Live vaccines should not be given concurrently with Erelzi. No data are available on the secondary transmission of infection by live vaccines in patients receiving etanercept. In a double-blind, placebo-controlled, randomised clinical study in adult patients with psoriatic arthritis, 184 patients also received a multivalent pneumococcal polysaccharide vaccine at week 4. In this study, most psoriatic arthritis patients receiving etanercept were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower, and few patients had two-fold rises in titres compared to patients not receiving etanercept.
The clinical significance of this is unknown. Autoantibody formation Treatment with Erelzi may result in the formation of autoimmune antibodies (see section 4.8). Haematologic reactions Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with etanercept. Caution should be exercised in patients being treated with Erelzi who have a previous history of blood dyscrasias.
All patients and parents/caregivers should be advised that if the patient develops signs and symptoms suggestive of blood dyscrasias or infections (e.g., persistent fever, sore throat, bruising, bleeding, paleness) whilst on Erelzi, they should seek immediate medical advice. Such patients should be investigated urgently, including full blood count; if blood dyscrasias are confirmed, Erelzi should be discontinued. Neurological disorders There have been rare reports of CNS demyelinating disorders in patients treated with etanercept (see section 4.8).
Additionally, there have been rare reports of peripheral demyelinating polyneuropathies (including Guillain-Barrй syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy). Although no clinical trials have been performed evaluating etanercept therapy in patients with multiple sclerosis, clinical trials of other TNF antagonists in patients with multiple sclerosis have shown increases in disease activity.
A careful risk/benefit evaluation, including a neurologic assessment, is recommended when prescribing Erelzi to patients with pre-existing or recent onset of demyelinating disease, or to those who are considered to have an increased risk of developing demyelinating disease. Combination therapy In a controlled clinical trial of two years duration in rheumatoid arthritis patients, the combination of etanercept and methotrexate did not result in unexpected safety findings, and the safety profile of etanercept when given in combination with methotrexate was similar to the profiles reported in studies of etanercept and methotrexate alone.
Long-term studies to assess the safety of the combination are ongoing. The long-term safety of etanercept in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established. The use of etanercept in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied. Renal and hepatic impairment Based on pharmacokinetic data (see section 5.2), no dose adjustment is needed in patients with renal or hepatic impairment; clinical experience in such patients is limited. Congestive heart failure (Cardiac failure congestive) Physicians should use caution when using Erelzi in patients who have congestive heart failure (CHF).
There have been post-marketing reports of worsening of CHF, with and without identifiable 8