sorders
Arthralgia 7% 8%
Urinary system disorders
Urinary tract infection 6% 8%
Cardiovascular disorders, general
Hypertension 5% 7%
The most common serious adverse reactions observed in clinical trials of infliximab wereinfections [see Adverse Reactions (6.1)]. Other serious, medically relevant adverse reactions≥ 0.2% or clinically significant adverse reactions by body system were as follows:
Body as a whole: allergic reaction, edema Blood: pancytopenia
Cardiovascular: hypotension
Gastrointestinal: constipation, intestinal obstruction
Central and Peripheral Nervous: dizziness
Heart Rate and Rhythm: bradycardia
Liver and Biliary: hepatitis
Metabolic and Nutritional: dehydration
Platelet, Bleeding and Clotting: thrombocytopenia
Neoplasms: lymphoma
Red Blood Cell: anemia, hemolytic anemia
Resistance Mechanism: cellulitis, sepsis, serum sickness, sarcoidosis
Respiratory: lower respiratory tract infection (including pneumonia), pleurisy, pulmonary
edema
Skin and Appendages: increased sweating
Vascular (Extracardiac): thrombophlebitis
White Cell and Reticuloendothelial: leukopenia, lymphadenopathy
Adverse Reactions in Pediatric Patients
Pediatric Crohn’s Disease
There were some differences in the adverse reactions observed in the pediatric patientsreceiving infliximab compared to those observed in adults with Crohn’s disease. Thesedifferences are discussed in the following paragraphs.
The following adverse reactions were reported more commonly in 103 randomized pediatricCrohn’s disease patients administered 5 mg/kg infliximab through 54 weeks than in 385 adultCrohn’s disease patients receiving a similar treatment regimen: anemia (11%), leukopenia(9%), flushing (9%), viral infection (8%), neutropenia (7%), bone fracture (7%), bacterialinfection (6%), and respiratory tract allergic reaction (6%).
Infections were reported in 56% of randomized pediatric patients in Study Peds Crohn’s andin 50% of adult patients in Study Crohn’s I. In Study Peds Crohn’s, infections were reportedmore frequently for patients who received every 8-week as opposed to every 12-weekinfusions (74% and 38%, respectively), while serious infections were reported for 3 patientsin the every 8-week and 4 patients in the every 12-week maintenance treatment group. Themost commonly reported infections were upper respiratory tract infection and pharyngitis,and the most commonly reported serious infection was abscess. Pneumonia was reported for3 patients, (2 in the every 8week and 1 in the every 12-week maintenance treatment groups).
Herpes zoster was reported for 2 patients in the every 8-week maintenance treatment group.
In Study Peds Crohn’s, 18% of randomized patients experienced 1 or more infusion reactions,with no notable difference between treatment groups. Of the 112 patients in Study Peds Crohn’s, there were no serious infusion reactions, and 2 patients had non-seriousanaphylactoid reactions.
In Study Peds Crohn’s, in which all patients received stable doses of 6-MP, AZA, or MTX,excluding inconclusive samples, 3 of 24 patients had antibodies to infliximab. Although 105patients were tested for antibodies to infliximab, 81 patients were classified as inconclusivebecause they could not be ruled as negative due to assay interference by the presence ofinfliximab in the sample.
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