ubtypes
including pustular and palmoplantar)
Opportunistic infections, including atypical mycobacterial infection, herpes zoster, aspergillosis andPneumocystis jiroveci pneumonia, and protozoal infections have also been reported in postmarketing use.
Rare (< 0.1%) cases of IBD have been reported in JIA patients receiving etanercept, which is not effective for thetreatment of IBD.
7 DRUG INTERACTIONS
Specific drug interaction studies have not been conducted with etanercept products.
7.1 Vaccines
Most PsA patients receiving etanercept were able to mount effective B-cell immune responses to pneumococcalpolysaccharide vaccine, but titers in aggregate were moderately lower and fewer patients had 2-fold rises in titerscompared to patients not receiving etanercept. The clinical significance of this is unknown. Patients receiving Eticovomay receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission ofinfection by live vaccines in patients receiving etanercept products.
Patients with a significant exposure to varicella virus should temporarily discontinue Eticovo therapy and beconsidered for prophylactic treatment with varicella zoster immune globulin [see Warnings and Precautions (5.8,5.10)].
7.2 Immune-Modulating Biologic Products
In a study in which patients with active RA were treated for up to 24 weeks with concurrent etanercept and anakinratherapy, a 7% rate of serious infections was observed, which was higher than that observed with etanercept alone(0%) [see Warnings and Precautions (5.12)] and did not result in higher ACR response rates compared to etanerceptalone. The most common infections consisted of bacterial pneumonia (4 cases) and cellulitis (4 cases). One patientwith pulmonary fibrosis and pneumonia died due to respiratory failure. Two percent of patients treated concurrentlywith etanercept and anakinra developed neutropenia (ANC < 1 x 109/L).
In clinical studies, concurrent administration of abatacept and etanercept resulted in increased incidences of seriousadverse events, including infections, and did not demonstrate increased clinical benefit [see Warnings andPrecautions (5.12)].
7.3 Cyclophosphamide
The use of Eticovo in patients receiving concurrent cyclophosphamide therapy is not recommended [see Warningsand Precautions (5.11)].
7.4 Sulfasalazine
Patients in a clinical study who were on established therapy with sulfasalazine, to which etanercept was added, werenoted to develop a mild decrease in mean neutrophil counts in comparison to groups treated with either etanercept orsulfasalazine alone. The clinical significance of this observation is unknown.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available studies with use of etanercept during pregnancy do not reliably support an association between etanerceptand major birth defects. Clinical data are available from the Organization of Teratology Information Specialists(OTIS) Pregnancy Registry in women with rheumatic diseases or psoriasis and a Scandinavian study in pregnant
women with chronic inflammatory disease. Both the OTIS Registry and the Scandinavian study showed theproportion of liveborn infants with major birth defects was higher for women exposed to etanercept compared todiseased etanercept unexposed women. However, the lack of pattern of major birth defects is reassuring and differences betwee |
