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Flixabi is a brand name for Infliximab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rheumatoid arthritis Flixabi, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.…
Verbatim from this product's EMA label. Tap a section to expand.
Flixabi treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis. Flixabi should be administered intravenously.
Flixabi infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues. Patients treated with Flixabi should be given the package leaflet and the patient reminder card. g. corticosteroids and immunosuppressants should be optimised.
Posology Adults (≥ 18 years) Rheumatoid arthritis 3 mg/kg given based on the body weight (bw) as an intravenous infusion followed by additional 3 mg/kg bw infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Flixabi must be given concomitantly with methotrexate. 4 Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. 5 mg/kg bw every 8 weeks. Alternatively, administration of 3 mg/kg bw as often as every 4 weeks may be considered.
If adequate response is achieved, patients should be continued on the selected dose or dose frequency. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment or after dose adjustment.
Moderately to severely active Crohn’s disease 5 mg/kg bw given as an intravenous infusion followed by an additional 5 mg/kg bw infusion 2 weeks after the first infusion. If a patient does not respond after 2 doses, no additional treatment with infliximab should be given.
Available data do not support further infliximab treatment, in patients not responding within 6 weeks of the initial infusion. 4). 1). Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment.
Fistulising, active Crohn’s disease 5 mg/kg bw given as an intravenous infusion followed by additional 5 mg/kg bw infusions at 2 and 6 weeks after the first infusion. If a patient does not respond after 3 doses, no additional treatment with infliximab should be given.
4). 1). Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment. In Crohn’s disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/risk of the alternative strategies for continued treatment are lacking.
5% of control patients. 4). Tabulated list of adverse reactions Table 1 lists ADRs based on experience from clinical studies as well as adverse reactions, some with fatal outcome, reported from post-marketing experience. Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. g. influenza, herpes virus infection). g. sepsis, cellulitis, abscess). g. candidiasis, onychomycosis).
Rare:
Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation.
Not known:
Vaccine breakthrough infection (after in utero exposure to infliximab)*.
Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare:
Lymphoma, non-Hodgkin’s lymphoma, Hodgkin’s disease, leukaemia, melanoma, cervical cancer.
Not known:
Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn’s disease or ulcerative colitis), Merkel cell carcinoma, Kaposi’s sarcoma.
Blood and lymphatic system disorders Common:
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). Acute infusion-related reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following infusion.
If acute infusion-related reactions occur, the infusion must be interrupted immediately. Emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway must be available. , an antihistamine, hydrocortisone and/or paracetamol to prevent mild and transient effects.
Antibodies to infliximab may develop and have been associated with an increased frequency of infusion- related reactions. A low proportion of the infusion-related reactions was serious allergic reactions. An association between development of antibodies to infliximab and reduced duration of response has also been observed.
Concomitant administration of immunomodulators has been associated with lower incidence of antibodies to infliximab and a reduction in the frequency of infusion-related reactions. The effect of concomitant immunomodulator therapy was more profound in episodically-treated patients than in patients given maintenance therapy.
Patients who discontinue immunosuppressants prior to or during infliximab treatment are at greater risk of developing these antibodies. Antibodies to infliximab cannot always be detected in serum samples. 8). In clinical studies, delayed hypersensitivity reactions have been reported.
Available data suggest an increased risk for delayed hypersensitivity with increasing infliximab-free interval. 8). If patients are re-treated after a prolonged period, they must be closely monitored for signs and symptoms of delayed hypersensitivity.
Infections Patients must be monitored closely for infections including tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections before, during and after treatment with infliximab. Because the elimination of infliximab may take up to six months, monitoring should be continued throughout this period.
1. 4). 8).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Infliximab in European Union.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Ulcerative colitis 5 mg/kg bw given as an intravenous infusion followed by additional 5 mg/kg bw infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. e. three doses. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.
Ankylosing spondylitis 5 mg/kg bw given as an intravenous infusion followed by additional 5 mg/kg bw infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. e. after 2 doses), no additional treatment with infliximab should be given.
5 Psoriatic arthritis 5 mg/kg bw given as an intravenous infusion followed by additional 5 mg/kg bw infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Psoriasis 5 mg/kg bw given as an intravenous infusion followed by additional 5 mg/kg bw infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
e. after 4 doses), no additional treatment with infliximab should be given. Re-administration for Crohn’s disease and rheumatoid arthritis If the signs and symptoms of disease recur, infliximab can be re-administered within 16 weeks following the last infusion.
8). The safety and efficacy of re- administration after an infliximab-free interval of more than 16 weeks has not been established. This applies to both Crohn’s disease patients and rheumatoid arthritis patients. 8). 8). Re-administration for […]
Neutropenia, leucopenia, anaemia, lymphadenopathy. 16 Uncommon: Thrombocytopenia, lymphopenia, lymphocytosis.
Rare:
Agranulocytosis (including infants exposed in utero to infliximab), thrombotic thrombocytopenic purpura, pancytopenia, haemolytic anaemia, idiopathic thrombocytopenic purpura.
Immune system disorders Common:
Allergic respiratory symptom.
Uncommon:
Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction.
Rare:
Anaphylactic shock, vasculitis, sarcoid-like reaction.
Metabolism and nutrition disorders Uncommon:
Dyslipidaemia.
Psychiatric disorders Common:
Depression, insomnia.
Uncommon:
Amnesia, agitation, confusion, somnolence, nervousness.
Rare:
Apathy.
Nervous system disorders Very common:
Headache.
Common:
Vertigo, dizziness, hypoaesthesia, paraesthesia.
Uncommon:
Seizure, neuropathy.
Rare:
Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy).
Not known:
Cerebrovascular accidents in close temporal association with infusion.
Eye disorders Common:
Conjunctivitis.
Uncommon:
Keratitis, periorbital oedema, hordeolum.
Rare:
Endophthalmitis.
Not known:
Transient visual loss occurring during or within 2 hours of infusion.
Cardiac disorders Common:
Tachycardia, palpitation.
Uncommon:
Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia.
Rare:
Cyanosis, pericardial effusion.
Not known:
Myocardial ischaemia/myocardial infarction.
Vascular disorders Common:
Hypotension, hypertension, ecchymosis, hot flush, flushing.
Uncommon:
Peripheral ischaemia, thrombophlebitis, haematoma.
Rare:
Circulatory failure, petechia, vasospasm.
Respiratory, thoracic and mediastinal disorders Very common:
Upper respiratory tract infection, sinusitis. g. bronchitis, pneumonia), dyspnoea, epistaxis.
Uncommon:
Pulmonary oedema, bronchospasm, pleurisy, pleural effusion.
Rare:
Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis).
Gastrointestinal disorders Very common:
Abdominal pain, nausea.
Common:
Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation. 17 Uncommon: Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis.
Hepatobiliary disorders Common:
Hepatic function abnormal, transaminases increased.
Uncommon:
Hepatitis, hepatocellular damage, cholecystitis.
Rare:
Autoimmune hepatitis, jaundice.
Not known:
Liver failure.
Skin and subcutaneous tissue disorders Common:
New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia.
Uncommon:
Bullous eruption, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation.
Rare:
Toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), acute generalised exanthematous pustulosis (AGEP), lichenoid reactions.
Not known:
Worsening of symptoms of dermatomyositis.
Musculoskeletal and connective tissue disorders Common:
Arthralgia, myalgia, back pain. Renal and urinary disorders […]
Further treatment with infliximab must not be given if a patient develops a serious infection or sepsis. 8 Caution should be exercised when considering the use of infliximab in patients with chronic infection or a history of recurrent infections, including concomitant immunosuppressive therapy.
Patients should be advised of and avoid exposure to potential risk factors for infection as appropriate. Tumour necrosis factor alpha (TNFα) mediates inflammation and modulates cellular immune responses. Experimental data show that TNFα is essential for the clearing of intracellular infections.
Clinical experience shows that host defence against infection is compromised in some patients treated with infliximab. It should be noted that suppression of TNFα may mask symptoms of infection such as fever. Early recognition of atypical clinical presentations of serious infections and of typical clinical presentation of rare and unusual infections is critical in order to minimise delays in diagnosis and treatment.
Patients taking TNF-blockers are more susceptible to serious infections. Tuberculosis, mycobacterial infection, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients treated with infliximab.
Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of > 5% include aspergillosis, candidiasis, listeriosis and pneumocystosis. Patients who develop a new infection while undergoing treatment with infliximab, should be monitored closely and undergo a complete diagnostic evaluation.
Administration of infliximab should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled. Tuberculosis There have been reports of active tuberculosis in patients receiving infliximab.
It should be noted that in the majority of these reports tuberculosis was extrapulmonary, presenting as either local or disseminated disease. Before starting treatment with infliximab, all patients must be evaluated for both active and inactive (‘latent’) tuberculosis.
This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy. g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay) should be performed in all patients (local recommendations may apply).
It is recommended that the conduct of these tests should be recorded in the patient’s reminder card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
3). If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted. In all situations described below, the benefit/risk balance of infliximab therapy should be very carefully considered.
If inactive (‘latent’) tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of infliximab, […]