emicade must not be continued in patients who develop new or worsening symptoms of heart failure (see sections 4.3 and 4.8).
Haematologic reactions
There have been reports of pancytopenia, leucopenia, neutropenia, and thrombocytopenia in patients receiving TNF-blockers, including Remicade. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor). Discontinuation of Remicade therapy should be considered in patients with confirmed significant haematologic abnormalities.
Others
There is limited safety experience of Remicade treatment in patients who have undergone surgical procedures, including arthroplasty. The long half-life of infliximab should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on Remicade should be closely monitored for infections, and appropriate actions should be taken.
Failure to respond to treatment for Crohn's disease may indicate the presence of a fixed fibrotic stricture that may require surgical treatment. Available data suggest that infliximab does not worsen or cause strictures.
Special populations
Elderly patients ( 65 years)
The incidence of serious infections in Remicade-treated patients 65 years and older was greater than in those under 65 years of age. Some of those had a fatal outcome. Particular attention regarding the risk for infection should be paid when treating the elderly (see section 4.8).
Paediatric population
Infections
In clinical studies, infections have been reported in a higher proportion of padediatric patients compared to adult patients (see section 4.8).
Vaccinations
It is recommended that paediatric Crohn's disease patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Remicade therapy.
Malignancies and lymphoproliferative disorders
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy 18 years of age), including Remicade in the post-marketing setting. Approximately half the cases were lymphomas. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression. A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.
Rare post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with TNF-blocking agents including infliximab. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. All Remicade cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were reported in adolescent or young adult males. All of these patients had received treatment with AZA or 6-MP concomitantly with or immediately prior to Remicade. The potential risk with the combination of AZA or 6-MP and Remicade should be carefully considered. A risk for the development for hepatosplenic T-cell lymphoma in patients treated with Remicade cannot be excluded (see sections 4.2 and 4.8).
4.5 Interaction with other medicinal products and other forms of interaction
No interactions studies have been performed.
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