iodic skin examinations should be considered for all patients at increased risk for skin cancer.
Pediatric Patients
Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatmentwith TNF-blocking agents (initiation of therapy at ≤ 18 years of age), including etanercept products. Approximatelyhalf the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented avariety of different malignancies and included rare malignancies usually associated with immunosuppression andmalignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of30 months of therapy (range 1 to 84 months). Most of the patients were receiving concomitant immunosuppressants.
These cases were reported postmarketing and are derived from a variety of sources, including registries andspontaneous postmarketing reports.
In clinical trials of 1140 pediatric patients representing 1927.2 patient-years of therapy, no malignancies, includinglymphoma or NMSC, have been reported.
Postmarketing Use
In global postmarketing adult and pediatric use, lymphoma and other malignancies have been reported.
5.4 Patients With Heart Failure
Two clinical trials eva luating the use of etanercept in the treatment of heart failure were terminated early due to lackof efficacy. One of these studies suggested higher mortality in etanercept-treated patients compared to placebo [seeAdverse Reactions (6.2)]. There have been postmarketing reports of worsening of congestive heart failure (CHF), withand without identifiable precipitating factors, in patients taking etanercept products. There have also been rare(< 0.1%) reports of new onset CHF, including CHF in patients without known preexisting cardiovascular disease.
Some of these patients have been under 50 years of age. Physicians should exercise caution when using Eticovo inpatients who also have heart failure, and monitor patients carefully.
5.5 Hematologic Reactions
Rare (< 0.1%) reports of pancytopenia, including very rare (< 0.01%) reports of aplastic anemia, some with a fataloutcome, have been reported in patients treated with etanercept. The causal relationship to the therapy with etanerceptproducts remains unclear. Although no high-risk group has been identified, caution should be exercised in patientsbeing treated with Eticovo who have a previous history of significant hematologic abnormalities. All patients shouldbe advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias orinfection (eg, persistent fever, bruising, bleeding, pallor) while on Eticovo. Discontinuation of Eticovo therapy shouldbe considered in patients with confirmed significant hematologic abnormalities.
Two percent of patients treated concurrently with etanercept and anakinra developed neutropenia (ANC < 1 x 109/L).
While neutropenic, one patient developed cellulitis that resolved with antibiotic therapy.
5.6 Hepatitis B Reactivation
Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and hadreceived concomitant TNF-blocking agents, including very rare cases (< 0.01%) with etanercept, has been reported. Insome instances, hepatitis B reactivation occurring in conjunction with TNF blocker therapy has been fatal. Themajority of t |
