Remicade - pharmacological agents from the group of selective immunosuppressive drugs used to treat diseases such as rheumatoid arthritis, Crohn's disease.
Structure and Composition
According to the instructions Remicade is available as a lyophilisate for solution for parenteral administration. The active ingredient - infliximab. Also, the product contains auxiliary components - sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate.
Externally, the drug is a dense mass of white color, without foreign inclusions. Remicade is produced in glass bottles of 100 g
The pharmacological action of Remicade
According to the instructions Remicade has immunosuppressive effects. The drug is a derivative of a compound based on IgGl monoclonal antibodies. Remicade interacts with the tumor necrosis factor alpha, which plays a major role in the development of inflammatory and autoimmune diseases.
Remicade is recommended for the treatment of active forms of rheumatoid arthritis, ankylosing spondylitis and Crohn's disease. Also, this drug can be used for the treatment of ulcerative colitis (when the standard therapy is not effective) and psoriasis (severe forms that require systemic therapy, including psoriatic arthritis).
- hypersensitivity to the ingredients of the drug;
- severe heart failure;
- severe infectious diseases (tuberculosis, sepsis, abscess, abscess, secondary infection);
- Children under 6 years in the treatment of Crohn's disease;
- Children up to age 18 years in the treatment of other diseases;
- pregnancy and lactation.
Dosing and Administration
According to the instructions Remicade administered intravenously, infusion rate not exceeding 2 mL / min. The total duration of infusion should be at least 2 hours. Use special infusion systems with apyrogenic filter which has low belkovosvyazyvayuschey activity.
For the treatment of rheumatoid arthritis Remicade is used in combination with methotrexate. The initial dose of Remicade calculated as 3 mg / kg body weight. Reinfusion performed at 2 and 6 weeks after the first injection, and then repeated every 8 weeks. If after 12 weeks the effect of treatment is not necessary to consider the advisability of further therapy with this drug.
For treatment of severe Crohn's disease, the initial dose is calculated according to the formula 5 mg / kg body weight. After a single injection after 2 weeks must evaluate the effect in case of its absence subsequent application Remicade not advisable.
For patients who responded to infusion of Remicade, there are two options for continuing treatment:
- Remicade is introduced at 2 and 6 weeks after the first application, and then every 8 weeks;
- drug is introduced again only in recurrent disease, provided that, after the first infusion was not more than 16 weeks (because of the risk of allergic reactions of the delayed type).
When Crohn's disease fistulous single dose Remicade also calculated as 5 mg / kg of body weight, then the drug is administered repeatedly at 2 and 6 weeks. If after three infusions no effect, further Remicade treatment is not advisable. In case of a positive response to therapy is chosen from one treatment strategies for this:
- the drug is administered every 8 weeks;
- the drug is administered only at its recurrence, provided that it has been not more than 16 weeks from the first infusion Remicade (risk of delayed type allergic reactions).
In the treatment of psoriatic arthritis initial dose of 5 mg / kg body weight. Remicade is administered again at 2 and 6 weeks after the first infusion, then every 6-8 weeks. Treatment is useful to combine with methotrexate.
In the treatment of ankylosing spondylitis Remicade initial dose is determined by the formula 5 mg / kg body weight. The preparation was then re-introduced at 2 and 6 weeks after the first infusion. With a positive response to treatment Remicade drug should be administered every 6 - 8 weeks.
In the treatment of ulcerative colitis Remicade administered in a dose of 5 mg / kg of body weight, then the drug is administered at 2 and 6 weeks after the first infusion, and then every 8 weeks. For some patients the dose can be increased to 10 mg / kg. In the opinion of Remicade has a positive effect during the first 14 weeks of treatment.
The total duration of treatment Remicade is determined by the attending physician on an individual basis.
Remicade treatment is not recommended to be repeated after 16 weeks from the first administration. Repeated use of the drug in 2-4 years accompanied by the development of delayed-type allergic reactions in a significant proportion of patients. The risk of such reactions in the range of 16 weeks - 2 years has not been studied.
Side effects of Remicade
Ongoing clinical studies have shown that Remicade cause adverse reactions in approximately 60% of patients (compared to patients treated with placebo, the incidence of adverse reactions, 40%). In the opinion of Remicade frequently causes shortness of breath, headache, and urticaria, which occur during the infusion.
On the part of the cardiovascular system, reviews, Remicade can cause a decrease / increase in blood pressure, fainting, arrhythmia, bradycardia, palpitations, impaired peripheral circulation, vascular spasm.
From the hematopoietic system may develop thrombosis, bruising / ecchymosis, anemia, leukopenia, thrombocytopenia, lymphocytosis, lymphadenopathy.
From the nervous system and sensory organs may cause anxiety, depression, psychosis, somnolence, nervousness, dizziness, conjunctivitis, endophthalmitis.
The respiratory system Remicade, reviews, in rare cases, can cause the appearance of upper respiratory tract infections, pneumonia, sinusitis, bronchospasm, pleurisy, pulmonary edema.
From the digestive system may develop dyspepsia, nausea, diarrhea / constipation, cholecystitis, liver dysfunction.
With the genitourinary system during treatment with Remicade may have a urinary tract infection, vaginitis, cystitis.
Interaction with other drugs
During the intravenous infusion it is forbidden to mix a ready solution Remicade with other drugs.
Glucocorticoids have no significant effect on the pharmacokinetics of Remicade.
Use of the preparation together with methotrexate and other immunomodulators reduces the formation of antibodies to Remicade and increases its concentration in blood serum.
Specific guidance on the use of Remicade
The contents of each vial must first be dissolved in 10 ml of water for injection using a disposable syringe with a needle at least 0, 8 mm in diameter. The solution was then adjusted to a volume of 250 ml of isotonic sodium chloride solution.
Prior to Remicade treatment is necessary to prevent possible infection. If, during the use of the drug developed severe infections, it should be lifted immediately.
During treatment with Remicade to women of childbearing age should use reliable methods of contraception.