An Overview of Infliximab


Posted December 14, 2020 by beauty33

For rheumatoid arthritis, this product is a disease control anti-rheumatic drug. For patients with moderate to severe active rheumatoid arthritis...
 
For rheumatoid arthritis, this product is a disease control anti-rheumatic drug. For patients with moderate to severe active rheumatoid arthritis, the combination of this product and methotrexate can be used to: reduce symptoms and signs; improve physical function and prevent patient disability.

Crohn's disease, for patients with moderate to severe active Crohn's disease who have received poor results from traditional treatments, this product can be used to: reduce symptoms and signs; achieve and maintain clinical efficacy; promote mucosal healing; improve quality of life; reduce patients Use corticosteroids or stop using corticosteroids. Fistula Crohn's Disease For patients with fistula Crohn's disease, this product can be used to: reduce the number of intestinal-cutaneous fistulas and rectal-vaginal fistulas promote and maintain fistula healing; reduce symptoms and signs; improve quality of life. Ankylosing Spondylitis for patients with active ankylosing spondylitis, this product can be used to: reduce symptoms and signs, including increasing the range of activity; improve physical function; improve the quality of life.

Psoriasis, for patients with psoriasis, this product can be used for: chronic severe plaque psoriasis that requires systemic treatment and is ineffective, contraindicated or tolerated by other systemic treatments such as cyclosporine, methotrexate or photochemotherapy Sick adult patients. This product is only used for patients who can be treated under the close supervision of a doctor and regularly followed up by a doctor.

Infliximab precautions:
Infection
Bacterial infections (including sepsis and pneumonia), mycobacterial infections [including tuberculosis (most clinically manifested as blood-borne tuberculosis or extrapulmonary tuberculosis)], invasive fungal infections have been observed in patients treated with this product , Viral infections and other opportunistic infections, some of which may cause death.

Before treatment with this product, the patient should be assessed whether there are risk factors for tuberculosis (including close contact with patients with active tuberculosis), and the patient should be checked for latent tuberculosis infection. The tuberculin test may give false negative results, especially in severely ill or immunocompromised patients.

Before using this product, patients with latent tuberculosis infection should be treated.

Before using this product for treatment, anti-tuberculosis treatment should be considered for patients who have a history of latent or active tuberculosis and cannot be sure that they have received a sufficient course of treatment.

Before using this product for treatment, anti-tuberculosis treatment should also be considered for patients who have negative latent tuberculosis test results but have multiple or high risk factors for tuberculosis infection.

Only after consulting a tuberculosis treatment specialist and fully considering the potential risk of tuberculosis infection and the risk of anti-tuberculosis treatment, the decision to start anti-tuberculosis treatment for the above-mentioned patients can be made.

During and after treatment with this product, patients (including patients with negative results of latent tuberculosis infection test) should be closely monitored for signs and symptoms of active tuberculosis.

This product should not be used in patients with severe infections during active periods. Patients with chronic infection or history of repeated infections should use this product with caution. Patients should be informed and as far as possible to avoid potential risk factors that may cause infection.

Congestive heart failure
For patients with moderate to severe heart failure (New York Heart Association Class III/IV), it has not been found that the administration of 5 mg/kg of this product will increase the hospitalization rate and mortality caused by aggravated heart failure. However, at a dose of 5 mg/kg or less or for patients with mild heart failure (New York Heart Association I/II), especially in long-term treatment, adverse reactions cannot be ruled out. Therefore, for patients with heart failure, other treatments should be considered before using this product with caution, and the dose should not exceed 5 mg/kg. If you decide to use this product for patients with heart failure, you should closely observe it during the treatment. Once the symptoms of heart failure get worse or new symptoms of heart failure appear, this product should be stopped.

Infusion reaction/allergic reaction
Allergic reactions to this product can occur at different times, most of which occur during the infusion or within 2 hours after the infusion. Symptoms include urticaria, dyspnea and/or bronchospasm (rare), laryngeal edema, pharyngeal edema and hypotension blood pressure. After using this product for 1-14 days, individual patients with Crohn's disease have serological symptoms, including fever, rash, headache, sore throat, muscle pain, polyarthralgia, edema of hands and face, and/or difficulty swallowing. If an allergic reaction occurs, treatment should be taken immediately. When severe reactions occur, stop using this product.

ATTRACT test data show that some preventive measures (using acetaminophen and/or antihistamine drugs) can reduce the occurrence of infusion reactions. In order to reduce the occurrence of infusion reactions, especially for patients who have experienced infusion reactions before, the infusion speed should be slowed down.

Self-immune
Using this product for treatment may promote the formation of autoantibodies. Lupus-like syndrome is rare. If the patient has signs of lupus-like syndrome while receiving this product, the drug should be stopped immediately.

Nervous system
Rare cases where this product and other TNFα inhibitors are related to demyelinating diseases of the central nervous system, including multiple sclerosis (new or worsening clinical symptoms and/or confirmed by radiological examination). The rare cases of optic neuritis and seizures may be related to the use of this product. For patients who have had or have recently suffered from central nervous system demyelinating diseases, the pros and cons should be weighed before administering this product.

Hepatobiliary system
Very rare cases of jaundice and non-infectious hepatitis (some of which have the characteristics of autoimmune hepatitis) have been observed in the experience of this product after the market, and there have also been individual cases of liver failure leading to liver transplantation or death. Patients with signs and symptoms of liver dysfunction should be evaluated for their liver damage. If the patient's jaundice index and/or alanine aminotransferase rise to more than 5 times the upper limit of the normal range, stop using this product and conduct a comprehensive examination for abnormal conditions. As observed with other immunosuppressive agents, chronic carriers of hepatitis B virus (that is, those who are surface antigen positive) using this product have reactivation of hepatitis B. Before starting to use this product and during treatment with this product, appropriate evaluation and observation should be made for chronic carriers of hepatitis B virus.

Malignant tumor
Lymphoma
In all clinical controlled trials of TNF inhibitors, the incidence of lymphoma in the TNF inhibitor group was higher than that in the control group. In clinical trials using this product in patients with rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis, the incidence of lymphoma in the treatment group of this product was higher than that of the general population Expected value, but lymphoma is rare. Patients with Crohn’s disease or rheumatoid arthritis, especially when the disease is highly active and/or under long-term immunosuppressive therapy, have a higher risk of developing lymphoma than normal people (up to Several times).

T cell lymphoma of the liver and spleen
In the experience after this product was launched, there are rare reports of hepatosplenic T cell lymphoma in adolescent patients with Crohn's disease. This rare T-cell lymphoma is very aggressive and usually leads to death. All the above-mentioned patients with hepatosplenic T-cell lymphoma were treated with azathioprine or 6-mercaptopurine, and Crohn’s disease patients who were not treated with this product and treated with 6-mercaptopurine also had hepatosplenic T-cell lymphoma. . The relationship between this product and the occurrence of T-cell lymphoma is not clear.

Non-lymphoma malignant tumor
In some clinical controlled trials of TNF inhibitors, it was observed that the cases of non-lymphoma malignant tumors in the TNF inhibitor group were higher than those in the control group. The incidence of non-lymphoma malignant tumors in this product group was similar to the expected value of the general population, while the incidence of the control group was lower than expected.

In an exploratory evaluation of the use of this product in patients with moderate to severe chronic obstructive pulmonary disease (COPD), the product group reported more cases of malignant tumors than the control group. The above patients have a history of severe smoking.

The potential effect of TNF inhibitors on the occurrence of malignant tumors is not yet known. This product should be used with caution when patients with a history of malignant tumors are receiving treatment or patients with malignant tumors continue to be treated.

TNFα inhibitor combined with Anakinra
In the clinical study of the combined use of anakinra and TNFα inhibitor etanercept, severe infections have been observed. Compared with etanercept alone, the efficacy has not been enhanced. Based on the nature of the adverse events found in the combination of anakinra and etanercept, it can be speculated that the combination of anakinra and other TNFα inhibitors may produce similar adverse reactions. Therefore, it is not recommended to use this product in combination with Anakinra.

Vaccination
There is no data to show that patients receiving TNF inhibitor treatment have vaccination reaction or infection after being vaccinated with live vaccine, but it is not recommended to use this product and live vaccine at the same time. In the ASPIRE study, the proportion of patients with a 2-fold increase in the drug concentration of the multivalent pneumococcal vaccine in each treatment group showed that this product does not interfere with the T cell-dependent humoral immune response.
http://www.creativebiolabs.net/Anti-Human-TNF-Therapeutic-Antibody-Remicade-13554.htm
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Issued By http://www.creativebiolabs.net
Country United States
Categories Biotech
Last Updated December 14, 2020