MabThera

Description overdue on 11/12/2014

• Latin name: Mabthera
• ATC code: L01XC02
• Active substance: Rituximab (Rituximab)
• Manufacturer: F. Hoffmann-La Roche Ltd. (Switzerland), Roche Diagnostics (Germany)

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• Composition
• Product form
• Pharmacological action
• Pharmacodynamics and Pharmacokinetics
• Indications
• Contraindications
• During pregnancy (and lactation)
• Side effects
• Instructions for use of MabThera
• Overdose
• Cooperation
• Terms of sale
• Storage conditions
• Shelf life
• Analogs
• Reviews
• Price, where to buy

Composition

The composition includes a drug MabThera 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.

Product form

Mabthera medicament is manufactured as a concentrate for solution for intravenous infusion. Liquid or fully transparent, or has a pale yellow color.

• 10 ml - vials glass (2) - cardboard boxes;
• 50 ml - vials glass (1) - boxes cardboard.

Pharmacological action

MabThera is antitumor   and immunomodulatory   a drug with a high content of Rituximab   - Recombinant chimeric monoclonal antibody, have some impact on the body's cells. The antibodies specifically bind to the CD20 transmembrane antigen located on pre-B lymphocytes and mature B lymphocytes form. Feature transmembrane antigen CD20 is its absence of cells to which a small amount of travel through the bloodstream (hematopoietic). In the early progenitors (precursor) of white nucleated cells in the bone marrow and plasma cells without pathological disorders, as well as the cells of other tissues of the antigen is also absent.

The active substance of MabThera stimulates immune responses upon binding to the CD20 antigen on B-lymphocytes, which stimulates the process of lysing white nucleated cells.

In primary infusion of the drug, the patient may experience a decrease in the level of nucleated white blood cells. This effect disappears after six months of treatment with the drug and the level of white blood nucleated cells in peripheral blood returns to normal. The final recovery was observed after about 9 months of use of MabThera.

Pharmacodynamics and Pharmacokinetics

Rituximab , Part of MabThera is an antibody which is produced by immune cells belonging to a single cell clones. This means that the antibody is produced from a plasma cell precursor. This type of protein has been designed to recognize and attach to a specific structure (called an antigen), which is found in certain cells of the body.

Rituximab is attached to the antigen that leads to cell death. This helps in the treatment of lymphoma   and CLL (chronic lymphocytic leukemia) As cancerous B-lymphocytes are destroyed action of the active drug substance. At rheumatoid arthritis , B-lymphocytes are destroyed in the joints, which helps to reduce inflammation. At chronic lymphocytic leukemia   destruction of B-lymphocytes, reducing the productivity of anti-neutrophil cytoplasmic antibody.

People who received Rituximab   intravenously in amounts of 125 mg / m2 (m2 - measurement value of the body surface), 250 mg / m2 or 375 mg / m2 every week for one month, there was an increase in the amount of antibodies in the serum as a function of increasing the dose of the active ingredient.

In patients who received MabThera dose of 375 mg / m2, the average T1 / 2 of the active ingredient of the drug was equal to 68.1 hours. This reaction was observed immediately after the initial injection. As patients Cmax of 238.7 mg / ml. The index average plasma clearance was equal to 0.0459 l / h. An analysis conducted after the fourth dripping with MabThera showed: 189.9 hours, 480.7 g / ml and 0.0145 l / h.

Indications

The drug MabThera is indicated for adults for the following indications:

• Non-Hodgkin's Lymphoma   - MabThera is indicated for the treatment of patients with hypertension-III-IV follicular lymphoma in combination with chemotherapy. Mandatory requirement - the use of the drug can only be held not earlier therapeutic procedures for the treatment of this disease.
• Supportive therapy with this drug indicated for the treatment follicular lymphoma   together with the induction therapy.
• Monotherapy using this drug indicated for the treatment of patients with stage III-IV- follicular lymphoma During the second or next relapse after chemotherapy.
• The drug is indicated for the treatment of people who have been confirmed CD20-positive diffuse large B-cell non-Hodgkin lymphoma . This drug is used in combination with TSDVP (cyclophosphamide, doxorubicin, vincristine, prednisone) Chemotherapy .
• Chronic lymphocytic leukemia   - MabThera in combination with chemotherapy is indicated for the treatment of patients whose disease was detected for the first time and patients with relapses chronic lymphocytic leukemia .
• Rheumatoid arthritis   - MabThera is indicated for the treatment of adult patients with a diagnosis active severe rheumatoid arthritis . The drug is used in conjunction with Methotrexate Otherwise the treatment will not bring the desired effect.

Contraindications

The drug is prescribed with caution MabThera:

• People who have a large number of cancer cells circulating in the blood, or high tumor burden.
• People with lung cancer .
• People with any form of lung disease.
• People with different forms CVD .
• People who have previously been Chemotherapy . In this case, the probability of side effects on the cardiovascular system.
• People with low neutrophil   and Platelet   in blood.
• People whose immune system has a reduced ability to fight infections and diseases.
• People with a history of recurring or chronic infections.
• Persons with history hepatitis .

Purpose of treatment with MabThera are strictly contraindicated:

• People with active severe infections.
• People with poorly functioning immune system, for example, by previous courses Chemotherapy   or radiation therapy .
• People who have allergy   mouse protein.
• When treating rheumatoid arthritis , This drug should not be administered to people with severe Heart Failure   or other heart disease .
• For children.
• This medication should not be used with the possible manifestations of allergic reactions due to the impact of one of the components of the drug.

Pregnancy and breast-feeding

Similar preparations with great care prescribed for women who are pregnant or breast-feeding. But if experts believe that use of the drug will benefit the mother outweigh the risks to the health of the unborn child, then its use is appropriate.

Experts are not established whether Rituximab   affect reproductive capacity or cause fetal harm when administered the drug during pregnancy. However, since Rituximab   the potential to cross the placenta and attack the B-cells of the developing baby, the drug is not prescribed to pregnant women. The only exception is when the obvious use several times more likely risk to the health of the baby hatched.

Also, this drug is not indicated for the treatment of women who are breastfeeding. Since MabThera administered intravenously, some of the drug passes into breast milk, it may not be the best way impact on the health of the child. Therefore, women who were treated with this drug, should not breastfeed for at least one year after the last infusion.

Side effects

Medications have a personal impact on the body of each person, so patients who were treated with MabThera, in some cases, there are various side effects listed below.

Note that despite the fact that the side-effects given enough, it does not mean that the treatment with the drug may be observed in all patients. In some cases, treatment may take place without causing the side effects of the drug.

Possible side effects:

• fever   (hyperthermia) or chills;
• weakness or loss of coordination;
• headache ;
• decrease in blood levels of white and red blood cells;
• increased susceptibility to infections;
• rash or itching;
• hair loss ;
• Sweating ;
• irregularities in the bowel (abdominal pain, indigestion, diarrhea . constipation   And so on);
• runny or itchy nose;
• severe swelling of the lips, face or tongue ( angioedema );
• decrease or increase in blood pressure;
• dizziness ;
• numbness of extremities;
• sleep disturbances (insomnia) ;
• anxiety, agitation, nervousness or depression ;
• sensation of ringing or other noise in the ears;
• breathing problems due to narrowing of the airways (bronchoconstriction) or other lung problems;
• throat irritation;
• muscle pain, joint pain, back or neck;
• elevated blood sugar ( hyperglycemia );
• swollen ankles due to fluid retention;
• heart problems, such as abnormal heart beat (arrhythmia) , Heart failure, chest pain or heart attack .

Instructions for use of MabThera

Instructions on MabThera to some extent complicated, so before using the drug should be thoroughly familiar with it.

Treatment with MabThera should be carried out under the close supervision of an experienced health care professional. Ideally, the administration of the drug should be administered in the presence of all the conditions for the resuscitation of patients in case of symptoms of serious adverse reactions. When the drug is used in conjunction with chemotherapy, injections are made cyclically on the first day of each treatment stage. Pre-patient should be given an antihistamine (to prevent allergic reactions) and antipyretic.

When treating non-Hodgkin lymphoma Usual dose when administered intravenously MabThera is 375 mg per unit body surface area (calculated on the patient's height and weight). The frequency of infusions and the number depends on the type of lymphoma being treated. Some patients received a total dose as an intravenous infusion, may receive a subsequent dose by subcutaneous injection. The recommended dose for subcutaneous injection of 1400 mg. Here the area of ​​the body is not included in the dosage injections.

For treatment CLL , Infusion intravenously done six times: the first dose is 375 mg / m 2, and then 500 mg / m 2 for all other doses. To avoid side effects due to the destruction of cancerous lymphocytes, patients should take the drug in parallel, which helps to stabilize the level of uric acid.

For treatment rheumatoid arthritis This preparation is administered as two intravenous infusions of 1,000 mg. The break between the infusion should be no less than 14 days. Patients usually respond to treatment from 16 to 24 weeks after initial treatment. After 24 weeks, the treatment may be repeated depending on the patient response.

Overdose

Cases of overdose MabThera is currently unknown, as a single dose Rituximab Exceeding 1000 mg / m2 are not subjected to scrutiny.

Interaction with other drugs

Rituximab   It can cause low blood pressure and reduce the effectiveness of drugs that stabilize it. For this reason, if the patient is taking medication to lower blood pressure, an expert must verify the discontinuation of the drug for at least 12 hours prior to infusion of MabThera.

If the medicine prescribed for the treatment of rheumatoid arthritis, the patient should inform your doctor about vaccination made the day before, for example, before visiting the exotic countries. Since this drug attacks the B cells which are part of the immune system, Rituximab   can reduce the performance of the antibody. This means that vaccines could be potentially less efficient during the treatment, as well as trigger the development of serious infections. For this reason, if the patient have been made any vaccinations MabThera infusions should be administered at least four weeks after the last vaccination.

The use of this drug in combination with other medical drugs for the treatment of active-form rheumatoid arthritis   It is not known (except Methotrexate ).

Terms of sale

The drug MabThera released strictly in pharmacies by prescription.

Storage conditions

The drug should be stored out of reach of children at a temperature of not less than 2 and no more than 8 degrees Celsius.

Shelf life

Shelf life is 30 months.

Analogs of MabThera

Match code ATC 4th level:

• Herceptin

Analogues ATC code, the composition of the active ingredients and the form of:

• Redituks   - Preparation of a concentrate for r-ra d / inf., 10 mg / ml and 10 ml (100 mg) and 50 (500 mg) in a vial;
• Rituksim - Preparation of a concentrate for r-ra d / inf., 10 mg / ml and 10 ml (100 mg) and 50 (500 mg) in a vial and №1 №2.

Analogs of the code ATH 4th level:

• Avastin   - Preparation of a concentrate for r-ra d / inf. 100 mg / 4 ml and 400 mg / 16 ml vial;
• Adtsetris   - A preparation in powder form d / conc. for p-ra d / inf. 50 mg vial;
• Vectibix   - Preparation of a concentrate for r-ra d / inf., 20 mg / ml, 20 ml and 5 ml vial;
• Herceptin   - Lyophilisate d / conc. for p-ra d / inf. 150 mg and 440 mg per vial;
• Quds   - A preparation in powder form d / conc. for p-ra d / inf. 100 mg and 160 mg in a vial.
• Trastumab   - The drug in powder form liof. d / for r. conc. d / inf. 150 mg vial;
• Erbitux   - A preparation in solution d / inf. 5 mg / ml, 100 ml and 5 mg / ml in 20 ml flask.

Reviews of MabThera

Reviews of MabThera on the forums there are different. Positive comments about the drug say that it is effective, and negative caused by a large number of contraindications and side effects. Neutrals reviews on the Internet about the medicines MabThera not.

Price MabThera

Buy MabThera in Moscow only in pharmacies and a prescription from the doctor. Price in Russia of the drug varies from 21 to 45 thousand. Rubles:

• MabThera solution for infusion 100mg 10ml №2 - the price of 21300 rubles. to 30550 rubles.
• MabThera solution for infusion 500mg 50ml №1- price of about 44,500 rubles.

Price MabThera in Ukraine varies over a wide range:

• MabThera solution for infusion 100mg 10ml №2 - price from 6383.52 to 7744.70 hryvnia hryvnia.
• MabThera solution for infusion 500mg 50ml №1- price of 12767.04 to 20460.66 hryvnia hryvnia.

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