Redditux (rituximab) concentrate for infusions 10 mg/ml. 10 ml/100 mg. vial №1

Description

Redditux (rituximab) concentrate for infusions 10 mg/ml. 10 ml/100 mg. vial №1

Composition

active substance: rituximab;

1 ml of concentrate for solution for infusion contains 10 mg of rituximab;

excipients: sodium citrate, polysorbate 80, sodium chloride, water for injections.

Medicinal form

Concentrate for solution for infusions.

Main physico-chemical properties: from transparent to opalescent (not more than reference standard III), from colorless to yellowish (not more than reference standard Y5) a solution that practically does not contain visible particles.

Pharmacotherapeutic group

Antineoplastic agents. Rituximab. Monoclonal antibodies.
ATX code L01X C02.

Pharmacological properties

Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody that is a glycosylated immunoglobulin with sequences from the human IgG1 constant domain and the light and heavy chains of the mouse variable domains. The antibody is produced by the culture of mammalian cells (Chinese hamster ovaries) in suspension and purified by affinity chromatography and ion exchange using special procedures for inactivating and removing viruses. Redditux specifically binds to the transmembrane antigen CD20, a non-glycosylated phosphoprotein located on pre-B lymphocytes and mature B lymphocytes. This antigen is expressed in more than 95% of cases in B-cell non-Hodgkin’s lymphomas. CD20 is located on normal and malignant B cells, but is absent on hematopoietic stem cells, pro-B cells, healthy plasma cells, and healthy cells of other tissues. After binding to the antibody, CD20 is not internalized and is not removed from the cell membrane into the intercellular environment. CD20 does not circulate in the plasma as a free antigen and therefore does not compete for binding with the antibody.

Indications

Redditux is used:

• Non-Hodgkin’s lymphomas (NHL);
• Chronic lymphocytic leukemia;
• Granulomatosis with polyangiitis and microscopic polyangiitis.

Contraindications

Redditux is not used:

• with hypersensitivity to the active substance (rituximab), any component of the drug, mouse proteins;
• with acute infectious diseases;
• with severe primary or secondary immunodeficiency;
• during pregnancy;
• during breastfeeding;
• under the age of 18.

Carefully:

• with a history of respiratory failure;
• with tumor infiltration of the lungs;
• when the number of circulating malignant cells is more than 25000 / μl, high tumor load;
• with neutropenia (less than 1500 / μl);
• with thrombocytopenia (less than 75,000 / μl);
• with chronic infection.

Application during pregnancy and lactation

Contraindicated.

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

Method of administration and dosage

Redditux is administered intravenously.

Dosage and duration of treatment depend on the indications of the therapy and is determined by a doctor who has experience in such therapy.

The recommended rate of the first infusion is 50 mg / hour, further it can be increased by 50 mg / hour every 30 minutes, bringing to a maximum rate of 400 mg / hour. Subsequent infusions begin at 100 mg / hr, increasing by 100 mg / hr every 30 minutes to a maximum rate of 400 mg / hr.

Overdose

Exceeding the dose may lead to an increased risk of infectious complications when the pool of B-lymphocytes is depleted.

If an overdose is suspected, it is necessary to monitor the composition of the peripheral blood, if necessary, prescribe symptomatic and supportive treatment.

Side effects:

• Infectious / parasitic diseases: bacterial, fungal, viral infections, incl. respiratory tract infections, herpes zoster, sepsis.
• Hematological disorders: leukopenia, neutropenia, thrombocytopenia, lymphadenopathy, anemia, bleeding disorders, hemolytic anemia, partial aplastic anemia.
• Respiratory disorders: rhinitis, respiratory diseases, bronchospasm, cough, shortness of breath, hypoxia, chest pain, impaired lung function, bronchial asthma, bronchiolitis obliterans.
• Immune disorders: angioedema, hypersensitivity reactions.
• Metabolic disorders: hyperglycemia, peripheral edema, weight loss, facial edema, hypocalcemia, increased LDH activity.
• General disorders: headache, chills, fever, asthenia, pain in tumor foci, hot flashes, flu-like syndrome, weakness, pain at the injection site.
• Digestive disorders: nausea, diarrhea, dyspepsia, vomiting, lack of appetite, stomatitis, dysphagia, constipation, sore throat, abdominal pain, abdominal enlargement.
• Cardiovascular disorders: lowering blood pressure, orthostatic hypotension, increased blood pressure, tachycardia, atrial fibrillation, arrhythmia, cardiac pathology, left ventricular heart failure, supraventricular / ventricular tachycardia, myocardial ischemia, bradycardia, angina pectoris.
• Neurological / mental disorders: dizziness, hypesthesia, paresthesia, sleep disturbance, agitation, anxiety, vasodilation, taste perversion, depression, nervousness.
• Musculoskeletal disorders: neck pain, myalgia, muscle hypertonia, arthralgia, back pain.
• Dermatological disorders: itching, rash, urticaria, sweating, increased sweating at night, alopecia.
• Ophthalmic disorders: conjunctivitis, lacrimation disorders.
• Otolaryngological disorders: noise and pain in the ears.
• Change in laboratory data: decrease in IgG levels.