Infliximab
When ATH:
L04AB02
Characteristic.
The chimeric mouse-human IgG1 monoclonal antibodies, consisting of the variable (Fv) region of high affinity neutralizing mouse monoclonal antibodies tumor necrosis factor-alpha and fragment molecules human IgGlk.
Pharmacological action.
Immunosuppressive.
Application.
Rheumatoid arthritis (active form), the ineffectiveness of previous therapy, including methotrexate (Combination therapy with methotrexate); Crohn's disease (active form), incl. with the formation of fistulas, in severe inefficiencies and corticosteroids and / or immunosuppressants.
Contraindications.
Hypersensitivity (incl. to others. murine proteins), sepsis, clinically apparent infection or abscess, pregnancy, lactation.
Restrictions apply.
Childhood (safety and efficacy in children and adolescents under the age of 18 years to be determined).
Pregnancy and breast-feeding.
Contraindicated in pregnancy.
Category actions result in FDA - B. (The study of reproduction in animals revealed no risk of adverse effects on the fetus, and adequate and well-controlled studies in pregnant women have not done.)
At the time of treatment should stop breastfeeding.
Side effects.
From the nervous system and sensory organs: 1-10% headache, dizziness; 0,1-1% depression, psychosis, anxiety, amnesia, apathy, nervousness, drowsiness, conjunctivitis, keratokonъyunktyvyt, endophthalmitis, periorbital edema.
Cardio-vascular system and blood (hematopoiesis, hemostasis): 0,1-10% tides, petechiae, ecchymosis / hematoma, hyper / hypotension, bradycardia, heartbeat, arrhythmia, vasospasm, the peripheral blood circulation, tromboflebit, fainting; 0,1-1% of anemia, leiko-, lymphoma, neutrons, thrombocytopenia, Lymphocytosis, lymphadenopathy.
From the respiratory system: 0,1-10%-sinusitis, nose bleed, upper respiratory tract infection, bronchitis, pneumonia, pleurisy, breathlessness, pulmonary edema.
From the digestive tract: 0,1-10%-Cheilitis, nausea, diarrhea or constipation, dyspepsia, gastro-esophageal reflux, diverticulitis, cholecystitis, abnormal liver function.
With the genitourinary system: 0,1-1% of urinary tract infections (pyelonephritis et al.), vaginitis, swelling.
For the skin: 0,1-10% — sweating, xerosis, hyperkeratosis, violation of skin pigmentation, cyanosis, fungal dermatitis (onixomikoz, eczema), seborrhea, mug, Warts, furunculosis, alopecia, bullous rash.
Allergic reactions: 0,1-10%-rash, itch, hives, bronchospasm, etc.. allergic reactions.
Other: 0,1-10% — the development of infections (flu, herpes, fever, abscess, cellulitis, sepsis, bacterial and fungal infections), fatigue, Infusion and pain (incl. chest pain, stomach); 0,1-1%-myalgia, arthralgia, the formation of autoantibodies, lupus-like syndrome, reactions at the injection site.
Cooperation.
Methotrexate reduces antibodies to infliximab and increases the concentration in plasma. The infusion solution is incompatible (should not be confused) Happy Birthday. Drug.
Overdose.
Clinical data on overdose lacking. A single dose of 20 mg/kg toxic effects have not been accompanied by.
Dosing and Administration.
B /, at no more than 2 mL/min for a period of not less than 2 hours using infuzionna system, having a non-pyrogenic filter, having low activity belkovosvyazyvayuschey. In rheumatoid arthritis: single dose 3 mg / kg, then through 2 and 6 weeks after the first injection and then every 8 Sun (the total number of introductions — 5-6). Treatment is carried out against the background of methotrexate. In Crohn's disease (active form): 5 mg / kg once; in the formation of fistulas- 5 mg / kg, then again after 2 Sun and 6 weeks after the first injection. In the case of recurrence of the disease possible resumption of treatment for 14 weeks after the last dose.
Precautions.
Before starting therapy should cure manifestnye infections and abscesses. If severe allergic reactions, serious infection or sepsis, development volchanochnopodobnogo syndrome treatment should be discontinued. The occurrence of acute allergic reactions necessitates reducing the rate of administration or discontinuation of infliximab infusion. After the removal or disappearance of the reaction introducing resumed at a slower rate. It is recommended that the use of antihistamines and paracetamol (for prophylaxis), corticosteroids and epinephrine (for relief) allergic reactions. Women of childbearing age at the time of treatment must use reliable methods of contraception. Breastfeeding not earlier, than 6 months after the end of treatment.
