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Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

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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


Crohn's Disease 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: 

  1. Cases of tuberculosis, or other severe infections such as sepsis, abscesses and opportunistic infections
  2. Patients with a history of hypersensitivity to infliximab (or any of its excipients) or other murine proteins 
  3. 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)


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.

Infliximab should not be initiated in patients with Crohn's and acute suppurative fistulas until the source of the infection is fully diagnosed.

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. 
In a clinical study of patients with Crohn's disease (SONIC), infusion-related reactions occurred in 16.6% (27/163) of patients receiving infliximab monotherapy, 5% (9/179) of patients receiving infliximab in combination with AZA, and 5.6% (9/161) of patients receiving AZA monotherapy. One serious infusion reaction (<1%) occurred in a patient on infliximab monotherapy.


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. In Crohn's Disease patients who received maintenance treatment antibodies to infliximab occurred overall in 3.3% of patients receiving immunosuppressants and 13.3% of patients not receiving immunosuppressants.


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 Crohn's disease patients

The following adverse reactions were reported more commonly in paediatric Crohn's disease patients in the REACH study (see section 5.1 of the SmPC) than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leucopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%). In addition, bone fracture (6.8%) was reported, however, a causal association has not been established. Other special considerations are discussed below.

Infusion-related reactions

In REACH, 17.5% of randomised patients experienced 1 or more infusion reactions. There were no serious infusion reactions, and 2 subjects in REACH had non-serious anaphylactic reactions.


Antibodies to infliximab were detected in 3 (2.9%) paediatric patients.


In the REACH study, infections were reported in 56.3% of randomised subjects treated with infliximab. Infections were reported more frequently for subjects who received q8 week as opposed to q12 week infusions (73.6% and 38.0%, respectively), while serious infections were reported for 3 subjects in the q8 week and 4 subjects in the q12 week maintenance treatment group. The most commonly reported infections were upper respiratory tract infection and pharyngitis, and the most commonly reported serious infection was abscess. Three cases of pneumonia (1 serious) and 2 cases of herpes zoster (both non-serious) were reported.

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Evidence – Crohn’s disease

Learn about the clinical evidence supporting the use of Inflectra in patients with Crohn’s disease

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Crohn’s disease dosing

Learn about the dosing and administration of Inflectra in patients with Crohn’s disease

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  1. Inflectra Summary of Product Characteristics.
PP-IFA-GBR-0542. November 2021

Quick Links

Read about the safety profile and contraindications with Inflectra in patients with ulcerative colitis.

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For UK Healthcare Professionals*

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*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-PFE-GBR-3863. November 2021



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