imab products, loss ofdetectable serum concentrations of infliximab products and possible loss of drug efficacy.
RENFLEXIS should be discontinued for severe hypersensitivity reactions. Medications forthe treatment of hypersensitivity reactions (e.g., acetaminophen, antihistamines,corticosteroids and/or epinephrine) should be available for immediate use in the event of areaction [see Adverse Reactions (6.1)].
In rheumatoid arthritis, Crohn’s disease and psoriasis clinical trials, re-administration ofinfliximab after a period of no treatment resulted in a higher incidence of infusion reactionsrelative to regular maintenance treatment [see Adverse Reactions (6.1)]. In general, thebenefit-risk of re-administration of RENFLEXIS after a period of no-treatment, especially asa re-induction regimen given at weeks 0, 2 and 6, should be carefully considered. In the case
where RENFLEXIS maintenance therapy for psoriasis is interrupted, RENFLEXIS should bereinitiated as a single dose followed by maintenance therapy.
5.8 Cardiovascular and Cerebrovascular Reactions During and After InfusionSerious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension,
hypertension, and arrhythmias have been reported during and within 24 hours of initiation ofinfliximab infusion. Cases of transient visual loss have been reported during or within 2 hoursof infusion of infliximab. Monitor patients during infusion and if serious reaction occurs,discontinue infusion. Further management of reactions should be dictated by signs andsymptoms [See Adverse Reactions (6)].
5.9 Neurologic Reactions
Agents that inhibit TNF have been associated with CNS manifestation of systemic vasculitis,seizure and new onset or exacerbation of clinical symptoms and/or radiographic evidence ofcentral nervous system demyelinating disorders, including multiple sclerosis and opticneuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome.
Prescribers should exercise caution in considering the use of RENFLEXIS in patients withthese neurologic disorders and should consider discontinuation of RENFLEXIS if thesedisorders develop.
5.10 Use with Anakinra
Serious infections and neutropenia were seen in clinical studies with concurrent use ofanakinra and another TNFα-blocking agent, etanercept, with no added clinical benefitcompared to etanercept alone. Because of the nature of the adverse reactions seen with thecombination of etanercept and anakinra therapy, similar toxicities may also result from thecombination of anakinra and other TNFα-blocking agents. Therefore, the combination ofRENFLEXIS and anakinra is not recommended.
5.11 Use with Abatacept
In clinical studies, concurrent administration of TNF-blocking agents and abatacept havebeen associated with an increased risk of infections including serious infections comparedwith TNF-blocking agents alone, without increased clinical benefit. Therefore, thecombination of RENFLEXIS and abatacept is not recommended [see Drug Interactions(7.1)].
5.12 Concurrent Administration with other Biological TherapeuticsThere is insufficient information regarding the concomitant use of infliximab products with
other biological therapeutics used to treat the same conditions as RENFLEXIS.
Theconcomitant use of RENFLEXIS with these biologics is not recommended because of thepossibility of an inc |
