Inflectra MUST NOT be given in:
Also consider the safety and screening recommendations below for any patient diagnosed with Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and severe plaque psoriasis for whom you are considering initiating Inflectra:1
Actively screen and monitor patients for infections
Screenings for latent/active tuberculosis and hepatitis B (before, during and for six month after completion of treatment)
If possible, it is recommended that patients be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Inflectra therapy. Patients on infliximab may receive concurrent vaccinations, except for live vaccines (see sections 4.5 and 4.6 of the SmpC).
The general condition of patients (particularly symptoms of bacterial, invasive viral infections, fever, ulcers, or purulent discharge from fistulas). Infliximab should not be initiated in patients with Crohn's and acute suppurative fistulas until the source of the infection is fully diagnosed.
Be aware that TNF alpha suppression may mask symptoms of infection such as fever.
Discontinue infliximab if patient develops a new serious infection or sepsis.
Discuss with patients and follow up on these potential health issues
Consider the long half-life of infliximab when planning certain vaccinations or surgical procedures
Closely monitor patients who require surgery for infections
Avoid concurrent administration of Inflectra with live vaccines or therapeutic infectious agents such as live attenuated bacteria
Also avoid administration of live vaccines in infants ‚≤6 months of age who have been exposed to infliximab in utero
Summary of the safety profile
Upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in clinical trials, occurring in 25.3% of infliximab-treated patients compared with 16.5% of control patients. The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4 in SmPC). Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last dose of treatment.
An infusion-related reaction was defined in clinical studies as any adverse event occurring during an infusion or within 1 hour after an infusion. In Phase III clinical studies, 18% of infliximab-treated patients compared with 5% of placebo-treated patients experienced an infusion-related reaction. Overall, a higher proportion of patients receiving infliximab monotherapy experienced an infusion-related reaction compared to patients receiving infliximab with concomitant immunomodulators.
Patients who developed antibodies to infliximab were more likely (approximately 2-3 fold) to develop infusion-related reactions. Use of concomitant immunosuppressant agents appeared to reduce the frequency of infusion-related reactions.
Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving infliximab. Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of >5% include pneumocystosis, candidiasis, listeriosis and aspergillosis (see section 4.4 of the SmPC).
Infliximab was studied in a clinical study in 120 patients (age range: 4-17 years old) with active juvenile rheumatoid arthritis despite methotrexate. Patients received 3 or 6 mg/kg infliximab as a 3-dose induction regimen (weeks 0, 2, 6 or weeks 14, 16, 20, respectively) followed by maintenance therapy every 8 weeks, in combination with methotrexate.
Infusion reactions occurred in 35% of patients with juvenile rheumatoid arthritis receiving 3 mg/kg compared with 17.5% of patients receiving 6 mg/kg. In the 3 mg/kg infliximab group, 4 out of 60 patients had a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 of which were among the serious infusion reactions). In the 6 mg/kg group, 2 out of 57 patients had a serious infusion reaction, one of whom had a possible anaphylactic reaction (see section 4.4 of the SmPC).
Antibodies to infliximab developed in 38% of patients receiving 3 mg/kg compared with 12% of patients receiving 6 mg/kg. The antibody titres were notably higher for the 3 mg/kg compared to the 6 mg/kg group.
Infections occurred in 68% (41/60) of children receiving 3 mg/kg over 52 weeks, 65% (37/57) of children receiving infliximab 6 mg/kg over 38 weeks and 47% (28/60) of children receiving placebo over 14 weeks (see section 4.4 of the SmPC).
Learn about the clinical evidence supporting the use of Inflectra in patients with rheumatoid arthritis
Learn about the dosing and administration of Inflectra in patients with rheumatoid arthritis
Find out more
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PP-PFE-GBR-2688. December 2020