nakinra or abatacept, with no added clinical benefit.
Because of the nature of the adverse reactions seen with these combinations with TNFblockertherapy, similar toxicities may also result from the combination of anakinra orabatacept with other TNFα-blocking agents. Therefore, the combination of RENFLEXIS andanakinra or abatacept is not recommended [see Warnings and Precautions (5.10 and 5.11)].
7.2 Use with Tocilizumab
The use of tocilizumab in combination with biological DMARDs such as TNF antagonists,including RENFLEXIS, should be avoided because of the possibility of increased
immunosuppression and increased risk of infection.
7.3 Use with Other Biological Therapeutics
The combination of RENFLEXIS with other biological therapeutics used to treat the sameconditions as RENFLEXIS is not recommended [see Warnings and Precautions (5.12)].
7.4 Methotrexate (MTX) and Other Concomitant Medications
Specific drug interaction studies, including interactions with MTX, have not been conducted.
The majority of patients in rheumatoid arthritis or Crohn’s disease clinical studies receivedone or more concomitant medications. In rheumatoid arthritis, concomitant medicationsbesides MTX were nonsteroidal anti-inflammatory agents (NSAIDs), folic acid,corticosteroids and/or narcotics. Concomitant Crohn’s disease medications were antibiotics,antivirals, corticosteroids, 6-MP/AZA and aminosalicylates.
In psoriatic arthritis clinical trials,concomitant medications included MTX in approximately half of the patients as well as NSAIDs, folic acid and corticosteroids. Concomitant MTX use may decrease the incidence ofanti-drug antibody production and increase infliximab product concentrations.
7.5 Immunosuppressants
Patients with Crohn’s disease who received immunosuppressants tended to experience fewerinfusion reactions compared to patients on no immunosuppressants [see Adverse Reactions(6.1)].
Serum infliximab concentrations appeared to be unaffected by baseline use ofmedications for the treatment of Crohn’s disease including corticosteroids, antibiotics
(metronidazole or ciprofloxacin) and aminosalicylates.
7.6 Cytochrome P450 Substrates
The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (e.g.,TNFα, IL-1, IL-6, IL-10, IFN) during chronic inflammation. Therefore, it is expected that fora molecule that antagonizes cytokine activity, such as infliximab products, the formation ofCYP450 enzymes could be normalized. Upon initiation or discontinuation of RENFLEXIS inpatients being treated with CYP450 substrates with a narrow therapeutic index, monitoring ofthe effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) isrecommended and the individual dose of the drug product may be adjusted as needed.
7.7 Live Vaccines/Therapeutic Infectious Agents
It is recommended that live vaccines not be given concurrently with RENFLEXIS. It is alsorecommended that live vaccines not be given to infants after in utero exposure to infliximabproducts for at least 6 months following birth [see Warnings and Precautions (5.15)].
It is recommended that therapeutic infectious agents not be given concurrently withRENFLEXIS [see Warnings and Precautions (5.15)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from published literature on the use of infliximab produc |
