediators. Severe infusion reactions are difficult to distinguish from hypersensitivity reactions or cytokine release syndrome. There are reports of lethal infusion reactions described during the post-marketing use of the drug. In most patients within 0.5-2 h after the first infusion of the drug Mabter appears fever with chills or tremors. Severe reactions include lung symptoms, arterial hypotension, hives, angioedema, nausea, vomiting, weakness, headache, itching, tongue irritation, or swelling of the pharynx (vascular edema), rhinitis, hot flashes, pain in the foci of the disease and, in some cases , signs of fast tumor lysis syndrome. Infusion reactions disappear after the interruption of the administration of MabThera drug and drug therapy (including intravenous infusion of 0.9% sodium chloride solution, Diphenhydramine and acetaminophen, bronchodilators, GCS). In most cases, after complete disappearance of the symptomatology, the infusion can be resumed at a rate of 50% of the preceding (eg 50 mg / h instead of 100 mg / h).In most patients with life-threatening infusion reactions, the course of treatment with rituximab was completely completed. Continuation of therapy after complete disappearance of symptoms is rarely accompanied by repeated development of severe infusion reactions.

In connection with the potential for the development of anaphylactic reactions and other hypersensitivity reactions with / in the introduction of protein preparations, it is necessary to have the means for their reduction: adrenaline, antihistamines and GCS.

Side effect of the lungs. Hypoxia, pulmonary infiltrates and acute respiratory failure. Some of these phenomena were preceded by severe bronchospasm and shortness of breath. Perhaps the increase in symptoms over time or clinical deterioration after initial improvement. Patients with pulmonary symptoms or other severe infusion reactions should be carefully observed until the symptoms are completely resolved. Acute respiratory failure may be accompanied by the formation of interstitial infiltrates in the lungs or pulmonary edema, often manifested in the first 1-2 hours after the start of the first infusion.With the development of severe reactions from the lungs, infusion of rituximab should be stopped immediately and intensive symptomatic therapy should be prescribed. Since the initial improvement in clinical symptoms may be replaced by worsening, patients should be carefully monitored before resolution of pulmonary symptoms.

Syndrome of rapid lysis of the tumor. MabThera mediates the rapid lysis of benign or malignant CD20-positive cells. Tumor lysis syndrome is possible after the first infusion of MabThera in patients with a large number of circulating malignant lymphocytes. Tumor lysis syndrome includes: hyperuricemia, hyperkalemia, hypocalcemia, hyperphosphatemia, acute renal failure, increased LDH activity. Patients at risk (patients with high tumor burden or with circulating malignant cells more than 25 000 / μL, for example, with chronic lymphocytic leukemia or lymphoma from cells of the mantle zone) need careful medical supervision and regular laboratory examination. With the development of symptoms of rapid lysis of the tumor, appropriate therapy is carried out.After complete relief of symptoms in a limited number of cases, MabThera continued therapy in combination with the prevention of rapid tumor lysis syndrome.

Patients with a large number of circulating malignant cells (more than 25 000 / mm3) or a high tumor burden (eg, with chronic lymphocytic leukemia or mantle cell lymphoma) who are at risk of extremely severe infusion reactions may be particularly high, MabThera should be given with extreme caution, under close supervision. The first infusion of the drug to such patients should be administered at a slower rate or divided the dose of the drug for 2 days during the first cycle of therapy and in each subsequent cycle if the number of circulating malignant cells remains> 25 000 / μL.

Side effect of the cardiovascular system. During the infusion, careful monitoring of patients with a history of cardiovascular disease is required in connection with the possibility of developing angina pectoris, arrhythmia (flutter and atrial fibrillation), heart failure or myocardial infarction.Because of the possibility of developing hypotension at least 12 hours before the infusion of Mabter's drug, antihypertensive drugs should be abolished.

Control of blood elements. Although MabThera monotherapy does not have a myelosuppressive effect, caution should be taken to prescribe the drug for neutropenia of less than 1500 / μL and / or thrombocytopenia less than 75,000 / μL, as the experience of its clinical use in such patients is limited. MabThera was used in patients after autologous bone marrow transplantation and in other risk groups with a possible violation of bone marrow function without causing the phenomena of myelotoxicity. During the treatment, it is necessary to regularly determine the detailed analysis of peripheral blood, including counting the number of platelets in accordance with routine practice.

Infections. MabThera should not be given to patients with severe acute infection.

Hepatitis B. In the appointment of a combination of MabThera and chemotherapy, reactivation of hepatitis B or fulminant hepatitis (including fatal outcome) was noted. Predisposing factors included both the stage of the underlying disease,and cytotoxic chemotherapy. Prior to the appointment of MabThera to patients at risk, hepatitis B should be excluded. When MabThera is prescribed to patients with hepatitis B virus and patients with hepatitis B, a history of clinical and laboratory signs of active hepatitis B should be carefully monitored, both during therapy and during several months after its completion.

Progressive multifocal leukoencephalopathy (PML). When using MabThera in patients with non-Hodgkin's lymphoma and chronic lymphatic leukemia, PML cases were observed. Most patients received MabThera in combination with chemotherapy or in combination with hematopoietic stem cell transplantation. If neurologic symptoms occur in such patients, differential diagnosis should be performed to exclude PML and consult a neurologist.

Immunization. The safety and effectiveness of immunization with live viral vaccines, after treatment with MabThera, has not been studied. Vaccination with live viral vaccines is not recommended. Vaccination with inactivated vaccines is possible, but the frequency of response may be reduced.In patients with recurrent non-Hodgkin's lymphoma of low grade, there was a decrease in the response rate for the administration of tetanus toxoid and KHL-neoantigen (KHL-hemocyanin of the fisurelia mollusk) compared to patients not receiving MabThera (16% vs. 81% and 4% vs. 76%, respectively; the evaluation criterion is more than 2-fold increase in antibody titer). However, the average antibody titre to the antigen set (Streptococcus pneumoniae, influenza A, parotitis, rubella, varicella) did not change for at least 6 months after MabThera therapy (when compared with antibody titers before treatment).

Rheumatoid arthritis, granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic polyangiitis

In relation to other autoimmune diseases, the efficacy and safety of the use of MabThera is not established.

Infusion reactions. The development of infusion reactions may be due to the release of cytokines and / or other mediators. Before each infusion of MabThera drug, it is necessary to perform a premedication with an analgesic / antipyretic and an antihistamine drug. In addition, before each infusion with MabThera, patients with rheumatoid arthritis should receive premedication of GCS to reduce the frequency and severity of infusion reactions.

In most cases, the infusion reactions in patients with rheumatoid arthritis were of mild or moderate severity. During the postmarketing period, heavy infusion reactions with a fatal outcome were recorded. It is necessary to carefully monitor patients with previously identified diseases of the cardiovascular system, as well as those who previously had undesirable reactions from the heart and lungs. The most frequent infusion reactions were: headache, itching, sensation of sore throat, hot flashes, rashes, hives, increased blood pressure and fever. Infusion reactions were more often observed after the first infusion of any course of treatment than after the second infusion. The subsequent infusions of MabThera's drug were easier to transfer than the first. Serious infusion reactions were observed in less than 1% of patients, most often during the first infusion of the first cycle. Infusion reactions disappear after slowing or interrupting the administration of MabThera drug and drug therapy (antipyretic, antihistamines and sometimes oxygen, intravenous administration of 0.9% sodium chloride solution, bronchodilators and, if necessary, SCS).With the development of infusion reactions, depending on their severity and necessary treatment, the administration of MabThera should be temporarily suspended or canceled.

In most cases, after complete disappearance of the symptomatology, the infusion can be resumed at a rate of 50% of the preceding (eg 50 mg / h instead of 100 mg / h).

In connection with the potential for the development of anaphylactic reactions and other immediate-type hypersensitivity reactions with intravenous administration of protein preparations, it is necessary to have the means for their reduction: adrenaline, antihistamine and glucocorticosteroid preparations.

The infusion reactions observed with granulomatosis with polyangiitis and microscopic polyangiitis corresponded to those described in rheumatoid arthritis. The lower frequency and severity of the infusion reactions with granulomatosis with polyangiitis and microscopic polyangiitis could be associated with the use of high doses of glucocorticosteroids.

Side effect of the cardiovascular system. Because of the possibility of developing hypotension at least 12 hours before the infusion of Mabter's drug, antihypertensive drugs should be abolished.

Careful observation of patients with a history of cardiovascular disease is required in connection with the possibility of developing angina or arrhythmia (flutter and atrial fibrillation), heart failure or myocardial infarction.

Infections. In connection with the possible increase in the risk of infectious complications, MabThera should not be given to patients with acute infection or severe immunodeficiency (hypogammaglobulinemia or low CD4, CD8). Caution should be exercised when administering MabThera in patients with chronic infection or in the presence of conditions predisposing to the development of serious infections. If an infection occurs, appropriate therapy should be prescribed.

Hepatitis B. When using MabThera in patients with rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, there were cases of exacerbation of hepatitis B (including fatal outcome). Prior to the appointment of MabThera to patients at risk, hepatitis B should be excluded. When MabThera is prescribed for patients with hepatitis B virus and for patients with hepatitis B, a history should be carefully monitoredthe emergence of clinical and laboratory signs of active hepatitis B both during therapy and for several months after its termination.

Progressive multifocal leukoencephalopathy (PML). During the period of post-marketing application of MabThera's drug to patients with autoimmune diseases, incl. with rheumatoid arthritis, fatal cases of PML were observed. Some patients had multiple PML risk factors: co-morbidities, long-term use of immunosuppressive therapy or chemotherapy. PML cases have also been reported in patients with autoimmune diseases not receiving MabThera. If neurologic symptoms occur in such patients, differential diagnosis should be performed to exclude PML and consult a neurologist.

Before using MabThera in patients with rheumatoid arthritis, the vaccine status of the patient should be studied and acted according to the appropriate recommendations.Vaccination should be completed at least 4 weeks before the appointment of rituximab.

After 6 months of therapy with MabThera and methotrexate, the response rate for polysaccharide pneumococcal vaccine was reduced (43% vs 82%, at least 2 serotypes of pneumococcal antibodies), KHL-neoantigen (KHL-hemician of the fisurelia mollusk) (47% vs 93%) compared with Methotrexate monotherapy. After therapy with MabThera and methotrexate, the response rate for tetanus toxoid was similar to that of monotherapy with methotrexate (39% versus 42%).

If necessary, vaccination with inactivated vaccines should be completed at least 4 weeks before the second course of therapy.

The number of patients with rheumatoid arthritis and a positive titer of antibodies to Streptococcus pneumoniae, influenza A, mumps, rubella, chicken pox and tetanus toxin did not change before and 1 year after initiation of therapy with MabThera.

Anti-Chimeric Antibodies. The appearance of anti-chimeric antibodies in most patients with rheumatoid arthritis was not accompanied by clinical manifestations or increased risk of reactions during subsequent infusions,but rarely their presence may be associated with more severe allergic or infusion reactions with repeated infusions during the following courses and an ineffective effect on reducing the B-cell pool during subsequent courses of therapy.

Patients with rheumatoid arthritis who had not previously received methotrexate. MabThera is not recommended for the treatment of patients who have not previously received methotrexate, favorable benefit / risk ratio for this category of patients is not confirmed.

Recycling

Disposal of MabThera should be carried out in accordance with local requirements.

Impact on the ability to drive vehicles and manage mechanisms

Whether rituximab affects the ability to manage and work with machines and mechanisms is unknown, although the pharmacological activity and the described undesirable phenomena do not give grounds for assuming such an effect.

Drug Interactions

Data on drug interactions of MabThera drug are limited.

In patients with chronic lymphocytic leukemia with the simultaneous use of MabThera, fludarabine and cyclophosphamide, pharmacokinetic parameters do not change.Concurrent administration of methotrexate does not affect the pharmacokinetics of rituximab in patients with rheumatoid arthritis.

When administered with other monoclonal antibodies for diagnostic or therapeutic purposes, patients with antibodies against mouse proteins or anti-chimera antibodies increase the risk of allergic reactions.

In patients with rheumatoid arthritis, the incidence of serious infections during MabThera therapy (before therapy with other biological basic anti-inflammatory drugs (DMAP)) is 6.1 per 100 patient-years, while during subsequent therapy with other DMAPs, 4.9 per 100 patient-years .

When MabThera is administered, polyvinyl chloride or polyethylene infusion systems or bags can be used due to the compatibility of the material with the drug.

Analogs of the drug MabThera

MabThera has no structural analogs for the active substance.

Analogues on the curative effect (remedies for the treatment of rheumatoid arthritis):

Azathioprine;
Actasulide;
Amelotex;
Arava;
Arkoxy;
Arthrosylen;
Aertal;
Wobenzym;
Voltaren;
Decortin;
Dexalgin;
Dexamethasone;
Derinat;
Dicloran;
Diclofenac;
Dimexide;
Diprospan;
Dolgit;
Donalgin;
Ibuprofen;
Indomethacin;
Ketonal;
Ketoprofen;
Coxib;
Xsefokam;
Meloksikam;
Movalis;
Nyz;
Naklofen;
Nalgezin;
Naproxen;
Nimulid;
Panavir;
Plaquenil;
Polyoxidonium;
Prednisolone;
Sulfasalazine;
Fastum gel;
Finalal;
Flamax;
Celebrex;
Cyclosporin;
Cycloferon;
Эветрекс;
Endoxane;
Eralfon.

If there are no analogues of the medication for the active substance, you can go to the links below for diseases, from which the corresponding drug helps, and to look at the available analogs for therapeutic effects.

Used for the treatment of diseases: leukemia, arthritis, granulomatosis, lymphoma, lymphocytic leukemia, follicular lymphoma, rheumatoid arthritis, Wegener's granulomatosis, oncology, non-Hodgkin's lymphoma