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RENFLEXIS(infliximab-abda)for injection, for intravenous use(二十一)
p to 3 times the upper limit of normal (ULN) were seen in 18% ofpediatric patients in Crohn’s disease clinical trials; 4% had ALT elevations ≥ 3 x ULN, and 1%had elevations ≥ 5 x ULN. (Median follow-up was 53 weeks.)
6.2 Post-marketing Experience
Adverse reactions have been identified during post approval use of infliximab products inadult and pediatric patients. Because these reactions are reported voluntarily from apopulation of uncertain size, it is not always possible to reliably estimate their frequency orestablish a causal relationship to drug exposure.
The following adverse reactions, some with fatal outcome, have been reported during postapprovaluse of infliximab products: neutropenia [see Warnings and Precautions (5.6)],
agranulocytosis (including infants exposed in utero to infliximab products), interstitial lungdisease (including pulmonary fibrosis/interstitial pneumonitis and rapidly progressivedisease), idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura,pericardial effusion, systemic and cutaneous vasculitis, erythema multiforme, StevensJohnsonSyndrome, toxic epidermal necrolysis, peripheral demyelinating disorders (such asGuillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, andmultifocal motor neuropathy), new onset and worsening psoriasis (all subtypes includingpustular, primarily palmoplantar), transverse myelitis, and neuropathies (additionalneurologic reactions have also been observed) [see Warnings and Precautions (5.9)], acuteliver failure, jaundice, hepatitis, and cholestasis [see Warnings and Precautions (5.4)],serious infections [see Warnings and Precautions (5.1)], malignancies, including leukemia,melanoma , Merkel cell carcinoma, and cervical cancer [see Warnings and Precautions (5.2)]and vaccine breakthrough infection including bovine tuberculosis (disseminated BCGinfection) following vaccination in an infant exposed in utero to infliximab [see Warningsand Precautions (5.15)].
Infusion-related Reactions
In post-marketing experience, cases of anaphylactic reactions, including anaphylactic shock,laryngeal/pharyngeal edema and severe bronchospasm, and seizure have been associated withadministration of infliximab products.
Cases of transient visual loss have been reported in association with infliximab productsduring or within 2 hours of infusion. Cerebrovascular accidents, myocardial
ischemia/infarction (some fatal), and arrhythmia occurring within 24 hours of initiation ofinfusion have also been reported [see Warnings and Precautions (5.8)].
Adverse Reactions in Pediatric Patients
The following serious adverse reactions have been reported in the post-marketing experiencein children: infections (some fatal) including opportunistic infections and tuberculosis,infusion reactions, and hypersensitivity reactions.
Serious adverse reactions in the post-marketing experience with infliximab products in thepediatric population have also included malignancies, including hepatosplenic T-celllymphomas [see Boxed Warnings and Warnings and Precautions (5.2)], transient hepaticenzyme abnormalities, lupus-like syndromes, and the development of autoantibodies.
7 DRUG INTERACTIONS
7.1 Use with Anakinra or Abatacept
An increased risk of serious infections was seen in clinical studies of other TNFα-blockingagents used in combination with a |
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