For Inflectra® (infliximab) Prescribing Information for Great Britain click here.
Adverse event reporting information can be found at the bottom of the page.
Safety profile and efficacy
Contraindications
Ulcerative Colitis Selected Important Safety Information
The Inflectra Summary of Product Characteristics (SmPC) should be read and understood in full before prescribing this medicine.1
Inflectra MUST NOT be given in:
- Cases of tuberculosis, or other severe infections such as sepsis, abscesses and opportunistic infections
- Patients with a history of hypersensitivity to infliximab (or any of its excipients) or other murine proteins
- Patients with moderate or severe heart failure (NYHA class III/IV)
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)
Vaccinate
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).
Monitor
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
- Heart problems
- Lymphoma or other cancer
- Lung disease or heavy smoking
- Conditions that affect the nervous system, such as multiple sclerosis, Guillain-Barre syndrome, and optic neuritis
- Abnormal skin openings
- Imminent operations
- Dental issues, including planned operations or procedures
- Symptoms and signs of liver dysfunction
Haematologic abnormalities (e.g. persistent fever, bruising, etc)
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
The administration of live vaccines to a breastfed infant when the mother is receiving infliximab is not recommended unless infant infliximab serum levels are undetectable.
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.
Description of selected adverse drug reactions
Infusion-related reactions
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.
Immunogenicity
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.
Infections
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).
Paediatric ulcerative colitis patients
Overall, the adverse reactions reported in the paediatric ulcerative colitis trial (C0168T72) and adult ulcerative colitis (ACT 1 and ACT 2) studies were generally consistent. In C0168T72, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever, and headache. The most common adverse event was worsening of ulcerative colitis, the incidence of which was higher in patients on the q12 week vs. the q8 week dosing regimen
Infusion-related reactions
Overall, 8 (13.3%) of 60 treated patients experienced one or more infusion reactions, with 4 of 22 (18.2%) in the q8 week and 3 of 23 (13.0%) in the q12 week treatment maintenance group. No serious infusion reactions were reported. All infusion reactions were mild or moderate in intensity.
Immunogenicity
Antibodies to infliximab were detected in 4 (7.7%) patients through week 54.
Infections
Infections were reported in 31 (51.7%) of 60 treated patients in C0168T72 and 22 (36.7%) required oral or parenteral antimicrobial treatment. The proportion of patients with infections in C0168T72 was similar to that in the paediatric Crohn's disease study (REACH) but higher than the proportion in the adults ulcerative colitis studies (ACT 1 and ACT 2). The overall incidence of infections in C0168T72 was 13/22 (59%) in the every 8 week maintenance treatment group and 14/23 (60.9%) in the every 12 week maintenance treatment group. Upper respiratory tract infection (7/60 [12%]) and pharyngitis (5/60 [8%]) were the most frequently reported respiratory system infections. Serious infections were reported in 12% (7/60) of all treated patients.
In this study, there were more patients in the 12 to 17 year age group than in the 6 to 11 year age group (45/60 [75.0%]) vs.15/60 [25.0%]). While the numbers of patients in each subgroup are too small to make any definitive conclusions about the effect of age on safety events, there were higher proportions of patients with serious adverse events and discontinuation due to adverse events in the younger age group than in the older age group. While the proportion of patients with infections was also higher in the younger age group, for serious infections, the proportions were similar in the two age groups. Overall proportions of adverse events and infusion reactions were similar between the 6 to 11 and 12 to 17 year age groups.
Post-marketing experience
Post-marketing spontaneous serious adverse reactions with infliximab in the paediatric population have included malignancies including hepatosplenic T-cell lymphomas, transient hepatic enzyme abnormalities, lupus-like syndromes, and positive auto-antibodies (see sections 4.4 and 4.8 of the SmPC).
Explore more
Evidence – inflammatory bowel disease
Learn about the clinical evidence supporting the use of Inflectra inpatients with ulcerative colitis and crohn’s disease
Ulcerative colitis dosing
Learn about the dosing and administration of Inflectra in patients with Ulcerative colitis
- Inflectra Summary of Product Characteristics.
Quick Links
Read about the safety profile and contraindications with Inflectra in patients with rheumatoid arthritis.
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