RITUKSIMAB (Rituximab)

     Synonym : Mabtera, Mabthera.

     Description : It is a chimera monoclonal antibodies mouse / human with the specificity of CD20 molecules, found within the surface before and B-lymphocytes and mature ekspressiruyuscheysya more than 95% of B-cell NHL.

Transparent, colourless liquid supplied in sterile vials of apirogennogo single glass contains no preservatives.

     Pharmacology : drugs, antitumor effect.

Associated with the CD20 molecule on the surface of B-lymphocytes, consistently activates Complement, effector cells (antitelozavisimaya cell toxicity) or directly induces apoptosis. Sensibiliziruet line B-cell lymphoma rights to the cytotoxic action of certain chemotherapy drugs. After bonding with CD20 antibody does not circulate in the plasma as a free antigen, and does not compete for the binding of antibodies. Antihimernye antibodies designed to 1% of patients. The concentration of antibodies in serum increases with the increase in dosage. After the first dose of 375 mg / m 2 Cmax of 239 ug / ml after 4 of doubling. T1 / 2 increases in the treatment process from 68 h to 190 h, and plasma Cl decreased from 0.05 to 0.02 L / h. Contemporary to cumulation found in the body over 3-6 months after treatment. Median number of B-cells in peripheral blood after the first injection of preparation reduced to a level below normal, but after 6 months is beginning to recover, returning to normal between 9 and 12 months after completion of therapy. The effectiveness of therapy higher in patients with low tumor mass.

     Application : B-cell lymphoma cancer (recurring or himioustoychivye, low MALIGNANCY follikulyarnye or, in adults).

     Contraindications : Giperchuvstvitelnost to any component of the drug or to the mouse protein.

     Restrictions apply to : High Tumor load (size pockets than 10 cm), cardiovascular disease, neutropenia, pregnancy, childhood.

     Side Effects : weakness, fatigue, dizziness, anxiety, depression, parestezii, gipesteziya, arousal, sleep disturbance, anxiety, headache, abdominal pain, joints, muscles, back or chest, the place Infusion or locate tumors, muscle gipertonus, dyspnoea, irritation pharynx, rhinitis, increased cough, sinusitis, bronchitis, nausea, vomiting, increased abdomen, diarrhoea, neuralgia, anorexia, hypotension, arterial hypertension, aetiology / tachycardia, arrhythmia, increased strokes, heart failure decompensation, bronchospasm, tumor lysis syndrome (giperurikemiya, giperkaliemiya, gipokaltsiemiya, acute renal failure, increasing the LDG, respiratory insufficiency), thrombocytopenia, neutropenia, anemia, lower concentrations of serum immunoglobulins, infections, including faster, transitory increasing functional liver samples, lymphadenopathy, hyperglycemia, peripheral oedema, conjunctivitis, slezootdeleniya violations, the sense of taste, blood clotting, anafilakticheskie reactions, fever, chills, night sweating, muscle shaking, tides, angionevrotichesky swelling, itching, urticaria, or skin rashes.

     Networking : enhance the risk of allergic events or hypersensitivity reactions in patients with antibodies against proteins or antihimernye mouse antibodies.

     Dosing and Administration : W / in. Concentrate prior to throw in Tank vial (packet) clean, apirogennym, 0.9% aqueous solution of sodium chloride or 5% aqueous solution of glucose concentration to 1-4 mg / ml (solution can be stored for 12 hours at room temperature or for 24 hr at temperatures from 2 to 8 ° C); enter drip dose of 375 mg / m 2 body surface once a week for four weeks; Infusion initial speed in the first introduction of 50 mg / h, with a gradual increase to 50 mg / h every 30 mines (maximum speed of 400 mg / h); in subsequent proceedings can start with a speed of 100 mg / h and to increase it to 100 mg / h every 30 minutes to a maximum (400 mg / h).

     Precautions : Infuzii possible only in a hospital under close supervision or haematologist oncologist with experience of such treatment, and ready to be all that is necessary for coming up in full. With regard to the risk of hypotension recommended lifting antigipertenzivnyh preparations for the 12 hours before and throughout Infusion. It will be strictly observed Infusion regimes, not in / in a desk or in bolyusa. To prevent the release of "syndrome" Cytokines for 30-60 minutes before each procedure requires sedation : pain or analgesic (eg paracetamol) and antigistaminnoe (difengidramin etc.), but rather with the increased risk of allergic reactions, corticosteroids. Mild to moderate reactions expressed can be eliminated reducing the speed of which can be increased again after the disappearance of symptoms. Caution must be exercised (in the first introduction of lower-speed Infusion, careful observation) in patients with malignant pockets single size of 10 cm in diameter or with the number of circulating malignant cells more than 5.105 of 1 mm at the high frequency of serious adverse events. Because of the high risk of releasing Cytokines syndrome patients with unaccounted guidance on lung failure and neoplastic infiltration light possible appointment of a close monitoring and only if other treatments ineffective. "If they release syndrome" Cytokines Infusion should cease immediately and begin intensive symptomatic therapy. Be wary designate patients with neutropenia (less than 1,500 cells in 1 mm) and thrombocytopenia (less than 1 in 75,000 cells mm); Over the course of a regular monitoring of peripheral blood cell. During and in the year after treatment, women of childbearing age must use effective methods of contraception. Assign pregnant women only if the benefits of therapy over the potential risk to the foetus. Nursing women at the time of treatment are encouraged to stop breast-feeding.

Materials allowed to copy only with the active hyperlink to the handbook of medicines