Infliximab - Instructions For Use, Price, Reviews, Drug Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Infliximab

Infliximab: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Infliximab

ATX code: L04AB02

Active ingredient: infliximab (Infliximab)

Manufacturer: CJSC "Biocad" (Russia)

Description and photo update: 2019-10-07

Infliximab - an immunosuppressive drug, a tumor necrosis factor alpha (TNFα) inhibitor; has an anti-inflammatory effect.

Release form and composition

The drug is produced in the form of a lyophilisate for the preparation of a solution for infusion: a dense mass of white color, has no signs of melting and foreign inclusions (100 mg each in glass vials without color, in a cardboard box 1 bottle and instructions for the use of Infliximab).

1 bottle contains:

• active substance: infliximab - 100 mg;
• auxiliary components: sucrose, sodium hydrogen phosphate dihydrate, polysorbate-80, sodium dihydrogen phosphate dihydrate.

Pharmacological properties

Pharmacodynamics

Infliximab is an immunosuppressive drug that inhibits the functional activity of TNFα. Its active ingredient, infliximab, is a chimeric murine-human monoclonal antibody, which is characterized by high binding affinity for the transmembrane and soluble form of TNFα and lack of binding to lymphotoxin alpha (LTα).

In vitro in transgenic mice, infliximab prevents the development of polyarthritis caused by constitutional expression of human TNFα. Its introduction after the onset of the disease causes the healing of structural damage to the joints. In vivo, the drug promotes the rapid formation of stable complexes with human TNFα, accompanied by a decrease in the biological activity of TNFα.

In patients with rheumatoid arthritis in the joints, elevated concentrations of TNFα are determined, which correlate with the activity of the disease. Against the background of the use of infliximab, the infiltration of inflammatory cells into the inflamed areas of the joints and the expression of molecules that mediate cell adhesion, chemoattraction and tissue damage decrease. After therapy, there is a decrease in the concentration of interleukin-6 (IL-6) and C-reactive protein (CRP) in the serum, an increase in the level of hemoglobin compared to its concentration before treatment.

There was no clinically significant decrease in the number of lymphocytes in the peripheral blood; their proliferative response to mitogenic stimulation was comparable to that of cells in untreated patients.

In psoriasis, infliximab treatment helps to reduce inflammation in the epidermal layer, normalize the differentiation of keratinocytes in psoriatic plaques.

Short-term use of Infliximab for psoriatic arthritis reduces the number of T cells and blood vessels in the synovial membrane and affected skin areas.

The results of histological examination of samples of the affected colon tissues obtained by biopsy before infliximab administration and 4 weeks after it indicate a significant decrease in the concentration of TNFα. In addition, additional histological studies confirm its positive effect on the reduction of infiltration of inflammatory cells and the content of inflammation markers in the affected areas of the intestine. Endoscopic research methods confirm the healing of the intestinal mucosa.

In patients with Crohn's disease, infliximab therapy is accompanied by a significant decrease in the concentration of the nonspecific serum marker of inflammation, CRP. The total number of peripheral blood leukocytes changes to a minimum, however, there is a tendency to normalize their number for neutrophils, lymphocytes and monocytes.

Stimulation of peripheral blood mononuclear cells with infliximab does not cause a decrease in the proliferative response when compared with that in untreated patients. No significant changes in cytokine secretion by stimulated peripheral blood mononuclear cells were found after infliximab administration. When studying mononuclear cells from biopsies of the lamina propria of the intestinal mucosa, it was found that treatment with Infliximab causes a decrease in the number of cells that express TNFα and interferon-gamma.

Pharmacokinetics

After a single intravenous (iv) infusion of infliximab at a dose of 1, 3, 5, 10 or 20 mg per 1 kg of patient weight (mg / kg), its maximum concentration (C _max) in blood serum and AUC (area under the curve " concentration - time ") increase in proportion to the dose increase. The volume of distribution (V _d) in the equilibrium state (median 3–4.1 l) does not depend on the dose, which is evidence of the predominant circulation of infliximab in the vascular bed. There is no time dependence of pharmacokinetics.

The route of elimination of infliximab has not been established; it was not detected in urine.

The clearance and V _d in rheumatoid arthritis are independent of the age or body weight of the patients.

The pharmacokinetics of infliximab in patients with kidney and / or liver disease and in elderly patients has not been established.

With _max infliximab against the background of a single injection at a dose of 3 mg / kg is 0.077 mg / ml, 5 mg / kg - 0.118 mg / ml, 10 mg / kg - 0.277 mg / ml. The terminal half-life is 8-9.5 days. In blood serum, infliximab is determined within 56 days both after a single administration of Infliximab at a dose of 5 mg / kg in most patients with Crohn's disease, and during maintenance therapy of rheumatoid arthritis at a dose of 3 mg / kg with an interval of 56 days.

The introduction of the second dose is accompanied by a slight accumulation of infliximab in the blood serum; subsequent doses of the drug do not cause clinically significant accumulation.

In most cases, when treating the fistulous form of Crohn's disease in the blood serum, infliximab can be detected on average within 84 days after administration.

The impact of infliximab in patients aged 2 months to 17 years is non-linear with body weight.

Presumably, the steady state AUC (AUC _ss) after the use of infliximab at a dose of 5 mg / kg with an interval of 56 days in children aged 6 to 17 years was approximately 20%, and at the age of 2 to 6 years - by 40 % less than in adults.

Indications for use

Infliximab is indicated for the treatment of the following diseases:

• active form of rheumatoid arthritis - as part of combination therapy with methotrexate in order to reduce the symptoms of the disease, slow down the progression of joint damage and improve their functional state in patients in whom previous treatment with methotrexate or other basic anti-inflammatory drugs (DMARDs) was ineffective;
• Crohn's disease in active form (moderate or severe, including the formation of fistulas) in patients over the age of 18 years - in order to reduce symptoms of the disease, heal mucous membranes and close fistulas, achieve and maintain remission, lower the dose or withdrawal of glucocorticosteroids (GCS), improving the quality of life of patients in cases when the use of standard therapy with GCS and / or immunosuppressants is ineffective or there are contraindications to it;
• moderate or severe active Crohn's disease in children and adolescents aged 6 to 17 years - in order to reduce symptoms, achieve and maintain remission, reduce the dose or withdrawal of GCS and improve the quality of life of patients in case of ineffectiveness, intolerance or contraindications to the standard therapy;
• ulcerative colitis in adults - in order to reduce the symptoms of the disease, improve the quality of life of patients, heal the intestinal mucosa, reduce the dose or withdrawal of glucocorticosteroids, reduce the need for inpatient therapy, establish and maintain remission in cases where the use of traditional methods of treatment is not effective enough;
• ulcerative colitis of moderate or severe severity in children and adolescents aged 6 to 17 years - in cases where the use of standard therapy, including GCS, azathioprine or 6-mercaptopurine, does not give a sufficient response or is impossible due to the presence of contraindications or hypersensitivity to standard therapy;
• ankylosing spondylitis with laboratory signs of inflammatory activity and severe axial symptoms in patients who did not respond to standard therapy - to reduce symptoms and improve functional activity of the joints;
• active psoriatic arthritis with an inadequate response to DMARDs (including in combination with methotrexate) - in order to reduce the symptoms of arthritis, the degree of X-ray progression in peripheral psoriatic polyarthritis, and improve the functional activity of patients;
• moderate and severe psoriasis - in order to reduce inflammation in the skin, normalize the process of differentiation of keratinocytes in patients with insufficient response to standard systemic therapy, including methotrexate, cyclosporine or PUVA therapy (photochemotherapy), as well as in case of hypersensitivity and the presence of contraindications to standard therapy …

Contraindications

Absolute:

• chronic heart failure III – IV functional class according to NYHA classification (New York Heart Association);
• tuberculosis, sepsis, abscess, opportunistic infections and other severe forms of infectious processes;
• period of pregnancy;
• breast-feeding;
• age up to 18 years - for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis;
• age up to 6 years - for the treatment of Crohn's disease and ulcerative colitis;
• established hypersensitivity to other mouse proteins;
• individual intolerance to the components of the drug.

Infliximab should be prescribed with caution if there is a history of chronic or recurrent infections (including concomitant therapy with immunosuppressants), prolonged PUVA therapy, intensive immunosuppressive therapy and / or malignant tumors; with hepatitis B virus carriage, increased risk of malignant neoplasms in smokers, continued therapy in patients with advanced malignant neoplasms, chronic heart failure of I – II functional class according to NYHA classification, demyelinating diseases.

Infliximab, instructions for use: method and dosage

Infliximab can only be prescribed by doctors with experience in the diagnosis and treatment of rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease, psoriatic arthritis, or psoriasis.

The ready-made solution of the lyophilisate is injected intravenously by drip, the duration of the infusion should be at least 2 hours.

The procedure must be carried out under the supervision of a specialist who knows how to identify infusion reactions.

The infusion solution is prepared immediately before the procedure under aseptic conditions and with strict adherence to the following sequence of actions.

Based on the calculated dose, it is necessary to determine the required number of vials of the drug, given that the content of the active substance in one vial is 100 mg.

After removing the plastic cap from the bottle, the rubber stopper is treated with a 70% solution of ethyl alcohol. To dissolve the lyophilisate, use a syringe with a 0.8 mm needle (or less) and water for injection. Having made a sampling of 10 ml of water for injection into a syringe, the needle is inserted through the center of the stopper, and a stream of solvent is directed along the wall of the vial. Then, gently rotating the bottle, wait for the complete dissolution of the lyophilized powder. It is recommended to avoid prolonged mixing of the solution. Do not use vibrating movements or shake the bottle. If foam forms during dissolution, let the solution stand for 1/12 hour.

The solution in the vial must be opalescent, the presence of a small amount of translucent small particles, colorless or slightly yellow, is allowed. The solution should not be used if visual inspection reveals a color inconsistency, presence of foreign inclusions, or the particles present have an opaque structure.

The total volume of the infusion solution should be 250 ml. In this regard, from the vial or infusion bag of 0.9% sodium chloride solution containing 250 ml, it is necessary to remove the volume of the solution corresponding to the dissolved dose of infliximab in water for injection. Then, infliximab aqueous solution should be slowly added to this bottle (infusion bag) with 0.9% sodium chloride solution and gently mixed. After diluting the infusion solution, it is important to re-verify that the color is consistent and that there are no opaque particles or foreign particles. If present, the solution should be disposed of.

For intravenous administration, it is necessary to use only a separate infusion system equipped with a built-in sterile pyrogen-free filter with a pore size of no more than 1.2 μm, which has a low protein-binding activity.

After dilution, the solution remains stable for three hours.

Do not administer other drugs through the same infusion set!

The rest of the unused solution in the vial must be destroyed.

To prevent acute infusion reactions, patients should be closely monitored by a physician after the end of the infusion for one to two hours.

The procedure should be carried out in a medical facility equipped with a ventilator and equipped with emergency aid (including epinephrine, antihistamines, glucocorticosteroids).

To reduce the risk of infusion reactions, especially when they occur in patients with the previous administration of Infliximab, the rate of administration can be reduced. Preliminary administration of antihistamines, paracetamol and / or hydrocortisone is allowed.

The use of Infliximab is indicated against the background of optimization of concomitant therapy with glucocorticosteroids or immunosuppressants.

Recommended dosage regimen:

• rheumatoid arthritis (in combination with methotrexate): at the rate of 3 mg / kg of the patient's weight. The induction phase includes 3 infusions, which are given at intervals of 2 and 6 weeks after the first injection. Further, during the maintenance phase of treatment, procedures are carried out with an interval of 8 weeks. The clinical response is in most cases achieved within 12 weeks. If the response is insufficient or the effect of therapy is rapidly lost, the dose of Infliximab can be increased or the interval between infusions at a dose of 3 mg / kg reduced to 4 weeks. The infliximab dose should be increased in 1.5 mg / kg increments every 8 weeks until the 7.5 mg / kg dose is reached. After achieving the desired clinical effect, treatment is continued in the original dosage regimen. Patients who have not achieved the effect of treatment within the first 12 weeks,and for whom the measures taken to increase the dose or reduce the intervals between infusions did not bring the desired result, it is necessary to decide on the advisability of continuing treatment;
• active form of Crohn's disease in adults (moderate or severe): at a dose of 5 mg / kg of the patient's body weight, the second infusion should be carried out 2 weeks after the first. If there is no clinical response after two injections, it is impractical to continue using the drug. In patients who have achieved a response, treatment can be continued using one of the following options. The first option involves continuing the administration of Infliximab at a dose of 5 mg / kg 6 weeks after the first infusion, and then with an interval of 8 weeks. In some cases, in order to achieve a sufficient effect in the maintenance phase of treatment, it may be necessary to increase the dose to 10 mg / kg. When choosing the second option, repeated administration of the drug at a dose of 5 mg / kg is performed in case of relapse of the disease;
• active form of Crohn's disease, severe or moderate at the age of 6 to 17 years (in combination with immunomodulators: methotrexate, 6-mercaptopurine or azathioprine): the initial dose is 5 mg / kg of the child's body weight. After the first injection, the infusion in the same dose is repeated after 2 and 6 weeks, then - with an interval of 8 weeks. If there is no effect of therapy during the first 10 weeks, then it is not recommended to continue using infliximab. If it is necessary to reduce the interval between infusions in order to preserve the clinical effect, it should be borne in mind that this may increase the risk of developing adverse events;
• Crohn's disease with fistula formation in adults: 3 infusions at a dose of 5 mg / kg body weight of the patient with an interval of 2 and 6 weeks after the first injection. If there is no response to therapy, then it is impractical to continue treatment. In patients with a response to therapy, treatment can be continued at the previous dose with an injection interval every 8 weeks, including cases of increasing the dose to 10 mg / kg in order to achieve an effect. In addition, as an alternative, the issue of repeated use of Infliximab in the same dose, but only in case of relapse of the disease, can be considered;
• ulcerative colitis in adults and children aged 6–17 years: at a dose of 5 mg / kg body weight with an interval of 2 and 6 weeks after the first injection, then every 8 weeks. If necessary, in adult patients, it is allowed to increase the dose to 10 mg / kg to achieve the effect. If there is no effect of therapy in children within 8 weeks, and in adults - 14 weeks after the first infusion, it is necessary to consider discontinuing the drug;
• ankylosing spondylitis: at a dose of 5 mg / kg body weight, the induction phase - with an interval of 2 and 6 weeks after the first injection, maintenance therapy - every 6–8 weeks. Treatment is inappropriate to continue if there is no response after the first two doses (within the first 6 weeks);
• psoriatic arthritis and psoriasis: the initial dose is 5 mg / kg body weight. 2 and 6 weeks after the first injection, Infliximab is administered at the same dose, then every 8 weeks. If patients with psoriasis have no effect after four doses of the drug, infliximab treatment should be discontinued.

In patients with a response to therapy, the duration of the general course of treatment with Infliximab is determined individually by the attending physician.

In adult patients who are on maintenance therapy, the duration of the infusion can be reduced to 1 hour of administration if they tolerated the 2 hour administration of the first three infusions well. If an infusion reaction occurs against the background of accelerated administration of the drug, then you should return to the usual rate of administration.

Regardless of the indications, after a break in maintenance therapy, it is not recommended to resume treatment with repeated administration of Infliximab in the induction regimen.

In case of relapse in patients with rheumatoid arthritis or Crohn's disease, the drug can be re-prescribed within 16 weeks after the last dose of infliximab. The efficacy and safety of repeated administration at intervals exceeding 16 weeks has not been established. It should be borne in mind that the likelihood of developing hypersensitivity reactions in patients increases in cases where the interval before re-administration of Infliximab was less than 52 weeks.

Compared with the initial induction treatment regimen, re-prescribing the drug in exacerbation of psoriasis in the form of a single infusion after 20 weeks of interruption may not have a sufficient effect and be accompanied by a higher frequency of infusion reactions of mild to moderate severity. Re-use of infliximab in the induction mode in this case is also associated with an increased risk of infusion reactions (including severe).

The efficacy and safety of repeated use of infliximab in ulcerative colitis, ankylosing spondylitis, psoriatic arthritis according to a different treatment regimen has not been established.

When treating patients over the age of 65, dose adjustment is not required.

Side effects

The undesirable disorders described below are classified as follows: very common - ≥ 1/10; often - ≥ 1/100 and <1/10; infrequently - ≥ 1/1000 and <1/100; rarely - ≥ 1/10 000 and <1/1000; very rarely - <1/10 000; frequency not established - based on the available data, it is not possible to establish the frequency of occurrence of adverse reactions:

• benign, malignant and unspecified neoplasms (including polyps and cysts): rarely - leukemia, lymphoma, cervical cancer, melanoma, non-Hodgkin's lymphoma, Hodgkin's disease; frequency not established - Merkel carcinoma, hepatolienal T-cell lymphoma (with Crohn's disease and ulcerative colitis in adolescents and young adults);
• infections and parasitic diseases: very often - viral infections (including influenza, herpes); often - bacterial infections (including cellulitis, abscess, sepsis); infrequently - candidiasis and other fungal infections, tuberculosis; rarely - opportunistic infections [including cytomegalovirus infection, invasive fungal infections (histoplasmosis, aspergillosis, pneumocystosis, coccidioidomycosis, blastomycosis, cryptococcosis), bacterial infections (salmonellosis, listeriosis, atypical mycobacterial infection), hepatitis B infections, parasitic infections frequency not established - infection after vaccination (after intrauterine exposure to infliximab), including bovine tuberculosis caused by the tuberculosis vaccine;
• mental disorders: often - insomnia, depression; infrequently - drowsiness, nervousness, anxiety, confusion, amnesia; rarely, apathy;
• from the nervous system: very often - headache; often - dizziness, vertigo, hypesthesia, paresthesia; infrequently - neuropathy, epileptic seizure; rarely - acute disturbance of cerebral circulation (develops within 24 hours after the start of infusion), transverse myelitis, demyelinating disorders of the central nervous system (like optic neuritis, multiple sclerosis), demyelinating disorders of the peripheral nervous system (multifocal motor neuropathy, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy);
• from the lymphatic system and blood: often - anemia, neutropenia, lymphadenopathy, leukopenia; infrequently - lymphopenia, lymphocytosis, thrombocytopenia; rarely - agranulocytosis (including cases after intrauterine exposure to infliximab), pancytopenia, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, hemolytic anemia;
• from the immune system: often - respiratory allergic reactions; infrequently - lupus-like syndrome, anaphylactic reactions, serum sickness-type reactions, serum sickness; rarely - vasculitis, sarcoidosis-type reactions, anaphylactic shock;
• on the part of the organ of vision: often - conjunctivitis; infrequently - periorbital edema, keratitis, meibomitis; rarely - endophthalmitis; frequency not established - transient loss of vision (during infusion or within 2 hours after its end);
• from the heart: often - palpitations, tachycardia; infrequently - arrhythmia, fainting, development or worsening of heart failure, bradycardia; rarely - pericardial effusion, cyanosis; the frequency has not been established - myocardial ischemia, myocardial infarction (during IV administration or within 2 hours after infusion);
• on the part of the vessels: often - lowering blood pressure (BP), increased blood pressure, hot flashes, including strong ones, ecchymosis; infrequently - hematoma, thrombophlebitis, impaired peripheral circulation; rarely - vasospasm, petechiae, circulatory insufficiency;
• from the respiratory system, chest and mediastinal organs: very often - sinusitis, upper respiratory tract infections; often - shortness of breath, nosebleeds, lower respiratory tract infections (including bronchitis, pneumonia); infrequently - bronchospasm, pleural effusion, pleurisy, pulmonary edema; very rarely - interstitial lung disease (including pulmonary fibrosis, pneumonitis, rapid progression of the disease);
• from the hepatobiliary system: often - functional liver disorders, increased activity of hepatic transaminases; infrequently - cholecystitis, damage to hepatocytes, hepatitis; rarely - jaundice, autoimmune hepatitis; very rarely - liver failure;
• from the gastrointestinal tract: very often - nausea, abdominal pain; often - diarrhea, dyspepsia, constipation, gastrointestinal bleeding, gastroesophageal reflux; infrequently - intestinal stenosis, intestinal perforation, diverticulitis, cheilitis, pancreatitis;
• on the part of the skin and subcutaneous tissues: often - rash, itching, urticaria, dry skin, the appearance or exacerbation of psoriasis (mainly the palmar-plantar form), excessive sweating, alopecia, fungal dermatitis, eczema, pustular psoriasis; infrequently - seborrhea, furunculosis, bullous rash, onychomycosis, hyperkeratosis, rosacea, skin pigmentation disorders, skin papilloma; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme;
• from the musculoskeletal system and connective tissue: often - back pain, arthralgia, myalgia;
• from the breast and genitals: infrequently - vaginitis;
• from the urinary system: often - urinary tract infections; infrequently - pyelonephritis;
• general disorders and disorders at the injection site: very often - pain, infusion reactions; often - fatigue, chills, fever, chest pain, edema, reactions at the injection site; infrequently - slow wound healing; rarely - the formation of granulomatous foci;
• laboratory parameters: infrequently - the formation of autoantibodies; rarely - a violation of the production of complement factors.

Overdose

Symptoms of an Infliximab overdose have not been established. No toxic effects were found against the background of a single injection of infliximab at a dose of 20 mg / kg.

Treatment: in case of an overdose, the patient should be carefully monitored, if necessary, the appointment of symptomatic therapy is indicated.

special instructions

The use of Infliximab is associated with the development of acute infusion reactions that can occur within a few seconds during the infusion or within a few hours after its completion. If an acute reaction occurs during the period of intravenous administration of the drug, then the infusion should be stopped immediately and the appropriate therapy should be prescribed. In order to prevent minor and transient undesirable effects, the preliminary administration of hydrocortisone, paracetamol and / or antihistamines is allowed.

The increase in the frequency of infusion reactions can cause the formation of antibodies to infliximab, sometimes this leads to serious allergic reactions.

With the simultaneous use of immunomodulators, the number of cases of the formation of antibodies to infliximab and the frequency of infusion reactions decrease. The effectiveness of joint treatment with immunomodulators is more pronounced with episodic administration of the drug than with maintenance therapy.

The risk of antibody formation is increased in patients who have stopped using immunosuppressive drugs before starting infliximab treatment or during therapy.

It should be borne in mind that antibodies to infliximab cannot always be detected in serum samples.

In patients with a serious drug reaction, infusion should not be continued.

In the course of clinical studies, it was found that with an increase in the interval without taking Infliximab, the risk of developing delayed-type hypersensitivity reactions increases. Patients should be informed about the need for medical attention to relieve these conditions.

Treatment with TNF inhibitors is associated with an increased risk of serious infections, therefore exposure to potential risk factors for infections must be avoided. Due to the fact that the elimination of infliximab continues for 6 months after the last injection, careful monitoring of the patient is required for signs of infection, including tuberculosis, both during the treatment period and within 6 months after its cancellation. If signs of serious infection or sepsis appear, therapy should be discontinued.

Particular care should be taken when prescribing the drug to patients with a history of recurrent infection or chronic infections, including those on concomitant immunosuppressive therapy.

It must be borne in mind that the drug is capable of masking fever. This can negatively affect the timely recognition of both atypical clinical symptoms of serious infections and typical clinical manifestations of rare and atypical infections, the delay in diagnosis and treatment of which can have fatal consequences. The most dangerous and frequently occurring opportunistic infections include candidiasis, pneumocystosis, listeriosis, and aspergillosis.

If a serious infection or sepsis develops again, Infliximab is stopped and antibacterial or antifungal agents are prescribed.

In connection with the risk of developing active tuberculosis in the presence of infliximab, a thorough examination of the patient should be carried out before starting treatment to detect an active or latent tuberculosis process, including a chest X-ray and a tuberculin test. It is necessary to establish whether there was a disease of tuberculosis in the past, the presence of contacts with patients with tuberculosis, concomitant or preliminary therapy with immunosuppressants. With active tuberculosis, infliximab therapy should not be started. If latent tuberculosis is suspected, the risks and benefits of therapy with Infliximab should be carefully weighed.

The likelihood of developing invasive fungal infections (including aspergillosis, pneumocystosis, candidiasis, histoplasmosis, coccidioidomycosis, blastomycosis) increases when a patient develops a serious systemic disease.

Treatment of patients with Crohn's disease with acute purulent fistulas should be started only after other possible foci of infection, including abscess, have been identified and eliminated.

When diagnosing jaundice or an increase in alanine aminotransferase activity (5 times higher than the upper value of the norm), infliximab should be canceled and the violation should be carefully investigated.

After preliminary therapy with another biological agent, the use of Infliximab should be started with caution due to the increased risk of developing adverse events, including infections, against the background of cross-biological activity.

Symptoms of lupus-like syndrome and positive test results for antibodies to double-stranded DNA (deoxyribonucleic acid) may indicate the development of autoimmune processes in the patient. This is the basis for discontinuing drug therapy.

In case of development of demyelinating diseases of the central nervous system, the drug should be canceled.

With the simultaneous appointment of Infliximab with azathioprine or 6-mercapturine, the possible risk of developing hepatolienal T-cell lymphoma should be considered, especially in patients with Crohn's disease or ulcerative colitis.

All patients should undergo periodic skin examinations, especially patients with risk factors for the development of skin malignant neoplasms.

Patients should be informed that they should immediately inform the doctor about the occurrence of any unwanted effects after infusion.

It has been found that women with rheumatoid arthritis treated with infliximab have an increased risk of cervical cancer. Therefore, the use of the drug should be accompanied by periodic preventive examinations in women, including patients over the age of 60 years.

Patients with ulcerative colitis and an increased risk of developing colonic dysplasia or carcinoma should be regularly evaluated for dysplasia, including after stopping therapy.

When dysplasia is newly diagnosed in patients receiving infliximab therapy, the decision to continue or discontinue treatment should be made after careful assessment of the risks and benefits of therapy.

When planning surgery, the long half-life of infliximab should be taken into account. If it is necessary to carry out an operation in a patient receiving infliximab therapy, it is recommended to carefully monitor possible infections and their timely therapy if they occur.

The lack of clinical response in patients with Crohn's disease may indicate the presence of a fixed fibrotic stricture, which may require surgical treatment. It is assumed that infliximab does not contribute to the deterioration or formation of strictures.

Influence on the ability to drive vehicles and complex mechanisms

The use of Infliximab can cause dizziness and other undesirable actions that have a negative impact on concentration and the speed of psychomotor reactions, therefore, during the treatment period, it is recommended to be careful when working with complex mechanisms or driving vehicles.

Application during pregnancy and lactation

Women of childbearing age should be advised to use reliable contraception without fail, both during the entire treatment period and after the end of infliximab use for at least 6 months.

It is not recommended to use Infliximab during gestation and breastfeeding.

The use of the drug during pregnancy does not affect its successful outcome, but intrauterine exposure to infliximab can disrupt the normal immune response of the newborn and increase the risk of various infections in the child, including disseminated infection.

The effect of the drug on fertility and reproductive function has not been established.

Pediatric use

Age contraindications for the use of Infliximab:

• patients under the age of 18: treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis;
• children under 6 years of age: treatment for Crohn's disease and ulcerative colitis.

It should be borne in mind that infections in children with the use of infliximab occur more often than in adults. Before starting treatment, it is recommended to receive a complete preventive vaccination in accordance with the vaccination schedule.

With impaired renal function

The efficacy and safety of infliximab in patients with impaired renal function has not been established.

For violations of liver function

The efficacy and safety of infliximab in patients with impaired liver function have not been established.

Use in the elderly

When treating patients over the age of 65 years, general recommendations for the dosage regimen should be used.

Careful monitoring of infections is required when treating patients aged 65 and over.

Drug interactions

There are no results of special studies of the interaction of Infliximab with other drugs.

It is assumed that when the drug is combined with methotrexate or other immunomodulators, the formation of antibodies to infliximab decreases, and its concentration in plasma increases.

There is no clinically significant disruption of the pharmacokinetics of infliximab when combined with glucocorticosteroids.

Combined intake with other biological agents used for similar indications (including anakinra, abatacept), live vaccines is not recommended. The use of live vaccines increases the risk of clinical infection, including disseminated infection. In cases where the child has been exposed to infliximab in utero, live vaccines should not be given to the newborn for 6 months.

The simultaneous use of therapeutic agents containing infectious agents is contraindicated.

Analogs

Infliximab analogs are: Remicade, Flammegis, Humira, Simponi, Enbrel, Simzia.

Terms and conditions of storage

Keep out of the reach of children.

Store at 2–8 ° C in a dark place, do not freeze. Before dissolution, a one-time storage at a temperature of 25 ° C is allowed for no more than six months within the expiration date.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews of Infliximab

Reviews of Infliximab are positive. Patients indicate the high efficacy of the drug, report that, against the background of the use of the drug, efficiency and normal well-being return. Some patients, along with the clinical effect in relation to the underlying disease, describe the side effects that they had to face.

Infliximab price in pharmacies

The price of Infliximab for a package containing 1 bottle of lyophilisate can range from 23,235 rubles.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!